IMA IN THE PHARMACEUTICAL
Transcription
IMA IN THE PHARMACEUTICAL
IMA IN THE PHARMACEUTICAL AND COSMETIC INDUSTRIES IMA IN THE PHARMACEUTICAL AND COSMETIC INDUSTRIES www.ima.it IMA AT YOUR SIDE SUPPORTING YOU WITH INNOVATION Innovation is ensured through across the board levels of excellence. Such innovation for designers and manufacturers of automatic processing and packaging machinery starts with a long process involving the most thorough research. The chances of success are good when such a process actively involves the final user. This is why the best approach to innovation is to start with a constructive spirit of collaboration between the supplier and the customer. Founded in 1961, IMA is the world leader in the manufacture of automatic machines for the processing and packaging of pharmaceutical products and of tea in filter bags. IMA IS YOUR KEY TO ENSURING CONTINUING EFFICIENCY AND COMPETITIVENESS IN THE GLOBAL MARKET: ALWAYS AT YOUR SIDE IMA is present in over 70 countries, supported by a sales network made up of nine branches which provide sales and service in Spain, Portugal, France, the UK, Germany, Austria, the US, Thailand and China, representative offices in central-eastern Europe and over 50 agencies. The Group has seven production plants in Italy, one in Germany, one in the UK, one in the Netherlands, two in the USA, two in India and three in China. IMA’ s strategic objective is the reinforcement of the position of leadership at world level, in the role of “general Contractor” for entire production lines. IMA produces the world’s widest range of automatic process and packaging equipment for the primary and secondary pharmaceutical manufacturing processes. With the total acquisition of the freeze drying machinery business of the BOC Edwards Pharmaceutical Systems Group, undisputed leader in this sector, the IMA Group has consolidated its strategy of presenting itself to customers as a sole provider of complete solutions. IMA Edwards, with its wide product offering including state of the art loading & unloading systems, operates through production facilities based in the USA, the Netherlands and China. Getting innovation to circulate on a world scale is equally essential if a firm is to come out on top of an ever changing market scenario with constantly new demands and requirements. But IMA is not only “machines”. We invest nearly 7% of the turnover in R&D to develop new technologies related to the machines, working groups, material handling, etc. THE CAPACITY FOR INNOVATION IS AN ABSOLUTE PRIORITY IF A COMPANY WANTS TO GROW AND RETAIN THE COMPETITIVE EDGE Getting innovation to circulate on a world scale is equally essential if a firm is to come out on top of an ever changing market scenario with constantly new demands and requirements. 2 IMA AT YOUR SIDE SUPPORTING YOU WITH INNOVATION Granulation equipment Intermittent and continuous capsule filling machines Check weighing machines for capsules and tablets Centrifugal die filling tablet presses Force feed tablet press machines Peripheral equipment Automatic equipment for coating process Powder handling and washing systems High, medium and low speed blister packaging machines Bottle Unscramblers Vision System Counters Electronic Counters Slat Counters Desiccant Inserters Cottoners Cap and Container Elevators Tablet Elevators Rotary Tables Integrated aseptic systems Bottle Blowing machines Rotary washing machines Linear washing machines External rotary washing machines De-pyrogenating tunnels Aseptic liquid filling & closing machines Aseptic powder filling & closing machines Macrodosing powder filling machines Multifunction liquid filling & closing machines Liquid filling & closing machines for cosmetics Industrial freeze dryers Pilot freeze dryers Loading systems Labelling & ancillary equipment Depacking machines Tray loaders Horizontal cartoning machines Vertical cartoning machines V Overwrapping machines Stretch /shrinkwrapping machines Case packing machines Traypacking machines Palletizing machines Tray forming machines Complete processing and packaging lines Granulation equipment Intermittent and continuous capsule filling 3 SALES AND SERVICE THROUGH THE WORLD A team of experts is available, to ensure that all requirements are carefully examined in close collaboration with the customer during the initial stages of project development in order to identify the optimum technical solution every time. IMA has the size, core skills, experience and expertise needed to deal with complex and customized projects. IMA can manage large-scale projects, design and manufacture solutions to meet special end-user requirements. Our After-Sales Service is staffed by skilled engineers and supervisors who take customer calls and provide prompt support with any type of electrical or mechanical query. After-sales service is also provided by skilled engineers working out of IMA branches and subsidiaries. On-site after-sales network in many countries, fully co-ordinated from IMA headquarters. These locally based engineers have been trained in Italy and Germany. IMA guarantees technical assistance at the customer’s site throughout the entire life-cycle of a machine. In order to ensure the highest levels of technical assistance, IMA employs trained, skilled technicians who are kept constantly up to date with the latest technical developments in their sector. Having a locally-based TA technician brings IMA closer to the customer ensuring that we have a fuller understanding of customers’ production needs and can thus ensure high levels of customer satisfaction. Ima’s Wide-ranging Sales Network Currently Comprises Ima Subsidiaries Offering Sales And After Sales Services In Italy, France, Spain, United Kingdom, Germany, Austria, United States, UNITED KINGDOM IMA UK LTD Central And South America, FRANCE IMA FRANCE E.U.R.L. China As Well As Representative GERMANY IMA GERMANY GMBH Offices In Central And Eastern CENTRAL AND EASTERN EUROPE I.M.A. EST European Countries, HIGH STANDARDS IN AFTERSALES TECHNICAL ASSISTANCE HAS ALWAYS BEEN CENTRAL TO IMA’S CUSTOMER ORIENTED POLICY South East Asia, SPAIN IMA IBERICA PROCESSING AND PACKAGING SL And Over Agents. U.S.A., CANADA AND PUERTO RICO IMA NORTH AMERICA, INC. Three Manufacturing And CENTRAL AND SOUTH AMERICA IMAUTOMATICHE LDA Madeira (Portugal) After-sales Joint-ventures In China. Dealers In Japan. A global approach to customer problems. Prompt and effective technical assistance throughout the entire life cycle of the machine. Global management of line problems for complete lines supplied by ima. Direct involvement of engineering departments as required. (Offices in Bucharest, Moscow, Prague and Warsaw) SOUTH EAST ASIA AND OCEANIA IMA PACIFIC CO. LTD. Bangkok (Thailand) CHINA IMA PACKAGING AND PROCESSING EQUIPMENT (BEIJING) CO. LTD. TIANJIN IMA MACHINERY CO. LTD. ZIBO IMA XINHUA PHARMATECH CO. LTD. IMA EDWARDS BEIJING PHARMACEUTICAL SYSTEMS IMA IS A GLOBAL SUPPLIER FOR THE PHARMACEUTICAL AND COSMETIC INDUSTRIES 4 5 ENGINEERING AND COMPLIANCE SERVICES P.A.T. P.A.T. system goals: (PROCESS ANALYTICAL TECHNOLOGY) < Improves process knowledge, allowing identification and management of variability (risk mitigation strategies); < Improves product quality, by developing processes that can consistently ensure quality (quality by design); < Increases automation to improve operator safety and reduce human errors, product wastes and reprocessing; < Can replace the QC lab’s historical role of raw materials testing, batch testing, and finished product testing; < Reduces inventory and production cycle times by using on-, in-, and/or atline measurements and controls and therefore reduces manufacturing costs (real time release, no quarantine, no inprocess inventory, less testing costs); < Facilitates products and process innovation and improvement. In September 2004 FDA published the guide “PAT – A Framework for Innovative Development, Manufacturing and Quality Assurance”, encouraging manufacturers to use the latest scientific advances in pharmaceutical manufacturing and technology within a Risk-Based Approach environment. P.A.T. is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. A in-depth knowledge of the products to be filled and of the packaging methods in general are the essential pre-requisites to design complete packaging and processing lines developed customizing the different production requirements and offering a “turn-key” solution which also includes backup and technical service. The services offered range from the technical commercial approach to the systems packet(designing and proposal of line configurations with a high number of variables) to the technical – functional aspect (capacity to prefigure, programme and organise the production and integrated commissioning of several machines from several production sources) to the efficient centralised advisory service that provides the pharmaceutical partners with a unique reference point. Thanks to its flexible product range and highly qualified engineering staff, IMA can rightly be considered as the company capable of offering global solutions to complex requirements. After several years of using the most advanced technology, and through the constant research and development of innovative engineering solutions IMA is able to satisfy a wide range of packaging requirements. We have kept pace with innovations in pharmaceutical technologies & processes thanks to teams of highly motivated personnel radically rethinking everything once considered being standard. This has put IMA years ahead of other automatic machinery manufacturers, achieving levels of quality and productivity unheard of in the past. IMA focus on developing and implementing P.A.T. systems and is therefore your perfect partner to evaluate customized solutions. OUR OBJECTIVE IS TO ESTABLISH A PARTNERSHIP WITH OUR CLIENTS, NOT ONLY SUPPLYING EQUIPMENT BUT ALSO PROVIDING SOLUTIONS FOR YOUR COMPLEX PROJECTS AND, WHERE APPROPRIATE, INCORPORATING THE SKILLS AND CAPABILITIES OF THE WHOLE IMA GROUP 6 7 IMA’S QUALITY SYSTEM IMA LEADER IN RESEARCH Upon concluding the development oriented around regulation DIN/ISO9001 and after rigourous auditing IMA was awarded the ISO9001 Certification in 1997. This means that all the stipulated criteria for quality, inspection and testing regulations have been fulfilled without reservation. Regular internal audits and six-month supervisory auditing conducted by SGS guarantee that internal quality procedures are continuously updated. Investment in research and development ensures that we canfulfil this commitment. Quality standards can be grouped in the following categories: - standards of processes, which include extensive documentation of the quality system, organisation and management principles, detailed operation structuring. - standards which pertain specifically to pharmaceutical safety. These essentially consist of the integration of GMP regulations into the quality regulations and result in safety precautions in the individual levels of management and production. IMA has obtained the gost r Certificate and the Hygienic Certificate to export to Russia thus getting customer free from this commitment. WE AIMS TO PRODUCE FLEXIBLE, TOP PERFORMANCE VALIDATED MACHINES AND LINES PRODUCING QUALITYCERTIFIED PRODUCTS IMA has always assisted the users of its machines in achieving effective production, guaranteeing, by means of constant research and development, the maximum efficiency, flexibility and versatility of the technology supplied as well as the certified quality of its organisation and quality of packaged products by means of expert support in the validation of machines and production lines. The main enterprises to work with IMA are those which like the Pharmaceutical Industry make particular high demands on the quality assurance systems. 8 In planning automatic machines that most effectively satisfy the primary, secondary and end-of-line packaging demands of the pharmaceutical and cosmetics industries. IMA made the strategic and operational decision to be at the forefront of Research and Development and by using all their expertise and technology in automatic processing and packaging equipment sector IMA has achieved both product and market leadership. IMA's engineering team comprises approximately 460 designers and engineers specialised in various disciplines (mechanics, electronics, software); it is a highly proficient and experienced team capable of interpreting the requests of the product marketing people into projects for machines and lines incorporating the most advanced technological solutions available. The IMA Group holds over 630 patents registered in various countries and the professional skills of its research staff are acknowledged throughout the world. PRODUCT INNOVATION IS DEVELOPED BY MEANS OF CONTINUOUS CONTACT WITH CUSTOMERS, LEADING TO AVANTGARDE SOLUTIONS WHICH RESPOND TO THE CUSTOMER’S REQUIREMENTS AS WELL TO MARKET DEMAND 9 L SO ID ES S DO O T LU I S N O IMA Active is the ideal partner for each solid dose processing phase: Granulation, Tableting, Capsule Filling, Coating, Handling and Washing. The IMA Active solutions are based on dedicated experience and technology, and take advantage of the know-how of experts specialised in individual product lines, but also capable of using this knowledge to work together with others as part of a team. This is why IMA Active is your partner for excellence, not just for integrated equipment but also for specific installations. 10 11 GRANULATION IMA HIGH SHEAR MIXER GRANULATORS, MILLS AND FLUID BED DRYERS CAN BE EASILY INTEGRATED FOR CLOSED GRANULATION LINES. IMA’s experience in granulation has grown with the acquisition of Zanchetta that had launched on the market the first High Shear Granulator Dryer with tilting bowl in 1984. Furthermore IMA’s experience in Fluid Bed Technology and a constant commitment to innovation assures a wide range of equipment and technical solution for wet granulation and drying. All IMA equipment are based on a modular design so to match any kind of requirements providing the highest manufacturing flexibility, safety and performance either in terms of process or cleaning. IMA granulation technology is available in laboratory and pilot scale too. 12 GHIBLI VORTEX ROTO CUBE Ghibli Fluid Bed Equipment can be configured according to a modular design to perform granulation, drying or coating process. Patented design of rotating filter chamber allows easy maintenance and replacement of filters made of different materials according to the purpose. For CIP arrangement and easy cleaning validation IMA patented stainless steel filters with dedicated CIP devices. Vortex High Shear Mixer Granulator has a basic simple design to facilitate process and cleaning operation. Vortex can be easily integrated with Mills and Fluid Bed Dryers for close granulation lines to minimize contamination during product transfer. Roto Cube High Shear Granulator Dryer allows to manufacture the entire granulation drying process in a single self contained bowl. Vacuum and tilting bowl features take the highest efficiency in drying. It is quite easy to equip Roto Cube for CIP or integrate it in a plant for totally contained process. The lifting bowl options facilitates product loading and unloading operations. 13 TABLETING WEIGHT CHECKING Precisa series of check weighers for capsules and tablets features a balcony structure, guaranteeing easy access to the work area. The continuous motion system used for placing the product on the weighing cells eliminates vibrations and ensures the maximum accuracy even at high speeds. IMA Active includes two tablet presses production sites, one in Italy and one in Germany, where Kilian force feed presses are manufactured. IMA’s presence in the tableting market is very recent, beginning in 1995, when the first of the revolutionary Comprima series of tableting machines was launched. The acquisition of Kilian, in January 2000, has brought on the tableting side, the long experience and the high differentiation of technical solutions IMA already had in the capsules sector. IMA Solid Dose is now the only manufacturer of tablet presses offering both centrifugal and force feed die feeding presses, both Cleaning In Place and Interchangeable turret. 14 A complete range of peripheral equipment is also available including Advantech Plus dedusting unit, metal detectors, systems for checking diameter, hardness and thickness of the tablets, quality sampling devices, etc. E150 PLUS AND S250 PLUS COMPRIMA SYNTHESIS PRESSIMA E150 Plus and S250 Plus Kilian force feed tablet presses are probably some of the most famous tablet presses in the world, well known for their proverbial reliability, low service costs and long life. They are easy to operate, with quick cleaning and machine conversion, manufactured to produce excellent quality tablets at high output and reasonable price. Comprima series of presses feature centrifugal die filling, guaranteeing yields up to 99,5% and improving powder feeding: maximum production speeds are possible even with shaped tablets or difficult to handle products. The long compression time improves tablet quality even at high speeds, while the complete separation between processing area and mechanical parts reduces size change time and makes it possible to fit the machine with a completely automatic Clean In Place. The Synthesis tablet press machines feature force feed die filling technology. The interchangeable die table and the complete separation of the production area from the mechanical parts allow fast cleaning operations, quick size changeover, less maintenance operations and no risk of cross contamination. The patented punch bellow arrangement guarantees 100% “black spot” free tablets. The machines are all equipped with a quality control system for automatic machine set-up and can be fitted with a Wash In Place System. The Pressima rotary tablet press is for galenic and research applications. It is the only press of its type equipped with an interchangeable die table. This very flexible machine is designed for compressing small batch production and the instrumented version allows complete control of all production parameters. Good accessibility facilitates cleaning and maintenance. 15 CAPSULE FILLING AND BANDING IMATIC and ZANASI capsule fillers can be configurated for contained production of high potent products IMA’s experience in capsule filling goes back to the first automatic machine for dosing pharmaceutical and non pharmaceutical products in Hard Gelatine Capsules, produced in the 50's by Zanasi, acquired by IMA in 1985. IMA is the only manufacturer of capsule fillers in the world in a position to offer a complete range of machines for the processing of hard gelatine capsules, including both continuous and intermittent motion machines, and a wide range of dosing systems and technological solutions, ensuring excellent results for all types of products. The latest innovation is the Hermetica capsule banding machine. 16 ZANASI IMPRESSA IMATIC HERMETICA The Zanasi and Zanasi Plus intermittent motion capsule fillers for low and medium production requirements represent probably one of the most successful products in the capsule filling field: they are easy to operate and maintain, with very low size changeover and cleaning times and high flexibility. The PLUS version features the same user friendly structure but with an increased number of dosing units and automatic adjustment of working parameters. The new Zanasi Lab models ensure maximum flexibility for R&D and clinical trials. The Impressa capsule fillers are intermittent motion machines covering medium and high speed requirements. The powder dosing unit with tamping pins and the volumetric pellet dosing unit working principles minimise product losses, avoid product contamination with metal particles and allow separate adjustment and control of weight and compression, ensuring at the same time flexibility and dosing precision. The machine can be also fitted with a volumetric liquid dosing group. The Imatic series of continuous motion capsule fillers covers medium and high speed requirements. The single turret operating system ensures maximum dosing precision and reliability even at very high speeds, and allows the machine to be fully automated. All size parts have been paired, reducing the number of parts to be changed in order to minimise non productive times, a completely automatic Clean In Place system can also be applied. Hermetica is a highly automated capsule banding machine: the banding is achieved through the application of a ring of liquid gelatine on the external surface of the capsule. The machine features easy operation and automatic handling of gelatine working parameters. A 100% checking system through camera can be additionally fitted, to control and select each individual banded capsule. 17 COATING In both solid wall and perforated pan, the well-designed spraying system ensures easy maintenance, simple inspection operations and quick changeover from one product to another. All cleaning operations are easy and fast thanks to the automatic clean-in-place system: the cleaning cycle can be adjusted according to each product requirements. The quality and the process technology offered by the IMA Coating Equipment are the result of the experience derived from over 800 successful installations all over the world. This experience, together with the continuous research, the strict collaboration with raw material producers and universities allow to develop high quality equipment for an optimal production process. ALL SIZES AND SHAPES OF PRODUCT CAN BE PROCESSED ON GS SOLID WALL PAN: SHAPE AND SURFACE SMOOTHNESS LEAD TO PERFECT CORES MIXING AND UNIFORM DISTRIBUTION OF COATING MATERIAL 18 SOLID WALL PANS PERFORATED PANS IMA GS coating equipment, with solid wall pan, can process all sizes and shapes of product without clogging: tablets, microgranules and pellet film and sugar coating can be performed on the same machine. The patented core drying system, consisting of two air blowing or exhausting paddles, immersed in the product bed, guarantees a uniform and constant drying effect. GS Evolution machines, made for highly automated installations, can be also configured for processing high potent products. The innovative IMA Perfima perforated pans maintain the same shape and mixing baffles positioning of the IMA GS pans: this shape has proven over the years to guarantee the best mixing results. The unidirectional air flo w guarantees a perfect drying of the cores avoiding turbulences inside the pan. IMA is the only manufacturer able to supply both solid wall and perforated pans ensuring a perfect mixing, a uniform coating and the highest flexibility, allowing a wide range of batches to be processed in the same drum 19 HANDLING AND WASHING Zanchetta powder handling and washing systems make it possible to link all IMA equipment on a complete installation for solid dose production IMA's experience in the handling and washing market began in 2003 and became stronger thanks to the acquisition of Zanchetta in 2007, a company with a long-standing knowhow on these equipment. Thanks to this acquisition IMA is able to offer complete installations for solid dose production, from raw material dispensing to processing and feeding of the final packaging lines, as well as a wide range of washing equipment: from the simplest washing group to completely automatic washing cabins and fastrooms. 20 PHBIN AND PHDRUM CYCLOPS AND CANGURO HERCULES The PH-Bin and PH-Drum are product containers designed for handling powders and granulates for the pharmaceutical, food and chemical industry. Both equipment are manufactured in Stainless Steel with Pharma finishing complying the most restrictive GMP rules. T-BINs are also available for tablets and capsules handling. The Cyclops series of Bin Tumblers, for blending and homogenising powders and granulates, feature the innovative TRIGON System, a universal Bin Blocking System with a unique Pharma GMP design, simplifying loading and unloading operations. The Canguro tumbler is available for standard bin blending. The possibility of “Through the Wall” installation minimizes the space in the production area, reducing cleaning times. Hercules Lifting Columns are designed to lift IBCs, drums, small containers or small machines as pneumatic conveyors or mills. These machines comply the most restrictive GMP rules and are safe thanks to the unique Self Brake System to hold up the load in case of emergency. Different Hercules models are available according to lifting capacity; the bigger versions can be additionally fitted with the MIX feature for Bin/Drum Blending. AIR CHAMBER AND TMAIL The Air Chamber and the T-Mail are product transfer systems suitable for powders, granules, tablets or capsules. These equipment avoid product de-mixing or damage and guarantee very low cleaning times thanks to the disposable polyethylene liner. TWINVALVE WASHING SYSTEMS The highly innovative TwinValve connection System is designed for maximum efficiency for both standard and high potent products. The possibility to use compressed air and/ or water cleaning on the same connection makes the installation suitable for working a wide range of active products. TwinValve can be easily retrofitted on existing installations. Different washing systems can be supplied with different levels of automation and functions. The HydroWash is a self-regulating modular C.I.P. group working in manual and semiautomatic washing configuration. Atlantis or Ocean bin washing cabins are available in different configurations and dimensions to wash bins, drums and pallets. Venus components washer is also available to wash small components such as hoppers, small containers and drums. 21 NG & SI S S CE ION O PR LUT C TI SO P E A S LIN G FIL IMA LIFE, in the aseptic processing field, offers the pharmaceutical industry a wide range of machines designed to meet the most stringent FDA and EMEA regulations, from advanced equipment through to traditional fillers for generics. Acting not only as a machine manufacturer but mostly as a solution provider, IMA LIFE satisfy the increasing requirements of the pharmaceutical industry with products based on consolidated technology as well as with new developments deriving from a continuous partnership with pharmaceutical multinationals worldwide. 22 23 BLOWING, WASHING AND STERILIZING IMA LIFE, is a world leader in the production of equipment for washing and sterilization of pharmaceutical ampoules, vials and bottles. All machines are intended for applications requiring equipment of high scientific and technological content, where the industry must comply with very strict standards. 24 High technology for the safety of sterilizing processes. Validatable sterilization & depyrogenation technology for the highest requirements of the pharmaceutical industry. Decontamination technologies. We manufacture our washers using strict decontamination methods, to supply downstream machines with containers which are absolutely clean and free from any kind of particles. BLOWING MACHINES MISTRAL SERIES ROTARY WASHING MACHINES VEGA SERIES Suitable for the dry-cleaning of bottles and containers in general, that do not need cleaning with water or detergents but rather the removal of solid granular or dusty solids by a sterile air jet. Blowing machines of the Mistral Series can be part of complete packaging lines or can serve as stand-alone machines. The Mistral Series of blowing tables include machines from medium to high-speed capacity, ranging from 120 to 400 vials/min. Cleaning systems for small vials and ampoules with a production speed from 200 to 400 vials/min and a production range from 2 to 100 ml vials. - 8 washing stations inside and outside by intensive rinsing and spraying - Mechanical function with gentle handling of containers - Pre-washing in an ultrasonic bath - Water recycling stations, siliconizing station - Quick change-over 25 BLOWING, WASHING AND STERILIZING TUNNEL WORKING CYCLE 26 EXTERNAL VIAL WASHERS HYDRA 300 LINEAR WASHING MACHINES HYDRA SERIES DEPYROGENATING TUNNELS BLUE GALAXY SERIES The importance of decontaminating filled and capped vials coming out from an aseptic processing line is satisfied by this series of very flexible external vial washers Washing machines for vials and bottles, available in 22 models, to handle containers from 2 to 500 ml, with a production speed from 175 to 600 vials/min. Designed according to cGMP recommendations, satisfying the highest quality standards required by pharmaceutical industries. - The standard versions are equipped with 8 washing stations, that can be increased up to 13 - Quick size change-over and simple use - Single or double recycle station - Automatic drainage - Steam in place (S.I.P.) with temperature recording BLUE GALAXY is a Series of de-pyrogenating tunnels designed to be inserted in production lines that require continuous depyrogenation by means of dry heat, that guarantee air quality as per US Federal Standards 209/e, the repeatability and the absolute control of the process for glass vials and ampoules. The wide range of tunnels manufactured enables us to satisfy any production requirement, in the same way as the high technology allows the use of our tunnels for any kind of application. Ima Life tunnels can be easily integrated into lines for processing products with high toxicity and/or be in line with isolators. In this case, the tunnel can be equipped with DRY HEAT STERILIZATION of the cooling zone or with an exclusive, Ima Life patented system FOR STERILIZING WITH VHP. 27 ASEPTIC LIQUID & POWDER PROCESSING Latest trend in aseptic manufacturing. MAC: Proven Aseptic Technology, automation and control of a Production Line combined with the Compact Area typical of R&D environments. Standard SVP vial processing as a batch or continuous process using premium technology. A COMPACT AND SINGLE UNIT THAT MEETS ALL STRINGENT FDA AND EMEA REGULATIONS, ELIMINATING RISKS AND ENSURING REPEATABILITY AND COST REDUCTION MAC is suitable for: - Laboratory Batches - Small Production Capacity - Clinical Trials Repeatable processes and reduction in risks associated with reduced customization and cost saving. FROM MACHINE MANUFACTURER TO SOLUTION PROVIDER MAC MODULAR ASEPTIC COMPACT SYSTEM MAC is a MODULAR ASEPTIC COMPACT SYSTEM designed according to a new working philosophy based on a consolidated filling technology for aseptic environments. MAC incorporates a washer, tunnel, filling, stoppering and capping operation in a single mono-block system for liquid, lyo or powder with RABS or Isolator. All control parts are integrated on the monoblock frame and include most of the utility generators necessary for correct functioning and operation. These features make the unit easy to transport on standard shipping systems. 28 29 ASEPTIC LIQUID & POWDER PROCESSING 30 ASEPTIC LIQUID FILLING IN VIALS STERIFILL SERIES ASEPTIC LIQUID FILLING IN PLASTIC UNIT DOSE IMA Life machines for aseptic liquid filling in vials are distinguished by their rigorous design detail, the result of careful research in fluid dynamics, to guarantee maximum product protection for all aseptic filling environments (such as traditional clean rooms or isolation technology). Compact and ergonomic design assure great flexibility in all types of lay-out. Statistical & 100% IPC control of filled weight, along with very advanced CIP/SIP units and with a positive transport system, allow the machines to reach a very high standard in product quality. The production ranges from medium to high speed sterile filling & stoppering machines, with or without R.A.B.S. or isolator, with a production speed from 100 to 600 vials/min. The use of unit dose containers to pack sterile pharmaceutical products is becoming increasingly popular due to the many advantages offered in terms of product safety, dose accuracy and ease of use. IMA Life has developed the SL series of machines dedicated to the dosing of liquid products into monodose containers that can satisfy all production requirements. With a high degree of flexibility, these machines can reach an output up to 375 unit doses/min and can be easily integrated in high-speed production lines. SL SERIES ASEPTIC POWDER FILLING IN VIALS MICRODOSING SERIES The machines of the Microdosing series are used by major international companies for the dosing of injectable powders in vials, establishing IMA Life as the world leader in the micro dosing machine market. The heritage of more than 40 years dedicated to all aspects of pharmaceutical powder filling, with hundreds of machines produced and working all over the world: all this allows the development of this very innovative filler which features 100% checkweighing system for all vials filled. Using the vacuum/pressure dosing system, the machines of this series can reach on output speed up to 400 vials/min and they are all pre-arranged for RABS or Isolator attachment. ASEPTIC CAPPING ALU SERIES The machines dedicated to the capping of vials for injectable products are an extremely important and critical path of the production process, since they guarantee the hermetic seal and therefore the integrity of the drug inside the container. IMA Life designed and built the ALU Series of capping machines with a new system to control the vertical load applied on each vial and a low particle generation capping system with vial rotation against an idle disc. The ALU Series is therefore particularly suitable for installation in clean-rooms or under isolators. Special aseptic applications have been developed to apply ADD Vantage and Bio-Set sterile caps. The machines of the ALU Series reach an output speed of 600 vials/min. 31 ASEPTIC LIQUID & POWDER PROCESSING INTEGRATED SOLUTIONS IMA Life provides fully integrated, allinclusive solutions tailored specifically to individual customer requirements. Our systems are implemented by a team assembled from highly experienced individuals who are specialised in addressing the special challenges associated with regulated pharmaceutical environments. Our resources are able to help you every step of the way; from equipment specification and selection through to process support and validation, helping to eliminate time and cost overruns which can occur at critical interfaces. Quality extends beyond our systems offerings and on into the broad range of services we can provide, so that with IMA Life you can be assured of continued productivity and reliability. OPTIMIZED PROCESS INCREASE PRODUCTION EFFICIENCY ISOLATION TECHNOLOGY Isolation technology is now used with Increasing frequency. Combined with automated filling systems for liquid or powders, isolation technology minimises the direct human intervention in the processing area and is now a technology that is being rapidly adopted by the pharmaceutical industry. The use of this technology on filling machines offers obvious 32 economic advantages as well as operating benefits while assuring greater product sterility. Although interest on the part of the pharmaceutical industry in the use of isolators is relatively recent, ima life has already acquired a solid experience, producing aseptic filling lines for dosing liquids and powders using Various types of isolators and creating highly flexible mechanical interfaces. 33 FILLING & CLOSING IN PHARMACEUTICAL AND COSMETICS Almost machines for more than different applications: this is the experience and background that IMA LIFE makes available to its pharmaceutical customers in the field of multipurpose liquid filling and closing machines. The machines of the Multifill Series, either intermittent or continuous motion, fill different types of product applying different types of closures (ophthalmics preparations, intranasal products, suspensions, oral drops, drinkables, sugary syrups, detergent/disinfectant solutions etc.). COUPLED WITH YEARS OF CONSOLIDATED EXPERIENCE THE IMA LIFE CONTINUOUS INNOVATIVE SPIRIT SETS A MILESTONE IN DRUGS PROCESSING ASSURING FLEXIBILITY AND RELIABILITY AT THE SAME TIME. 34 LIQUID FILLING & CLOSING MACHINES MULTIFILL SERIES INLINE LIQUID FILLERS FLEXIFILL SERIES POWDER FILLING & CLOSING MACHINES MACROMATICA Particularly versatile MULTIFILL F800 Series has been conceived to reach an output speed of up to 450 bpm with up to 24 filling heads and 10 closing heads. The dosing volume can be set up to 1000 ml. Thanks to its constructive modular design, the machine can handle all types of plastic and glass bottles, in any shape, and all the closures typical of the pharmaceutical industry. Ideal for big batches production, MULTIFILL F800 series of machines can be equipped with the latest generation of completely automatic CIP-SIP systems. Fast and simple change-over, together with low maintenance, guarantees user friendliness. Designed to satisfy the flexibility demand of the pharmaceutical industry this series of fillers consists of various kinds of machines that can be either electronically or mechanically driven, intermittent or continuous motion. Macromatica is suitable for filling powders into bottles for the preparation of syrups. It is designed and built on the basis of the experience gained in powder microdosing with the Microfill series of machines. Very compact and ergonomic, FLEXIFILL offers high flexibility in terms of liquid drugs as well as container shape and type; reliable and innovative, based on modular constructive design, this Series of machines has an output speed ranging from 120 to 250 bottles/min. Macromatica can also be fitted with two dosing discs and therefore maintain a high production speed and efficiency, even with large doses, or in case of dosing shared in two operations with poor flowing powders, to maintain a high production efficiency. 35 FREEZE DRYING SOLUTIONS IMA Edwards has been supplying pharmaceutical process equipment for more than 50 years, but our origins arise from when the Edwards Vacuum company was founded in the UK at the beginning of the 20th century. Having initially focused solely on vacuum equipment, Edwards broadened its product portfolio with the major step of entering the pharmaceutical freeze drying sector in the early 1950’s. This freeze drying business evolved from the UK into a production facility in Italy, and having been acquired by BOC Group in 1968, it further expanded in the 1980’s with a production site in Germany. As the pharmaceutical market grew in the US so did Edwards freeze drying business by establishing our current facility in Tonawanda, NY in 1989. Moving to 1995, the Dongen facility in The Netherlands was acquired which brought with it considerable expertise in vial handling which has spurred our existing leadership position in automated loading and unloading systems. As we moved into the 21st century, we completed our production footprint by starting up in Beijing, China in 2004. Today we stand as an integral part of the IMA Group and are widely recognised as the world leader in freeze drying solutions. For more than half a century, Edwards has provided the benchmark for freeze drying solutions to the pharmaceutical and biotech industry. With a truly global presence with main facilities well positioned to serve customers in all corners of the world. With over 1000 freeze dryers installed in over 50 different countries, IMA Edwards is ready to leverage this experience to better serve its customers needs. 36 IMA EDWARDS PRODUCTION RANGE: NDUSTRIAL FREEZE DRYERS PILOT FREEZE DRYERS LOADING SYSTEMS 37 FREEZE DRYING INDUSTRIAL EQUIPMENT IMA Edwards freeze dryers support a wide range of pharmaceutical packaging needs. The Lyofast and Lyomax ranges cover anything from pilot models up to large production units. Products can be conditioned in bulk, vials, ampoules or other type of containers such as cartridges or syringes. IMA EDWARDS HAS BEEN CONSISTENTLY AT THE LEADING EDGE OF FREEZE DRYING AND LOADING SYSTEMS INNOVATION… PUTTING NEW TECHNOLOGY TO WORK FOR ITS CUSTOMERS 38 LYOMAX LYOFAST MINIFAST Lyomax comprises the most comprehensive range of custom-built freeze dryers for those who require more than a standard solution. Lyomax can provide the solution from 1 m2 to 100 m2 applying state of the art engeenering in vacuum, refrigeration, stoppering and heat transfer technology. Created for configure-to-order applications using Modular Design Technology, Lyomax can be designed, manufactured and qualified to meet any requirement. With Lyomax, virtually any configuration is possible, whether single floor, multi-level or pass-through. A series of standard modules provide the foundation of the Lyofast model concept. Pre-engineering results in time and cost benefits, while a wide range of standard options ensure sufficient flexibility over a broad range of configurations. By constructing from a series of standard modules, IMA Edwards is able to compress project schedules and reduce lead timeseven with large capacity equipment. Compared to a custom-built lyophiliser, the lead time for Lyofast is reduced by up to 50%. This provides the customer with a competitive edge by reducing the time to market. With the introduction of the Minifast range of lyophilisers, IMA Edwards has established the connecting factor between a typical bench-top freeze dryer used in laboratories and the industrial Lyofast or Lyomax range of freeze dryers. The Minifast provides you with the direct ‘line of sight’ required by the FDA between the pilot type freeze dryer that is suitable for scale-up and the larger full production freeze dryers. In order to gain control of development time and cost in custom engineering, IMA Edwards applies Modular Design Technology (MDT), which allows for the well-balanced use of pre-engineered modules wherever possible. The Lyomax range is equipped with the latest SCADA system, managing a robust series of PLCs to cover global requirements. The machines are all qualified in accordance with GAMP4 and comply with the latest FDA and EMEA requirements. PILOT FREEZE DRYERS 39 FREEZE DRYING LOADING SYSTEMS AUTOMATIC & SEMIAUTOMATIC The drive for automation is clear from a number of angles: IMA Edwards is one of the few suppliers in the world that designs, manufactures and tests a full range of PROVEN SYSTEMS FOR FULLY AUTOMATIC LOADING AND UNLOADING VIALS into industrial freeze dryers. < Minimises human intervention and thereby supports the assurance of product sterility (SAL levels); reduces bio-burden; and reduces operating costs < Protection of operators depending on potency of products < Repeatable standards and reduction in room air classification < Increased equipment availability THE SYSTEMS ARE DESIGNED TO CONTINUOUSLY TRANSFER VIALS FROM THE LIQUID FILLING EQUIPMENT TO THE FREEZE DRYER AND FROM THE FREEZE DRYER TO THE ALUCAPPER FIXED SYSTEMS FLEXIBLE SYSTEMS MIXED SYSTEMS APPLICATION DEMANDS Fixed automatic loading systems are generally a more cost-effective solution when one or two freeze dryers require loading, and simultaneous operation is not required for loading and unloading. More freeze dryers can be supported if they are in pass-through configuration. Flexible loading systems can serve multiple freeze dryers and perform multiple scheduled tasks. Loading systems consist of a loading accumulation table (LAT), integrated with the out-feed of the fill line, which collects and moves vials in a vial pack equivalent in shape and size to each freeze dryer shelf. Once a vial pack is created on the LAT, a Transfer Cart (TCAR) collects the vial pack and transfers the pack onto the designated freeze dryer shelf. At the end of the freeze drying process, the TCAR collects the vial packs from the designated freeze dryer shelf and transfers the vial pack to an unloading accumulation table (UAT) or Unloading Accumulation Buffer (UAB), where the vials are de-scrambled for single lining to the alu-capper. These systems offer a combination using fixed and flexible solutions: IMA Edwards not only designs your systems to ensure operating excellence, but also ensures your time to market is efficient from installation, documentation and commissioning through to process validation, certifcation and qualification. The Fixed system consists of a conveyor integrated with the out-feed of the filling line, which transports vials to a loading/unloading station installed in front of the freeze dryer. 40 - Only pass-through configurations, loading operating up to 450 vials per minute and unloading up to 900 - Fixed loading and Flexible unloading - Flexible loading and Fixed unloading - vial formats from 14.25mm to 51mm - vial diameters from 2ml to 100ml vial sizes - Loading row by row on a bridging plate with the last row pushing the whole package onto the shelf - Loading a number of rows together onto the bridging plate as an individual package then into final shelf position - Loading a number of rows together onto the leading edge of the shelf, with each next row sequencing the entire pack - Advanced, proven techniques to cope with various cold shelf loading considerations: airflow, temperature differences between environment and shelf, condensation levels on shelf, ice on shelf, elapsed/dwell time from filler to buffer to loading system. 41 FREEZE DRYING SERVICES Technology has always been at the heart of everything IMA Edwards does. In putting this technology to work and gaining control of development time and the expense of customer engineering, IMA Edwards applies Modular Design Technology (MDT). This provides the opportunity for the wellbalanced use of pre-engineered modules in a customer’s application. PREVENTIVE MAINTENANCE Using its extensive experience, IMA Edwards will provide the customer with a comprehensive, tailored solution based upon specific needs. The preventive maintenance program is an integral part of the cGMP approach, and therefore has to be carried out by qualified personnel only. All maintenance will be properly documented to support the customer during corporate audits and regulatory inspections. An effective and approved preventive maintenance programme will: - Assure compliance and the continuity of validated equipment status - Make the operation of equipment reliable - Minimise downtime - Considerably extend equipment life-span 42 WITH ITS WORLDWIDE PRESENCE AND HIGHLY TALENTED AND PROACTIVE STAFF, IMA EDWARDS CAN HELP THE CUSTOMER ANY TIME. TAKING PRIDE IN ITS RESPONSIVE APPROACH OFFERING THE CUSTOMER SERVICE CONTRACTS TAILORED TO INDIVIDUAL NEEDS GUARANTEEING OPTIMAL PERFORMANCE OF YOUR SYSTEMS AT ANY POINT “IN TIME”. ON TOP OF ITS COMPREHENSIVE SPARE PARTS PROGRAMMES, IMA EDWARDS OFFERS A WIDE RANGE OF VALUEADDING SERVICES VALIDATION SUPPORT IMA Edwards can provide the customer with an omni-comprehensive package of documentation for on-site validation. The package can include DQ, IQ, OQ and PQ protocols and support by specialists for execution. IMA Edwards can support equipment qualification with a variety of different approaches: - Integration between commissioning and qualification. Based on written procedures, approved by the customer, IMA Edwards defines rules (deviation management, project change control, etc.) to limit the duplication of effort between FAT/SAT and IQ/OQ/PQ. - Risk analysis. Through the analysis of the critical process parameters and written rationale, IMA Edwards supports the customer in defining the scope of the qualification, setting up initial and periodic qualification programmes, and integrating the commissioning and qualification efforts. CONTROL SYSTEM UPGRADES FREEZE DRYING CYCLE DEVELOPMENT IMA Edwards can support the customer in assessing its control system with respect to compliance with current regulations, including GAMP IV and 21 CFR part 11. Upgrades are available for SCADA, PLC, and Field instrumentation and are fully debugged and bench tested in a simulation environment through to FAT and SAT. They include a fully compliant documentation package and can include: - Validation master plan - User requirements specification - Design qualification/traceability matrix - Functional design specification for PLC - Block diagrams - Pin chart - Functional design specification for SCADA - Hardware design specification - Software design specification for PLC and SCADA - FAT (Factory Acceptance Tests) and SAT (Site Acceptance Test) protocols Our laboratory facilities can offer a complete set of equipment and facilities for cycle development study, enabling focus on: - Optimising the freezing temperature and cooling time - Vacuum to optimise the heat transfer from shelves to product avoiding undesirable melting - Product temperature to optimise the primary and secondary drying time modifying the shelf temperature and vacuum with calibrated leak (nitrogen gas bleeding) - The secondary drying phase using calibrated leak and shelf temperature to reduce time and meet the customer request for residual moisture - Measurement of the residual moisture - Karl Fischer analyser to verify the residual moisture after lyophilisation - DSC analyser to verify the eutectic point and phase transitions CALIBRATION SERVICES TRAINING SERVICES Calibration must fulfill both maintenance and compliance requirements. IMA Edwards can develop a comprehensive programme for you using its extensive experience. Gain direction for classifying instruments and setting appropriate limits to ensure product quality. Avoid unnecessary deviation investigations. IMA Edwards can also provide you with calibration procedures and perform calibration of your instruments with highly qualified technicians and fully traceable primary instruments. IMA Edwards offers a variety of training programmes for Machine operators, Electrical and mechanical engineers, Maintenance engineers, and Supervisory personnel. Programmes are designed not only to improve the participants’ overall understanding of the production equipment, but also to enhance their confidence and performance levels to provide the customer with a beneficial return for its business. Training programme options: - Level 1: System fundamentals, operation and error recovery - Level 2: Preventive maintenance techniques - Level 3: Corrective maintenance techniques - Train the trainer: Course development and material delivery 43 LABELLING & ANCILLARY EQUIPMENT SELFADHESIVE TECHNOLOGY FOR LABELLING OF AMPOULES, SYRINGES, VIALS, BOTTLES AND CARTONS WITH FLEXIBILITY, VERSATILITY AT HIGH SPEED IMA Life production includes a wide range of labelling machines which can be an integral part of complete packaging lines or serve as stand-alone machines known as Sensitive Series, which comprises a number of highly flexible and high performance selfadhesive labellers, specifically designed to meet the demand of the pharmaceutical field. SENSITIVE SERIES V/VL SERIES Easy to use and designed according to the latest cGMP’s the Sensitive Series can cover all the requirements typical of the pharmaceutical processing, handling glass and plastic bottles and vials, ampoules, cartridges, syringes and containers with irregular shapes. Front and rear labelling of elliptical or rectangular based products as well as application of vignette labels or self-adhesive tamper evident seals on formed cartons are included in the range. The Sensitive Series offers today the highest reliability and the possibility to install different kinds of printing systems, such as hot foil, ink jet, thermal transfer, laser and all the state of the art control units, like vision systems, camera pixel counters, bar code readers, 2D code readers. Following the increasing demand in automation of lyophilization processes, IMA Life has designed and developed a range of special traying facilities to ease the loading/unloading operations typical of lyophilization lines, facilitating transfer operations of vials to/ from the freeze-dryers. The V and VL Series of tray loaders represent the ideal solution to all activities concerned with the automatic unloading and collecting of vials onto trays. The range of models of the Sensitive Series, is the solution for various problems concerning primary labelling such as : - wrap-around labelling of cylindrical products like ampoules, cartridges, vials and bottles - front /rear labelling of elliptical or rectangular based products - application of vignette labels or self-adhesive tamper evident seals on formed cartons The distribution and label application units are driven by stepping motors. To support the machines’ high specification all models can be equipped with-: - overprinting units (hot foil, ink-jet, thermal transfer) - bar code readers - checking units - control camera systems (ocr-ocv) - automatic reject units - semi-automatic splicing of label reel without machine stop 44 STARPACK SERIES The Starpack debundling machines have been developed to solve the problem of extracting cylindrical glass containers from polyethylene shrink wrapping and feeding them onto a production line or downstream machine. Semi-automatic and automatic de-packers offer the possibility of further enhancing the performances of complete processing lines, with an output speed up to 240 bundels/min. 45 IN G KA C PA G L SO U NS O TI Protect your products: IMA SAFE is at the forefront for packaging pharmaceuticals and cosmetics. A complete range of primary and secondary packaging machines provides customers with flexible solutions with high efficiency outputs. IMA SAFE offers the widest range of BLISTER & TRAY PACKAGING MACHINES, TABLET & CAPSULE COUNTERS, TUBE FILLERS, horizontal and vertical CARTONERS and END-OF-LINE EQUIPMENT. Global technical services and assistance reinforce and enhance IMA Safe’s market leadership. 46 47 BLISTER & TRAY PACKAGING IMA SAFE’s experience in blister packaging goes back to 1976 when the C60 was launched. The C60 was manufactured with totally new concepts that were the cornerstone to the new era in blister packaging; the first monobloc blister machine with integrated cartoner with the ability to count, stack and introduce blisters automatically. With a speed of 350 blisters/min and 150 cartons/ min, it was the fastest machine in the market. Today, IMA SAFE blister machines incorporate the latest developments in technology, electronic and mechanical engineering and are designed to ensure high production efficiency and low maintenance. < continuous forming film motion < highly efficient feeding systems < integrated cartoners with positive blister transport < stand-alone solutions for specific requirements (e.g. wallet) < reduced changeover and cleaning times < balcony design for greater accessibility < high mechanical efficiency < operator friendly < visibility of the material flow < conformity to gmp < less product and material waste < validatable processes With almost 40 years of experience dedicated to blister packaging and thanks to more than 3.200 blister machines supplied worldwide, IMA SAFE has the expertise and core skills needed to the supply solutions to meet even the most complex end-user’s requirements. Much of IMA’s success can also be attributed to having the widest range of blister and tray packaging machines that the market has to offer, as well as a well having an established worldwide presence and technical assistance. WE SOLVE PROBLEMS IN PRODUCT FEEDING ON A DAILY BASIS Customers know that they can rely on IMA SAFE’s experience in feeding systems. IMA SAFE feeding systems are built in accordance with the GMP and FDA regulations especially in terms of selecting suitable materials that remain in contact with the product. Careful and innovative feeding systems are designed to facilitate cleaning and to reduce changeover times to a minimum. Thanks to more than 7000 feeding units supplied worldwide, IMA SAFE reaches the highest levels of efficiency (99,9%) in handling every possible kind of product shape. A specific department within IMA Safe is dedicated to product feeding solutions and includes several GMP test rooms for product feeding under controlled environmental conditions. Solutions are found which are based upon each unique project. < Minimal invest with high O.E.E. < Fast and easy changeover < Flexibility in handling all materials < Roller and platen sealing LOW SPEED FOR BLISTER AND TRAY IMA SAFE proposes a vast range of solutions for low output blister and tray packaging machines which enable high Overall Equipment Efficiencies. Roller sealing and platen sealing models are manufactured at the IMA plants in Italy and India (IMA SAFE PG). Machines are GMP designed and address the needs of the operator for ease of use. 48 PG CLINIPACK PG TR100 SERIES PG C102 TR130S PG SUPER TR135 PG ROTOVAC 210 SERIES 90 BLISTERSTRAYS/MIN. 150 BLISTERS/MIN. 160 BLISTERSTRAYS/MIN. 220 BLISTERS/MIN. 225 BLISTERS/MIN. 230 BLISTERS/MIN. 240300 BLISTERS/MIN 49 BLISTER & TRAY PACKAGING technical features: < stainless steel covering < balcony construction for easier cleaning and easy insertion of feeding units < product area and technical areas separate; < reduced energy consumption < rapid size changeovers thanks to preset positioning < fast and easy changeover and cleaning with downtimes reduced to a minimum < minimum maintenance and supervision < complete automation with simplicity of use With the Giant1, “the fastest micro-line”, IMA has become the only company which has successfully addressed the problem of product recall; a problem which faces the entire drug manufacturing industry. The patented blister cutting system assures that rejected, faulty, blisters cannot be re-inserted in further packaging process. HIGH SPEED MEDIUM SPEED Machines from 300 to 600 blisters/minute with solutions that include both stand alone or integrated cartoners. Machines are designed to maximise the time needed for format changes and cleaning. A high level of O.E.E (overall equipment efficiency) is possible, even when multiple format or batch changes are needed during a single work shift. 50 C80R C90A91 C80A81 TR200 GIANT1 400/600 BLISTERS/MIN. 400 BLISTERS/MIN. 270 CARTONS/MIN. 400 BLISTERS/MIN. 250 CARTONS/MIN. 360 BLISTERS/MIN. 350 BLISTERS/MIN. 175 CARTONS/MIN. When high production output levels are needed - from 600 to 1300 blisters/min and up to 400 cartons/min. Each machine is designed for rapid and easy format change over and to work with all packaging materials and blister formats. Maximum flexibility combined with highest production efficiency. C96A96 C98 C80HS 1300 BLISTERS/MIN. 450 CARTONS/MIN. 800 BLISTERS/MIN. 700 BLISTERS/MIN. 51 COUNTING EQUIPMENT IMA SAFE, together with IMA SAFE Nova and IMA SAFE Swiftpack, can act as sole supplier of the widest range of solutions to the tablet and capsule counting industry intended mainly for the pharmaceutical sector. The Lakso, Merrill and King brands of high-speed slat fillers have a long and renowned history and have evolved over the last 50 years to encompass a full range of fillers for speeds of up to 400 bpm. Furthermore the Swiftpack brand, formed in 1985, has established itself as a leader within the electronic tablet and capsule counting industries by having sold over 3,000 machines. With hundreds of successful installations around the world, IMA SAFE Nova and IMA SAFE Swiftpack have proven their ability as line integrators of low and high speed packaging lines. Whether integrating their own equipment or complementary machines, their extensive machine knowledge and proven record of using the latest technologies and methods positions them as the best source to provide turnkey integrated bottle packaging systems. IMA SAFE, YOUR ONE STOP SHOP FOR THE PURCHASE OF COMPLETE COUNTING LINES: < SLAT COUNTERS < ELECTRONIC COUNTERS < VISION SYSTEM COUNTING < ASSOCIATED EQUIPMENT: FULL RANGE OF SLAT COUNTERS DESIGNED TO MEET HIGH LEVEL GMP AND FEATURING QUICK CHANGEOVER, COUNT VERIFICATION AND COLOUR TOUCHSCREEN OPERATOR INTERFACE - unscramblers, bottle cleaning - desiccant inserters, cotton inserters, induction sealer - cap, product and container elevators - intermittent and rotary cappers - product and bottle inspection stations, quality check point stations, checkweigher - cartoning machines from to bottles per minute - wrapping machines, tray packers, casepacking machines, palletizers - bench top counters for: laboratories, quality control depts, pharmacies, drug distribution centres, distributors and hospitals - turntable, conveyors 52 SLAT COUNTERS IMA SAFE offers a wide range of slat counters to suit any application. With a high level of GMP design, tool-free changeover and controls incorporating product recipe and changeover module, cleaning and changeover are quick and easy. As the world leader in slat counting, IMA SAFE has successfully designed slats to run all types of product shapes and counts with a very high level of filling efficiency. MERRILL HYBRID 72-39 UP TO 400 BPM OR 40,000 PRODUCTS SL 16 UP TO 180 BPM OR 18,000 PRODUCTS SL 39 UP TO 400 BPM OR 40,000 PRODUCTS 53 COUNTING EQUIPMENT INTEGRATED SOLUTIONS: SOLVING SPACE ISSUES WHILE MAINTAINING QUALITY DESIGNED TO AVOID CROSSCONTAMINATION, THE ONLY MACHINE AVAILABLE ON THE MARKET THAT PROVIDES HIGHLY ACCURATE PRODUCT INSPECTION AND SINGLE PRODUCT REJECTION. ELECTRONIC COUNTING SYSTEMS Infrared System: Products are counted thru the use of infrared sensors. Electrostatic Field System (EFS): Products are not only counted but examined in order to assure their geometric integrity. A key aspect of IMA SAFE’s Electrical Counting Systems is the very limited number of parts which are in contact with the product The UNILINE and MONOPHARM systems, represent two innovative solutions which integrate multiple functions into one compact monobloc counting machine. 54 VISION COUNTERS SWIFTVISION/SWIFTVISION II TWIN SWIFTVISION/ SWIFTVISION II SWIFTPHARM TWIN SWIFTPHARM MONOPHARM UNILINE UP TO 60 BPM OR 6,000 PRODUCTS UP TO 120 BPM OR 12,000 PRODUCTS UP TO 120 BPM OR 12,000 PRODUCTS UP TO 240 BPM OR 24,000 PRODUCTS UP TO 50 BPM OR 5,000 PRODUCTS UP TO 150 BPM The vision counter is based on the vibratory tray method of feeding products to a counting head, but also adds the capability of product inspection (one side) and rejection of non-conforming products. This inspection and rejection capability is achieved through the use of a vacuum drum that takes the products from the vibratory trays and presents them to a high-resolution colour camera system which controls of colour, area, perimeter and length. CONTA 150 CONTA 300 UP TO 150 BPM OR 6,000 PRODUCTS UP TO 240 BPM OR 12,000 PRODUCTS 55 TUBE FILLING Located in Senago near Milan, IMA SAFE CO.MA.DI.S. is specialized in the production of tube filling and closing machines for all types of tubes, from aluminium to polythene, laminate and polyfoil ones to meet the most stringent requirements of the pharmaceutical, cosmetic and chemical industries. The acquisition of CO.MA.DI.S., in April 2001, has brought to IMA the long experience gained on this production side; with more than 2,500 machines supplied all over the world the know-how developed and the design flexibility are the keys to manufacture high quality machinery and provide customised solutions. The production range has been always distinguished by a high degree of innovation, the design and manufacturing characterized by the highest technological standards, to assure high productivity coupled with flexibility and reliability. The CO.MA.DI.S.. production program currently includes 14 different models in several versions, equipped with 1, 2 or 3 filling nozzles for a wide range of applications. Output up to 240 tubes/minute. The success of these tube fillers represents not only the great experience gained in the field, but derives also from a continuous co-partnership in the development with customers all over the world. 56 CO.MA.DI.S. TUBE FILLING AND CLOSING MACHINES ARE VERY EASY TO USE AND CAPABLE OF HANDLING ALMOST EVERY TYPE OF PRODUCTS SUCH AS GELS, OINTMENTS, CREAMS, TOOTHPASTE, GLUES, SILICON, IN DIFFERENT TYPE OF TUBES. THE SEALING SYSTEMS VARY ACCORDING TO THE TUBE TYPE HOT JAWS OR HOT AIR SYSTEMS. LOW SPEED SINGLE NOZZLE MEDIUM SPEED SINGLE NOZZLE HIGH SPEED MULTIPLE NOZZLE - Semiautomatic tube filler C630 UP TO 30 TUBES/MINUTE - Semiautomatic/automatic tube filler C945 UP TO 45 TUBES/MINUTE - Automatic tube filler C960 UP TO 60 TUBES/MINUTE C970 UP TO 70 TUBES/MINUTE - Automatic tube filler C1090 UP TO 90 TUBES/MINUTE C1110 UP TO 110 TUBES/MINUTE C1090 SERVOMATIC UP TO 90 TUBES/MINUTE - Automatic tube filler CD150 UP TO 150 TUBES/MINUTE CD180 UP TO 180 TUBES/MINUTE CT240 UP TO 240 TUBES/MINUTE 57 CARTONING Since the mid 1970’s IMA SAFE has had the reputation of innovator in cartoning technology. IMA SAFE cartoning machines are designed to run efficiently, reliably, quietly and with fast changeovers. Maintenance needs are minimised. Each machine is designed to optimize valuable floor space and innovative solutions, such as carton transport by way of belts, tuck closing solutions and balcony construction are the result of IMA SAFE’s focus on increasing production output. Compact and versatile, IMA SAFE cartoning machines ensure high operation standards and are suitable to flexible packaging needs. VALUE COMPETITIVE, FLEXIBLE, SAFE, OPERATOR FRIENDLY AND COMPACT CARTONERS INTERMITTENT MOTION HORIZONTAL CARTONERS CONTINUOUS MOTION HORIZONTAL CARTONERS Several models of horizontal intermittent motion cartoners providing cost efficient operation at speeds up to 190 cartons per minute, compact layout and best ergonomics. A series of cartoners offering best uptime for high speed packaging lines up to 400 cartons per minute. EASY PG IC150 K150 A83E/EH FLEXA 58 70 CARTONS/MINUTE 100 CARTONS/MINUTE 110 CARTONS/MINUTE 160 CARTONS/MINUTE 190 CARTONS/MINUTE FLEXA DYNAMICA 190 CARTONS/MINUTE 400 CARTONS/MINUTE FEEDING SYSTEMS Cost effective and flexible feeding systems are available which offer a wide range of solutions for both pharmaceutical and cosmetic products. Systems have been developed to facilitate modular feeding concepts which are necessary to meet the market’s needs as well as product variants which are increasing over time. 59 END-OF-LINE EQUIPMENT IMA’s high quality standards also apply to the End of Line machines making them ideal to complete all packaging lines produced within the Group. IMA SAFE Line has to date supplied over 6500 machines to various sectors such as the pharmaceutical, cosmetic, tea, coffee, food, confectionery and tobacco markets. Almost 30 years of experience combined with the most advanced research and manufacturing technology allow IMA SAFE Line to offer specific solutions to the demands of overwrapping, stretch/ shrink wrapping, casepacking, traypacking and palletising. OVERWRAPPING MACHINES IMA SAFE Line can supply a wide range of machines in the overwrapping field for the following applications: - Single carton overwrapping machines 3791 SERIES 3701/3711/3721 SERIES 3705 FROM 25 TO 250 CARTONS/MIN. - High quality single cosmetic carton overwrapping machines 3791U AC 60 AC120 FROM 25 TO 120 CARTONS/MIN. - Cartons collator overwrapping machines 3791AB AC60 3711ABV 3786 SERIES 3703 SERIES AF60 FROM 10 TO 100 BUNDLES/MIN. 60 IMA SAFE LINE MANUFACTURES A COMPLETE RANGE OF ENDOFLINE MACHINES AND CAN SUPPLY TURNKEY SOLUTIONS. STRETCHBANDING & SHRINK WRAPPING MACHINES SIDE AND TOP LOADING CASE PACKING MACHINES IMA SAFE Line has developed reliable solutions for the following applications: Even in this field IMA SAFE Line can offer innovative solutions for the following applications: - High speed collator stretch-banding machine for cartons MS 300 SERIES UP TO 40 BUNDLES/MINUTE MS 250 UP TO 60 BUNDLES/MINUTE - Stretch-banding machine for naked blisters MS 300 BLISTER UP TO 40 BUNDLES/MINUTE - Bottle collator shrinkwrapping machines MS 450+T450 UP TO 45 BUNDLES/MINUTE - High speed bottle collator shrink-wrapping machines 3727 BAN UP TO 60 BUNDLES/MINUTE - Side loading casepacking for cartons CP18 UP TO 14 CASES/MIN. CP28/48 UP TO 10 CASES/MIN. CP38 UP TO 30 CASES/MIN. CP50 UP TO 50 CASES/MIN. CPM SEMIAUTOMATIC CASEPACKER - Top loading casepacking for loose or bundled bottles CPV15 UP TO 1520 CASES/MIN. 3754 UP TO 50 CASES/MIN. 61 END-OF-LINE EQUIPMENT 62 TRAYPACKING MACHINES PALLETIZING MACHINES IMA SAFE Line can also propose a full range of machines in this market sector to cover the following applications: To complete the packaging lines, IMA SAFE Line can supply solutions to the following applications: - Trayforming and filling machine for cartons TP60 UP TO 60 TRAYS/MIN. - Displaybox forming and filling machine for cartons, bottles, vials and sachets with lid closing FR30 UP TO 30 TRAYS/MIN. - Individual palletizing machine MINIFLEX UP TO 6 CYCLES/MIN. 2FPS UP TO 10 CYCLES/MIN. FLEX PALLETIZER UP TO 15 CYCLES/MIN. DEPALLETIZER UP TO 5 CYCLES/MIN. INTEGRATED SYSTEMS FOR CASEPACKING AND PALLETIZING - Integrated side-loading case-packing and palletizing CP18/28+FLEX UP TO 10 CASES/MIN. CP18/28 + MINIFLEX UP TO 6 CASES/MIN. - Integrated top-loading case-packing and palletizing VERTICAL CARTOPALLET UP TO 7,5 CASES/MIN. VERTICAL CARTOPALLET HIGH SPEED UP TO 15 CASES/MIN. 63 IMA GROUP IN THE WORLD IMA S.p.A. ADMINISTRATION OFFICES Via Tosarelli, 184 40055 Castenaso (Bologna) - Italy Tel. +39 051 783111 - Fax +39 051 784422 IMA ACTIVE DIVISION SOLID DOSE SOLUTIONS Via I° Maggio, 14 40064 Ozzano Emilia (Bologna) - Italy Tel. +39 051 6514111 - Fax +39 051 6514287 mktg.soliddose@ima.it IMA KILIAN GmbH & Co. KG TABLET PRESS MACHINES Scarletallee, 11 D - 50735 Köln - Germany Tel. +49 0221 717402 - Fax +49 0221 7174110 mktg.soliddose@ima.it ZANCHETTA S.r.l. POWDER HANDLING AND WASHING SYSTEMS, GRANULATION EQUIPMENT Via della Contea 24 - 55015 San Salvatore Montecarlo (Lucca) - Italy Tel. +39 0583 2171 - Fax: +39 0583 217317 mktg.soliddose@ima.it IMA LIFE S.r.l. ASEPTIC PROCESSING & FILLING SOLUTIONS Ozzano Production Facility: Via Emilia, 428/442 40064 Ozzano Emilia (Bologna) - Italy Tel. +39 051 6514111 - Fax +39 051 6514821 mktg.filling@ima.it Calenzano Production Facility: Via Petrarca, 34/38/40 50041 Calenzano (Firenze) - Italy Tel. +39 055 883231 - Fax +39 055 8879745 IMA EDWARDS FREEZE DRYING SOLUTIONS USA Regional Headquarters: 2175 Military Road - Tonawanda, NY 14150 USA Tel. +1 716 695 6354 European Regional Headquarters: Steenstraat 7 - Dongen, NE 5107, The Netherlands Tel. +31 162 383 500 Asian Regional Headquarters: 101 Wangjing Lize Zhong Yuan, Chaoyang District Beijing, China Tel. +86 10 64399688 www.imaedwards.com sales@imaedwards.com 64 IMA SAFE S.r.l. PACKAGING SOLUTIONS Via I° Maggio, 14 40064 Ozzano Emilia (Bologna) - Italy Tel. +39 051 6514111 - Fax +39 051 6414743 mktg.packaging@ima.it IMA SAFE LINE END OF LINE SOLUTIONS Via Romagnoli, 2 40010 Bentivoglio (Bologna) - Italy Tel. +39 051 6642111 - Fax +39 051 6642255 imaeol@ima.it CO.MA.DI.S. S.p.A. TUBE FILLING MACHINES Via Piemonte, 34 20030 Senago (Milano) - Italy Tel. +39 02 99010284 - Fax +39 02 99010803 sales@comadis.ima.it NOVA PACKAGING SYSTEMS Inc. COUNTING EQUIPMENT 7 New Lancaster Road, Leominster, MA USA 01453 Tel. +1 978 537 8534 - Tool-Free 800 851 1518 Fax +1 978 840 0730 www.imanova.com PRECISION GEARS Ltd. THERMOFORMING AND CARTONING MACHINES Corporate Office & Factory: Plot No. R-677, MIDC T.T.C Indl. Area, Thane Belapur Area, Rabale, Navi Mumbai 400 701, India Tel.: +91 22 67179191 - Fax: +91 22 27600888 sales@precisiongears-ima.com SWIFTPACK AUTOMATION Ltd. COUNTING EQUIPMENT Swiftpack House, 3 Arden Road, Alcester, Warwickshire B49 6HN United Kingdom Tel. +44 0 1789 400880 - Fax +44 0 1789 400780 sales@imaswiftpack.com www.imaswiftpack.com For information on the IMA subsidiaries and sales offices, visit our website: www.ima.it (contacts section)