Considerations in Powder Filling
Transcription
Considerations in Powder Filling
Your Source for Complete Filling and Packaging Solutions www.cozzoli.com Considerations in Powder Filling Dennis Martin Regional Director Cozzoli Machine Company A Century of Innovation Since 1919 Cozzoli Machine Company has provided technologically advanced machinery for the packaging industry, worldwide. Cozzoli’s expertise lies in aseptic and non-aseptic pharmaceutical, cosmetic, health and beauty aids. In pharmaceutical powder filling, every effort is generally made to eliminate waste, avoid contamination, save product, increase operating efficiency, as well as comply with regulatory requirements. But what do you look for in powder filling technology to avoid these common issues? 1986 Cozzoli Machine Company has made great strides in understanding the pharmaceutical powder filling/cleaning processes. 2010 We want to share with you our insights and the technology we developed to counter obstacles typical to powder filling. This information can help simplify your operation, increase productivity and meet regulatory compliance. Cozzoli’s first powder filling patent was designed to improve the existing powder filling process for better accuracy, reliability, easy cleaning and less waste. The goal was to create a powder filling machine that was simple, accurate, high-speed, and low cost that was of rugged construction. The resulting machine is capable of running for long periods of time, with low maintenance and quick changeover to different types and volumes of filling material. This machine is easy to clean and sterilize, with simple and troublefree operation. With it’s accurate and consistent fills, this powder filling technology is especially useful for pharmaceutical applications. This filling method can be scaled from tabletop application with two fill stations to full production of up to twelve, using the same type heads. This filling method is useful for any number of powder filling applications, from 50 mg to 75 grams in a single dose (and is capable of multiple doses). This allows one machine to perform many fill requirements. But it's most interesting for pharmaceutical sterile fills. Performing regulatory mandated media fills test for pharmaceutical powder products required a separate liquid filler and additional personnel. And, it was not possible to simulate production conditions. Cozzoli’s powder filling technology can handle liquid filling for media testing. Therefore, testing can be conducted using only production equipment and personnel, resulting in better accuracy. The feature that is unique to this filling method is the capability to do media fills with the same filler, simply by filling the hopper with liquid growth media instead of product powder. This is unlike other methods that require additional filling equipment. The media is dispensed into vials, just the same as powder would be, and then the vials need to be incubated. The negative incubation results, where media shows no growth, will substantiate the sterile fill capability, as required by the FDA or other regulatory body. Other features include the enclosed powder pathway, preventing possible external contamination. Simultaneous dose and filter purge, eliminating purging waste. When the dosing process finishes, a pulse cleans residue powder from inside the dosing chamber and filter and directs it into the container. This is an example of helping customers meet their regulatory requirements in a simple way. In addition, this filling method allows for fast and easy cleaning, as opposed to other methods. Primarily we focus on accurate filling, aseptic/sterile methods, and easy cleaning for eliminating contamination or cross-contamination. An additional constraint is the high cost of space, so our equipment is designed and optimized for small areas. The accuracy of up to +\- 1% of fill volume means less product loss. No scraper blades or particle-generating components are used, minimizing the threat of contamination further. Dosing weight can be individually adjusted during operation. Case Study: Pharmaceutical Powder Filling Line Cozzoli Machine Company developed a powder filling line for filling antibiotic powders into vials in a sterile pharmaceutical environment. This fully ntegrated line handles multiple size vials and varying doses with ease. Complete automated processing will reduce risk for contamination. Case Study, Continued Functions include: • Washing vials, Sterilizing/depyrogenating, • Filling antibiotic powder, • Closing with stoppers • Crimp capping the vials The line fills powder from 250 mg to 3.0 gm in single dose, with batch sizes ranging from 1750 vials to a maximum 33,000 vials. Output per hour is 9000 vials of ISO 10R with one shot dosing. Case Study, Continued The individual machines on the line, all supplied from Cozzoli, include: AW160 washing machine ST200 sterilizing tunnel UT42 unscrambling table PF8 powder filler • CWS100 check weighing system • RS400 stoppering machine • Swing conveyor (for easy access to other side of line) • CM200 crimping machine About Cozzoli Machine Company Cozzoli Machine Company provides technologically advanced machinery for the packaging industry. As a global supplier of precision cleaning, sterilizing, filling, and closing systems, Cozzoli is your single source provider for individual components to fully integrated lines. About Dennis Martin Mr. Dennis Martin is the Regional Director for Cozzoli Machine Company. A respected member of the Cozzoli team for almost ten years, Dennis has over 40 years of technical and sales experience in the packaging industry covering retail packaging, chemical, food, pharmaceutical, cosmetic and personal care. Contact Us For more information about our powder filling technology or this presentation, please contact Dennis Martin at dmartin@cozzoli.com. Cozzoli Machine Company 50 Schoolhouse Road • Somerset, NJ 07856 USA Tel: 732-564-0400 • Fax: 732-564-0444 Email: sales@cozzoli.com • www.cozzoli.com Connect with us: An American Company