MS-SerieS - Medipak Systems

MS-Series
High-performance inspection for
ampules, vials and cartridges
MS-series
Purity and sterility of parenterals –
vital to patients’ health
Increasing manufacturing capacities are continuously leading
to higher production speeds requiring highly sophisticated
technologies to inspect product at all levels. Compared to
other pharmaceuticals, the production of parenteral products
is much more complex and bears the risk of many contaminations. Since parenterals are typically injected and directly enter the bloodstream, particulates might cause adverse
Camera inspection
Leak detection
¡for particles
¡for cosmetic defects
High voltage for micro-cracks and pinholes
Laser for pressure in head space
Cap
Tip
Leak Detection
reactions. However, one of the most challenging aspects
of container quality control is the assurance of container/
closure integrity.
Whatever your requirements: inspection for particles in the
product or cosmetic defects of the container, as well as verification of container integrity – we offer the appropriate inspection technology for your needs.
Color Code Ring
Particles
OPC
Cap
Cap
Crimp
Stopper/Neck
Crimp
Stopper/Neck
Shoulder
Shoulder
Sidewall
Sidewall
Sidewall
Sidewall
Particles
Beads
Particles
Cake
Plunger
Bottom
Bottom
Ampule
2 | Seidenader
Heel
Bottom
Bottom
Cartridge
Vial Liquid
Vial Lyo
The modular design of major machine functions for infeed,
inspection and outfeed enables us to build customized
machines from standardized modules. The MS platform is
equipped as standard with vision systems for the inspection
of solutions, suspensions and emulsions as well as oil-based
or lyophilized products in ampules, cartridges and vials up to
100 ml. To complement camera inspection, additional technologies such as high voltage can be included, to reliably
verify container integrity and product sterility.
your Benefits
¡Inspection of up to 24,000 containers per hour
¡Handling of ampules, vials and cartridges
up to Ø 52 mm, and up to 100 ml
¡Inspection of solutions, suspensions,
emulsions, oil-based and lyophilized products
¡Minimized false reject rate thanks to
integrated automatic re-inspection of defined
defect parameters
¡Maximized inspection performance thanks to
- up to 24 images per particle station
- up to 3 light techniques per particle station
- up to 3 particle stations
¡Individual rotation profiles thanks
to servo drives on each position in the
inspection carousel
¡Large inspection turret to optimize
rotation and inspection time, even for
viscous and suspension products
¡Quick changeover thanks to fewer format parts
Seidenader | 3
MS-series
850
1500
Design Features
1
2
1010
“Hyseptic” standard
¡Sealed and covered optical elements
¡Column concept for good access and easy cleaning
¡Trimmed edges, hidden cables
¡Strict separation of product handling and machine
engineering areas
¡GMP compliant
2 PRODUCT HANDLING
¡Vacuum transport for smooth product handling
¡Reduced number of side guides to avoid friction
¡Vacuum pump for reduced air consumption
Infeed
1
3 CAMERA INSPECTION
Infeed via split timing screw which creates empty positions for
the re-inspection process and stops infeed to empty machine
without leaving uninspected products.
¡Continuous motion – no moving cameras, no moving
lights – thanks to a central oscillating mirror moving in synchronization with the transport of the container
¡Servo drives for each position in the inspection carousel
allow individual rotation profiles:
¡Manual loading from trays with Seidenader A-MAG, with
tight splitting at infeed starwheel to slow down its rotation
speed at same throughput
¡Inline interface with upstream machine to transport stable
containers directly to the infeed timing screw
¡Inline connection, with turntable for manual loading
4 | Seidenader
- Different kind of liquids require different rotation speeds to be brought into the dedicated motion
- Different kinds of particles require different rotation speeds to be whirled up
- Rotation speed and brake point are stored in the indivi-
dual product configuration (recipe)
400
1400
3
1050
6
7
5
4
1400
1400
4
Automatic Re-inspection
Integrated re-inspection (short) for defined defect categories
¡To minimize false reject rate
¡To avoid uninspected products during a production run
5
High voltage leak detection
Integrated high voltage leak detection (HVLD PRO or HVLD
SLIM) for liquid filled containers, with one operator interface
for camera and HV inspection – 360° inspection of the container guaranteed
980
All units are in millimetres.
Footprint illustrated is example only.
6 Head space analyzer
Head space analyzer (HSA), for 100% testing of containers,
inline and at high speeds, to verify container integrity of lyofilled vials
Outfeed
7
Each inspection result and each defect category can be allocated to a dedicated outfeed channel.
¡ Up to 8 channels for good products, rejects or not inspected
¡Inline connection to downstream machine
Seidenader | 5
MS-series
Technical Data
Seidenader MS-40
max. throughput containers/h
24,000
max. number of camera stations (in carousel)
9 (6)
servo-driven positions in carousel
60
range of container Ø
up to 52 mm
range of containers
ampules, vials, cartridges
range of products
solutions, suspensions, emulsions, oil-based
and lyophilized products
combo machine liquid and lyo
yes
automatic re-inspection
short
dimension of base machine (excl. cabinet)
1,400 x 1,900 mm
vacuum transport technology
with external electrical vacuum pump
yes
Seidenader | 7
Seidenader Services Tailored to Your Needs
Seidenader Customer Support
Our Customer Support Team is available during business hours to help you
with urgent questions you may have about your Seidenader machine or any
other technical issues. 24/7 support is also available as an additional option.
Seidenader After Sales Services
Maintenance, spare part orders or retrofit requests – your direct contact
is a designated customer support team to coordinate all your inquiries
regarding our comprehensive range of after sales services.
Seidenader Academy
Reduce your installation time to a minimum by taking advantage of customized training sessions for integrators and users of our products – from the
basics to the tips & tricks to run your machine in the most efficient way.
Seidenader 04.2014
Seidenader Qualification Support
Profit from our validation support package and minimize validation and
start-up time. Our specialists develop test plans and qualification protocols
and provide support during execution.
Seidenader Maschinenbau GmbH
Lilienthalstr. 8 · 85570 Markt Schwaben · Germany · www.seidenader.com
T +49 8121 802-0 · F +49 8121 802-100 · info@seidenader.de
www.seidenader.com