CVT TM Slitec TM Series - inspection machines for vials, ampoules, cartridges and syringes

Transcription

1 CVT TM Slitec TM Series - inspection machines for vials, ampoules, cartridges and syringes

2 The Highest Quality requires perfection inside and outside. CVT TM inspection machine series with the unique Slitec TM feature assures control and perfection in completed product inside and out. The CVT TM series of inspection machines for vials, ampoules, cartridges and syringes was specifically designed for this critical operation. Anyone who is familiar with the high precision of Bosch Moeller&Devicon will appreciate the high quality of the CVT TM Slitec TM series machines.the CVT TM series with Slitec TM is suitable for many output ranges and meets the strictest requirements of the pharmaceutical industry regarding reliable identification of particles as well as cosmetic defects. Particles in the drug, cosmetic defects or damages during the packaging process can not only cause serious problems to the health of the patient but cause serious problems to the image of a pharmaceutical company. Bosch Moeller&Devicon has therefore developed an inspection machine that guarantees the highest quality, functionality and appearance of a drug. The heart of the machine is the unique patented Slitec TM inspection method that requires no moving parts - respectively camera or lightening system. Instead, the window from the camera is divided into several virtual frames so that during the passing of the containers several images are taken, one in each frame. Each image is analysed for the presence of particles and then compared to the other images taken of the same container. In order to insure perfection of inspection, two independent inspection stations are integrated where they both inspect each container. The results of both inspections must agree with each other to determine final disposition of each container. If there are different inspection results for the same container these so called grey containers will be automatically and continuously returned back to the infeed and re-inspected. With this system, the false reject rate is reduced to a minimum. Based on customer and product requirements, further camera stations (up to five camera stations altogether) can be added on request depending on the detection principle needed. 2

3 Trust is good Certainty is better The CVT TM Slitec TM machine provides certainty in your production with it s redundant inspection philosophy. Output CVT TM series machines range in output between 200 to 600 containers per minute depending on the application, containers and number of stations on the turret. Infeed Infeed options range from loading directly from trays (standard) to feeding directly from an upstream machine (In-line), to feeding from a turntable buffer or by way of a puck system or other handling system like a syringe or cartridge detrayer. All infeed systems utilize a servo driven infeed scroll and starwheel system that allows smooth transfer into the particle inspection carousel. Transport The carousel for particle inspection has 40, 50 or 100 stations depending on container diameter, desired output and filled product characteristics. The containers are securely held at the top and bottom allowing on open view of the body. Each container station has it s own servo drive to assure reliable and validatable rotation which is a critical part of the particle inspection process. Transport through the additional cosmetic inspection stations is performed by a series of starwheels. Particle Inspection Particle inspection with CVT TM Slitec TM technology provides certainty in your production. Our many years of experience at high speed particle inspection have allowed us to create the newest and most reliable system. Through the use of today s computer, vision and lighting technology, this new systems is undoubtedly the most capable and validatable system available in the market. Additionally, at Bosch Moeller&Devicon, we assist and support you in all qualification areas. Our experience allows us to provide professional project planning and execution. Our experienced GAMP type approach to validation documentation provides further certainty and assurance in your validation process and shortens the time to market. 3

4 Chips and cracks inspection Particle inspection 1 Particle inspection 2 Cap inspection Cosmetic inspection A wide variety of optional cosmetic inspections can be added to the machine after particle inspection. These modules are designed to provide a full 360 degree inspection capability of each container. Reject station Containers that fail either particle or cosmetic inspection are automatically ejected into trays or bins. The configuration and quantity of the eject trays or bins is flexible. Outfeed Outfeed options range from trays (standard) to conveyor belts to special handling systems and other types of systems depending upon the container type and line configuration needed. All packaging materials are additionally inspected for chips and cracks Ampoules Cartridges Black spots, deformation Color of the cap Color-ring identification Crimp cap control Fill level Detection of mixing ball Position of the plunger Rubber plunger defects Vials liquid Position and color of flip-off cap Crimp cap control Fill level Syringes Fingerflange control Rubber plunger defects Position of the plunger Vials dry Fill level Stopper placement Splinter check Needle shield defects Particles on the cake surface 4

5 CVT TM Slitec TM 4050 The customer benefits - overview No moving cameras or lights No wearparts higher reliability, less maintenance, no drift over time Less spareparts reduced inventory Fast and easy validation Reduced qualification time of up to 50% because of: No moving camera or lightsource parts during inspection The rotation of each container is servo driven, providing precise and reproducable rotation Basic validation for modules is available (test sheets and risk analysis ready) White box validation. Meaning the software is written and organised in a way that you can look in it and easy understand it (contrary to a black box) Standardized documentation With the classified in house cleanroom facilities at Bosch Moeller&Devicon, validation test or sample sets can be created Modular mechanical system Compact footprint Fast and easy size part changeover. Size parts can be changed by the operator without tools Modules for cosmetic inspection can be selected (even without particle inspection) and are also suitable for retrofit Integrated main drive with a minimum of mechanic components like belts, bearings and gears Modular automation system Various control Systems available Fully CFR21 Part 11 compliant Interface to SCADA-System GAMP 4 compliant The machine is designed and built in accordance with the cgmp guidelines. 5

6 Bosch Packaging Technology Product Division Pharma Headquarters Robert Bosch GmbH Packaging Technology Division Waiblingen Phone: Fax: Brazil Sigpack Tecnologia de Embalagem Ltda. São Paulo Phone: Fax: China Bosch Packaging Technology (Hangzhou) Co.Ltd. Hangzhou Phone: Fax: Denmark Moeller & Devicon A/S Sandved Phone: Fax: France Bosch Techniques d Emballage S.A.S. Reichstett Phone: Fax: pafr@boschpackaging.com Germany Robert Bosch GmbH Packaging Technology Division Product Division Pharma Liquid Crailsheim Phone: Fax: pa@boschpackaging.com Great Britain Bosch Packaging Services Ltd. Derby Phone: Fax: uk-hub@sigpack.com India Motor Industries Co.Ltd. Bangalore Phone: Fax: vtin@in.bosch.com Japan Bosch Packaging Technology K.K. Tokyo Phone: Fax: vtjp@boschpackaging.com Bosch Packaging Technology K.K. Chiba Phone: Fax: vtjp@boschpackaging.com Singapore Bosch Packaging Technology (Singapore) Pte. Ltd. Singapore Phone: Fax: sigpackasia@sigpack.com USA Bosch Packaging Technology Inc. Pharma Divison MN-Minneapolis Phone: Fax: sales@boschpackaging.com PA/ADV 04/05 1,5 E WA Iorio, Sulzbach Paper: natural white, without chlorine All rights reserved Moeller & Devicon A/S A Bosch Packaging Technology Company Langgade 43 DK-4262 Sandved Phone: Fax: info@m-d.dk