New Product Brief PreVAS Single-use Dosing System. Packaging Technology. 3 Disposable Dosing Systems

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1 3 Disposable Dosing Systems New Product Brief PreVAS Single-use Dosing System Packaging Technology Copyright 2010 Bosch Packaging Technology. PreVAS Brochure V Subject to change without notice.

2 1 Single-use Dosing Systems Introducing PreVAS the single-use dosing system: Pre-Validated Pre-Assembled Pre-Sterilized The PreVAS family of sterilized single-use dosing systems by Bosch represents a new chapter in dosing system technology. PreVAS is the first completely pre-assembled, and pre-sterilized dosing system available (These systems can be used in clinical and production environments in both the pharmaceutical and biotech filling markets) that is supplied with supporting validation documentation. This allows risk free scale up of filling operations in a single-use format. PreVAS removes several risk factors. There is no longer a need for complicated cleaning procedures and validation protocols. The entire system is quickly installed and operational in a fraction of the time that previous systems required. The product is completely contained in the system reducing operator exposure to products. Reduced risk: A new system for each batch means there is no risk of cross contamination and no risk of improperly cleaned/sterilized parts. Reduced Validation: Supplied validation documentation reduces the amount of time spent on cleaning, sterilization, and validation activities. Reduced costs: The cost of a dosing system is often less than the cost of the labor, time, and materials involved in sterilizing a traditional system. Increased productivity: With quicker changeover time between batches your facility can remain productive for more hours of the day. Reduced resource consumption: No need for cleaning/sterilization means no autoclave, steam, water, or labor used in cleaning/ sterilization procedures. Improved operator safety: greatly reduced exposure of the product to operators.

3 5 Disposable Dosing Systems Single-use Dosing Systems 2 Pre-Validated PreVAS systems are available with validation documentation. Minimum (single pump) and maximum (split 8 pump) fluid path systems were evaluated providing bracketed qualification documentation for systems falling within this range. Validation documentation available for the systems include: Pump pressure leak, integrity testing, & fill accuracy Component particulate endotoxin, extractables and, & Class VI (USP 87 &88) testing Bracketed system sterility (with verification dose determination based on ISO11137) PreVAS Applications Biopharm High Potency Drug Filling Vaccine Production Contract Manufacturing Clinical Trials Vial Filling Syringe Filling Cartridge Filling Ampoule Filling PreVAS Components Product Bag (optional) Supply Connector Tubing Fittings Pumps Needles

4 3 Single-use Dosing Systems PreVAS with Bosch Peristaltic Pump PreVAS singl-use rolling diaphragm pumps mounted on an FLC filling sytem. Pre-Assembled PreVAS Dosing Systems are complete pre-assembled systems built to each project s unique specifications. Assembly takes place in a class 10,000 clean-room environment, using industry accepted components and materials. Tailor-made systems Clean room assembled Industry accepted materials Complete systems, ready-to-use PreVAS Delivers the Whole Package One of the goals in developing the PreVAS single-use dosing system was to create a package that gives the customer everything they need, eliminating extra steps and procedures. The PreVAS single-use dosing system delivers. The system provides rocksolid performance comparable to traditional stainless steel models. The pre-assembled system is easy to use: Open the bag and install; quick and simple. Finally, systems come complete with validation documentation demonstrating that it is suitable for use and has been rigorously tested. PreVAS Delivers the Whole Package Performance Integrated dosing system Repeatable Accurancy Presicion Dosing Dependability Scalabiltiy Ease of Use Completely assembled system Clean-room packaged Tailor-made systems Pre sterilized Single use Validation Pumps Pressure leak test Integrity test Fill accuracy Component Endotoxin Extractables Particulate Class VI testing System Bracketed sterility, endo toxin, particulate, & package integrity testing

5 7 Disposable Dosing Systems Single-Use Dosing Systems 4 Pre-Sterilized All PreVAS systems are Gamma irradiated to ensure complete sterilization of the system. Each double-bagged PreVAS System contains a gamma exposure indicator, and meets ISO guidelines. Double bagged Gamma irradiated Gamma exposure indicator ISO VD max 25 based dose determination The Rolling Diaphragm Pump (RDP) The RDP has been a long time staple of Bosch customers in the pharmaceutical filling industry. Its design offers high accuracy with minimal stress to the product it handles. Stainless-steel RDP s require cleaning, which can be a time consuming and expensive process. The single-use pumps eliminate this cleaning/sterilization step from your process. The new PreVAS Single-use Rolling Diaphragm Pump takes the best design elements from the original stainless steel pumps, and adds the convenience of a disposable solution in an affordable package. Anatomy of a Rolling Diaphragm Pump Exhaust Stroke Intake Stroke Stainless Steel and Single-use Rolling diaphragm Pumps

6 5 Single-use Dosing Systems Specifications Component Options Picture System Connector Quick Disconnect Tri-Clamp Adampter Sterile Connector Other Bag Assembly None 2 Liter 5 Liter 10 Liter Manifold Configuration Inline Split Line Bleed Valve Recirculation Loop Number of Pumps/Needles Pumping System Type Peristaltic Dual Line 6cc RDP 50cc RDP Needles (Inside Diameter) 1.2mm 1.5mm 2.1mm 3.0mm 3.8mm 4.6mm 5.2mm Packaging Requirements Double Bagged Tripple Bagged RTP Port for Isolator/RABS

7 9 Disposable Dosing Systems Single-use Dosing Systems 6 Pump Information Specifications Materials Medical Grade Polycarbonate Platinum Cured Silicone USP/NF Class VI Certified Animal Derivative Componant Free (ADCF) Dosing Range RDP 0.05ml to 6.2ml (6cc version) 5.0ml to 52ml (50cc version) Dosing Range Peristaltic Other Preassembled and Integrity Tested Washed, Flushed, and Dried Filling Needles Specifications Materials 316L Stainless Steel Tubing Medical Grade Polycarbonate USP/NF Class VI Certified Animal Derivative Component Free (ADCF) Available Sizes (ID, mm) 1.2 / 1.6 / 2.1 / 3.0 / 3.8 / 4.6 / 5.2 Other Washed, Flushed and Dried Examples of PreVAS Systems 2 Pump System, Peristaltic No Product Bag Systems Systems Specifications Materials Platinum Cured Silicone Tubing USD/NF Class VI Certifies Connectors/Fittings 4 Pump System, No Product Bag Split 8 Pump System with Bag Other Cleanroom Assembled Double Bagged Tailor-made for Eash Application Single-use Filling Needle Left to right Single-use Rolling Diaphragm Pump Single-use Needle Bagged, Sterilized PreVAS System Bagged, Sterilized Single-use Needle

8 Robert Bosch Packaging Technology 8700 Wyoming Avenue North Minneapolis, MN USA Phone: Fax: Robert Bosch GmbH Packaging Technology Division Product Division Pharma Liquid Crailsheim Phone Fax packaging@bosch.com