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New Product BriefPreVAS | Single-use Dosing System

Packaging Technology

Copyright 2010 Bosch Packaging Technology. PreVAS Brochure V3 7-2010. Subject to change without notice.

Introducing PreVAS the single-use dosing system:Pre-Validated Pre-AssembledPre-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.

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PreVAS Applications Biopharm High Potency Drug Filling Vaccine Production Contract Manufacturing Clinical Trials Vial Filling Syringe Filling Cartridge Filling Ampoule Filling

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 availa-ble 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)

Pre-ValidatedPreVAS Components

Product Bag (optional)

Supply Connector

Tubing

Fittings

Pumps

Needles

Single-use Dosing Systems | 2

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 acceptedcomponents and materials.

Tailor-made systems Clean room assembled Industry accepted materials Complete systems, ready-to-use

Pre-Assembled

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

Ease of Use Completely assembled system Clean-room packaged Tailor-made systems Pre sterilized Single use

Performance Integrated dosing system Repeatable Accurancy Presicion Dosing Dependability Scalabiltiy

PreVAS – Delivers the Whole Package

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 rock-solid 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 with Bosch Peristaltic Pump

PreVAS singl-use rolling diaphragm pumps mounted on an FLC filling sytem.

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All PreVAS systems are Gamma irradi-ated to ensure complete sterilization of the system. Each double-bagged PreVAS System contains a gamma exposure indicator, and meets ISO 11137 guidelines.

Double bagged Gamma irradiated Gamma exposure indicator ISO 11137 VD max 25 based dose determination

Pre-Sterilized

Anatomy of a Rolling Diaphragm Pump

Exhaust Stroke

Intake Stroke

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.

Stainless Steel and Single-useRolling diaphragm Pumps

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Specifications

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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 1 2 3 4 5 6 7 8 9 10

11 12 13 14 15 16

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

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Examples of PreVAS Systems

2 Pump System, No Product Bag

Peristaltic Systems

Left to right

Single-use Rolling Diaphragm Pump

Single-use Needle

Bagged, Sterilized PreVAS System

Bagged, Sterilized

Single-use Needle

Split 8 PumpSystem with Bag

Single-use FillingNeedle

4 Pump System, No Product Bag

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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

Systems Specifications

Materials Platinum Cured Silicone Tubing

USD/NF Class VI Certifies Connectors/Fittings

Other Cleanroom Assembled

Double Bagged

Tailor-made for Eash Application

Robert Bosch Packaging Technology

8700 Wyoming Avenue North Minneapolis, MN 55445USAPhone: 763-424-4700Fax: 763-493-6776sales@boschpackaging.comwww.boschpharma-us.com

Robert Bosch GmbH

Packaging Technology DivisionProduct Division Pharma LiquidCrailsheimPhone +49 79 51 4 02-1Fax +49 79 51 4 02-2 58Email: packaging@bosch.comwww.bosch.com/pa