PreVAS Single-Use Dosing Systems

PreVAS quick links: Commercial Availability Info
Specs and Quote Builder Validation Update
More Info on Single-Use Needles Case Study

Introducing PreVAS
the single-use dosing system:
Pre-Validated
Pre-Assembled
Pre-Sterilized

 

The PreVAS family of aseptic 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 for the clinical and production pharmaceutical and biotech filling market 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 from your filling operation. There is no more 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 single-use 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 by your staff.
– Reduced costs: The cost of a dosing system is 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 remains 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.

Pre-Validated
Each PreVAS system is delivered with a validation package. Minimum (single pump) and maximum (split 8 pump) fluid path systems were evaluated providing bracketed qualification documentation for systems falling within this range.

Validation packet available for each system includes:

– Pump pressure leak, & integrity testing
– Component stress, bioburden, extractable & leachable, endotoxin, & Class VI (USP 87 &88) testing
– Bracketed system sterility with verification dose determination based on ISO 11137 & particulate testing (USP 788)

PreVAS Applications

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

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PreVAS single-use needles and needle mounting blockPreVAS single-use needles and needle mounting block.



PreVAS single-use rolling diaphragm pumps mounted on an FLC filling system.


Pre-Assembled
PreVAS Dosing Systems are pre-assembled, complete 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 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, the system comes complete with a validation package demonstrating that it is suitable for use and has been rigorously tested.

PreVAS delivers the whole package


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, indicating required exposure was achieved.

 

– Double bagged
– Gamma irradiated
– Gamma exposure indicator
– ISO 11137 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 and assembly, which can be a time-consuming and expensive process. The single-use pumps eliminate the cleaning/sterilization & assembly steps 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 single-use solution in an affordable package.


Rolling Diaphragm Pump

PreVAS quick links: Commercial Availability Info
Specs and Quote Builder Validation Update
More Info on Single-Use Needles Case Study
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