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Bosch’s Klaus Ullherr, new FXS Combi, PreVAS featured in January PharmTech.com

January’s PharmTech.com features an article titled “Filling Pre-sterilized Containers | Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.”

This article features expert insight from Bosch product manager Klaus Ullherr, and also discusses the Bosch FXS Combi filling and closing machine for pre-sterilized nested syringes, vials, and cartridges. New innovations in Bosch’s PreVAS product line are also mentioned.

Click here to read the article.


Single-use filling system PreVAS nominated for German Packaging Award

PreVAS

Bosch Packaging Technology`s single-use filling system PreVAS has been nominated for a German Packaging Award in the “Packaging Machines (technology)” category, which recognizes outstanding technical solutions for packaging manufacturing. To be nominated, a company must have developed a certain machine or new technology that improves the quality, cost-effectiveness and efficiency of the packaging process. …more


On Display at Interphex 2012: PreVAS Single Use Dosing Systems

The PreVAS family of aseptic single-use dosing systems by Bosch 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. Click here for a product brochure.


See the Bosch line of single use dosing systems, PreVAS, at Interphex 2012.


Use the links below to see our other 2012 Interphex exhibits

Click on any display for more information

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PreVAS Commercial Availability Information

PreVAS systems now available

Current availability of PreVAS systems and components

Complete PreVAS Systems:

  • Single-use Pumps
  • Single-use Needles
  • Product Supply Manifold
  • Vacuum Manifold
  • Platinum cured silicone tubing (length is flexible and based on customer need)

6cc pump size

  • 1, 2, 4, 6, 8, and split 8 pump configurations
  • Same functionality and accuracy as legacy Stainless Steel 6cc pump
  • Mounts in existing TL & Bosch machines in place of stainless steel Rolling Diaphragm Pumps
  • Tested accurate to 400,000 cycles (same as 24 hrs for 7 days)
  • Available with or without product bag
  • Animal derivative component free
  • +/- 0.5% accuracy


Peristaltic systems

  • 1, 2, 4, 6, 8 pump configurations

Peristaltic


Needles:

1.2mm, 1.6mm, 2.1mm, 3.0mm

  • Autoclave
  • Gamma-irradiated
  • Ready to Gamma
  • Inner tube constructed of 316L stainless steel tubing
  • Molded with medical grade polycarbonate
  • USP/NF Class VI certified

needles


Machine Conversion Components:

  • FSM 2700 conversion kit includes:
    • Pump mounts
    • Manifold Support
    • Needle mount
  • FSM 1010 conversions kit includes:
    • Pump mounts
    • Manifold support
    • Needle mount
  • Pump mounts
    • ¼ turn lock to hold PreVAS pumps
    • Available for the 6cc and 50cc PreVAS pump
    • Mounts to traditional pump mount bars
    • Autoclavable Stainless Steel
    • Special PreVAS pump mount

    Pump Mount

  • Manifold supports
    • Replaces traditional SS version
    • Autoclavable
    • Holds silicone tubing manifold over pump system
    • Available for different PreVAS tubing sizes

    Manifold Supports


  • Needle holder (block style)
    • Replaces traditional SS version
    • Autoclavable
    • Key slot design for clean mounting of pre-sterilized needles

    Needle Holder (block style)


  • Needle holder (clip style)
    • Autoclavable

    Needle Holder (Clip Style)


For further information, please contact us at 763-424-4700.

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

 –


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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AAPS Denver – Bosch Packaging Technology Booth 763: Stop by our booth next week to meet our team, drink a coffee, and take a look at the portfolio of lab equipment we are briging to the show

Bosch Packing Technology will be at AAPS Denver next week exhibiting the following lab scale products: Mycromix High-Shear Mixer, Solidlab 1 Fluid Bed / Drum Coater/Blender, TPR 200 Tablet Press, and PreVas / Uno Liquid fill systems.

Stop by our Booth (763) for a coffee and to …more


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