Press Release Summary:
Designed to eliminate cross contamination risk between batch runs when filling liquid pharmaceuticals, Prevas Disposable Dosing System accommodates vials, ampoules, and syringes. It installs on liquid filling lines and features completely disposable product path. Shipped completely pre-assembled, pre-sterilized, pre-validated, single-use system is comprised of bulk product bag, positive displacement-rolling diaphragm pump, filling needles, and tubes.
Original Press Release:
New Prevas Disposable Dosing System for Filling Liquid Pharmaceuticals Reduces Validation and Production Costs
Disposable format reduces costly and time-consuming validation
New system eliminates cross contamination risk between batch runs
Quick changeover increases productivity
Bosch Packaging Technology introduces the Prevas Disposable Dosing System for filling liquid pharmaceuticals. The Prevas system is designed for installation on liquid filling lines for vials, ampoules, and syringes. The system features a completely disposable product path and incorporates a bulk product bag, a positive displacement-rolling diaphragm pump, filling needles and tubes into one assembly.
The Prevas system is the first completely pre-assembled, pre-sterilized, pre-validated single-use system available for the pharmaceutical and biotech market. The Prevas product path assembly is attached to the filling system and connects to the product stream via sterile plug-and-use connections. This eliminates preparatory steps associated with stainless steel construction, such as cleaning, assembly and disassembly, autoclaving and clean-in-place (CIP) or sterilize-in-place (SIP) operations, minimizing the costs and labor associated with these cleaning procedures. After the fill process is completed, the product path assembly is removed and replaced, with minimal downtime and increased productivity.
The Prevas system utilizes a positive displacement rolling diaphragm pump based on the same proven technology used in the industry for years, yet is engineered out of clear pharmaceutical grade plastic. A traditional stainless steel pump would require labor-intensive disassembly, cleaning and reassembly. In addition, the filling needles in conventional stainless steel operations are easily damaged and notoriously difficult to clean properly. The Prevas system incorporates new needles for every use, eliminating this problem.
The single-use format reduces the time and costs of the cleaning validation protocols necessary for an entirely metallic product path. Each system is pre-validated to conform to USP/NF standards and comes with a comprehensive validation package. Components are free of animal and endotoxic products and have been tested for leachables and extractables. The materials and validation procedures were developed in partnership with Thermo Fisher Scientific, an industry leader in the production of single-use components for the pharmaceutical and biotech markets. Appropriate for both the clinical phase as well as full production runs, the Prevas minimizes the processing variables and risk associated with scale-up.
A disposable format virtually eliminates the potential for cross contamination between batches. A new system for each product run eliminates the risk of improperly cleaned product contact parts. The Prevas system is double bagged and is assembled in a class 10,000 cleanroom. It is pre-sterilized with gamma radiation and has a monitoring sticker. The product is completely contained within the system to reduce operator exposure.
"Disposables are a growing trend in the biotech and pharmaceutical processing market," says Jeff Jackson, Director of Product Management Pharma US, Bosch Packaging Technology. "Yet much of that activity has taken place further upstream. The Prevas system combines all the advantages of a disposable application with Bosch's technology and expertise in the liquid filling arena."
About Bosch Packaging Technology
Bosch Packaging Technology, based in Waiblingen (Germany), is the leading suppliers for holistic systems for packaging and process technology. In 14 countries worldwide the company develops, produces and distributes modules and systems for the pharmaceutical, confectionery and cosmetics industries, as well as other food and non-food industries. Learn more under www.boschpackaging.com
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The Bosch Group is a leading global supplier of technology and services. In the areas of automotive and industrial technology, consumer goods, and building technology, some 260,000 associates generated sales of 43.7 billion euros in fiscal 2006. The Bosch Group comprises Robert Bosch GmbH and its roughly 300 subsidiary and regional companies in over 50 countries. This worldwide development, manufacturing, and sales network is the foundation for further growth. Bosch spends more than three billion euros each year for research and development, and in 2006 applied for over 3,000 patents worldwide. The company was set up in Stuttgart in 1886 by Robert Bosch (1861-1942) as "Workshop for Precision Mechanics and Electrical Engineering."
The special ownership structure of Robert Bosch GmbH guarantees the entrepreneurial freedom of the Bosch Group, making it possible for the company to plan over the long term and to undertake significant up-front investments in the safeguarding of its future. Ninety-two percent of the share capital of Robert Bosch GmbH is held by Robert Bosch Stiftung GmbH, a charitable foundation. The majority of voting rights are held by Robert Bosch Industrietreuhand KG, an industrial trust. The entrepreneurial ownership functions are carried out by the trust. The remaining shares are held by the Bosch family and by Robert Bosch GmbH.
Additional information can be accessed at www.bosch.com.
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