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About Baker > Custom Engineered > Pharmaceutical Manufacturing Equipment
ParenteralGARDTM
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ParenteralGARDTM | This innovative concept provides many of the benefits of a complete barrier isolation system without rigorous and risky validation requirements and at a very attractive price. Dramatic improvements in sterility assurance levels up to 100 times cleaner when compared to a conventional ISO Class 5 (Class 100) cleanroom with a gowned operator are readily achieved.
The ParenteralGARDTM integrated system in combination with aseptic filling machines is designed to provide significant, reliable reduction in both total airborne particulates and viable counts in the critical zones of your aseptic process.
Specialty Isolators
Examples of The Baker Company’s work in the pharmaceutical manufacturing area are described below. In both cases, Baker engineers worked directly with engineers from major pharmaceutical companies to design and validate specialized isolators to meet the specific manufacturing requirements.
Sterile Potent Compound Filling Line Isolator
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Sterile Potent Compound
Filling Line Isolator | In this case, the manufacturer of a highly potent, injectable chemotherapy drug required an isolator to enclose its filling line. The Baker Company responded by building the country’s first three-chamber negative pressure filling line isolator that offered personnel, product and environmental protection. Our client also required integration with a UV tunnel for vial entry and an active exit “mousehole” for the continuous exiting of filled and stoppered vials.
This ground-breaking Isolator gained quick FDA approval and has been in continuous operation since 1996.
Classed Capping Isolator
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Classed Capping Isolator | Working closely with our client, the filling machine manufacturer, the conveyor system fabricator and the capping machine vendor, The Baker Company managed all aspects of equipment integration. The result was a complete synergistic system that provided a sensible and seamless process flow. The classed capping isolator provides a physical barrier between the operators and the product during filling and capping operations while insuring ISO Class 5 (Class 100) conditions. The Baker Company specially designed a “point of source” exhaust plenum at the capper crimping rail to capture particles. This technique captures contamination as it is generated and prevents upstream migration of viable and nonviable particulate. The vial exit mousehole is configurable to allow the fine tuning of exiting air with different vial sizes. The isolator is equipped with 22 gloveports so that all interior surfaces are reachable with a gloved hand.
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