Containment & Isolation White Papers & Case Studies
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Fumigation Within A Pharmaceutical Aseptic Filling Line
Bioquell's Room Bio-Decontamination Service was required for a major multi-national pharmaceutical company needed a solution that woul removed Staphylococcus edpdermidis from specific zones in an aseptic filling line with areas ranging from European GMP Grade A to Grade D. The solution neeeded to meet FDS regulatory requirements and have proven efficacy documentation againt S. epidermidis.
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Variability In Sterility Test Processes And The Benefits Of Modular Workstations
This paper reviews some of the current operational practices that incorporate sterility testing and provides an insight into the role of hydrogen peroxide vapor bio-decontamination and continuous particle monitoring. By James Drinkwater, Bioquell UK Process & Compliance Director
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Advantages Of Gamma Irradiation For Effective Sterilization Methods
Many sterilization methods are available for pharmaceuticals, healthcare devices, and labware, including steam, sterile-filtration, ethylene oxide, vapor-phase hydrogen peroxide, electron-beam irradiation, and gamma irradiation. Each technique needs to be evaluated before use based on various criteria. Most importantly, one must consider how the technique will affect the final product characteristics and performance. By Betty Howard, Radiation TechTeam Manager, STERIS Isomedix Services
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Strategies For Gamma Sterilization Of Pharmaceuticals
A crucial step in pharmaceutical production is sterilization. There are many sterilization methods to choose from, such as steam, sterile filtration, ethylene oxide gas (EtO), electron beam (E-beam), and gamma radiation. Each technique has aspects that make it suitable or unsuitable for the sterilization of a particular product. By Ruth Garcia, Betty Howard, Rose LaRue, Glenn Parton, and John Walker, Steris Isomedix Services
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Ultraviolet Disinfection: Crucial Link In The Sterilization Chain
Many manufacturers face the challenge of maintaining sterile products and processes. In most cases, there’s no one-size-fits-all solution. By Alex Verayo
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How To Reduce Cleanroom Costs
As cleanrooms grow in size and sophistication, energy demands go up significantly. Even worse, 24/7/365 operation puts substantial particulate loads on filters, increasing maintenance costs and possibly causing unpredictable – and expensive – cleanroom maintenance shutdowns. By Alex Verayo
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Real-Time Facility Monitoring For Quality And Compliance
A facility monitoring system is a process monitoring tool that collects data from sensors called particle counters. Over time, as reliability of particle counting instruments evolves, this creates opportunities to implement real-time quality control strategies. This leads to quality-based monitoring and immediate decision-making to reliably produce high quality drugs without excessive regulatory oversight.
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Designing An Effective Pharmaceutical Containment Blending System
The same pharmaceutical Intermediate Bulk Container (IBC) that is used for shipping and storage can also be used for blending.
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Surrogate Testing Of A Downflow Booth Complete With Integrated Tray Dryer
Walker Barrier Systems was tasked with providing two downflow booths, each with integrated tray dryer (client provision) mounted in the side wall. The booth was to be used for filling trays with wet cake, as well as the dispensing of dried product from the trays into drums using a custom designed “tray dispensing hopper”.
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Container Closure Integrity Testing For Prefilled Syringes
In this article, we highlight our current thinking in an attempt to devise a systematic approach for CCI testing method selection, development, and validation.