Cleaning, Sterilization & Bio Decontamination White Papers & Case Studies

61. Integration Of Tray Dryers & Nutsche Filter In Containment Isolator System

    Walker Barrier Systems was tasked with providing a system to contain potent and toxic active pharmaceutical compounds to 0.5μg/m³ exposure level (TWA over operation duration), for an existing Lab space. The unit was designed for product filtration, drying in vacuum heat oven, hand sieving and discharging and final dispensing for further processing, using a Hicoflex system, for an existing Laboratory. By Gary Partington

62. Flexibility In Sterility Testing And Managing Risks Of False Positives

    This paper reviews the background to false positives and false negatives associated with the sterility test process. It explores the potential causes of such results and suggests methods of mitigation. By James Drinkwater, Bioquell UK Process & Compliance Director 

63. Unither Pharmaceuticals Deploys Fully Automated Production Line

    Unither is a world leader in the manufacture of formulations for the pharmaceutical industry. Its plant at Gannat, in the Department of Allier, is a specialised production site for manufacture of pharmaceuticals.

64. Top 10 Considerations When Selecting An Isolator Supplier

    While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.

65. 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.

66. Decontaminate A Pharmaceutical Production Facility In Less Than 24 Hours

    Bioquell's Room Bio-Decontamination Service (RBDS) was the only solution for the a major multinational pharmaceutical company that required their production lines within a European manufacturing facility to be sterilized in a short period of time.

67. Decontamination Comparison: Hydrogen Peroxide Vapor (HPV) vs. Ultraviolet Radiation (UVC)

    The fundamental differences between these technologies, in terms of their mode of antimicrobial action and the method of delivery, result in a marked difference in microbiological impact. Bioquell HPV eradicates pathogens on hospital surfaces and achieves a 6-log sporicidal reduction in vitro.

68. Hydrogen Peroxide Decontamination: Vapor Vs. Aerosolized Systems

    When facing a microbial contamination challenge, hether from multidrug-resistant organisms in a hospital or in bio-pharmaceutical production facilities, not all hydrogen peroxide-based decontamination systems are the same.

69. 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

70. Factors To Consider When Selecting Bio-Decontamination Services

    RBDS or Room Bio-decontamination service is not only about the practical side of service delivery. By Yvonne Yeo