Cleaning, Sterilization & Bio Decontamination White Papers & Case Studies

  1. Essentials Of Moist Heat Sterilization Kinetics

    The F0 algorithm was firstly introduced 1968 in the international practice of food industry, and proposed by FDA in 1976 for the pharmaceutical sterilization of Large Volume Parenterals: it is now officially included in most Pharmacopoeias.

  2. Continued Process Verification Methods In Cleaning Validation

    An increasing interest in continued process verification has led to the spread of on-line assay methods in cleaning processes. This paper deals with two different on-line applications: conductivity sampling and the Total Organic Carbon analysis for washing machines.

  3. Disinfectant Validation: A Roadmap For Regulatory Compliance

    By Carol A. Burnett, Jim Polarine, Jr., Elaine Kopis Sartain, and David J Shields.

    The U.S. FDA (United States Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), HPRA (Health Products Regulatory Authority) and CFDA (China Food and Drug Administration), amongst others, routinely make observations about disinfectant validation studies and disinfectant practices.

  4. What You Should Know About Pharmaceutical Cleaning Validation

    Learn the basics of cleaning validation, as well as the kinds of support services you should seek from suppliers of critical cleaning products in order to optimize your cleaning validation process.