Cleaning, Sterilization & Bio Decontamination White Papers & Case Studies

  1. Key Considerations When Purchasing An Ultra-Low Temperature Freezer 2/8/2016

    Ultra-low temperature freezers have a typical service life between twelve and fifteen years. When considering the replacement of a ULT ten years old, or older, there are many variables to consider.

  2. Why Change Is Inevitable In Aseptic Manufacturing 2/2/2016

    The new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs.

  3. Risk Analysis For Aseptic Processing: The Akers-Agalloco Method 9/24/2015

    Aseptic processing in pharmaceuticals is not without its complications. This white paper discusses an easy-to-use aseptic processing method that is based on real-world risk factors.

  4. Key Factors In The Removal Of Bacterial Endotoxins And A Cleaning Strategy 7/7/2015

    This article discusses the removal of bacterial endotoxins in a washing process and the need for a continuous monitoring activity according to common cleaning validation practices. Results of washing tests performed with different load materials following an effective cleaning strategy to remove microbiological soil are presented. In addition, this paper compares two different online assay methods: conductivity analysis and Total Organic Carbon analysis.

  5. Rouge & Biofilm: Compounding Cleaning Challenges 9/18/2014

    Rouge may facilitate the development of more tenacious biofilms. Both rouge and biofilm represent cleaning and decontamination challenges to manufacturers. By Michael Gietl and Paul Lopolito

  6. A Prominent BSL3 Required A Solution With Extremely High Biodecontamination Standards 7/4/2013

    There are many methods of biodecontamination available on the market today. Each method has its advantages and disadvantages depending upon the scope of the project and desired level of bioburden reduction. In this particular case, a very high standard was set.

  7. Drastically Reduced Isolator Decontamination Cycles 2/28/2013

    With the use of catalytic aeration, M + P is able to reduce the duration of the aeration phase in isolators by about 50 %. The aeration phase is the most time consuming cycle during H2O2 decontamination. By Felix Henning, Optima Packaging Group GmbH 

  8. Emerging Fourth Generation Pharmaceutical Containment Technologies 2/25/2013

    Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional clean room facilities of the 20th century are being rapidly replaced with advanced barrier based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients. By Sterling Kline, RA IPS

  9. Materials Of Construction For Biopharmaceutical Water Systems 1/15/2013

    Stainless steels are uniquely qualified for bioprocessing applications not only because of their long service life, availability, and fabricability, but also because they are non-corroding, non-contaminant, can be polished to very smooth finishes, are strong and rigid, can withstand heat and chemical sterilization treatments, and are easily welded. By Michelle M. Gonzalez

  10. Alternatives to Traditional Fume Hoods: Ductless Enclosures And Fume Hoods 12/20/2012

    Safety is the primary purpose of any filtered enclosure or ventilated fume hood. In most situations, fume hoods remain the equipment of choice for ventilating hazardous airborne chemicals from the laboratory. By Gary Roepke, Senior Project Engineer, Labconco Corporation