Cleaning, Sterilization & Bio Decontamination White Papers & Case Studies

  1. Pharma Manufacturers Should Get Cleaning Validation Support From Supplier 2/2/2017

    Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost reduced if the cleaner supplier can provide support.

  2. Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help? 10/14/2016

    In aseptic manufacturing, laser induced fluorescence shows great potential to replace growth-based methods in certain manufacturing paradigms — highly automated, near-continuous processes.

  3. Integrating New Containment Technologies Into Large Sampling Areas 8/23/2016

    To allow a pharma facility to maintain regulatory compliance with ISO 5 conditions ensuring product protection, a positive to ambient pressure regime was used within the airlocks.

  4. Purchasing Laboratory Equipment: New vs. Used 3/4/2016

    The purchase decision should not be taken lightly, or solely driven by price. Careful consideration is necessary before venturing into the used resale market for biological lab equipment.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.