How To Optimize Your Weighing Process
Many factors found in the laboratory can influence the behavior of a balance. Learn how to anticipate and regulate them to achieve the ideal settings for your balance and the most reliable weighing results. By Michelle Sheridan, Sales Specialist, Premium Weighing Sartorius Corporation
WHITE PAPERS & CASE STUDIES
Enhancing Isolator H2O2 Decontamination Processes
Hydrogen Peroxide (H2O2) decontamination is the most widely used and accepted form of decontamination in isolators.
Highlights On “Equivalent Time” F0 Sterilization
It has been experimentally shown that the reaction of thermal degradation of micro-organisms obeys the laws of a first order chemical reaction (i.e. like a chemical decomposition reaction) in which the reaction rate is proportional, in each moment, only to the amount of product still to be degraded (or decomposed).
Particle Testing in Cleanroom High-Pressure Gas Lines for ISO 14644
This paper provides guidelines for the testing of high pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines and the EU GMP Guidelines. Specifically, this applications paper relates to satisfying the air particle concentration limits of Class 100 (ISO 5) where product is exposed to the air environment.
Rouge & Biofilm: Compounding Cleaning Challenges
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
Variability In Sterility Test Processes And The Benefits Of Modular Workstations
A review 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.
Be In Control Of Product Quality – Do Not Just Rely, But Understand
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC