Process – Validation of a Cascading Retort Product - 4 ounce plastic cups of fruit in syrup Retort - Cascading Retort, 7 racks with each rack holding 12 trays Overview A total of 9 loggers were used in this study, 3 MPRF (Micropack Radio Frequency) temperature and 6 MPIII (Micropack III) temperature loggers. The MPRF loggers were programmed with a 5 second interval and the 6 MPIII loggers were ...
Considerations in the Use of DataTrace RH Data Loggers for Monitoring Ethylene Oxide Sterilization Processes
Data loggers that measure relative humidity (RH) and temperature are routinely used in Ethylene Oxide (EO) sterilization processes for validation and routine monitoring. An understanding of the effects of EO exposure on the sensing element of the RH data logger is critical to the ...
When it comes to the steam sterilization of liquid media, there are a number of user concerns that are handled in various ways. Monitoring these cycles with biological indicators (BIs) and the various restrictions and cycle modifications that are done can lead to a false positive or failed cycle. Here are only a few of the cycle modifications done or restrictions applied by users for the steam ...
The use of advanced monitoring technologies in four key aspects of EtO sterilization can yield substantial business and regulatory benefits.
The use of ethylene oxide (EtO) gas has long been a dominant mode of terminal sterilization. Today, close to half of all medical devices produced in the United States are processed with EtO.
Asset Management Organizations today are under tremendous pressure to increase productivity and efficiency, reduce total cost of ownership, and focus on core business competencies. To meet these business objectives, many are looking to external business partners to manage non-core business competencies, especially in the area of instrument and equipment management, service and support. In today’s ...
In a typical cell culture process for making therapeutics, cultures need to be closely monitored for their viability, genetic stability, production potential, and for potential contamination. It is essential that the levels of key nutrients and metabolites as well as cell concentration be known. This allows the operator to maintain the culture appropriately, by using the correct feeding strategy ...
Process variability is a leading cause in biopharmaceutical batch failure and impacts the value and profitability of the industry. Thermo Fisher Scientific controls inherent variability through the use of the Thermo Scientific Antaris line of Fourier transform near-infrared (FT-NIR) spectrometers.
DASGIP develops and manufactures technologically advanced Parallel Bioreactor Systems for the cultivation of microbial and mammalian cells at bench top scale. www.dasgip.com
o Parallel operation of 4, 8 or more vessels o Suitable for cell cultivation and microbial fermentation o Control hardware optimized for small scale process development o Hard- and software designed for efficient parallel ...
The Micropack III DataTrace system from Mesa Laboratories was found to provide highly accurate temperature measurements for up to one year and longer. By analyzing routine recertification data collected in Mesa's calibration laboratory it was demonstrated that 70% of the temperature data loggers maintained their published accuracy specification of +/- 0.1°C for one year or more, and 99% of the ...
Close control of the EtO sterilization process is required to ensure the safety of medical devices. Requirements for validation and control of EtO sterilization have increased substantially in recent years. The ANSI/AAMI/ISO (American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization) 11135 standard "Medical ...
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