IMA Life at the Pharma Microbiology Congress | 23-24 November 2022 (virtual) and 30 November 2022 (Milan, Italy)
IMA Life is pleased to take part in the Pharma Microbiology Congress, the European annual meeting point of professionals involved in the sterile manufacturing of medicinal products and medical device.
A full immersion on the latest regulatory updates, new technologies for the detection and containment of contamination, best practice and strategies to improve the sterility assurance of the manufacturing and control of sterile medicines.
Do not miss IMA Life presentation on November 23, 2022 at 12:35 PM.
PRESENTATION TITLE AND ABSTRACT
Enzyme Indicators: Real application and evaluation of a new system for rapid monitoring and validation of Vapor Hydrogen Peroxide Decontamination Process.
Enzyme Indicators (EIs) are strips of thermostable Adenylate kinase (tAK), an enzyme that has been found to be inactivated by VPHP (Vapour Phase Hydrogen Peroxide) in dose and time dependence, with advantages of having rapid result (within minutes) and using not viable organisms. This presentation will describe tests performed with Enzyme indicators in order to investigate indicator variability and correlation to biological indicators. All tests were executed in the IsoTechLab isolator pilot, which is a complete real isolator filling production line with automatic VPHP decontamination cycles.
Alessandra Benassi Alessandra holds a Pharmacy degree from the University of Bologna. She deals with sterility assurance within IMA Life and also follows the validation of VHP cycles in isolated aseptic lines.
She joined IMA Life in 2013; previously she worked in the field of quality assurance in a pharmaceutical company.
Giancarla holds a biology degree from Federico II University of Naples. She is sterility assurance specialist at IMA Life and also follows the validation of VPHP decontamination cycles in isolated aseptic lines.
She joined IMA Life in 2014; previously she worked for six years in the quality assurance and validation group at an Italian pharmaceutical company.