Contact plates and swabs are common methods for surface monitoring in aseptic production. The published recovery rates for swabs and contact plates can vary strongly due to differences in methods, surfaces and test microorganisms.
The manufacturing of drugs in isolators is a growing trend, and due to the stringent requirements, microorganisms must be detected at very low numbers from the surfaces, such as stainless steel, but also isolator gloves, e.g. made from Neoprene®.
Tim Cser, Sr. Technology Specialist, gives insight on this study that proves the suitability of ICR Swabs and contact plates TSA w. LTHThio ICR+ to detect low numbers of several bacteria strains from stainless steel and Neoprene®. The ICR Swab is designed for presence/absence tests on difficult to access surfaces, where ICR contact plates are used for enumeration of microorganisms on flat surfaces in cleanrooms and isolators. As reference, an agar overlay method was chosen to determine the number of surviving microorganisms.
Based on our results, both methods are suitable for the detection of low levels of bacteria on Neoprene® gloves and Stainless Steel surfaces.
Sr. Technology Specialist
Tim Cser is a Senior Technology Specialist with Merck. Tim graduated in 1997 from Cal Poly, San Luis Obispo with a degree in Microbiology with an emphasis on Industrial Microbiology. Tim started his career with Clorox working on antimicrobial effectiveness studies. He continued his career at Biolog where he gained 7 years of experience with microbial identifications. For the last 14 years he’s worked at Merck in a variety of roles involving Pharmaceutical/Biotech QC Microbiology.
Session 1:presented December 7, 2021
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