Optimize Your Contamination Control Strategy in Pharmaceutical Microbiology
Advanced Solutions for Effective Microbial Detection and Control
Effective contamination control is essential in pharmaceutical microbiology to ensure product safety and purity. Our solutions support your contamination control strategy with regulatory-compliant equipment and consumables. From microbial enumeration and sterility testing to microbial air monitoring, we provide the tools needed to identify viable microorganisms at every production stage, minimizing risks and ensuring compliance.
Filtration of Viscous Samples for Microbiological Quality Control
Microbial enumeration via membrane filtration is challenging with viscous, oily substances. Pharmacopoeial guidelines suggest temperature adjustment or dilution. This study examined temperature and dilution effects on filtration rates of viscous oils. Microsart® @filter units' material allows sample dilution in isopropyl myristate, enabling rapid filtration at room temperature
DownloadKey Strategies for Ensuring Reliable and Compliant Sterility Testing in Pharmaceutical Labs
Sterility testing ensures sterile products are free from viable microorganisms, confirming batch suitability for release. This guide covers best practices, focusing on membrane filtration and minimizing false negatives. It includes validation, compliance with standards, and advanced tools like Sterisart® Universal Pump. Rapid detection methods, including qPCR, are also discussed.
DownloadAir Monitoring in Cleanroom Environments by Gelatin Filters according to EN 17141 and ISO 14698
Controlled environments are classified by airborne particle concentrations, with limits for viable and non-viable particles. Biocontamination control strategies are essential per standards like EN 17141 and EU GMP Annex 1. This note shows that microbial air monitoring via Gelatin Membrane Filtration meets EN 17141 and ISO 14698 requirements.
DownloadBenchmarking of Two Real-Time PCR-Based Rapid Sterility Testing Kits
Advanced Therapy Medicinal Products (ATMPs) require sterility testing for bacterial and fungal contamination before administration. PCR-based rapid sterility tests enhance patient safety by reducing turnaround time from 14 days to hours. This note compares the Microsart® ATMP Sterile Release kit with another PCR solution for sensitivity and convenience.
DownloadEnumeration of Clostridium perfringens— Microbiological Performance Testing of Membrane Filters in Accordance with EN ISO 7704:2023
The revised EN ISO 7704:2023 standard outlines performance testing for membrane filters in water quality analysis. It requires demonstrating filter suitability with each culture medium batch. This study tests membrane filters per EN ISO 7704:2023, using EN ISO 14189, and examines media impact on productivity. The Sartorius high flow membrane filters were found to comply with the new EN ISO 7704:2023 standard.
DownloadThe Sterisart® Septum Enables Reliable Sampling from a Closed System Sterility Testing Unit
This study evaluated the Sterisart® closed system sterility testing device with a septum for repeated sterile sampling. The results show that the septum remains intact and the media sterile after more than 100 samplings. The Sterisart® septum allows easy inoculation and sampling, integrating conventional sterility testing with rapid detection methods.
DownloadSterility Testing Redefined
This playbook details our history of sterility testing since the 1960s and highlights the Sterisart® portfolio, including canisters and the 4th Generation Universal Pump. It provides guidance on canister selection for specific applications, lists available accessories and provides access to our service team. Informative content supports confident decision-making for sterility testing solutions.
DownloadEquivalency of PCR-Based Rapid Sterility Testing and the Compendial Culture Method According to Ph. Eur. 2.6.1., JP 4.06 and USP
This study compared the microbial detection of Microsart® ATMP Bacteria and Fungi PCR Kits with compendial sterility testing. Samples spiked with various bacteria and fungi showed full equivalence to traditional methods. In particular, Microsart® ATMP Fungi showed higher sensitivity in the detection of Candida albicans, confirming its effectiveness in sterility testing.
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