Sterility testing

Our sterility testing Culture Media and Rinsing Fluids are a critical component of your Steritest™ solution. They provide the highest level of quality and testing confidence, they have been formulated and tested to meet the requirements of the USP <71>, EU Pharmacopoeia < 2.6.1> and JP Pharmacopoeia <4.06>. Steritest™ sterility Culture Media and Rinsing Fluids are manufactured in an ISO 9001, environmentally controlled production center. Each lot undergoes a stringent quality control (QC) procedure, including pH, sterility and growth promotion tests according to USP, EP and JP methods. Our manufacturing approach ensures the highest level of clarity for our culture media and rinsing fluids, therefore improving accuracy and significantly reducing the risk of incorrect interpretation and false results.

The Isolator facilitates the isolation of a product or process while providing the required sterile/aseptic environment. It is factory-configured to operate at positive or negative pressure in single or recirculating airflow. This equipment provides a comprehensive range of personnel and product protection in addition to the surrounding work areas and the environment.

- CRM Vitroids™ and LENTICULE® reference strains contain live microbial strains with confirmed concentrations (accredited according to ISO/IEC 17025), produced under standardized conditions, and reproducible in compliance with ISO 17034:2016 regulations.- Maximum number of generations: 3, cross-referenced with ATCC and WDCM – Shelf life of 16 - 24 months.

S-Pak Filters 0.45 µm 47 mm white gridded are made from mixed esters of cellulose and have been optimized for MF method microbiological analysis of water or other liquids

Automated, rapid detection and enumeration of microbial contamination based on ATP bioluminescence

Designed to integrate perfectly into all testing environments, streamlining your workflow, maximizing safety and convenience.