EPM: Outline the expertise you offer in sterility testing.
OM: For 40 years, we have been helping our customers to develop, improve and validate their sterility test methods. The knowledge we’ve accumulated is really valuable to help our customers through seminars (the ‘Steritest schools’) and application services. It’s also helpful for us to design and improve test devices fitting to multiple sample containers and compatible with many formulations.
EPM: What are the key developments that have taken place in this field during the 40 years you have been carrying out this service?
OM: First of all, Merck Millipore invented the concept of a pre-sterilised closed filtration chamber to protect the sample from external contamination. We made the sterility testing reliable. This is highly critical for our customers, knowing that a false positive test result requires a thorough investigation and that retests are allowed by the current Pharmacopeias only under very specific circumstances.
We have constantly improved our devices, firstly by sealing the filter membrane to the canister wall to avoid sample bypass and adsorption of inhibitory products on the filter edge. Another action against false negative risks was to extend the filter offering with the PVDF membrane, a low binding material recommended to filter and efficiently rinse antibiotics. We have also introduced a device resistant to solvents. We are still the only ones on the market to offer those unique features!
EPM: How does Steritest benefit lab technicians?
OM: Our customers will find among our extensive range of needle adapters and accessories the device that best fits their needs. The Steritest devices, operated on our advanced filtration pumps, are designed to maximize safety and convenience for microbiologists around the world. Thanks to our double-packed filtration devices and media, the packaging decontamination before loading the testing environment can be skipped. The technicians save time and again reduce false positive risks.
EPM: What is the secret to the company's success?
OM: We’ve always listened to our customers in order to create easy-to-use products that provide reliable results and streamline their testing workflow.
In addition, we are helping them to ensure compliance. Our service experts provide a comprehensive range of application and validation services (ready-to-use validation protocol compliant to GMP/GLP requirements, on site IQ/OQ execution and PQ consultancy). I should not forget the maintenance agreements ensuring hardware reliability over time. We have developed a real partnership with our customers.
What's next for the coming 40 years?
I am excited to announce that the sixth generation of Steritest pumps will be launched soon; reliable sterility testing will become even easier! Forty years is just a beginning.