Sterility testing is a key GMP microbiology testing requirement for sterile pharmaceuticals, medical devices, and materials to ensure safety from viable microorganisms before release and administration. Sterility testing is required during the sterilization validation process, as well as for routine release testing. These tests are either carried out by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment.
Compendial methods for the sterility testing of pharmaceutical products requires samples to be cultured using specific culture media. Our sterility testing media and rinsing fluids are critical components of Steritest® solution. They provide the highest level of quality and testing confidence and have been formulated complying with the USP 71, EU Pharmacopoeia 2.6.1, and JP Pharmacopoeia 4.06 requirements. The culture media and rinse fluids used for sterility testing are manufactured in an ISO 9001, environmentally controlled production center. Each batch undergoes a stringent quality control (QC) procedure, including pH, sterility, and growth promotion tests following the USP, EP, and JP methods. Our manufacturing approach of culture media and rinsing fluids ensures the highest level of clarity, thus improving accuracy and significantly reducing the risk of false results.
Our Steritest® culture media and rinsing fluids combined with our closed membrane filtration devices, peristaltic pump, and specific accessories offer an optimized and fully regulatory-compliant testing process.
Steritest® canisters, when combined with our Steritest® culture media and rinsing fluids, offer a high quality, reliable and fully regulatory compliant testing process. All the sterility testing steps such as filtration, rinsing, media transferring, and incubation can be performed within the Steritest® NEO closed system - reducing the risk of cross-contamination.
Getting your sterility needs for filtration, rinsing, and incubation from one supplier simplifies the process, ensures convenience, and streamlines the process for sterility testing.
Membrane filtration and direct inoculation are two recommended methods of sterility testing for pharmaceuticals, and this requires samples to be cultured in different culture media that can promote the growth of residual anaerobes, as well as aerobes and fungi. The samples are incubated for 14 days at 32.5 °C and 22.5 °C respectively, before the examination. The turbidity in the culture media may indicate growth and must be investigated. The commonly used culture media are:
Soybean-Casein Digest Medium (Trypticase Soy Broth, TSB) is a sterility testing media suitable for the detection of aerobic bacteria and fungi. The composition and growth performance of this medium comply with the USP, EP, and JP standards. It is also used as pre-enrichment broth for non-sterile products.
Fluid Thioglycollate Medium (FTM) is primarily intended for the detection of anaerobic bacteria. However, it also enables the detection of aerobic bacteria. The USP, EP, and JP have recommended the media for determining the phenol coefficient and sporicidal effect of disinfectants in antibiotics, biologicals, etc. However, it is intended for the examination of clear liquid or water-soluble materials.
Clear Thioglycollate Medium has the same growth promotion properties as the standard FTM and is compliant with the USP, EP, and JP. This alternative formulation brings extra visual clarity versus the FTM, which has slight turbidity or haze due to the presence of agar. A high visual clarity medium is preferred by many users when compared with the slightly turbid appearance of FTM.
Ensure a constant supply of culture media manufactured in a high-production quality center in Molsheim, France. Also, the production and quality control standards of the media are the same as our Steritest® devices. The manufacturing process is designed to minimize visible particles – improving reading accuracy and reducing the risk of false results. Steritest® canisters and culture media are tested and validated together to work seamlessly for reliable results.
Rinse fluid is used as a diluting or rinsing solution for membrane filtration sterility testing in pharmaceutical products. Our ready-to-use rinse solutions provide the highest level of quality and testing confidence. They have been formulated and tested to meet the pharmacopeia requirements. Rinsing fluids are used for sterility testing of medical devices by flushing the hollow tubes, such as transfusion and infusion assemblies, where the fluid pathway is labeled as sterile.
Fluid A is suitable as a general rinse buffer and compatible with most samples. Excellent for dissolving or diluting samples, reconstituting commercial microorganisms, or as a transport medium for microorganisms.
Fluid D is suitable for testing samples that contain lecithin or oil and are compatible with most antibiotics. Excellent for rinsing sterile pathways of devices and typically used for rinse method testing of medical devices.
Fluid K is suitable for testing samples that contain petrolatum, oils, or oily solutions. Excellent for rinsing pathways of medical devices and for samples that are “difficult” to filter or dissolve.
Sterile Isopropyl myristate (IPM) is suitable for improving the dissolution of viscous products, ointments, and creams before membrane filtration.
The sterilized double Tyvek® packaging helps to minimize the risk of cross-contamination in laminar flow hoods and to secure efficient decontamination of isolator chambers. These products are supplied as 100 mL screw cap bottles and screw caps with septum closure. The sterilization efficiency of the packaging, including the space between the protective cap and the septum, is verified on each batch with biological indicators. With the double-packed media and rinse solutions:
The rinse bottle features an optimal rimless cap, designed to minimize the risk of cross-contamination and growth inhibition. Additionally, the bottle uses a softer rubber septum to reduce the chance of coring. We use special packaging for shipment to protect bottle integrity and not impact supply. The double packaging optimizes the cleaning workflow and minimizes false positive-negative results.
We offer tailor-made products if none of the above products are appropriate for your application. Indeed, with the multipurpose filling lines, we can produce a wide range of customized products and volume sizes, as well as a large choice of bottle closures. You can adapt an existing formula or request a product with your individual formulation made from scratch.
Steritest®culture media and rinse solutions are validated and packaged in convenient test volumes, with aseptically designed septum closures (screw caps or flip caps) for ease of operation, thus fulfilling all your sterility and bioburden testing needs.
Fluids A, D, and K can be used in combination with the Steritest® sterility testing system or for bioburden testing to rinse membranes and dilute or dissolve samples. Detailed certificates of quality (COQ) are available to download from the website.
"The use of double packed Steritest® culture broths TSB and FTM for sterility testing is a great improvement in terms of sterility assurance, standardization and cost saving:
— PHAM Hoang, Biology QC Manager, Virbac, France
Discover our full sterility testing portfolio based on over 45 years of experience and expertise. Our large variety of devices and pumps, along with sterile culture media and rinsing fluids can help you to stay compliant, whether you use membrane filtration or direct inoculation methods. Reduce the sterility testing workload and focus on your critical lab activities thanks to our extended Steritest® services portfolio. The experienced application and validation engineers will assist in method development and validation implementation within the QC microbiology laboratory. They will also provide basic and advanced technical training on sterility testing, in person or remotely.
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