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Sterility Testing Culture Media & Rinsing Fluids

All-in-One Validated Solution for Sterility Testing

Sterility testing is a crucial requirement in GMP microbiology for ensuring the safety of sterile pharmaceuticals, medical devices, and materials. It is performed to detect viable microorganisms before their release and administration.

Our sterility testing media and rinsing fluids are essential components of the Steritest® solution. They comply with the requirements of USP 71, EU Pharmacopoeia 2.6.1, and JP Pharmacopoeia 4.06. This ensures a robust supply chain, high-quality media, accuracy, and reduces the risk of false results.

Our Steritest® culture media and rinsing fluids combined with Steritest® canisters and Steritest® Symbio pump and accessories offer a reliable and fully compliant testing process. It allows for filtration, rinsing, media transferring, and incubation within the Steritest® NEO closed system, minimizing the risk of cross-contamination. Special packaging is employed to protect bottle integrity during shipment without impacting supply. The double packaging further optimizes the cleaning workflow and minimizes false positive-negative results.

Manufactured in an ISO 9001, environmentally controlled production center, our culture media and rinse fluids undergo stringent quality control procedures, including tests for pH, sterility, and growth promotion according to USP, EP, and JP methods.

Sterility Testing Culture Media

Sterility testing culture media

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)

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)

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

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.

 

Table 1. Sterility testing culture medium solution. Click on the product number to learn more.

Sterility Testing Rinse Fluids and Solvent

Sterility Testing Rinsing Fluids

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

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

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

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)

Sterile Isopropyl Myristate (IPM) can be used in combination with the green Steritest® canister to improve the dissolution of viscous products, ointments, and creams before membrane filtration.

Table 2. Sterility testing rinse fluid solution with packaging information. Click on the product number to learn more.

Sterility Testing Double-packed Culture Media and Rinse Solutions

Double-packed Sterility Testing Culture Media and Rinse Fluids

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:

  • Streamline and optimize the cleaning procedures
  • Minimize the risk of cross-contamination and false results
  • Reduce the bioburden load on the testing environment
  • Secure efficient decontamination of isolator chambers
Table 3. Sterility testing culture media and rinse fluid solution with sterilized double Tyvek® packaging. Click on the product number to learn more.

CUSTOMIZED CULTURE MEDIA FOR SPECIAL APPLICATIONS

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.

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