Sterility Testing Culture Media & Rinsing Fluids

Steritest™ culture media and rinsing fluids

Our sterility 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 media and rinse solutions 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 media and rinsing fluids, therefore improving accuracy and significantly reducing the risk of incorrect interpretation and 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

Sterility testing culture media

Culture Media for Sterility TestingSoybean-Casein Digest Medium (Trypticase Soy Broth, TSB) is suitable for the culture of both fungi and aerobic bacteria. This medium is used for sterility testing by membrane filtration or by direct inoculation. It is also used as pre-enrichment broth for nonsterile products. Compliant to the USP, EP and JP.

Fluid Thioglycollate Medium (FTM) is primarily intended for the detection of anaerobic bacteria. However, it also enables aerobic bacterial detection. This medium is used for sterility testing by membrane filtration or direct inoculation as described in the USP, EP and JP.

Clear Thioglycollate Medium has the same growth promotion properties as the standard FTM and is compliant to the USP, EP and JP. This alternative formulation brings extra visual clarity versus the FTM which has a slight turbidity or haze due to presence of agar. A high visual clarity medium is preferred by many users, when compared with the slightly turbid appearance of FTM.

 

Medium Solution Bottle Closure Volume (mL) Qty/pk Product Number
Trypticase Soy Broth, TSB (Soybean-Casein Digest Medium) Screw cap with septum 100 mL 12 STBMTSB12
  Screw cap with septum – double packed 100 mL 12 STBMTSB12DP
  Crimp cap with septum 100 mL 10 1.46317
  Screw cap with 3 mini septa 100 mL 10 1.46458
  Tube, screw cap with 2 mini septa 9 mL 20 1.46432
  Tube, screw cap with 2 mini septa 9 mL 100 1.46432
Fluid Thioglycollate Medium, FTM Screw cap with septum 100 mL 12 STBMFTM12
  Screw cap with septum – double packed 100 mL 12 STBMFTM12DP
  Crimp cap with septum 100 mL 10 1.46406
  Tube, screw cap with 2 mini septa 10 mL 20 1.46139
  Tube, screw cap with 2 mini septa 10 mL 100 1.46139
  Tube, screw cap with 2 mini septa 9 mL 20 1.46220
  Tube, screw cap with 2 mini septa 9 mL 100 1.46220
Clear Thioglycollate Medium, CTM Screw cap with septum 100 mL 12 STBMCTM12
  Screw cap with septum – double packed 100 mL 12 STBMCTM12DP
  Crimp cap with septum 100 mL 10 1.46456
  Red screw cap and septum 100 mL 10 1.46333

Other volumes might be available as customized products, please contact us

Rinsing fluids for sterility testingSterility testing rinse fluids

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 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)Sterile Isopropyl myristate (IPM) is suitable for improving dissolution of viscous products, ointments and creams prior to membrane filtration

 

Rinse fluid solution bottle Closure Volume (mL) Qty/pk Product number
USP Rinse Fluid A Screw cap with septum 600 mL 4 STBMRFA64
  Crimp cap with septum 600 mL 6 Contact us
  Screw cap with septum 300 mL 4 STBMRFA34
  Crimp cap with septum 300 mL 6 1.46415
  Screw cap with septum 100 mL 12 STBMRFA12
  Screw cap with septum – double packed 100 mL 12 STBMRFA12DP
  Crimp cap with septum 100 mL 10 1.46470
USP Rinse Fluid D Crimp cap with septum 300 mL 6 1.46483
  Screw cap with septum 300 mL 4 STBMRFD34
USP Rinse Fluid K Screw cap with septum 300 mL 4 STBMRFK34
  Crimp cap with septum 300 mL 6 Contact us
Sterile Isopropyl myristate (IPM) Crimp cap with septum 360 mL 6 146628

Other volumes might be available, please contact us

Double packed sterility media & rinse fluids

Double packed Sterility Testing Media & Rinse FluidsSterility testing culture media and rinsing fluids are also available in double packed format.

The sterilized double Tyvek® packaging helps to minimize the risk of cross-contamination in laminar flow hoods and to secure an efficient decontamination of isolator chambers. These products are supplied as 100 mL screw cap bottles, screw cap 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.

 

Medium and Rinse fluid bottle Closure Volume (mL) Qty/pk Product Number
Clear Thioglycollate Medium Screw cap with septum – double packed 100 mL 12 STBMCTM12DP
Fluid Thioglycollate Medium Screw cap with septum – double packed 100 mL 12 STBMFTM12DP
Trypcase Soy Broth (Soybean-Casein Digest Medium) Screw cap with septum – double packed 100 mL 12 STBMTSB12DP
USP Rinse Fluid A Screw cap with septum – double packed 100 mL 12 STBMRFA12DP

Customized sterility culture media for special applications

If none of the above products are appropriate for your application, we also offer tailor-made products. Indeed, with our multipurpose filling lines, we are able to produce a wide range of customized products and volume sizes, as well as a large choice of bottle closures.

Customized sterility culture media request form

A broad product range and multiple formats for all your sterility testing applications

All sterility 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 of 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 are available to download from our website.

IPM can be used in combination with the green Steritest™ canister.

 

"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:
  • Higher sterility assurance level thanks to the sterilized double packing
  • Easier and faster cleaning procedures"
— PHAM Hoang, Biology QC Manager, Virbac, France

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