Culture Media & Rinsing Fluids

 
 

Culture Media & Rinsing Fluids for Sterility Testing

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Steritest™ Sterility Media and Rinsing Fluids

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 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 culture media and rinsing fluids, therefore improving accuracy and significantly reducing the risk of incorrect interpretation and false results.


Sterility Culture Media



Sterility Culture Media

Soybean-Casein Digest Medium (Trypticase Soy Broth) 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. A high visual clarity medium is preferred by many users, when compared with the slightly turbid appearance of FTM.

Culture Media Bottle Closure Volume (mL) Qty/Pk Catalog 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
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
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

Rinsing Fluids for Sterility Testing


Double Packed Sterility Media & Rinse Fluids

Fluid A 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 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 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 Isopropylmyristate (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 Catalog Number
USP Rinse Fluid A          Screw cap with septum 900 mL 4 STBMRFA94
600 mL 4 STBMRFA64
300 mL 4 STBMRFA34
100 mL 12 STBMRFA12
Screw cap with septum –
double packed
100 mL 12 STBMRFA12DP
Crimp cap with septum 600 mL 6 Contact us
300 mL 6 1.46415
100 mL 12 1.46470
USP Rinse Fluid D Screw cap with septum 300 mL 4 STBMRFD34
Crimp cap with septum 300 mL 6 1.46483
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 1.46628

Double Packed Sterility Media & Rinse Fluids



Rinsing Fluids for Sterility Testing

Double Packaging Sterility culture media and rinsing fluids are also available in double packed format.
The sterilized double Tyvek® packaging facilitates cleaning and 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 Catalog Number
Trypticase Soy Broth, TSB
(Soybean-Casein Digest Medium)
Screw cap with septum –
double packed
600 mL 12 STBMTSB12DP
Fluid Thioglycollate Medium, FTM Screw cap with septum –
double packed
300 mL 12 STBMFTM12DP
Clear Thioglycollate Medium, CTM Screw cap with septum –
double packed
100 mL 12 STBMCTM12DP
USP Rinse Fluid A Screw cap with septum –
double packed
100 mL 12 STBMRFA12DP

Customized for Special Applications

If a specific modification is required for your application, please feel free to contact us. With our multipurpose filling lines at Merck, we are able to produce a wide range of customized products and volume sizes, as well as a large choice of bottle closures.


A Broad Product Range and Multiple Formats for All Your Sterility Testing Applications

All sterility 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 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/dissolve samples. Detailed certificates of quality are available to download from our 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:
  • Higher sterility assurance level thanks to the sterilized double packaging
  • Easier and faster cleaning procedures"
-- PHAM Hoang, Biology QC Manager, Virbac, France

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