Culture Media & Rinsing Fluids for Sterility Testing


Now Also Available in Double Packed Format

Merck Millipore sterility media and rinse fluids are a critical component of our Steritest™ solution. They provide the highest level of purity and testing confidence, and have been formulated and tested to meet the requirements of the United States, European and Japanese pharmacopoeias.

"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

Made for Your Confidence and Convenience: Steritest™ Sterility Media and Rinsing Fluids

Steritest™ Sterility Media and Rinse Solutions are manufactured in an ISO 9001, environmentally controlled production center. Each lot is certified for pH, sterility and growth promotion using ATCC strains specified by the USP, EP, and JP, as well as stringent Merck Millipore QC procedures. Our approach to manufacturing ensures all Steritest™ Sterility Media and Rinsing Fluids provide the highest level of clarity for improved reading accuracy, thus significantly reducing the risk of incorrect interpretation and false results.

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/dissolve samples.

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 Millipore, we are able to produce a wide range of customized products and volume sizes, as well as a large choice of bottle closures. 

Sterility Culture Media

Merck Millipore offers the following sterility culture media:
Sterility Culture Media

Soybean-Casein Digest Medium (Trypcase Soy Broth)
The Soybean-Casein Digest Medium, also known as Trypcase 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 non sterile products. Compliant to the USP, EP and JP.

Fluid Thioglycollate Medium
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
Clear Thioglycollate Medium has the same growth promotion properties as the standard FTM and is compliant to the USP, EP and JP. The 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 hazy or opalescent appearance of FTM.

Ordering Information

Download Data Sheet

Rinsing Fluids for Sterility Testing

Rinsing fluidsFluid 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 needed 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.

Ordering Information

Download Data Sheet

Double Packed Sterility Media & Rinse Fluids for Increased Test Method Reliability

Double packaging

Trypcase Soy Broth (Soybean-Casein Digest Medium), Fluid Thioglycollate Medium, Clear Thioglycollate Medium, and USP Rinse Fluid A are also available in double packed format.

The sterilized double Tyvek® packaging allows to streamline the cleaning procedures, to minimize the risk of cross-contamination in laminar flow hoods and to secure an efficient decontamination of isolator chambers. The products are supplied as 100 mL 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.

Ordering Information

Download Data Sheet

 
 
Sterility Testing Media and Rinse Fluids

Data Sheet
Sterility Testing Media
and Rinse Fluids


Download Here
 

Eventos

jul 25
07/25/15 - 07/28/15
IAFP Annual Meeting
Oregon Convention Center
Portland, OR, USA
Purificación de agua,Fabricación biofarmcéutica ,Analítica y preparación de la muestra Norteamérica 20150725
sep 04
09/04/15
SCS Fall Meeting
EPFL Lausanne
Lausanne, Switzerland
Purificación de agua,Reactivos, compuestos químicos y material de laboratorio, Investigación en ciencias de la vida ,Microbiología industrial,Kits de DIV/OEM, materiales y reactivos,Analítica y preparación de la muestra Europa 20150904