Culture Media & Rinsing Fluids for Sterility Testing

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.

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.

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.