Sabouraud Media Protect Pharmaceutical Production Processes Against Yeast and Mould

Sabouraud Liquid Medium and Sabouraud Dextrose Agar from Thermo Scientific are widely favoured by many microbiologists in the pharmaceutical industry for the reliable cultivation and differentiation of yeasts and moulds.

These culture media have applications in environmental monitoring and sterility testing, enabling corrective measures to be implemented rapidly if unacceptable levels of microbial loading indicate lapses in process control.

Sabouraud Liquid Medium (order ref CM0147) is a mycological sterility test medium which can also be used to determine the fungistatic activity of pharmaceutical products. It may additionally be used for the cultivation of yeasts and moulds (e.g. Candida albicans and Aspergillus niger) and acidophilic bacteria. The medium conforms to the recommendations of the US Pharmacopoeia (USP) for determination of fungistatic activity in order to avoid false sterility tests (ref 1).

Sabouraud Dextrose Agar (order ref CM0041) is an acidic pH medium for the isolation of dermatophytes, other fungi and yeasts, and is available as a prepared medium with or without neutralisers. This modification of Sabouraud medium (as described by Gwendoline Carlier – ref 2) has been shown to give reliable results with Microsporum audouini, Microsporum canis, Trichophyton mentagrophytes, Trichophyton flavum, Trichophyton rubrum and Candida albicans.

The fungi maintain their typical cultural appearance and may thus be readily identified according to the standard macroscopic characters described by Sabouraud (ref 3). Sabouraud Dextrose Agar may also be used as the basis of a Pagano-Levin medium (ref 4) for the isolation of Candida albicans.

Like all Thermo Scientific culture media, both Sabouraud Liquid Medium and Sabouraud Dextrose Agar undergo quantitative quality control testing, using a low-dose inoculum to ensure optimum performance. Full product specifications can be provided on request.

Sterility testing is widely employed in the pharmaceutical industry to provide assurance that production areas and processes being used do not pose a threat of microbial contamination. The favoured method for the manufacture of sterile pharmaceutical products includes a terminal sterilisation process, such as steam sterilisation or irradiation, but many types of product are unable to withstand such treatment. In these cases, it is necessary to employ aseptic filling techniques which operate in a controlled, rather than sterile environment and are therefore susceptible to contamination. Thermo Scientific’s Sabouraud Liquid Medium and Sabouraud Dextrose Agar provide a reliable means of monitoring contamination levels to relevant industry standards in respect of yeasts and moulds.

References
1. United States Pharmacopoeia: 1995 Sterility Testing
2. Carlier Gwendoline I.M. (1948) Brit. J. Derm. Syph. 60. 61-63
3. Sabouraud R. (1910) ‘Les Teignes’, Masson, Paris 4. Pagano J., Levin J.G. and Trejo W. (1957-58) Antibiotics Annual 1957-58. 137-143.