Soybean casein digest medium

Tryptic soya broth (soybean-casein digest medium) for normal media fill run... 

In the membrane filtration method, the product samples are put aseptically into a volume of non-inhibitory diluent and then passed through a sterile 0.45 pm membrane filter (Fig. 1). The membrane is rinsed through with additional volumes of diluent, then aseptically cut in half. Half is transferred to a container of soybean casein digest medium (SCDM) and the other to fluid thioglycollate medium (FTM). 

Sterility tests are normally performed by incubating the sample with fluid thioglycollate medium at 30-35° C for 14 days or with soybean-casein digest medium at 20-25° C for 14 days. The sample volume should be as large as that for human dosage. If bacterial growth is observed in either test, the preparation is considered asterile. For PET radiopharmaceuticals, these tests must be started within 24 h after the release of the product. 

Doolan and coworkers [18] used three compendial recovery conditions to construct survival curves for naturally contaminated medical devices soybean casein digest medium incubated at 20-25 C, the same incubated at 30-35 C. and fluid ihioglycollatc medium incubated at 30-35 C for 14 days. Three tests for sterility therefore constituted the basis for observing the presence of viable microorganisms in three replicate conditions making up one sample. 

Frieben et al. [2] filled vials with Soybean Casein Digest Medium, sealed them, and then immersed them inverted in a suspension of 10 Escherichia coli... 

CULTURE MEDIUM SOYBEAN-CASEIN DIGEST DEHYDRATED 500 GRAMS 6550011561629 BT 2363 ... 

Media-hlled vials (soybean casein digest broth or fluid thioglycollate medium) are hlled on the hlling line, transported to the freeze drier, loaded into the chamber, subjected to a simulated lyophilization process, stoppered, sealed, and incubated for 14 days at 25°C. The minimum number of vials to be used is 5000. 

Soybean casein digest broth shall be used for normal media runs, but thioglycolate broth shall be used for the detection of anaerobic organisms, especially when a filtered nitrogen purge is used to ensure anaerobic conditions. Prepare the media according to manufacturing direction. Adjust pH the medium is sterilized by 0.2 p. Sterile filtration technique is used. 

Each filling trial should consist of at least 3000 items (it is normal practice to exceed the minimum to account for breakages, etc.). The medium of choice is Soybean Casein Digest Broth VSP. Where necessary, for instance in antibiotic filling processes where, no matter how effective the cleaning, residues cannot be excluded, an inactivating agent (e.g., penicillinase) should be added to the medium at an appropriate concentration. 

The technique of membrane filtration is used whenever the nature of the product permits. The membrane is transferred to the growth medium, or the medium is transferred onto the membrane. Alternatively, the prepared sample is inoculated directly into the appropriate media. This method is only used when the product (e.g. some vaccines) cannot be dissolved or diluted in a nontoxic diluent. The media used are fluid thioglycolate medium (FTM) for aerobic, micro-aerophilic and anaerobic bacteria, and Soybean casein digest broth (SCDB) for aerobic bacteria and fungi. FTM and SCDB are incubated at 30-35 °C and 20-25 °C respectively, both for a period of not less than 14 days. This relatively long incubation period seems to be justified, because an unacceptable proportion of contaminants would be missed by limiting incubation to 7 days [60]. 

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