Soyabean Casein Digest Medium, Sterile Powder (Tryptone Soya Broth, Sterile Powder)

Intended Use

Soyabean Casein Digest Medium, Sterile powder is a gamma (g) irradiated sterile powder recommended for the evaluation of sterility in manufacturing process.

Composition**

Final pH (at 25°C): 7.3±0.2

**Formula adjusted, standardized to suit performance parameters

Directions

Sterile powder can be used directly for the evaluation of sterility in manufacturing process. For sterile liquid medium aseptically add 30 grams in 1000 ml sterile distilled / purified water. Heat if necessary to dissolve the medium completely. DO NOT AUTOCLAVE OR OVERHEAT. Excessive heating is detrimental. Dispense aseptically in sterile tubes or flasks as desired.

Note: If any fibres are observed in the solution it is recommended to filter the solution through 0.22 micron filter to eliminate any possibility of presence of fibres.

Principle And Interpretation

Soyabean Casein Digest Medium is recommended by various pharmacopoeia as sterility testing medium (1, 2). It is also used for the sensitivity testing by the tube dilution method for antimicrobial agents (3).

The combination of pancreatic digest of casein and papaic digest of soyabean meal makes this medium nutritious by providing amino acids and long chain peptides for the growth of microorganisms. Dextrose and dipotassium phosphate serves as the carbohydrate source and the buffer in the medium. Sodium chloride maintains the osmotic balance of the medium.

Quality Control

Appearance: Cream to yellow may have green tinge homogeneous free flowing powder

Colour and Clarity of prepared medium: Light amber coloured clear solution

Reaction: Reaction of 3.0% w/v aqueous solution at 25°C. pH: 7.3±0.2

pH: 7.10-7.50

Sterility Testing: No growth is observed after 14 days for Bacteria at 30-35°C and for Fungi at 20-25°C.

Test for Mycoplasma (PCR): Negative for Mycoplasma

Stability test: Light yellow coloured clear solution without any precipitation or sedimentation at room temperature for 7 days

Growth promoting properties: Clearly visible growth of microorganism comparable to that previously obtained with previously tested and approved lot of medium occurs at the specified temperature for not more than the shortest period of time specified inoculating <=100cfu (at 30-35°C for 18-24 hours).

Sterility Testing + Validation

The medium is tested with suitable strains of microrganisms inoculating <=100cfu and incubating at 20-25℃ for not more than 3 days in case of bacteria and not more than 5 days in case of fungi.

Cultural Response

Growth promoting

Sterility Testing- Growth promotion+Validation

Storage and Shelf Life

Store below 30°C and the prepared medium at 2-8°C. Use before expiry date on the label.

Reference

1. The United States Pharmacopoeia / National Formulary, 2012, 35.The United States Pharmacopeial Convention Inc., Rockville, MD.
2. Indian Pharmacopeia, 2010, Govt. of India, Ministry of Health and Family Welfare, New Delhi, India.
3. Wright and Welch, 1959-60, Antibiotics Ann., 61.