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

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VM011G
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Gamma Irradiated sterile powders from 3 different manufacturing lots. Each lot is tested for GPT, Sterility & Filterability for the evaluation of sterility of manufacturing process.

Composition**

Ingredients Gms / Litre
Pancreatic digest of casein 17.000
Papaic digest of soyabean meal 3.000
Sodium chloride 5.000
Dipotassium phosphate 2.500
Dextrose 2.500
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 022 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 (qPCR)
None detected.

Growth Promotion Test
In accordance with the harmonized method of USP/EP.

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

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

Cultural Response

Growth promoting

Organism Growth Incubation period Inoculum (CFU) Incubation temperature
Salmonella Abony NCTC 6017 luxuriant 18-24 hrs 50-100 30-35 °C
Streptococcus pneumoniae ATCC 6305 luxuriant 18-24 hrs 50-100 30-35 °C
Pseudomonas aeruginosa ATCC 27853 luxuriant 18-24 hrs 50-100 30-35 °C
Staphylococcus aureus ATCC 25923 luxuriant 18-24 hrs 50-100 30-35 °C
Escherichia coli ATCC 25922 luxuriant 18-24 hrs 50-100 30-35 °C
Escherichia coli NCTC 9002 luxuriant 18-24 hrs 50-100 30-35 °C
Pseudomonas aeruginosa ATCC 9027 luxuriant 18-24 hrs 50-100 30-35 °C
Bacillus subtilis ATCC 6633 luxuriant 18-24 hrs 50-100 30-35 °C
Staphylococcus aureus ATCC 6538 luxuriant 18-24 hrs 50-100 30-35 °C
Escherichia coli ATCC 8739 luxuriant 18-24 hrs 50-100 30-35 °C
Micrococcus luteus ATCC 9341 luxuriant 18-24 hrs 50-100 30-35 °C
Salmonella Typhimurium ATCC 14028 luxuriant 18-24 hrs 50-100 30-35 °C

Sterility Testing- Growth promotion+Validation

Organism Growth Incubation period Inoculum (CFU) Incubation temperature
Staphylococcus aureus ATCC 6538 luxuriant <=3 d 50-100 20-25 °C
Escherichia coli ATCC 8739 luxuriant <=3 d 50-100 20-25 °C
Escherichia coli NCTC 9002 luxuriant <=3 d 50-100 20-25 °C
Pseudomonas aeruginosa ATCC 9027 luxuriant <=3 d 50-100 20-25 °C
Pseudomonas aeruginosa ATCC 27853 luxuriant <=3 d 50-100 20-25 °C
Micrococcus luteus ATCC 9341 luxuriant <=3 d 50-100 20-25 °C
Staphylococcus aureus ATCC 25923 luxuriant <=3 d 50-100 20-25 °C
Escherichia coli ATCC 25922 luxuriant <=3 d 50-100 20-25 °C
Candida albicans ATCC 2091 luxuriant <=5 d 50-100 20-25 °C
*Aspergillus brasiliensis ATCC 16404 luxuriant <=5 d 50-100 20-25 °C
Bacillus subtilis ATCC 6633 luxuriant <=3 d 50-100 20-25 °C
Salmonella Typhimurium ATCC 14028 luxuriant <=3 d 50-100 20-25 °C
Salmonella Abony NCTC 6017 luxuriant <=3 d 50-100 20-25 °C
Streptococcus pneumoniae ATCC 6305 luxuriant <=3 d 50-100 20-25 °C
Candida albicans ATCC 10231 luxuriant <=5 d 50-100 20-25 °C

Storage and Shelf Life

Store between 10 - 30°C. Use before expiry date on the label.

More Information
Product Name Soyabean Casein Digest Medium, Sterile Powder (Tryptone Soya Broth, Sterile Powder)
SKU VM011G
Customized Product Available No
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