Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended use
Recommended as a general purpose medium used for cultivation of a wide variety of microorganisms from pharmaceutical products in accordance with harmonized method of USP/EP/BP/JP/IP.
Composition
| Ingredients | g / L |
|---|---|
| Tryptone # | 15.000 |
| Soya peptone ## | 5.000 |
| Sodium chloride | 5.000 |
| Agar | 15.000 |
| pH after sterilization (at 25°C) | 7.3±0.2 |
Formula adjusted, standardized to suit performance parameters
# Pancreatic digest of casein## Papaic digest of soyabean (soybean)
Directions
Soyabean Casein Digest Agar is a ready to use solid media in glass bottle. The medium is pre-sterilized, hence it does not need sterilization. Medium in the bottle can be melted either by using a pre-heated water bath or any other method. Slightly loosen the cap before melting. When complete melting of medium is observed dispense the medium in tubes as butts /slants or in plates as desired and allow to solidify. If on plate, either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically.
Principle And Interpretation
Various pharmacopoeias recommend Soyabean Casein Digest Agar as sterility testing medium. It is used in validation of sterility checking procedure in accordance with the microbial limit testing harmonized methodology of USP/EP/BP/JP/ IP (1-5). The medium is also used in microbial limit test and antimicrobial preservative- effective test. The combination of tryptone and soya peptone makes these media nutritious by providing amino acids and long chain peptides for the growth of microorganisms. Natural sugars of soya enhance growth of microorganism. Sodium chloride maintains the osmotic balance in the medium. Agar is the solidifying agent. The total aerobic count is considered to be equal to the number of colony forming units found on this medium, if colonies of fungi are detected on this medium they are counted along with total aerobic count.
Type of specimen
Pharmaceutical samples
Specimen Collection and Handling
For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per pharmaceutical guidelines (1-5). After use, contaminated materials must be sterilized by autoclaving before discarding.
Warning and Precautions
Read the label before opening the container. Wear protective gloves/protective clothing/eye protection/face protection. Follow good microbiological lab practices while handling specimens and culture. Standard precautions as per established guidelines should be followed while handling clinical specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations
- Individual organisms differ in their growth requirement and may show variable growth patterns on the medium.
- Each lot of the medium has been tested for the organisms specified on the COA. It is recommended to users to validate the medium for any specific microorganism other than mentioned in the COA based on the user's unique requirement.
Performance and Evaluation
Performance of the medium is expected when used as per the direction on the label within the expiry period when stored at recommended temperature.
Quality Control
Appearance: Sterile glass bottle containing slightly opalescent Soybean-Casein Digest Agar.
Colour of medium: Light yellow coloured coloured medium
Quantity of medium: 250 ml of medium in glass bottle.
pH: 7.10-7.50
Sterility Check: Passes release criteria
Growth Promotion Test
Growth Promotion was carried out in accordance with the harmonized method of USP/EP/BP/JP, and growth was observed after an incubation at 30-35°C for 18-24 hours for bacteria and <=5 days in case of fungi. Recovery rate is considered 100% for bacteria growth on Soyabean Casein Digest Agar and fungus growth on Sabouraud Dextrose Agar.
Growth promoting properties
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 <=100 cfu (at 30-35°C for <=18 hours for bacteria and <=5 days for fungi). Growth of fungal cultures is also observed at 20-25°C for <=5 days.
Cultural Response
| Organism | Inoculum (CFU) | Observed Lot Recovery value (CFU) | Incubation period | Incubation temperature | |
|---|---|---|---|---|---|
| **Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Escherichia coli ATCC 8739 (00012*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Salmonella Abony NCTC 6017 (00029*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| $ Kokuria rhizophila ATCC 9341 | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Salmonella Typhimurium ATCC 14028 (00031*) | 50-100 | 35-100 | >=70% | 18-24 hrs | 30-35 °C |
| Candida albicans ATCC 10231 (00054*) | 50-100 | 35-100 | >=70% | <=5 d | 30-35 °C |
| Candida albicans ATCC 2091 (00055*) | 50-100 | 35-100 | >=70% | <=5 d | 30-35 °C |
| #Aspergillus brasiliensis ATCC 16404 (00053*) | 50-100 | 35-100 | >=70% | <=5 d | 30-35 °C |
| Candida albicans ATCC 10231 (00054*) | 50-100 | 35-100 | >=70% | <=5 d | 20-25 °C |
| Candida albicans ATCC 2091 (00055*) | 50-100 | 35-100 | >=70% | <=5 d | 20-25 °C |
| #Aspergillus brasiliensis ATCC 16404 (00053*) | 50-100 | 35-100 | >=70% | <=5 d | 20-25 °C |
| $$Clostridium sporogenes ATCC 19404 (00008*) | 50-100 | 35-100 | >=70% | <=48 hours | 30-35 °C |
Key: (*) Corresponding WDCM numbers
V Formerly known as Pseudomonas aeruginosa
$ Formerly known as Micrococcus luteus
** Formerly known as Bacillus subtilis subsp. spizizenii
# Formerly known as Aspergillus niger
$$ Incubated anaerobically
Storage and Shelf Life
On receipt store between 15-30°C. Use before expiry date on the label. Product performance is best if used within stated expiry period.
Disposal
User must ensure safe disposal by autoclaving and/or incineration of used or unusable preparations of this product. Follow established laboratory procedures in disposing of infectious materials and material that comes into contact with sample must be decontaminated and disposed of in accordance with current laboratory techniques (6,7).
| Product Name | Soyabean Casein Digest Agar |
|---|---|
| SKU | SMH290CCL |
| Customized Product Available | No |
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