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 (Medium 2).
Composition**
| Ingredients | g/L |
|---|---|
| Tryptone # | 15.000 |
| Soya peptone ## | 5.000 |
| Sodium chloride | 5.000 |
| Glycerol | 10.000ml |
| 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
Either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically on the plate.
Principle And Interpretation
Various pharmacopoeias recommend Soybean Casein Digest Agar as sterility testing medium. It is also used in validation of sterility checking procedure in accordance with the microbial limit testing harmonized methodology of USP/EP/BP/JP/IP (1-5). This medium is 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 soy enhance growth of microorganism. Sodium chloride maintains the osmotic balance in the medium. Agar is the solidifying agent. Glycerol helps in retaining moisture of plates. 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 pack. 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 specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations
- Individual strain of a microorganism may have unique growth requirements with respect to nutrients and physical conditions. Based on which the growth pattern of each varies on a medium and some even may display significant delay in development.
- Environmental Monitoring Test : Exposure of media plates for 4 h as a settle plate or in air sampler or even under laminar air flow may lead reduction in some available moisture on the surface. This may cause development of tiny cracks in the agar or slight shrinkage. This however, does not impact the performance of the media.
- 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.
- It is recommended to store the plates at 24-30°C to avoid minimum condensation.
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 Soybean Casein Digest Agar w/ 1% Glycerol in 55mm scored disposable plates with convex surface and absence of black particles/ cracks/ bubbles. (γ-irradiated)
Colour of medium
Light yellow coloured medium
Quantity of medium
20 ml of medium in 55 mm scored disposable plates.
pH
7.10-7.50
Dose of irradiation (Kgy)
13.00-20.00
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 <=3 days for bacteria and <=5 days for fungus. 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). Growth is also observed at 20-25°C for <=5 days for fungus.
Cultural Response
| Organism | Inoculum (CFU) | Growth | Observed Lot value (CFU) | Recovery | Incubation temperature | Incubation period |
|---|---|---|---|---|---|---|
| Growth promoting | ||||||
| **Bacillus spizizenii ATCC 6633 (00003*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Escherichia coli ATCC 25922 (00013*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Escherichia coli ATCC 8739 (00012*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Pseudomonas aeruginosa ATCC 27853 (00025*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Salmonella Abony NCTC 6017 |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| $ Kokuria rhizophila ATCC 9341 |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Salmonella Typhimurium ATCC 14028 (00031*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 18-24 hrs |
| Candida albicans ATCC 10231 (00054*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | <=5 d |
| Candida albicans ATCC 2091 (00055*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | <=5 d |
| #Aspergillus brasiliensis ATCC 16404 (00053*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | <=5 d |
| Candida albicans ATCC 10231 (00054*) |
50-100 | luxuriant | 35-100 | >=70% | 20-25 °C | <=5 d |
| Candida albicans ATCC 2091 (00055*) |
50-100 | luxuriant | 35-100 | >=70% | 20-25 °C | <=5 d |
| #Aspergillus brasiliensis ATCC 16404 (00053*) |
50-100 | luxuriant | 35-100 | >=70% | 20-25 °C | <=5 d |
| Clostridium sporogenes ATCC 19404 (00008*) |
50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | <=48 hours |
Key: (*) Corresponding WDCM numbers.
^ Formerly known as Pseudomonas aeruginosa
# Formerly known as Aspergillus niger
**Formerly known as Bacillus subtilis subsp. spizizenii
$Formerly known as Micrococcus luteus
Storage and Shelf Life
On receipt store between 20-30°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 Plate w/ 1% Glycerol (γ-irradiated) |
|---|---|
| SKU | SPH290GG |
| Customized Product Available | No |
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