Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended use
Recommended a general purpose medium for cultivation of wide variety of organisms and for inactivation of penicillins, cephalosporins of first, second, third and fourth generation and penems.
Composition
| Tryptone # | 15.000 |
| Soya peptone ## | 5.000 |
| Sodium chloride | 5.000 |
| Agar | 15.000 |
| ẞ Lactamase mixture | 500.000IU |
| Final pH (at 25°C) | 7.3±0.2 |
**Formula adjusted, standardized to suit performance parameters
# Equivalent to Pancreatic digest of casein, ##Papaic digest of soyabean
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). Tryptone Soya Agar with ẞ Lactamase mixture is used in plates for the detection and enumeration of microorganisms present on surfaces of sanitary importances and also in environmental monitoring of clean room for facilities where production of Cephalosporins is carried out. Tryptone and soya peptone provide nitrogenous compounds and other nutrients essential for microbial replication. ẞ Lactamase mixture added in the medium will inactivate the penicillins, cephalosporins of first, second, third and fourth generation and penems, thus enabling the growth of resistant strains present in the environment of clean rooms where production of antibiotics is carried out.
Type of specimen
Pharmaceutical samples
Specimen Collection and Handling:
For Pharmaceutical samples follow appropriate techniques for sample collection, handling and processing as per pharmacopoeias (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 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 Soyabean Casein Digest Agar w/ ẞ-lactamase mixture in 55mm scored disposable plates with convex surface and absence of black particles/ cracks/bubbles. (Gamma irradiated, Triple pack)
Colour
Light yellow coloured medium.
Quantity of Medium
20ml of medium in 55 mm scored plate.
Sterility Check
Passes release criteria
pH
7.10-7.50
Dose of Irradiation (Kgy)
13.00-20.00
Cultural Response
Growth Promotion Test of as such plates was carried out and growth was observed after incubation at 30-35°C for <= 3 days in case of bacteria and <= 5 days in case of fungi. Simultaneously growth promotion test was carried out on plates which were seeded with 100 mcg/ml of respective antibiotics.
Recovery Rate
Recovery rate is considered 100% for bacteria growth on Soyabean Casein Digest Agar
| Organism | Inoculum (CFU) | Growth | Lot value (CFU) | Incubation temperature | Incubation period | Recovery |
|---|---|---|---|---|---|---|
| Escherichia coli ATCC 25922 (00013*) | ||||||
| w/o antibiotic | 50-100 | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% |
| w/ Cephalothin | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Cefamandole | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Cefotaxime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Ceftazidime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Cefepime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Imipenem | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | ||||||
| w/o antibiotic | 50-100 | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% |
| w/ Cephalothin | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Cefamandole | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Cefotaxime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Ceftazidime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Cefepime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/ Penicillin | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| Staphylococcus aureus subsp. aureus ATCC 29213 (00131*) | ||||||
| w/o antibiotic | 50-100 | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% |
| w/Penicillin | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | ||||||
| w/o antibiotic | 50-100 | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% |
| w/Cefotaxime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/Ceftazidime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/Cefepime | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| w/Imipenem | Luxuriant | 35-100 | 30-35 °C | 18-24 hrs | >=70% | |
| Candida albicans ATCC 10231 (00054*) | ||||||
| 50-100 | luxuriant | 35-100 | 30-35 °C | <=5 d | >=70% | |
| Candida albicans ATCC 2091 (00055*) | ||||||
| 50-100 | luxuriant | 35-100 | 30-35 °C | <=5 d | >=70% | |
| #Aspergillus brasiliensis ATCC 16404 (00053*) | ||||||
| 50-100 | luxuriant | 35-100 | 30-35 °C | <=5 d | >=70% | |
| #Aspergillus brasiliensis ATCC 16404 (00053*) | ||||||
| 50-100 | Luxuriant | 35-100 | 20-25 °C | <=5 d | >=70% | |
Key: * - Corresponding WDCM numbers, (#) - Formerly known as Aspergillus niger
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/ β-Lactamase mixture (Tryptone Soya Agar Plate w/ β-Lactamase mixture) (γ-irradiated)(Triple Pack) |
|---|---|
| SKU | SP1804GT |
| Customized Product Available | No |
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