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 for cultivation of wide variety of organisms and for inactivation of cephalosporins of first, second, third and fourth generation.
Composition**
| Ingredients | Gms / Litre |
|---|---|
| Tryptone | 15.000 |
| Soya peptone | 5.000 |
| Sodium chloride | 5.000 |
| Agar | 15.000 |
| ẞ-Lactamase II | 500 IU |
| Final pH (at 25°C) | 7.30±0.2 |
**Formula adjusted, standardized to suit performance parameters
Directions
Either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically on the plate.
Principle And Interpretation
Soyabean Casein Digest Agar is recommended by various pharmacopoeias and is in accordance with the microbial limit testing harmonized methodology of USP/EP/BP/JP/IP (1-5).Tryptone Soya Agar with ẞ-Lactamase II 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 II added in the medium will inactivate the ẞ-lactam antibiotics 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 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 hr 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.
- Further biochemical testing is required for complete identification.
- 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 plate with ẞ - lactamase II in 90mm disposable plates with smooth surface and absence of black particles/ cracks/ bubbles
Colour of medium
Light yellow coloured medium.
Quantity of Medium
30ml of medium in 90mm plates.
pH
7.10 -7.50
Sterility Check
Passes release criteria
Cultural Response
Growth Promotion Test of plates without antibiotic was carried out and growth was observed after incubation at 30-35°C for <= 3 days. Simultaneously growth promotion test was carried out on plates which were seeded with 1 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% | |
Growth promoting
| Organism | Inoculum (CFU) | Growth | Lot value (CFU) | Incubation temperature | Incubation period | Recovery |
|---|---|---|---|---|---|---|
| Bacillus subtilis ATCC 6633 (00003*) | 50-100 | luxuriant | 35-100 | 30-35 °C | <=5 d | >=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
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 II (Tryptone Soya Agar Plate w/ β-Lactamase II) |
|---|---|
| SKU | MP1805 |
| Customized Product Available | No |
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