HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
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Ready Media in Bottles or Tubes or Slants#4fa25a
Intended Use
Recommended as a sterility test medium also used for cultivation of wide variety of microorganisms and for determining efficiency of sanitization of containers, equipment surfaces, water miscible cosmetics etc.
Composition**
| Ingredients | g/L |
|---|---|
| Tryptone # | 17.000 |
| Soya peptone ## | 3.000 |
| Sodium chloride | 5.000 |
| Dipotassium hydrogen phosphate | 2.500 |
| Glucose monohydrate | 2.500 |
| Polysorbate 80 (Tween 80) | 1.000 |
| Final pH (at 25°C) | 7.3±0.2 |
**Formula adjusted, standardized to suit performance parameters
# Pancreatic digest of casein
## Papaic digest of soybean (soyabean)
Directions
Label the ready to use LQ198CK bottle. Unscrew the cap and inoculate sample. Incubate at specified temperature and time.
Principle And Interpretation
Soyabean Casein Digest Medium is recommended by various pharmacopoeias as a sterility testing and as a microbial limit testing medium (1-5). This medium is a highly nutritious medium used for cultivation of a wide variety of organisms (6). The combination of Tryptone and soya peptone makes the medium nutritious by providing nitrogenous, carbonaceous substances, amino acids and long chain peptides for the growth of microorganisms. Sodium chloride maintains the osmotic balance of the medium. Polysorbate 80 (Tween 80) acts as a neutralizer to inactivate residual disinfectants from where the sample is collected (7). Collection of samples from areas before and after the treatment with disinfectant evaluates cleaning procedures in environmental sanitation. The presence and number of microorganisms is determined by the appearance of colonies on the agar surface. After counting the colonies, carry out biochemical testing for identification.
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 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.
- Further isolation and biochemical tests must be carried out for confirmation.
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 Tryptone Soya Broth w/ 0.1% Polysorbate 80 in glass bottle.
Colour
Light yellow coloured clear solution.
Quantity of Medium
100 ml of medium in glass bottle.
Sterility Check
Passes release criteria
pH
7.10-7.50
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 18-24 hours for bacteria and 5 days for fungal). Growth promotion is carried out as per USP/EP/BP/JP.
| Organism | Inoculum (CFU) | Growth | Incubation temperature | Incubation period |
|---|---|---|---|---|
| Growth promoting | ||||
| Staphylococcus aureus subsp aureus ATCC 6538 (00032*) | 50-100 | luxuriant | 35°C | 18Hours |
| Staphylococcus aureus subsp aureus ATCC 25923 (00034*) | 50-100 | luxuriant | 35°C | 18Hours |
| Escherichia coli ATCC 8739 (00012*) | 50-100 | luxuriant | 35°C | 18Hours |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | luxuriant | 35°C | 18Hours |
| ^Pseudomonas paraaeruginosa ATCC 9027 (00026*) | 50-100 | luxuriant | 35°C | 18Hours |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | luxuriant | 35°C | 18Hours |
| **Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | luxuriant | 35°C | 18Hours |
| $Kocuria rhizophila ATCC 9341 | 50-100 | luxuriant | 35°C | 18Hours |
| Salmonella Typhimurium ATCC 14028 (00031*) | 50-100 | luxuriant | 35°C | 18Hours |
| Salmonella Abony NCTC 6017 (00029*) | 50-100 | luxuriant | 35°C | 18Hours |
| Candida albicans ATCC 10231 (00054*) | 50-100 | luxuriant | 25°C | 2 Days |
| Candida albicans ATCC 2091 (00055*) | 50-100 | luxuriant | 25°C | 2 Days |
| #Aspergillus brasiliensis ATCC 16404 (00053*) | 50-100 | luxuriant | 25°C | 3 Days |
Key: (*) Corresponding WDCM numbers,
**Formerly known as Bacillus subtilis subsp.
spizizenii
$ Formerly known as Micrococcus luteus
# Formerly known as Aspergillus
niger
^ Formerly known as Pseudomonas aeruginosa
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 (8,9).
| Product Name | Soyabean Casein Digest Medium w/ 0.1% Polysorbate 80 |
|---|---|
| SKU | LQ198CK |
| Customized Product Available | No |
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