Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Liquid Medium in Tubes#4fa25a
Intended Use
It is 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 |
| Dibasic potassium phosphate | 2.500 |
| Glucose monohydrate | 2.500 |
| Soya lecithin | 5.000 |
| Tween 80 | 10.000 |
| Final pH (at 25°C) | 7.3±0.5 |
#- Equivalent to Pancreatic digest of casein, $-Equivalent to Papaic digest of Soyabean meal
Formula adjusted, standardized to suit performance parameters
Directions
Label the ready to use LQ257IX bottle. In sterile environment, unscrew the bottle. Inoculate or add the sample to be tested. mix the sample well. Incubate at specified temperature for specified time. For GPT testing inoculate 50-100 cfu inoculum & incubate at specified temperature.
Principle And Interpretation
Soybean Casein Digest Medium is recommended as a sterility testing medium in accordance with the harmonized method of USP/EP/BP/JP/IP (1-5). In LQ257IX, addition of soya lecithin and polysorbate 80 acts as neutralizers. It is used for the sensitivity testing of antimicrobial agents by the tube dilution method (6). It is also employed in diagnostic research in microbiology.
The combination of tryptone and soya peptone makes this medium nutritious by providing nitrogenous and carbonaceous compounds, long chain amino acids and other essential nutrients for the growth of microorganisms. Natural sugars in soybean promote growth of fastidious organism. Glucose monohydrate is the fermentable carbohydrate and dibasic potassium phosphate serves as the buffer in the medium. Sodium chloride maintains the osmotic balance of the medium. Lecithin and polysorbate 80 (Tween 80) are neutralizers reported to inactivate residual disinfectants from where the sample is collected (7). Lecithin neutralizes quaternary ammonium compounds and polysorbate 80 neutralizes phenolic disinfectants, hexachlorophene, formalin and with lecithin ethanol (8). This medium is recommended for sterility checking.
Type of specimen
Pharmaceutical and cosmetic samples
Specimen Collection and Handling
For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per guidelines and local standards (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 Medium w/0.5% Soya Lecithin & 1% Polysorbate 80 in a glass bottle.
Colour: Light yellow to amber coloured opaque solution (Turbidity does not affect the performance of the medium)
Quantity of Medium: 9ml of medium in wide mouth glass bottle.
pH: 6.80 -7.80
Sterility Check: Passes release criteria
Growth promoting properties
Clearly visible 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.
| Organism | Inoculum (CFU) | Growth |
|---|---|---|
| Escherichia coli ATCC 25922(00013*) | 50-100 | luxuriant |
| Escherichia coli ATCC 8739 (00012*) | 50-100 | luxuriant |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | luxuriant |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | luxuriant |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | luxuriant |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | luxuriant |
| **Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | luxuriant |
| Salmonella Typhimurium ATCC 14028 (00031*) | 50-100 | luxuriant |
| Salmonella Abony NCTC 6017 | 50-100 | luxuriant |
| $Kocuria rhizophila ATCC 9341 | 50-100 | luxuriant |
| Candida albicans ATCC 10231 (00054*) | 50-100 | luxuriant |
| Candida albicans ATCC 2091 (00055*) | 50-100 | luxuriant |
| #Aspergillus brasiliensis ATCC 16404 (00053*) | 50-100 | luxuriant |
(*) 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
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 (9,10).
| Product Name | Soyabean Casein Digest Medium w/0.5% Soya lecithin & 1% Polysorbate 80 |
|---|---|
| SKU | LQ257IX |
| Customized Product Available | No |
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