Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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T.A.T. Broth with Tween 20
For sterility testing of highly viscous or gelatinous substances such as salves, ointments and other cosmetic products, in accordance with US Pharmacopoeia
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Sterility Testing#CC293D
Intended Use
Recommended for sterility testing of highly viscous or gelatinous substances such as salves, ointments and other cosmetic products, in accordance with USP.
Composition**
| Ingredients | g/L |
|---|---|
| Tryptone | 20.000 |
| Lecithin | 5.000 |
**Formula adjusted, standardized to suit performance parameters
Directions
Suspend 25.0 grams in 960 ml purified/distilled water and add 40 ml of Tween 20. Heat if necessary to dissolve the medium completely. Dispense into tubes or flasks as desired. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.
Principle And Interpretation
T.A.T. Broth is prepared according to the formula recommended by United States Food and Drug Administration and United States Pharmacopoeia (1,2) for enrichment and further isolation and cultivation of gram-negative bacteria in cosmetics, tropical drugs and sterility testing of viscous or gelatinous substances.
Type of specimen
Pharmaceutical and Cosmetics samples for sterility testing.
Specimen Collection and Handling:
Prepare decimal dilutions of the sample to be tested from 10-1 to 10-6. Inoculate 1 gram (1 ml) sample and 1 ml of each dilution into 40 ml of T.A.T. Broth (3). After incubation subculture the growth on MacConkey Agar (MH081) and TSI Agar (MU021). 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 :
- Further biochemical and serological tests must be carried out for further identification.
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
Off-white to yellow homogeneous free flowing powder
Colour and Clarity of prepared medium
Light yellow coloured clear to slightly opalescent solution
Cultural Response
Cultural characteristics observed with added Polysorbate 20 after an incubation at 35-37°C for 24-48 hours.
| Organism | Inoculum (CFU) | Growth |
|---|---|---|
| $ Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | good-luxuriant |
| Candida albicans ATCC 10231 (00054*) | 50-100 | fair-good |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | good-luxuriant |
| Salmonella Typhi ATCC 6539 | 50-100 | good-luxuriant |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | good-luxuriant |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | good- luxuriant |
Key: *Corresponding WDCM numbers.
$ Formerly known as Bacillus subtilis subsp. spizizenii
^ Formerly known as Pseudomonas aeruginosa
Storage and Shelf Life
Store between 10-30°C in a tightly closed container and the prepared medium at 20-30°C. Use before expiry date on the label. On opening, product should be properly stored dry, after tightly capping the bottle in order to prevent lump formation due to the hygroscopic nature of the product. Improper storage of the product may lead to lump formation. Store in dry ventilated area protected from extremes of temperature and sources of ignition. Seal the container tightly after use. 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 (4,5).
| Product Name | T.A.T. Broth with Tween 20 |
|---|---|
| SKU | MU562 |
| Product Type | Regular |
| Physical Form | Powder |
| Origin | Animal |
| Packaging type | HDPE |
| References | 1. Food and Drug Administration, 1969, Procedure for Examination of Tropical Drugs and Cosmetics. 2.Orth, 1993, Handbook of Cosmetic Microbiology, Marcel Dekker, Inc., New York, N.Y. 3.MacFaddin J. F., 1985, Media for Isolation-Cultivation-Identification-Maintenance of Medical Bacteria, Vol. I, Williamsand Wilkins, Baltimore. |
| Customized Product Available | No |
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