HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
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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 | Gms/Litre |
|---|---|
| Tryptone | 20.000 |
| Azolectin | 5.000 |
| Final pH (at 25°C) | 7.2±0.2 |
**Formula adjusted, standardized to suit performance parameters
Directions
Label the ready to use LQ525IX bottle. Inoculate 50-100 cfu sample and Incubate at specified temperature and time.
Principle And Interpretation
T.A.T. Broth is prepared according to the formula recommended by United States Food and Drug Administration (1) for enrichment and further isolation and cultivation of gram-negative bacteria in cosmetics, tropical drugs and in the sterility testing of viscous or gelatinous substances. It is especially adapted for the testing of cosmetics.
Cosmetics and pharmaceutical products are subject to contamination during manufacturing and subsequent use by consumers (2). Preservatives are used in aqueous products to make them self-sterilizing for vegetative bacteria, yeasts and moulds, and bacteriostatic or bactericidal for spores (2).
Tryptone provides the nitrogen, vitamins, amino acids and carbon in T.A.T. Broth Base. Azolectin and polysorbate 20 neutralize preservatives in the cosmetics or pharmaceutical products, allowing bacteria to grow.
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 (MP081) and TSI Agar (M021). 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: Sterile T.A.T. Broth in a glass bottle.
Colour: Light yellow coloured clear to slightly opalescent solution.
Quantity of Medium: 9ml of medium in glass bottle.
Sterility test: Passes release criteria
pH: 7.00-7.40
Cultural Response
Cultural characteristics observed after an incubation at 35-37°C for 24-48 hours with added Polysorbate 20.
| Organism | Inoculum (CFU) | Growth |
|---|---|---|
| ##Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | good-luxuriant |
| Candida albicans ATCC 10231 (00054*) | 50-100 | good-luxuriant |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | fair-good |
| Staphylococcus aureus subsp. ATCC 25923 (00034*) | 50-100 | good-luxuriant |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | good-luxuriant |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | fair-good |
Key: *Corresponding WDCM numbers. ## - Formerly known as Bacillus subtilis subsp. spizizenii ^ Formerly known as Pseudomonas aeruginosa
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 (4,5).
| Product Name | TAT Broth |
|---|---|
| SKU | LQ525IX |
| Customized Product Available | No |
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