HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
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Intended use
For sterility testing of highly viscous or gelatinous substances such as salves, ointments and other cosmetic product.
Composition**
| Ingredients | g/L |
|---|---|
| Tryptone | 20.000 |
| Azolectin | 5.000 |
| Polysorbate 20 (Tween 20) | 40.00 |
**Formula adjusted, standardized to suit performance parameters
Directions
Label the ready to use LQ203C bottle. Inoculate the 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 and United States Pharmacopoeia (1,2) 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 (3). Preservatives are used in aqueous products to make them self-sterilizing for vegetative bacteria, yeasts and moulds, and bacteriostatic or bactericidal for spores (3).
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.
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 (4). After incubation, subculture the growth on MacConkey Agar (M081) and TSI Agar (M021).
Type of specimen
Pharmaceutical & Industrial sample: salves, ointments and other cosmetic product.
Specimen Collection and Handling
For Pharmaceutical, Industrial samples follow appropriate techniques for handling specimens as per established guidelines (1,2).
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
- Due to nutritional variation, certain species may show poor growth.
- Further isolation and biochemical tests should 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 T.A.T. Medium in a glass bottle.
Colour: Light yellow coloured clear to slightly opalescent solution
Quantity of Medium: 100 ml of medium in glass bottle.
pH: 7.00-7.40
Sterility Check: Passes release criteria
Cultural Response: Cultural characteristics observed 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 | good-luxuriant |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | fair-good |
| Staphylococcus aureus subsp. aureus 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 Pseudomonas aeruginosa
$Formerly known as Bacillus subtilis subsp. spizizenii
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 (5,6).
| Product Name | T.A.T. Broth |
|---|---|
| SKU | LQ203C |
| Customized Product Available | No |
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