Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended Use
(y irradiated) Recommended for the evaluation of sterility in manufacturing process in accordance with USP.
Composition
| Ingredients | g/L |
|---|---|
| Tryptone | 15.000 |
| Yeast extract | 5.000 |
| Dextrose monohydrate | 5.500 |
| Sodium chloride | 2.500 |
| L-Cysteine | 0.500 |
| Sodium thioglycollate | 0.500 |
| pH after sterilization | 7.1±0.2 |
Formula adjusted, standardized to suit performance parameters
Directions
Sterile powder can be used directly for the evaluation of sterility in manufacturing process. For sterile liquid medium aseptically add 28.5 grams (the equivalent weight of dehydrated medium per litre)in 1000 ml sterile distilled/ purified water. Heat if necessary to dissolve the medium completely. DO NOT AUTOCLAVE OR OVERHEAT. Excessive heating is detrimental. Dispense aseptically in sterile tubes or flasks as desired.
Note: It is preferable to use freshly prepared medium, alternatively it should be boiled and cooled just once prior to use, as on reheating, toxic oxygen radicals are formed.
Principle And Interpretation
Alternative Thioglycollate Medium is formulated as described in N.I.H. Memorandum (1), U.S. Pharmacopeia (2). Alternative Thioglycollate Medium contains sodium thioglycollate that can neutralize the bacteriostatic effect of mercurial preservatives. Absence of agar makes it suitable for testing viscous materials and devices having tubes with small lumina. Tryptone, yeast extract, dextrose, L-cystine provides nitrogenous and carbonaceous compounds, vitamin B complex, trace elements and other essential growth nutrients.
Type of specimen
Pharmaceutical: Sterility testing of viscous products.
Specimen Collection and Handling
For pharmaceutical products, follow appropriate techniques for sample processing in case of viscous materials as mentioned under sterility. (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
- The tubes should not be reheated as frequent boiling leads to development of toxic products.
- Prior to use the medium should be boiled once to remove the absorbed oxygen.
- Before inoculation, the tubes should be brought to room temperature.
- The medium should not be used in fermentation process as medium contains yeast extract which is high in carbohydrate content.
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
Cream to yellow homogeneous free flowing powder
Colour and Clarity of prepared medium
Light yellow coloured clear solution without any precipitate.
Reaction
Reaction of 2.9% w/v aqueous solution at 25°C. pH : 7.1±0.2
pH
6.90-7.30
Growth Promotion Test
As per United States Pharmacopoeia
Sterility test
No bacterial and fungal growth is observed after 14 days at 30-35°C.
Cultural Response
Cultural characteristics observed after an incubation at 30-35°C for not more than 3 days.
| Organism | Inoculum (CFU) | Growth |
|---|---|---|
| Growth Promotion Test | ||
| Clostridium sporogenes ATCC 19404 (00008*) | 50-100 | luxuriant |
| Clostridium sporogenes ATCC 11437 | 50-100 | luxuriant |
| $$Phocaeicola vulgatus ATCC 8482 | 50-100 | luxuriant |
| Additional Microbiological testing | ||
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | luxuriant |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | luxuriant |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | luxuriant |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | luxuriant |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | luxuriant |
| Escherichia coli ATCC 8739 (00012*) | 50-100 | luxuriant |
| Salmonella Abony NCTC 6017 (00029*) | 50-100 | luxuriant |
| Clostridium perfringens ATCC 13124 (00007*) | 50-100 | luxuriant |
| Bacteroides fragilis ATCC 23745 | 50-100 | luxuriant |
Key: (*) Corresponding WDCM numbers.
$$ Formerly known as Bacteroides vulgatus
^ Formerly known as Pseudomonas aeruginosa
Storage and Shelf Life
Store between 10-30°C in tightly closed container and the prepared medium at 15-25°C. Use before expiry date on the label. On opening, product should be properly stored dry, after tightly capping the bottle inorder 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 (3,4).
| Product Name | Alternative Thioglycollate Medium, Sterile Powder |
|---|---|
| SKU | MU010G |
| Customized Product Available | No |
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