HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
Your enquiry has been submitted
Something problem with the server. Try again.
Intended use
Recommended as sterility test medium prepared in accordance with USP, EP, BP,IP.
Composition**
| Ingredients | g/L |
|---|---|
| Tryptone # | 15.000 |
| Yeast extract | 5.000 |
| Glucose monohydrate | 5.500 |
| Sodium chloride | 2.500 |
| L-Cystine | 0.500 |
| Sodium thioglycollate | 0.500 |
| Resazurin sodium | 0.001 |
| Agar | 0.750 |
| pH after sterilization (at 25°C) | 7.1±0.2 |
**Formula adjusted, standardized to suit performance parameters
# - Equivalent to Pancreatic digest of casein
Directions
Label the ready to use LQ026DW bottle. Inoculate <=100 cfu sample and incubate at specified temperature and time.
Note: If more than upper one-third of the medium has acquired a pink-purple colour, the medium may be restored once by heating in a water bath or in free flowing steam until the pink-purple colour disappears.
Principle And Interpretation
Brewer (1) formulated Fluid Thioglycollate Medium for rapid cultivation of aerobes as well as anaerobes including microaerophiles by adding a reducing agent and small amount of agar. The USP (2), BP (3), EP (4), IP (5), AOAC (6) and ISO (7) have recommended the media for sterility testing of antibiotics, biologicals and foods and for determining the phenol coefficient and sporicidal effect of disinfectants. However, it is intended for the examination of clear liquid or water-soluble materials. Fluid Thioglycollate Medium is also routinely used to check the sterility of stored blood in blood banks (8). Tryptone, yeast extract, glucose provide carbon, nitrogen compounds, long chain amino acids, vitamin B complex growth factors necessary for bacterial multiplication. L-cystine and sodium thioglycollate allows Clostridium to grow in this medium even under aerobic conditions. Also the small amount of agar used in the medium favors the growth of aerobes as well as anaerobes in the medium by maintaining low redox potential for stabilizing the medium (1). Sodium thioglycollate act as a reducing agent and neutralizes the toxic effects of mercurial preservatives and peroxides formed in the medium, thereby promoting anaerobiosis, and making the medium suitable to test materials containing heavy metals (9). Any increase in the oxygen content is indicated by a colour change of redox indicator, resazurin to red (8,10,11).
Type of specimen
Pharmaceutical samples for sterility testing
Specimen Collection and Handling
For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per guidelines (2-5).
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
- It is intended for the examination of clear liquid or water-soluble materials.
- Further biochemical and serological testing must be carried out for complete 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 Fluid Thioglycollate Medium in glass bottle (Double packed)
Colour
Light yellow to pink coloured clear to slightly opalescent solution with upper 10% or less medium will form pink-purple ring
on venting the rubber stopper
Note: During transportation the medium may appear pink -purple colour due to presence of redox indicator.
Quantity of Medium
100 ml of medium in glass bottle
pH
6.90-7.30
Sterility Check
Passes release criteria
Growth Promotion Test
As per USP/EP/BP/IP
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 or not more than 3 days for aerobes and anaerobes.
Sterility Testing + Validation
The medium is tested with suitable strains of microrganisms inoculating <=100cfu and incubating at 20-25°C for not more
than 3 days in case of bacteria and not more than 5 days in case of fungi.
| Organism | Inoculum (CFU) | Growth | Incubation at |
|---|---|---|---|
| Growth promoting | |||
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | ≤ 100 | luxuriant | 30-35°C |
| # Bacillus spizizenii ATCC 6633 (00003*) | ≤ 100 | luxuriant | 30-35°C |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | < 100 | luxuriant | 30-35°C |
| ##Kocuria rhizophila ATCC 9341 | ≤ 100 | luxuriant | 30-35°C |
| Clostridium sporogenes ATCC 19404 (00008*) | ≤ 100 | luxuriant | 30-35°C |
| Clostridium sporogenes ATCC 11437 | < 100 | luxuriant | 30-35°C |
| ** Phocaeicola vulgatus ATCC 8482 | ≤ 100 | luxuriant | 30-35°C |
| Sterility Testing- Growth promotion+Validation | |||
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | < 100 | luxuriant | 20-25°C |
| # Bacillus spizizenii ATCC 6633 (00003*) | < 100 | luxuriant | 20-25°C |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | < 100 | luxuriant | 20-25°C |
| ##Kocuria rhizophila ATCC 9341 | ≤ 100 | luxuriant | 20-25°C |
| Candida albicans ATCC 10231 (00054*) | < 100 | luxuriant | 20-25°C |
| $Aspergillus brasiliensis ATCC 16404 (00053*) | ≤ 100 | luxuriant | 20-25°C |
Testing in accordance with EN ISO 11133:2014/Amd.1:2018(E) (10)
Cultural characteristics observed after an incubation at 36-38°C for 18-24 hours
| Organism | Inoculum (CFU) | Growth | Incubation at |
|---|---|---|---|
| Clostridium perfringens ATCC 13124 (00007*) | 50-100 | luxuriant | 36-38°C |
Key:
- (*) Corresponding WDCM numbers,
- # Formerly known as Bacillus subtilis subsp. spizizenii
- ## Formerly known as Micrococcus luteus
- ^Formerly known as Pseudomonas aeruginosa
- $ Formerly known as Aspergillus niger
- ** Formerly known as Bacteroides vulgatus
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 (12,13).
| Product Name | Fluid Thioglycollate Medium-Double Packed |
|---|---|
| SKU | LQ026DW |
| Customized Product Available | No |
Write Your Own Review