Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended Use
Diluent in testing of pharmaceuticalsand for determining efficiency of sanitization of containers, equipment surfaces, water miscible cosmetics etc.
Composition
| Ingredients | g/L |
|---|---|
| Peptone | 1.000 |
| Polysorbate 80 (Tween 80) | 5.000 |
| Soya lecithin | 0.700 |
| Final pH (at 25°C) | 7.1±0.2 |
Formula adjusted, standardized to suit performance parameters
Directions
Label the ready to use LQ561C bottle. In sterile environment, unscrew the bottle. Inoculate or add the sample to be tested. mix the sample well. Incubate at specified temperature for 24-48 hours.
Principle And Interpretation
Diluting Fluid A is recommended as rinsing fluid for membrane filter method used in validation tests for bacteriostasis and fungistasis activity of pharmaceutical articles before carrying out sterility test procedures as per USP (1). After filtering the specified quantity of the test specimen, the membrane is rinsed with measured portions of rinsing or diluting fluid. This rinse is inoculated with known number of test bacteria and fungi as specified in pharmacopoeia. The resultant growth is compared with positive control to determine presence of fungistasis or bacteriostasis activity in test specimen.
Type of Specimen
Pharmaceutical sample
Specimen Collection and Handling
For pharmaceutical sample samples follow appropriate techniques for handling specimens as per established guidelines (1). 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
- Use of this method is appropriate only when test samples are clear.
- Further serological and biochemical testing is required 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 Diluting Fluid A w/0.5% Polysorbate 80 & 0.07% Soya lecithin in a glass bottle.
Colour of medium
Light yellow coloured medium
Quantity of Medium
100 ml of medium in glass bottle.
pH
6.90-7.30
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 |
|---|---|---|
| Escherichia coli ATCC 8739 (00012*) | 50-100 | good |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | good |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | good |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | good |
| **Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | good |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | good |
| Candida albicans ATCC 10231 (00054*) | 50-100 | good |
| #Aspergillus brasiliensis ATCC 16404 (00053*) | 50-100 | good |
| Clostridium sporogenes ATCC 19404 | 50-100 | good |
Key: (*)Corresponding WDCM numbers.
^ Formerly known as Pseudomonas aeruginosa
# Formerly known as Aspergillus niger
** 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 (2,3).
| Product Name | Diluting Fluid A w/0.5% Polysorbate 80 & 0.07% Soya lecithin |
|---|---|
| SKU | LQ561C |
| Customized Product Available | No |
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