Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended use
Recommended for the cultivation of yeasts and moulds from pharmaceutical products in accordance with the microbial limit testing by harmonized methodology of USP/EP/BP/JP.
Composition**
| Ingredients | g/L |
|---|---|
| Infusion from potatoes | 200.000 |
| Dextrose (Glucose) | 20.000 |
| Agar | 15.000 |
| pH after sterilization (at 25°C) | 5.6±0.2 |
**Formula adjusted, standardized to suit performance parameters
Directions
Either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically on the plate.
Principle And Interpretation
Yeast and moulds constitute a large and divergent group of microorganisms consisting of several thousands species. Yeast and moulds can cause various degrees of food decomposition. Invasion and growth may occur on virtually any type of food if environmental conditions are not limiting. Some foodborne yeasts and moulds are undesirable because of potential hazards to human and animal health (1). Potato Dextrose Agar, prepared in accordance with the harmonized methodology of USP/EP/BP/JP (2,3,4,5) is recommended for microbial limit tests in pharmaceutical testing. It is also used for stimulating sporulation, for maintaining stock cultures of certain dermatophytes and for differentiation of typical varieties of dermatophytes on the basis of pigment production (6). Potato infusion and dextrose (glucose) promote luxuriant fungal growth. Adjusting the pH of the medium by tartaric acid to 3.5 inhibits the bacterial growth. Heating the medium after acidification should be avoided as it may hydrolyse the agar, which can render the agar unable to solidify
Type of specimen
Pharmaceutical samples
Specimen Collection and Handling
For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per pharmaceutical guidelines (2,3,4,5). After use, contaminated materials must be sterilized by autoclaving before discarding.
Warning and Precautions
Read the label before opening the pack. Wear protective gloves/protective clothing/eye protection/face protection. Follow good microbiological lab practices while handling specimens and culture. Standard guidelines should be followed while handling clinical specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations
- Some pathogenic fungi may produce infective spores which are easily dispersed in air, so examination should be carried out in safety cabinet
- Further biochemical tests should be carried out for confirmation.
- Individual organisms differ in their growth requirement and may show variable growth patterns on the medium
- Each lot of the medium has been tested for the organisms specified on the COA. It is recommended to users to validate the medium for any specific microorganism other than mentioned in the COA based on the user's unique requirement.
- It is recommended to store the plates ta 24-30°C to avoid minimum condensation.
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 Potato Dextrose Agar Plate in 55mm scored disposable plates with convex surface and absence of black particles/ cracks/bubbles. (y-irradiated)
Colour of medium: Light amber coloured medium
Quantity of medium: 20 ml of medium in 55 mm scored disposable plates.
pH: 5.40-5.80
Dose of irradiation (Kgy): 13.00-20.00
Sterility Check: Passes release criteria
Growth Promotion Test: Growth Promotion was carried out in accordance with the harmonized method of USP/EP/BP/JP, and growth was observed at 20-25°C for specified time. Recovery rate is considered as 100% for fungus growth on Sabouraud Dextrose Agar
Growth Promoting Properties: 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
Cultural Response: Cultural characteristics observed after incubation at 20-25 °C for 2-5 days. Recovery rate is considered as 100% for fungus growth on Sabouraud Dextrose Agar.
Test strain preparation
| Organism | Inoculum (CFU) | Growth | Observed Lot Recovery value (CFU) | Recovery | Incubation temperature | Incubation period |
|---|---|---|---|---|---|---|
| # Aspergillus brasiliensis ATCC 16404(00053*) | 50-100 | luxuriant | 25-100 | >=50% | 20-25 °C | 5-7 Day |
Key:(#) - Formerly known as Aspergillus niger, (*) - corresponding WDCM numbers
Storage and Shelf Life
On receipt store between 20-30°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 (7,8).
Reference
- Salfinger Y., and Tortorello M.L. Fifth (Ed.), 2015, Compendium of Methods for the Microbiological Examination of Foods, 5th Ed., American Public Health Association, Washington, D.C.
- The United States Pharmacopoeia-National Formulatory (USP-NF), 2022.
- European Pharmacopoeia, 2022, 10 th volume, European Directorate for the quality of medicines & Healthcare.
- The British Pharmacopoeia, 2022, Medicines and Healthcare products Regulatory Agency.
- The Japanese Pharmacopoeia, 17th edition, 2016, The Ministry of Health, Labour and welfare.
- MacFaddin J., 1985, Media for the Isolation-Cultivation-Identification-Maintenance of Medical Bacteria, Vol.1, Williams and Wilkins, Baltimore
- Isenberg, H.D. Clinical Microbiology Procedures Handbook 2nd Edition.
- Jorgensen, J.H., Pfaller, M.A., Carroll, K.C., Funke, G., Landry, M.L., Richter, S.S and Warnock., D.W. (2015) Manual of Clinical Microbiology, 11th Edition. Vol. 1.
| Product Name | Potato Dextrose Agar Plate (γ-irradiated) |
|---|---|
| SKU | SPH096G |
| Customized Product Available | No |
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