Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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90 mm Polystyrene Lockable Plates#4fa25a
Intended Use
Recommended for the subculture of Candida albicans in accordance with the harmonized method of USP/EP/BP/JP.
Composition**
| Ingredients | Gms / Litre |
|---|---|
| Dextrose (Glucose) | 40.000 |
| Mixture of Peptone and Tryptone (1:1)## | 10.000 |
| Agar | 15.000 |
| pH after sterilization( at 25°C) | 5.6±0.2 |
Mixture of Peptic digest of animal tissue and Pancreatic digest of casein (1:1)#
**Formula adjusted, standardized to suit performance parameters.
Directions
Regular isolation : Either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically on the plate.
For total yeast and mould count for monitoring in pharmaceutical, cosmetic or other industry: Open the plate, bring to room temperature and either inoculate the plates with specified organisms or follow the standards as directed in harmonized methodology of pharmacopoeias. Incubate the plates as specified for 20-25°C for <=5 days.
Principle And Interpretation
Sabouraud Dextrose Agar is Carliers modification (1) of the formulation described by Sabouraud (2) for the cultivation of fungi (yeasts, moulds), and aciduric microorganisms. Sabouraud Dextrose Agar is recommended for microbiological examination of non-sterile products in accordance with the harmonized method of USP/EP/BP/JP (3,4,5,6). This medium is also employed in microbial limit tests in pharmaceutical testing, food, cosmetics, and clinical specimens (7)
Peptone and Tryptone provides carbonaceous, nitrogenous compounds, long chain amino acids, vitamins and other essential growth nutrients. Dextrose (Glucose) provides an energy source. High dextrose concentration and low pH favors fungal growth and inhibits contaminating bacteria from clinical specimens (8).
Some pathogenic fungi may produce infective spores, which are easily dispersed in air, so examination should be carried out in safety cabinet. For heavily contaminated samples, the plate must be supplemented with inhibitory agents for inhibiting bacterial growth. Growth of white colonies may be indicative of presence of Candida albicans. The total combined yeast and molds count is considered to be equal to the number of colony forming unit found using this medium, if bacterial colonies are detected they are counted as part of total yeast and mold count. In case the bacterial colonies exceeds the acceptance criterion, then antibiotics can be supplemented in this medium.
Type of specimen
Pharmaceutical samples, Cosmetic samples
Specimen Collection and Handling
For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per pharmaceutical guidelines (3,4,5,6).
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
- Individual strain of a microorganism may have unique growth requirements with respect to nutrients and physical conditions. Based on which the growth pattern of each varies on a medium and some even may display significant delay in development.
- Environmental Monitoring Test: Exposure of media plates for 4 h as a settle plate or in air sampler or even under laminar air flow may lead reduction in some available moisture on the surface. This may cause development of tiny cracks in the agar or slight shrinkage. This however, does not impact the performance of the media.
- 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 at 24-30°C to avoid minimum condensation.
- Some pathogenic fungi may produce infective spores which are easily dispersed in air, so examination should be carried out in safety cabinet.
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 Sabouraud Dextrose Agar Plate in 90 mm disposable Lockable plates with smooth surface and absence of black particles/ cracks/ bubbles (Barcoded, Lockable, Gamma irradiated, Triple pack)
Colour of medium
Light yellow to amber coloured medium.
Quantity of medium
30 ml of medium in 90 mm disposable plates.
pH
5.40-5.80
Sterility Check
Passes release criteria
Growth Promotion Test
Growth Promotion was carried out in accordance with the harmonized method of ICH (USP/EP/BP/JP), after an incubation at 30-35°C for 24-48 hours. Recovery rate is considered as 100% for bacteria growth on Soybean Casein Digest Agar and 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 (at 30-35°C for <=24 hours).
Indicative properties
Colonies are comparable in appearance and indication reaction to those previously obtained with previously tested and approved lot of medium occurs for the specified temperature for a period of time within the range specified inoculating <=100cfu (at 30-35°C for 24-48 hours).
Cultural Response
| Organism | Inoculum (CFU) | Growth | Observed Lot Recovery value (CFU) | Incubation temperature | Incubation period | |
|---|---|---|---|---|---|---|
| Growth Promotion + Indicative | ||||||
| Candida albicans ATCC 10231 (00054*) | 50-100 | Luxuriant (white colonies) | 35-100 | >=70% | 30-35 °C | 24-48 hrs |
| Growth Promotion + Total yeast and mould count | ||||||
| Candida albicans ATCC 10231 (00054*) | 50-100 | luxuriant | 35-100 | >=70% | 20-25 °C | <=5 d |
| Aspergillus brasiliensis ATCC 16404 (00053*) | 50-100 | luxuriant | 35-100 | >=50% | 20-25 °C | <=5 d |
| Additional Microbiological Testing | ||||||
| Candida albicans ATCC 2091 (00055*) | 50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 24-48 hrs |
| Saccharomyces cerevisiae ATCC 9763 (00058*) | 50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 24-48 hrs |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | good(inhibited on media with low pH) | 35-100 | >=70% | 30-35 °C | 24-48 hrs |
| Escherichia coli ATCC 8739 (00012*) | 50-100 | good(inhibited on media with low pH) | 35-100 | >=70% | 30-35 °C | 24-48 hrs |
| Trichophyton rubrum ATCC 28191 | 50-100 | good | 20-25 °C | <=5 d | ||
| Lactobacillus casei ATCC 334 | 50-100 | luxuriant | 35-100 | >=70% | 30-35 °C | 24-48 hrs |
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 (9,10).
| Product Name | Sabouraud Dextrose Agar Plate (Lockable Plate)(γ-irradiated) (Triple pack) |
|---|---|
| SKU | MPH063LGT |
| Customized Product Available | No |
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