Soybean Casein Digest Agar Plate

SKU:
MPH290
Availability: In stock
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Intended use

Recommended as a general purpose medium used in cultivation of a wide variety of microorganisms from pharmaceutical products in accordance with harmonized method of USP/EP/BP/JP/IP (Medium 2).

Composition

IngredientsGms / Litre
Tryptone #15.000
Soya peptone ##5.000
Sodium chloride5.000
Agar15.000
pH after sterilization (at 25°C)7.3±0.2

**Formula adjusted, standardized to suit performance parameters

# Pancreatic digest of casein

## Papaic digest of soyabean (soybean)

Directions

Either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically on the plate.

Principle And Interpretation

Various pharmacopoeias recommend Tryptone Soya Agar Plate as sterility testing medium. It is also used in validation of sterility checking procedure in accordance with the microbial limit testing harmonized methodology of USP/ EP/BP/JP/IP (1,2,3,4,5). This medium is used in microbial limit test and antimicrobial preservative- effective test. Gunn et al (5) used this medium for the growth of fastidious organisms and study of haemolytic reaction after addition of 5% v/v blood. The combination of tryptone and soya peptone makes these media nutritious by providing amino acids and long chain peptides for the growth of microorganisms. Natural sugars of soy enhance growth of microorganism. Sodium chloride maintains the osmotic balance in the medium. Agar is the solidifying agent. The total aerobic count is considered to be equal to the number of colony forming units found on this medium, if colonies of fungi are detected on this medium they are counted along with total aerobic count.

Type of specimen

Pharmaceutical samples

Specimen Collection and Handling

For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per pharmaceutical guidelines (1,2,3,4,5).

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 precautions as per established guidelines should be followed while handling specimens. Safety guidelines may be referred in individual safety data sheets.

Limitations

  1. 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.
  2. 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.
  3. 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.
  4. 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 Tryptone Soya Agar in 90 mm disposable plates.

Colour of medium: Light yellow coloured coloured medium

Quantity of medium: 25 ml of medium in 90 mm disposable plates.

pH: 7.10-7.50

Sterility Test: 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 after an incubation at 30-35°C for 18-24 hours. Recovery rate is considered 100% for bacteria growth on Blood 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 18 hours).

OrganismInoculum (CFU)Observed Lot Recovery value (CFU)Incubation period
Bacillus subtilis subsp. spizizenii ATCC 6633 (00003*)50-10035-100>=70%18-24 hrs
Staphylococcus aureus subsp. aureus ATCC 25923 (00034*)50-10035-100>=70%18-24 hrs
Staphylococcus aureus subap. aureus ATCC 6538 (00032*)50-10035-100>=70%18-24 hrs
Escherichia coli ATCC 25922 (00013*)50-10035-100>=70%18-24 hrs
Escherichia coli ATCC 8739 (00012*)50-10035-100>=70%18-24 hrs
Escherichia coli NCTC 900250-10035-100>=70%18-24 hrs
Pseudomonas aeruginosa ATCC 27853 (00025*)50-10035-100>=70%18-24 hrs
Pseudomonas aeruginosa ATCC 9027 (00026*)50-10035-100>=70%18-24 hrs
Salmonella Abony NCTC 6017 (00029*)50-10035-100>=70%18-24 hrs
Micrococcus luteus ATCC 934150-10035-100>=70%18-24 hrs
Streptococcus pneumoniae ATCC 630550-10035-100>=70%18-24 hrs
Salmonella Typhimurium ATCC 14028 (00031*)50-10035-100>=70%18-24 hrs
Candida albicans ATCC 10231 (00054*)50-10035-100>=70%<=5 d
Candida albicans ATCC 2091 (00055*)50-10035-100>=70%<=5 d
#Aspergillus brasiliensis ATCC 16404 (00053*)50-10025-7050-70%<=5 d

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 (6,7).

More Information
Product Name Soybean Casein Digest Agar Plate
SKU MPH290
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Can TSA be used for both bacteria and fungi?

Yes, TSA supports both bacteria and fungi (yeasts and molds), though it's optimized for bacteria. For enhanced fungal recovery, use Sabouraud Dextrose Agar (SDA) or Potato Dextrose Agar (PDA). In pharmaceutical testing, TSA at 30-35°C recovers bacteria primarily; SDA at 20-25°C recovers fungi. Many labs run dual-temperature incubation: TSA at 30-35°C and 20-25°C to capture both bacterial and fungal contaminants. For comprehensive EM programs, use TSA + SDA in combination.

How is TSA used for pharmaceutical environmental monitoring?

In pharmaceutical EM programs, TSA / SCDA is the primary medium for viable particle counts in cleanrooms (ISO 5-8 environments). Use: (1) Settle plates (passive air monitoring), (2) Active air sampling (slit-to-agar, impaction), (3) Surface sampling (contact plates, swabs), (4) Personnel monitoring (glove prints, gown contact). Incubate at 30-35°C for 48 hours minimum. Count CFUs, identify if required by SOP. Action limits vary by cleanroom classification. TSA detects general aerobic contamination; add selective media for specific targets.

What is the incubation temperature and time for TSA?

Standard incubation: 30-35°C for 24-72 hours. Specific applications: (1) Total Aerobic Microbial Count: 30-35°C for <=3 days for bacteria and <=5 days for fungi (2) Pharmaceutical microbial limits (USP <61>): 30-35°C for 3-5 days, (3) Food testing: 30-35°C per method (FDA BAM, AOAC), (4) Environmental monitoring: 30-35°C for 48 hours. Some protocols use dual incubation: 30-35°C for bacteria and 20-25°C for fungi. Check colonies at 24, 48, and 72 hours. Prolonged incubation may be needed for slow-growing organisms.

Why is TSA considered a general purpose medium?

TSA contains tryptone and soya peptone providing amino acids, vitamins, and minerals supporting fastidious and non-fastidious organisms. No selective agents or inhibitors, so all viable bacteria, yeasts, and molds can grow. Neutral pH (7.3±0.2) suits most organisms. Used as control medium in selective/differential media testing. Supports gram-positive, gram-negative, aerobic, facultative anaerobic organisms, and most fungi. Recovery rates typically higher than nutrient agar due to richer formulation.

What is Tryptone Soya Agar (TSA) used for?

Tryptone Soya Agar (TSA) is a general-purpose, non-selective medium supporting growth of a wide variety of microorganisms. Used for: (1) Total viable count (TVC) / Total Aerobic Microbial Count (TAMC) in pharmaceutical, food, and Water testing, (2) Environmental monitoring in cleanrooms, (3) Sterility testing (surface method), (4) Sub-culturing and maintaining stock cultures, (5) Antibiotic susceptibility testing, (6) Microbial limit testing per USP. TSA is the most widely used culture medium in microbiology laboratories worldwide.