HiEncap™ Soyabean Casein Digest Medium (HiEncap™ Tryptone Soya Broth)

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EC011CCL
A general purpose medium used for cultivation of a wide variety of microorganismsn and sterility testing of moulds and lower bacteria.


Intended Use

Recommended a general purpose medium used for cultivation of a wide variety of microorganisms and sterility testing of moulds and lower bacteria.

Composition**

Ingredients Gms / Litre
Tryptone 17.000
Soya peptone 3.000
Sodium chloride 5.000
Dextrose (Glucose) 2.500
Dipotassium hydrogen phosphate 2.500
Final pH (at 25°C) 7.3±0.2

**Formula adjusted, standardized to suit performance parameters

Directions

Each capsule contains 7.5 grams of media. Suspend 1 capsule in 250 ml (4 capsules in 1000 ml) purified or distilled water. Heat to boiling to dissolve the medium completely. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes. Mix well and dispense as desired.

Note: If any fibres are observed in the solution, it is recommended to filter the solution by using a 0.22 micron filter to eliminate the possibility of presence of fibres.

Principle And Interpretation

Soyabean Casein Digest Medium is recommended by various pharmacopeias as a sterility testing and as a microbial limit testing medium (2,5,6). This medium is a highly nutritious medium used for cultivation of a wide variety of organisms (1). The combination of tryptone and soya peptone makes the medium nutritious by providing amino acids and long chain peptides for the growth of microorganisms. Dextrose and Dipotassium hydrogen phosphate serve as the carbohydrate source and the buffer, respectively in the medium. Sodium chloride maintains the osmotic balance of the medium.

Type of specimen

Pharmaceutical samples

Specimen Collection and Handling

For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per pharmaceutical guidelines (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 to individual safety data sheets.

Limitations

  1. Biochemical characterization is necessary to be performed on colonies from pure cultures for further identification.
  2. This medium is general purpose medium and may not support the growth of fastidious organisms.

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: Gelatin capsule containing cream to yellow coloured granulated media

Colour and Clarity of prepared medium: Light yellow coloured clear solution without any precipitate.

Quantity: Each capsule contains 7.5 grams of medium sufficient for 250 ml media

Reaction: pH of 3.0% w/v aqueous solution at 25°C . pH : 7.3±0.2

pH: 7.10-7.50

Cultural Response: Cultural characteristics observed after an incubation at 30-35°C for <= 3 days for Bacteria and at 20-25°C for <=5 days for fungii

Growth promoting

Organism Growth Incubation period Inoculum (CFU) Incubation temperature
Escherichia coli ATCC 8739 (00012*) luxuriant 18-24 hrs 50-100 30-35 °C
Escherichia coli ATCC 25922 (00013*) luxuriant 18-24 hrs 50-100 30-35 °C
Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) luxuriant 18-24 hrs 50-100 30-35 °C
Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) luxuriant 18-24 hrs 50-100 30-35 °C
Candida albicans ATCC 2091 (00055*) luxuriant <=5 d 50-100 30-35 °C
Streptococcus pneumoniae ATCC 6305 luxuriant 18-24 hrs 50-100 30-35 °C
Pseudomonas aeruginosa ATCC 27853 (00025*) luxuriant 18-24 hrs 50-100 30-35 °C
Salmonella Typhimurium ATCC 14028 (00031*) luxuriant 18-24 hrs 50-100 30-35 °C
Salmonella Abony NCTC 6017 (00029*) luxuriant 18-24 hrs 50-100 30-35 °C
Bacillus subtilis subsp. spizizenii ATCC 6633 (00003*) luxuriant 18-24 hrs 50-100 30-35 °C
Micrococcus luteus ATCC 9341 luxuriant 18-24 hrs 50-100 30-35 °C
Escherichia coli NCTC 9002 luxuriant 18-24 hrs 50-100 30-35 °C
Pseudomonas aeruginosa ATCC 9027 (00026*) luxuriant 18-24 hrs 50-100 30-35 °C

Sterility Testing- Growth promotion+Validation

Organism Growth Incubation period Inoculum (CFU) Incubation temperature
Micrococcus luteus ATCC 9341 luxuriant <=3 d 50-100 20-25 °C
Salmonella Abony NCTC 6017 (00029*) luxuriant <=3 d 50-100 20-25 °C
Candida albicans ATCC 10231 (00054*) luxuriant <=5 d 50-100 30-35 °C
#Aspergillus brasiliensis ATCC 16404 (00053*) luxuriant <=5 d 50-100 30-35 °C
Escherichia coli ATCC 8739 (00012*) luxuriant <=3 d 50-100 20-25 °C
Escherichia coli ATCC 25922 (00013*) luxuriant <=3 d 50-100 20-25 °C
Escherichia coli NCTC 9002 luxuriant <=3 d 50-100 20-25 °C
Bacillus subtilis subsp. spizizenii ATCC 6633 (00003*) luxuriant <=3 d 50-100 20-25 °C
Salmonella Typhimurium ATCC 14028 (00031*) luxuriant <=3 d 50-100 20-25 °C
Streptococcus pneumoniae ATCC 6305 luxuriant <=3 d 50-100 20-25 °C
Staphylococcus aureus ATCC 6538 (00032*) luxuriant <=3 d 50-100 20-25 °C
Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) luxuriant <=3 d 50-100 20-25 °C
Pseudomonas aeruginosa ATCC 9027 (00026*) luxuriant <=3 d 50-100 20-25 °C
Pseudomonas aeruginosa ATCC 27853 (00025*) luxuriant <=3 d 50-100 20-25 °C

Key:(*) Corresponding WDCM numbers #Formerly known as Aspergillus niger

Storage and Shelf Life

Store between 10-30°C in a tightly closed container and the prepared medium at 15-25°C. Use before expiry date on the label. On opening, product should be properly stored dry, after tightly capping the bottle in order to prevent lump formation due to the hygroscopic nature of the product. Improper storage of the product may lead to lump formation. Store in dry ventilated area protected from extremes of temperature and sources of ignition. Seal the container tightly after use. 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 (3,4).

More Information
Product Name HiEncap™ Soyabean Casein Digest Medium (HiEncap™ Tryptone Soya Broth)
SKU EC011CCL
Application/ Industry Clinical
Product Type HiEncap™
Physical Form Granulated Media in Gelatin Capsule
Origin Animal
Packaging type HDPE Jar
References 1.MacFaddin J. F., 1985, Media for Isolation-Cultivation-Identification-Maintenance of Medical Bacteria, Vol. 1, Williams& Wilkins, Baltimore, M.d.
2. The United States Pharmacopeia, 2008, USP31/NF26, The United States Pharmacopeial Convention, Rockville, MD.
3. Indian Pharmacopeia, 2007, Govt. of India, Ministry of Health and Family Welfare, New Delhi, India.
4. Forbes B. A., Sahm D. F. and Weissfeld A. S., 1998, Bailey & Scotts Diagnostic Microbiology, 10th Ed., Mosby, Inc. St.Louis, Mo.
Customized Product Available No
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