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Soyabean Casein Digest Medium (Tryptone Soya Broth)

Q: What is Soyabean Casein Digest Medium, and how is it used in sterility testing?

Soyabean Casein Digest Medium (SCDM), also known as Tryptone Soya Broth (TSB), is a nutrient-rich, non-selective medium that supports the growth of a wide range of **aerobic bacteria and fungi**. In sterility testing, the product sample is added to SCDM and incubated under specified conditions. If viable microorganisms are present, they multiply and may produce visible growth or turbidity. Therefore, SCDM helps detect microbial contamination in products intended to be sterile.

Q: How should Soyabean Casein Digest Medium be stored to maintain its efficacy?

For dehydrated media, store at 10–30°C in a cool, dry place with the container tightly closed to prevent moisture absorption. Protect the media from direct sunlight and extreme temperatures. Prepared media should generally be stored at 15–30°C and used promptly in accordance with validated laboratory procedures. Before use, inspect the media for turbidity after rehydration and complete dissolution, as well as for particles, discoloration, or signs of contamination. Perform Growth Promotion Testing (GPT), as required, to confirm satisfactory microbial growth performance.

Q: What are the safety precautions for handling Soyabean Casein Digest Medium?

Wear appropriate personal protective equipment (PPE), including a lab coat, gloves, and safety glasses, when preparing and handling the medium. Handle dehydrated powder inside a fume hood to minimize dust inhalation. Use heat-resistant gloves when handling hot, autoclaved flasks and allow the medium to cool to 45–50°C before dispensing. Close media containers tightly immediately after use to prevent moisture absorption and contamination. When inoculating microorganisms, work in a biosafety cabinet or laminar flow hood, as appropriate. Treat all used media and test samples as potentially infectious and dispose of them as biohazardous waste in accordance with local regulations. Use dedicated tools to minimize cross-contamination, disinfect work surfaces before and after use, and follow the laboratory’s established spill-response procedures.

Q: What are the main components and their functions in Soyabean Casein Digest Medium?

Soyabean Casein Digest Medium (SCDM) contains nutrients that support the growth of a wide range of microorganisms. Tryptone, a pancreatic digest of casein, provides amino acids, peptides, and nitrogen required for microbial growth. Soya peptone, supplies additional proteins, carbohydrates, and growth factors that support a wide range of microorganisms. Dextrose provides an accessible source of carbon and energy, while dipotassium phosphate helps maintain pH stability. Sodium chloride maintains osmotic balance, creating a nutrient-rich environment suitable for the growth of diverse group of microorganisms.

Q: How does Soyabean Casein Digest Medium compare with other similar media in performance?

Soyabean Casein Digest Medium (SCDM) or Tryptone Soya Broth (TSB) is a general-purpose, non-selective medium that provides broad microbial recovery, particularly for aerobic bacteria and fungi. Compared with selective media, it does not contain inhibitory agents, thus allowing a wider range of microorganisms to grow. Its performance is typically evaluated through Growth Promotion Testing (GPT) to confirm consistent microbial recovery. For sterility testing, SCDM is commonly used for the recovery of aerobes and fungi alongside Fluid Thioglycollate Medium (FTM) to provide broader microbial coverage.

Q: What is the intended use of Soyabean Casein Digest Medium?

Recommended as a general-purpose, nutrient-rich medium for cultivating a wide variety of microorganisms. It supports the growth of aerobic bacteria, yeasts, and moulds due to its balanced and highly nutritive composition. It is specifically recommended for sterility testing, particularly for detecting moulds and aerobic bacteria in pharmaceutical products. The medium is suitable for compendial sterility testing procedures requiring reliable recovery of viable microorganisms. It can also be used for sample enrichment as specified in USP Chapter 62, "Test for Specified Microorganisms," as well as routine culture maintenance and general microbiological quality control applications.

Q: What is the composition of Soyabean Casein Digest Medium and what are the functions of its components?

Tryptone at 17.0 g/L, a pancreatic digest of casein, provides amino acids, peptides and nitrogenous nutrients. Soya peptone at 3.0 g/L supplies additional proteins, carbohydrates, vitamins and growth factors for fastidious organisms. Sodium chloride at 5.0 g/L maintains osmotic balance. Dextrose at 2.5 g/L is the carbon and energy source. Dipotassium hydrogen phosphate at 2.5 g/L buffers pH. Final pH is 7.3 ± 0.2 at 25°C.

Q: What are the preparation and sterilization instructions for Soyabean Casein Digest Medium?

Suspend 30.0 g of dehydrated medium in 1000 mL of purified or distilled water. Heat gently if required until completely dissolved, mixing thoroughly for uniform distribution. Dispense into tubes or flasks as the application requires, then sterilise by autoclaving at 121°C and 15 lbs pressure for 15 minutes. If fibres are visible in the solution, filter through a 0.22 micron membrane before use.

Q: How are the results interpreted in Soyabean Casein Digest Medium?

After inoculation and incubation under prescribed conditions, the medium is examined for evidence of microbial growth. - Presence of turbidity or visible growth indicates the presence of viable microorganisms in the test sample. - Clear medium after the specified incubation period suggests absence of detectable aerobic microbial contamination under the test conditions. This straightforward visual assessment makes Soyabean Casein Digest Medium a reliable indicator medium in sterility and microbiological quality control testing.

Q: What are the physical and quality characteristics of Soyabean Casein Digest Medium?

The quality parameters of Soyabean Casein Digest Medium (SCDM) include a cream-to-yellow, homogeneous, free-flowing dehydrated powder, which is also available in granulated form. After preparation, it should produce a light yellow, clear solution without precipitation. The pH of a 2.98% w/v solution after sterilization should be 7.3 ± 0.2 at 25°C. During stability testing, the prepared medium should remain clear and free from sedimentation for up to 7 days when stored at room temperature.

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M011

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

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Description

Intended Use

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

Composition**

Ingredients	g/L
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

Suspend 30.0 grams in 1000 ml purified/ distilled water. Heat if necessary to dissolve the medium completely. Mix well and dispense in tubes or flasks as desired. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.

Note: If any fibres are observed in the solution, it is recommended to filter the solution through 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 (1,2,3). This medium is a highly nutritious medium used for cultivation of a wide variety of organisms (4).

The combination of Tryptone and soya peptone makes the medium nutritious by providing nitrogenous, carbonaceous substances, amino acids and long chain peptides for the growth of microorganisms. Dextrose/glucose serve as the carbohydrate source and dibasic potassium phosphate buffer the medium. Sodium chloride maintains the osmotic balance of the medium.

Type of specimen

Pharmaceutical samples, Clinical samples - urine, pus, wound samples.

Specimen Collection and Handling

For clinical samples, follow appropriate techniques for handling specimens as per established guidelines (5,6).

For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per pharmaceutical guidelines (2). After use, contaminated materials must be sterilized by autoclaving before discarding.

Warning and Precautions

In Vitro diagnostic Use. For professional use only. 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 clinical specimens. Safety guidelines may be referred in individual safety data sheets.

Limitations

Biochemical characterization is necessary to be performed on colonies from pure cultures for further identification.
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: Cream to yellow homogeneous free flowing powder

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

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

pH: 7.10-7.50

Stability test: Light yellow coloured clear solution without any precipitation or sedimentation at room temperature for 7 days

Growth promoting properties

Clearly visible 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 not more than 100 cfu (at 30-35°C for 18-24 hours for bacteria and 5days for fungal) Growth promotion is carried out as per USP/EP/BP/JP/IP.

Organism	Inoculum (CFU)	Growth	Incubation temperature	Incubation period
Salmonella Typhimurium ATCC 14028 (00031*)	50-100	luxuriant	30-35 °C	18-24 hrs
Salmonella Abony NCTC 6017 (00029*)	50-100	luxuriant	30-35 °C	18-24 hrs
^Pseudomonas paraeruginosa ATCC 9027 (00026*)	50-100	luxuriant	30-35 °C	18-24 hrs
Staphylococcus aureus subsp. aureus ATCC 6538 (00032*)	50-100	luxuriant	30-35 °C	18-24 hrs
Escherichia coli ATCC 25922 (00013*)	50-100	luxuriant	30-35 °C	18-24 hrs
Escherichia coli ATCC 8739 (00012*)	50-100	luxuriant	30-35 °C	18-24 hrs
** Bacillus spizizenii ATCC 6633 (00003*)	50-100	luxuriant	30-35 °C	18-24 hrs
$ Kocuria rhizophila ATCC 9341	50-100	luxuriant	30-35 °C	18-24 hrs
Pseudomonas aeruginosa ATCC 27853 (00025*)	50-100	luxuriant	30-35 °C	18-24 hrs
Candida albicans ATCC 10231 (00054*)	50-100	luxuriant	20-25 °C	<=5 d
Staphylococcus aureus subsp. aureus ATCC 25923 (00034*)	50-100	luxuriant	30-35 °C	18-24 hrs
Sterility Testing- Growth promotion+Validation
Staphylococcus aureus subsp. aureus ATCC 6538 (00032*)	50-100	luxuriant	20-25 °C	<=3 d
# Aspergillus brasiliensis ATCC 16404 (00053*)	50-100	luxuriant	20-25 °C	<=5 d
Candida albicans ATCC 2091 (00055*)	50-100	luxuriant	30-35 °C	<=5 d
Staphylococcus aureus subsp. aureus ATCC 25923 (00034*)	50-100	luxuriant	20-25 °C	<=3 d
Escherichia coli ATCC 25922 (00013*)	50-100	luxuriant	20-25 °C	<=3 d
^Pseudomonas paraeruginosa ATCC 9027 (00026*)	50-100	luxuriant	20-25 °C	<=3 d
** Bacillus spizizenii ATCC 6633 (00003*)	50-100	luxuriant	20-25 °C	<=3 d
Salmonella Typhimurium ATCC 14028 (00031*)	50-100	luxuriant	20-25 °C	<=3 d
Salmonella Abony NCTC 6017 (00029*)	50-100	luxuriant	20-25 °C	<=3 d
Escherichia coli ATCC 8739 (00012*)	50-100	luxuriant	20-25 °C	<=3 d
Pseudomonas aeruginosa ATCC 27853 (00025*)	50-100	luxuriant	20-25 °C	<=3 d
$ Kocuria rhizophila ATCC 9341	50-100	luxuriant	20-25 °C	<=3 d

Key: (*) Corresponding WDCM numbers

^ Formerly known as Pseudomonas aeruginosa

# Formerly known as Aspergillus niger

**Formerly known as Bacillus subtilis subsp. spizizenii

$ Formerly known as Micrococcus luteus

Storage and Shelf Life

Store between 10-30°C in a tightly closed container and the prepared medium at 15-30°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 clinical sample must be decontaminated and disposed of in accordance with current laboratory techniques (5,6).

Reference

Indian Pharmacopoeia, 2022, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare Government of India.
MacFaddin J. F., 1985, Media for Isolation-Cultivation-Identification-Maintenance of Medical Bacteria, Vol. 1, Williams & Wilkins, Baltimore, M.d.
The United States Pharmacopoeia-National Formulatory (USP-NF), 2022.
Forbes B. A., Sahm D. F. and Weissfeld A. S., 1998, Bailey & Scotts Diagnostic Microbiology, 10th Ed., Mosby, Inc. St. Louis, Mo.
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 Information

More Information
Product Name	Soyabean Casein Digest Medium (Tryptone Soya Broth)
SKU	M011
Product Type	Regular
Physical Form	Powder
Origin	Animal
Packaging type	HDPE
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, 2018, USP 41/NF36, The United States Pharmacopeial Convention, Rockville, MD. 3.Indian Pharmacopeia, 2018, 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. 5.Isenberg, H.D. Clinical Microbiology Procedures Handbook. 2nd Edition. 6.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.

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FAQ

What is Soyabean Casein Digest Medium, and how is it used in sterility testing?

Soyabean Casein Digest Medium (SCDM), also known as Tryptone Soya Broth (TSB), is a nutrient-rich, non-selective medium that supports the growth of a wide range of **aerobic bacteria and fungi**. In sterility testing, the product sample is added to SCDM and incubated under specified conditions. If viable microorganisms are present, they multiply and may produce visible growth or turbidity. Therefore, SCDM helps detect microbial contamination in products intended to be sterile.

How should Soyabean Casein Digest Medium be stored to maintain its efficacy?

For dehydrated media, store at 10–30°C in a cool, dry place with the container tightly closed to prevent moisture absorption. Protect the media from direct sunlight and extreme temperatures. Prepared media should generally be stored at 15–30°C and used promptly in accordance with validated laboratory procedures. Before use, inspect the media for turbidity after rehydration and complete dissolution, as well as for particles, discoloration, or signs of contamination. Perform Growth Promotion Testing (GPT), as required, to confirm satisfactory microbial growth performance.

What are the safety precautions for handling Soyabean Casein Digest Medium?

Wear appropriate personal protective equipment (PPE), including a lab coat, gloves, and safety glasses, when preparing and handling the medium. Handle dehydrated powder inside a fume hood to minimize dust inhalation. Use heat-resistant gloves when handling hot, autoclaved flasks and allow the medium to cool to 45–50°C before dispensing. Close media containers tightly immediately after use to prevent moisture absorption and contamination.

When inoculating microorganisms, work in a biosafety cabinet or laminar flow hood, as appropriate. Treat all used media and test samples as potentially infectious and dispose of them as biohazardous waste in accordance with local regulations. Use dedicated tools to minimize cross-contamination, disinfect work surfaces before and after use, and follow the laboratory’s established spill-response procedures.

What are the main components and their functions in Soyabean Casein Digest Medium?

Soyabean Casein Digest Medium (SCDM) contains nutrients that support the growth of a wide range of microorganisms. Tryptone, a pancreatic digest of casein, provides amino acids, peptides, and nitrogen required for microbial growth. Soya peptone, supplies additional proteins, carbohydrates, and growth factors that support a wide range of microorganisms. Dextrose provides an accessible source of carbon and energy, while dipotassium phosphate helps maintain pH stability. Sodium chloride maintains osmotic balance, creating a nutrient-rich environment suitable for the growth of diverse group of microorganisms.

How does Soyabean Casein Digest Medium compare with other similar media in performance?

Soyabean Casein Digest Medium (SCDM) or Tryptone Soya Broth (TSB) is a general-purpose, non-selective medium that provides broad microbial recovery, particularly for aerobic bacteria and fungi. Compared with selective media, it does not contain inhibitory agents, thus allowing a wider range of microorganisms to grow. Its performance is typically evaluated through Growth Promotion Testing (GPT) to confirm consistent microbial recovery. For sterility testing, SCDM is commonly used for the recovery of aerobes and fungi alongside Fluid Thioglycollate Medium (FTM) to provide broader microbial coverage.

What is the intended use of Soyabean Casein Digest Medium?

Recommended as a general-purpose, nutrient-rich medium for cultivating a wide variety of microorganisms. It supports the growth of aerobic bacteria, yeasts, and moulds due to its balanced and highly nutritive composition. It is specifically recommended for sterility testing, particularly for detecting moulds and aerobic bacteria in pharmaceutical products. The medium is suitable for compendial sterility testing procedures requiring reliable recovery of viable microorganisms. It can also be used for sample enrichment as specified in USP Chapter 62, "Test for Specified Microorganisms," as well as routine culture maintenance and general microbiological quality control applications.

What is the composition of Soyabean Casein Digest Medium and what are the functions of its components?

Tryptone at 17.0 g/L, a pancreatic digest of casein, provides amino acids, peptides and nitrogenous nutrients. Soya peptone at 3.0 g/L supplies additional proteins, carbohydrates, vitamins and growth factors for fastidious organisms. Sodium chloride at 5.0 g/L maintains osmotic balance. Dextrose at 2.5 g/L is the carbon and energy source. Dipotassium hydrogen phosphate at 2.5 g/L buffers pH. Final pH is 7.3 ± 0.2 at 25°C.

What are the preparation and sterilization instructions for Soyabean Casein Digest Medium?

Suspend 30.0 g of dehydrated medium in 1000 mL of purified or distilled water. Heat gently if required until completely dissolved, mixing thoroughly for uniform distribution. Dispense into tubes or flasks as the application requires, then sterilise by autoclaving at 121°C and 15 lbs pressure for 15 minutes. If fibres are visible in the solution, filter through a 0.22 micron membrane before use.

How are the results interpreted in Soyabean Casein Digest Medium?

After inoculation and incubation under prescribed conditions, the medium is examined for evidence of microbial growth. - Presence of turbidity or visible growth indicates the presence of viable microorganisms in the test sample. - Clear medium after the specified incubation period suggests absence of detectable aerobic microbial contamination under the test conditions. This straightforward visual assessment makes Soyabean Casein Digest Medium a reliable indicator medium in sterility and microbiological quality control testing.

What are the physical and quality characteristics of Soyabean Casein Digest Medium?

The quality parameters of Soyabean Casein Digest Medium (SCDM) include a cream-to-yellow, homogeneous, free-flowing dehydrated powder, which is also available in granulated form. After preparation, it should produce a light yellow, clear solution without precipitation. The pH of a 2.98% w/v solution after sterilization should be 7.3 ± 0.2 at 25°C. During stability testing, the prepared medium should remain clear and free from sedimentation for up to 7 days when stored at room temperature.

What is the principle of Soyabean Casein Digest Medium?

The principle of Soyabean Casein Digest Medium is to provide a balanced supply of nutrients required for the growth and recovery of a wide range of microorganisms. Tryptone and soya peptone provide amino acids, peptides, nitrogen, and growth factors; dextrose supplies carbon and energy; dipotassium hydrogen phosphate maintains pH stability; and sodium chloride maintains osmotic balance. This nutritive, non-selective formulation supports the recovery and proliferation of aerobic bacteria, yeasts, and moulds present in test samples.