HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
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Soyabean HiVeg™ Medium, Granulated, Sterile (Tryptone Soya HiVeg™ Broth, Granulated, Sterile)
A Gamma-irradiated sterile Hiveg powder recommended for the evaluation of sterility in manufacturing process.
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Intended Use
Soyabean HiVeg™ Medium, granulated, sterile is a gamma-irradiated medium recommended for the evaluation of sterility in manufacturing process
Composition
| Ingredients | Gms/Litre |
|---|---|
| HiVeg hydrolysate | 17.000 |
| Papaic digest of Soyabean meal | 3.000 |
| Sodium chloride | 5.000 |
| Dipotassium phosphate | 2.500 |
| Dextrose | 2.500 |
| Final pH (at 25°C) | 7.3±0.2 |
Formula adjusted, standardized to suit performance parameters
Directions
Sterile medium can be used directly for the evaluation of sterility in manufacturing process. For sterile liquid medium aseptically add 30 grams in 1000 ml sterile distilled water. Heat if necessary to dissolve the medium completely. DO NOT AUTOCLAVE OR OVERHEAT. Excessive heating is detrimental. Dispense aseptically in sterile tubes or flasks as desired.
Principle And Interpretation
This medium is prepared by completely replacing animal based peptones with vegetable peptones. Soyabean HiVeg Medium is modification of Soyabean Casein Digest Medium is recommended by various pharmacopoeia as sterility testing medium. It is also used for the sensitivity testing by the tube dilution method for antimicrobial agents.
The combination of HiVeg hydrolysate and papaic digest of soyabean meal makes this medium nutritious by providing amino acids and long chain peptides for the growth of microorganisms. Dextrose and dipotassium phosphate serves as the carbohydrate source and the buffer in the medium. Sodium chloride maintains the osmotic balance of the medium.
Quality Control
Appearance
Cream to yellow coloured granular medium may have green tinge
Colour and Clarity of prepared medium
Light amber coloured clear solution
Reaction
Reaction of 3.0% w/v aqueous solution at 25°C. pH: 7.3±0.2
pH
7.10-7.50
Sterility Testing
No growth is observed after 14 days for Bacteria at 30-35°C and for Fungi at 20-25°C.
Test for Mycoplasma (PCR)
Negative for Mycoplasma
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 <=100cfu (at 30-35°C for 18-24 hours).
Sterility Testing + Validation
The medium is tested with suitable strains of microrganisms inoculating <=100cfu and incubating at 20-25°C for not more than 3 days in case of bacteria and not more than 5 days in case of fungi.
Cultural Response
Growth promoting
| Organism | Inoculum (CFU) | Growth | Incubation temperature | Incubation period |
|---|---|---|---|---|
| Staphylococcus aureus ATCC 6538 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Staphylococcus aureus ATCC 25923 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Escherichia coli ATCC 8739 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Escherichia coli ATCC 25922 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Escherichia coli NCTC 9002 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Pseudomonas aeruginosa ATCC 9027 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Pseudomonas aeruginosa ATCC 27853 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Bacillus subtilis ATCC 6633 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Micrococcus luteus ATCC 9341 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Salmonella Typhimurium ATCC 14028 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Salmonella Abony NCTC 6017 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
| Streptococcus pneumoniae ATCC 6305 | 50-100 | luxuriant | 30-35 °C | 18-24 hrs |
Sterility Testing- Growth promotion+Validation
| Organism | Inoculum (CFU) | Growth | Incubation temperature | Incubation period |
|---|---|---|---|---|
| Staphylococcus aureus ATCC 6538 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Staphylococcus aureus ATCC 25923 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Escherichia coli ATCC 8739 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Escherichia coli ATCC 25922 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Escherichia coli NCTC 9002 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Pseudomonas aeruginosa ATCC 9027 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Pseudomonas aeruginosa ATCC 27853 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Bacillus subtilis ATCC 6633 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Micrococcus luteus ATCC 9341 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Salmonella Typhimurium ATCC 14028 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Salmonella Abony NCTC 6017 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Streptococcus pneumoniae ATCC 6305 | 50-100 | luxuriant | 20-25 °C | <=3 d |
| Candida albicans ATCC 10231 | 50-100 | luxuriant | 20-25 °C | <=5 d |
| Candida albicans ATCC 2091 | 50-100 | luxuriant | 20-25 °C | <=5 d |
| *Aspergillus brasiliensis ATCC 16404 | 50-100 | luxuriant | 20-25 °C | <=5 d |
Storage and Shelf Life
Store below 10-30°C in tightly closed container and prepared medium at 2-8°C. Use before expiry period on the label.
| Product Name | Soyabean HiVeg™ Medium, Granulated, Sterile (Tryptone Soya HiVeg™ Broth, Granulated, Sterile) |
|---|---|
| SKU | GMV011G |
| Product Type | Granulated |
| Physical Form | Sterile Granular |
| Origin | Animal Free (Veg) |
| 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. |
| Customized Product Available | No |
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