Clausen HiVeg™ Medium

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SKU:
MV552
Recommended by Nordic Pharmacopoeia Board for sterility testing.


Product Profile

Vegetable based (Code MV) Animal based (Code M)
MV552 M552
HiVeg hydrolysate Casein enzymic hydrolysate
Recommended for : Sterility testing.
Reconstitution : 40.0 g/l
Quantity on preparation (500g) : 12.5 L
pH (25°C) : 7.1 ± 0.2
Supplement : Polysorbate 80 & Glycerol
Sterilization : 121°C / 15 minutes.
Storage : Dry Medium - Below 30°C, Prepared Medium - Store at cool place (not at 4°C) and in the dark for not longer than a month.

Composition

Ingredients Grams/Litre
HiVeg hydrolysate 15.0
Papaic digest of soyabean meal 3.0
Yeast extract 6.0
Dextrose 6.0
Sodium chloride 2.5
Dipotassium phosphate 2.0
Sodium citrate 1.0
L-Cystine 0.5
L-Asparagine 1.25
Sodium dithionate 0.4
Sodium thioglycollate 0.5
Lecithin 0.3
Magnesium sulphate 0.4
Calcium chloride 0.004
Cobalt sulphate 0.001
Cupric sulphate 0.001
Ferrous sulphate 0.001
Zinc sulphate 0.001
Manganese chloride 0.002
Resazurin 0.001
Agar 0.75

Final pH (at 25°C) 7.1 ± 0.2

** Formula adjusted, standardized to suit performance parameters.

Directions

Suspend 40 grams in 1000 ml distilled water containing 3 grams polysorbate 80 and 5 grams glycerol. Heat to boiling to dissolve the medium completely. Dispense as desired and sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes. Place in cool dark place till use. DO NOT RESTERILIZE the medium.

Principle and Interpretation

Clausen HiVeg Medium is prepared by using HiVeg hydrolysate instead of Casein enzymic hydrolysate which is free of BSE/TSE risks. Clausen HiVeg medium is the modification of Clausen medium which was developed by Clausen (1) and this medium is also called as HS-T (Dithionite thioglycollate) broth and is recommended for sterility testing. Standard microbial contamination test is developed to establish the number of non-sterile units if any in a batch is below the specific level. Random sampling in sufficient quantity of the bulk should be examined.

In microbial contamination test for detecting the non-sterile units, two methods can be used viz. Membrane filter method and Dilution method.

Clausen HiVeg Medium like the conventional is a very nutritious medium consisting of HiVeg hydrolysate, Papaic digest of soyabean meal, yeast extract and dextrose. L-Cystine and thioglycollate act as reducing agents, and the essential metals help for isolating anaerobic sporeformers. Polysorbate 80 and lecithin are added in this medium to overcome the effects of cationic agents, which can exert bacteriostatic effect in vitro. This medium is clear in appearance and yellow coloured, but under aerobic condition it turns pink. Therefore at the time of use the upper third of the medium should be pink.

Quality Control

Appearance of powder
Yellow coloured, may have slightly greenish tinge, homogeneous, free flowing powder.

Colour and Clarity
Light straw coloured, clear to slightly opalescent solution with upper 10% or less medium pink on standing.

Reaction
Reaction of 4.0% w/v aqueous solution containing 0.3% w/v polysorbate 80 and 0.5% w/v glycerol is pH 7.1 ± 0.2 at 25°C.

Cultural Response

Cultural characteristics observed after an incubation at 35 - 37°C for 18- 48 hours.

Organisms (ATCC) Inoculum (CFU) Growth
Bacillus subtilis (6633) 102-103 luxuriant
Candida albicans (10231) 102-103 luxuriant
Clostridium sporogenes (11437) 102-103 luxuriant
Pseudomonas aeruginosa (27853) 102-103 luxuriant
Staphylococcus aureus (25923) 102-103 luxuriant
Staphylococcus epidermidis (12228) 102-103 luxuriant
Streptococcus pyogenes (19615) 102-103 luxuriant

MV552 Clausen HiVeg Medium

  1. Control
  2. Bacillus subtilis
  3. Candida albicans
  4. Pseudomonas aeruginosa
  5. Staphylococcus aureus
  6. Staphylococcus epidermidis
  7. Streptococcus pyogenes

References

  1. Clausen O.G., 1973, Pharmaceutica Acta Helvetiae, 48:541.
More Information
Product Name Clausen HiVeg™ Medium
SKU MV552
Product Type HiVeg™
Physical Form Powder
Origin Animal Free (Veg)
Packaging type HDPE
References 1. Clausen O.G., 1973, Pharmaceutica Acta Helvetiae, 48:541.
Customized Product Available No
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