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Veggietones

COLD FILTERABLE VEGETABLE PEPTONE BROTH

Code: VG0104

A gamma-irradiated cold filterable vegetable peptone broth suitable for microbiological media fill trials (MFT) in the pharmaceutical industry.

Formula

gm/litre

Vegetable Peptone

18.0

Dextrose

2.5

Di-potassium hydrogen phosphate

2.5

Yeast Extract

3.0

Sodium chloride

5.0

pH 7.1 ± 0.2 at 25°C

 

Directions
Suspend 31g of dehydrated powder in 1 litre of distilled water. Mix well to dissolve completely. Sterilise by filtration through a 0.2µm cellulose acetate filter. One Kilo of Cold Filterable VPB dehydrated powder will make 32.2 litres of medium.

Incubation of media fills is usually carried out for 14 days6 at both 20-25°C and 30-35°C. Where possible visual inspection of the units should be carried out on a daily or every second day basis. Micro-organisms from any contaminated units should be sub-cultured, purified and identified to species level. Refer to the appropriate regulatory body for full guidelines2,3,4,5.

Description
Cold Filterable VPB is a highly nutritious, general purpose medium which can support the growth of a wide range of bacteria, yeasts and fungi when incubated under the appropriate conditions. The peptone in this medium is derived from the kernel of the split yellow pea which is digested using fungal enzymes.

Each component of this medium has been specially screened and selected to give a highly filterable solution. The performance of the medium is tested according to the specifications for growth of control micro-organisms in Tryptone Soya Broth laid down in the European Pharmacopoeia 5th Edition 20052, the British Pharmacopoeia 20043, the United States Pharmacopoeia USP 28 20054 and the Japanese Pharmacopoeia JP 14 20015.

Packs of Cold Filterable VPB have been given a sterilising dose of gammairradiation (minimum 25 KGy) validated as a lethal dose for all yeasts, moulds and bacteria including bacterial spores and mycoplasmas.

Technique
A medium completely free from all animal-derived materials, particularly suitable for use in Media Fill Trials (MFT) for the pharmaceutical industry. Dehydrated Cold Filterable VPB can be substituted for the powdered components that go into making sterile aqueous drugs or added as a sterile liquid downstream of processing a placebo of sterile solid dosage form. After carrying out MFT the medium is incubated under appropriate conditions for the recovery of any bacteria, yeasts and moulds.

Oxoid pre-screen and select the raw materials that go into Cold Filterable VPB so that every batch of product will have a high Vcap value. Vcap is the theoretical maximum volumetric throughput for the filter under test. With this information the maximum filterable volume of VPB may be calculated before starting a MFT1. A filter management system is used with a test filter to determine Vcap values for each batch of Cold Filterable VPB. The final filterable volume of Cold Filterable VPB will depend on the membrane type, pore size and area of the process filter used.

Vcap is the extrapolation to a "flow = zero" point; the time to this point may be very long. Therefore Vcap is good for comparative analysis but is not practical for MFT where time for a process is limited. A more useful value is V90 which is calculated as 68% of Vcap and is the point at which flow has decayed to 10% of the initial rate. Contact your filter manufacturer for guidance. N.B. Cold Filterable VPB should not be used to validate the suitability of the chosen filtration system for its ability in providing a sterile drug product. The components of Cold Filterable VPB will be quite different to those found in an aqueous drug formulation and validation for this purpose should be carried out on the drug preparation itself.

Typical Vcap values for Oxoid Cold Filterable VPB:

FILTER MEMBRANE
Vcap (ML)
47 MM DISC
(AREA 14 CM2)
Vcap
(LITRES/M2)
Polyvinylidene fluoride (PVDF)
913
652
Polyethersulfone (PES)
1,274
950
Nylon (NR)
1,817
1,298


For further information please download, Cold Filterable VPB a user’s story in PDF format.

Storage conditions and Shelf Life
Store the dehydrated medium at 10-30°C and use before the expiry date on the label.
Prepared medium should only be used fresh.

Appearance
Dehydrated Medium: Straw coloured free flowing powder
Prepared medium: Clear to straw coloured solution.

Quality control

Positive controls:

Expected results

Staphylococcus aureus ATCC®6538 * Turbid growth.
Pseudomonas aeruginosa ATCC®9027 * Turbid growth.
Bacillus subtilis ATCC®6633 * Flocculent/surface growth
Aspergillus brasiliensis ATCC®16404 * White mycelia, black spores or no spores
Candida albicans ATCC®10231 * Flocculent/surface growth

Negative control:

 
Uninoculated medium No change

This organism is available as a Culti-Loop®.

The microbiological quality control of this product complies with the following current pharmacopoeias;
European Pharmacopoeia
British Pharmacopoeia
The United States Pharmacopoeia
The Japanese Pharmacopoeia

References
1.
Badmington F., Wilkins R., Payne M. and Nonig E.S. (1995) Vmax Testing for Practical Microfiltration Train Scale-Up in Biopharmaceutical Processing, Pharmaceutical Technology, September, p64-76.
2. European Pharmacopoeia
3. British Pharmacopoeia
4. United States Pharmacopoeia
5. Japanese Pharmacopoeia
6. Halls N., (2002) Microbiological Media Fills Explained. Sue Horwood Publishing Ltd, UK.

 
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