HiFill™ Test Medium

Intended use

HiFill™ Test Medium, Sterile powder is a gamma (γ) irradiated sterile powder recommended for the evaluation of sterility in manufacturing process for easy detection of contamination by Media Fill Test.

Composition**

**Formula adjusted, standardized to suit performance parameters

Directions

Sterile powder can be used directly for the evaluation of sterility in manufacturing process. For sterile liquid medium aseptically add 30.10 grams in 1000 ml sterile distilled / purified water. DO NOT AUTOCLAVE Dispense aseptically in sterile tubes or flasks as desired.

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

Principle And Interpretation

Soyabean Casein Digest Medium is recommended by various pharmacopoeia as sterility testing medium (1,2,3,4,5,7). Tryptone and Soya peptone in the medium provides nitrogenous and carbonaceous compounds, long chain amino acids, vitamins and other essential nutrients. Sodium chloride maintains the osmotic balance. Phosphate buffers the medium. Dextrose serves as an energy source. In this line the HiFill™ Test Medium with the addition of MFT indicator, helps to verify the microbiological growth in aseptic production process. MFT Indicator is the medium is utilized by all microorganisms and the microbial contamination is indicated by colour change from light yellow to maroon-red. It is an easier method for detection of contamination with no time consumption.

Type of specimen

Pharmaceutical samples

Specimen Collection and Handling

For pharmaceutical samples follow appropriate techniques for handling samples as per established guidelines (1,2,3,5,7). 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 in individual safety data sheets.

Limitations :

1. Further biochemical tests must be carried out for confirmation.

Performance and Evaluation

Performance of the medium is expected when used as per the direction on the label expiry period when stored at within the recommended temperature.

Quality Control

Appearance Cream to yellow homogeneous free flowing powder

Colour and Clarity of prepared medium Yellow coloured clear solution

Reaction Reaction of 3.01% w/v aqueous solution at 25°C. pH : 7.30±0.20

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.

Growth Promotion Cultural characteristics observed after an incubation at 30-35°C for <= 3days for Bacterial and at 20-25°C for <= 5days for Fungal (* under anaerobic condition).

Sterility Testing

Key : *Corresponding WDCM numbers.

Storage and Shelf Life

Store between 10-30°C in a tightly closed container and the prepared medium at 2-8°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 (4,6).

Reference

1. British Pharmacopoeia, 2017, The Stationery office British Pharmacopoeia
2. European Pharmacopoeia, 2016, European Dept. for the quality of Medicines.
3. Indian Pharmacopeia, 2018 Govt. of India, Ministry of Health and Family Welfare, New Delhi, India.
4. Isenberg, H.D. Clinical Microbiology Procedures Handbook 2nd Edition.
5. Japanese Pharmacopoeia, 2016.
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.
7. The United States Pharmacopoeia, 2018, The United States Pharmacopoeial Convention. Rockville, MD.