Aseptic Packing Line Medium

Intended Use

A fluid medium used in validating aseptic packing lines.

Composition

Final pH (at 25°C): 7.2±0.2

Formula adjusted, standardized to suit performance parameters

Directions

Suspend 17.5 grams in 1000 ml purified /distilled water. Heat if necessary to dissolve the medium completely. Dispense in tubes containing inverted Durham's tubes. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.

Principle And Interpretation

Aseptic Packing Line Medium is used in validating aseptic packing and filling lines. It is a basic medium for demonstrating growth by either acid or gas production.

Peptone and yeast extract provide basic nutrients. Sucrose is the carbohydrate source. Sodium chloride maintains osmotic balance. Phenol red is the pH indicator. Sucrose fermentation leads to the formation of acidic conditions which is detected by phenol red, observed as a colour change from red to yellow.

Type of specimen

Environmental sample

Specimen Collection and Handling

1. Dispense the reconstituted medium into packing line upstream of the sterilization process.
2. Incubate the filled packs at 30±2°C for upto 7 days.

Gas production is observed as trapped air bubbles in the Durhams tubes and acid production is visualized as a colour change of the medium to yellow. Growth is indicated as turbidity in the medium.

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

N.A.

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: Light yellow to light pink homogeneous free flowing powder.

Colour and Clarity of prepared medium: Orange red coloured clear solution in tubes.

Reaction: Reaction of 1.75% w/v aqueous solution at 25°C. pH : 7.2±0.2.

pH: 7.10-7.50

Cultural Response: Cultural characteristics observed after an incubation at 30±2°C for 18-48 hours.

*Corresponding WDCM numbers.

Storage and Shelf Life

Store between 10-30°C in a tightly closed container and the prepared medium at 15-25°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 (1,2).

Reference

1. Isenberg, H.D. Clinical Microbiology Procedures Handbook 2nd Edition.
2. 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.