A-A-5139A
Test Interval
Seven days after initial inoculation of product, sample Aluminum Hydroxide Gel by pipetting 1.0 ml from original container into 9.0 ml of phosphate buffer and perform a solution series. Prepare duplicate pour plates at 10-1, 10-3, and 10-5 dilution by pipetting 1.0 ml samples from each dilution into two 15 x 100 mm petri dishes. Add 18-20 ml of appropriate luquified Agar and swirl to mix. Allow plates to solidify and invert and incubate at 30-35oC for at least 48 hours. Incubate Aspergillus niger at 20-25 oC for at least seven days. Range of dilutions will have to be adjusted as bacterial populations increase or decrease. Repeat procedures in 4-a at 14.21 and 28 day intervals.
Calculations.
To determine the theoretical yield of 0.1 ml of each organism in 20 ml of Aluminum Hydroxide Gel, divide the CFU/ml of seed (obtained from count from backtiter plates performed from organism dilutions) by 200 (0.1 ml into 20 ml in a 1:200 dilution). This count should be NLT 103 organisms per ml of product after initial inoculation. Use this theoretical figure as a base to determine reduction during subsequent test intervals.
To determine the population in the product, multiply the average count of the two pour plates times the reciprocal of the dilution factor.
The test sample passes the Preservation Challenge test if the initial inoculums level does not increase by more than 50% by the third week, and remains at or below that level by the fourth week.
Workmanship. The suspension shall be free from defects which detract from its/their appearance or impair its/serviceability.
Unit. Bottle (BT).
For Size 1- One bottle containing 12 fl oz (355 ml), as specified, constitutes one unit. Unit bottles shall have either an inner or an outer tamper-evident seal.
For size 2- One bottle containing 2 oz (60 ml), as specified constitutes one unit. Unit bottle shall have either an inner or an outer tamper-evident seal.
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