The Antimicrobial Preservative Efficacy test measures the effectiveness of antimicrobial preservatives added to non-sterile dosage forms or multi-dose containers to prevent the growth of microorganisms that may be accidentally introduced during the manufacturing process or product use.
Antimicrobial efficacy should be demonstrated in all injections packaged in multi-dose containers, multi-dose topical and oral forms, and other dosage forms containing antimicrobial preservatives. This test should be performed on all aqueous-based products including ophthalmic, otic, nasal, oral, irrigation and dialysis fluids.
EUROLAB Tests performed by USP Antimicrobial Efficacy Tests General Part 51 meet the criteria established by USP. This testing may also be performed to comply with requirements detailed in the European Pharmacopoeia or other international standards. We have extensive experience working with USP organisms, as well as an excellent understanding of protective systems and effective neutralization techniques. We provide scientifically sound data by triplicate plating and offering multiple repeat testing. We also have the resources to test samples with minimal waiting time.
The Antimicrobial Preservative Efficacy study tests antimicrobial preservatives against the following organisms: Candida albicans (ATCC 10231), Aspergillus brasiliensis (ATCC 16404), Escherichia coli (ATCC 8739), Pseudomonas aeruginosa (ATCC 9027) and Staphyuscoc aCC (65).
Bacteria are grown on soy casein digestion agar plates (SCDA) and harvested on the day of the test. The yeast is grown on sabouraud dextrose agar (SDEX) and harvested on the day of the test. The mold is grown on SDEX and harvested one week before testing. Whole organisms are set at approximately 1.0 x 10 8 colony-forming units (CFU) / ml by diluting in sterile saline.
Separate test samples and positive control are prepared for each organism. After 0-hr, test samples and positive control are individually inoculated with each organism to reach a concentration of 1.0 x 10 5 1.0 x 10 - 6 CFU / mL. The volume of inoculum used is between 0.5% and 1.0% of the product volume. Positive controls and samples are tested immediately after inoculation to determine the level of inoculation and to provide confirmation that the samples have been inoculated.
After the samples are inoculated and 0 hours of testing, the samples are stored in a 20-25 ° C incubator for the remainder of the test. 7 days, 14 days and 28 days after inoculation, samples are removed from the incubator and tested for surviving organisms. At each of these time points, samples are taken, diluted in a suitable neutralizer, and plated according to the standard plate counting procedure to determine the residual organism concentration. Organisms recovered from each time point are compared with those seen in the 0 hour positive control. Changes in concentrations of organisms are converted to log reduction values to evaluate the antimicrobial efficacy of samples according to ISO 14730, EP or USP 51 criteria.
EUROLAB, with its highly expert team and internationally accredited laboratories, Antimicrobial Protective Efficacy Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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