BioScreen Preservative Effectiveness Testing
Antimicrobial Preservative Effectiveness Testing Global Pharmacopoeia Standards for Topical Products
The following table is a summary of the different tests and specifications required by specific regions for Antimicrobial (Preservative) Effectiveness Testing (AET). The regions encompass Japan, Europe (including Great Britain), and the United States. In addition to the designated organisms, additional organisms can be used to challenge the product.
Important note: The Validation Test demonstrates the efficiency of the neutralizers used in the plate count method in inactivating the antimicrobial preservatives contained in the test sample. This is required by all compendial methods. Failure to properly neutralize the preservative system during testing can result in false negative results where lack of organism recovery may be due to inhibition of the organism.
|
PCPC[1] |
PCPC |
USP |
JP |
EP/BP |
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|
Bacteria |
Two from Klebsiella pneumoniae, One from Pseudomonas aeruginosa and one from P. cepacia, |
Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa |
Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa |
Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa |
Staphylococcus aureus, Pseudomonas aeruginosa |
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|
Yeast |
Candida albicans or Candida parapsilosis |
Candida albicans |
Candida albicans |
Candida albicans |
Candida albicans |
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|
Mold |
Aspergillus niger or Penicillium luteum |
Aspergillus niger |
Aspergillus niger |
Aspergillus niger |
Aspergillus niger |
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|
Test Duration |
28 or 56 days |
28 or 56 days |
28 days |
28 days |
28 days |
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|
Sampling times in days For topical products |
0, 2, 7, 14, 21 & 28 |
0, 2, 7, 14, 21 & 28 |
14 & 28 |
7, 14, 21 & 28 |
0, 2, 7, 14 & 28 |
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|
Types of Product |
Water Miscible Cosmetics |
Eye Area Cosmetics |
1 Injections, 2 Topical, 3 Oral (non antacids) 4 Antacids |
1A Injections, 1B Topical, 1C Oral 1D Antacids II Nonaqueous |
C-1 Parenteral and Ophthalmic Preparations C-2 Oral Preparations C-3 Topical Preparations C-4 Ear Preparations |
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|
Acceptance Criteria Cosmetics (Topical) [2] |
Log Reduction |
Log Reduction |
Log Reduction |
Log Reduction |
Log Reduction[3] |
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|
7 d |
14 and 28d |
7 d |
14 and 28d |
7 d |
14d |
28d |
14d |
28d |
2d |
7d |
14d |
28d |
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|
Bacteria |
3 |
NI |
3 |
* |
- |
2 from Initial |
NI from |
2 |
NI from initial |
A B |
2 - |
3 - |
- 3 |
NI NI |
|
Fungi (yeast and mold) |
1 |
NI |
1 |
* |
- |
NI from Initial |
NI from initial |
NI from initial |
NI from initial |
A B |
- - |
- - |
2 1 |
NI NI |
[1] The PCPC test allows the microorganisms to be pooled into groups of bacteria, fungi and mold. Additional organisms are listed in the procedure. In addition, at least one rechallenge is recommended for an additional 28 days.
[2] The acceptance criteria listed above is only for topical products. The criteria will differ for other categories.
[3] The EP/BP A criteria express the recommended efficacy to be achieved. In justified cases where the A criteria cannot be attained, for example, for reasons of an increased risk of adverse reactions, the B criteria must be satisfied.