Technical Information Bulletin
downoad here |
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CTFA[1] |
USP |
JP |
EP/BP |
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Bacteria |
Two from Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Proteus species or Enterobacter gergoviae
One from Staphylococcus aureus or Staphylococcus epidermidis
Pseudomonas aeruginosa and one from P. cepacia, P. fluorescens, P putida, Flavobacterium sp or Acinetobacter sp.
Bacillus subtilis (Optional) |
Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa |
Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa |
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Yeast |
Candida albicans or Candida parapsilosis |
Candida albicans |
Candida albicans |
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Mold |
Aspergillus niger or Penicillium luteum |
Aspergillus niger |
Aspergillus niger |
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Test Duration |
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 |
14 & 28 |
7, 14, 21 & 28 |
0, 2, 7, 14 & 28 |
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Types of Product
|
1. Water Miscible Cosmetics 2. 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[3] |
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7 d |
14 and 28 d |
7d |
14d |
28d |
14d |
28d |
|
2d |
7d |
14d |
28d |
|
Bacteria |
3 |
NI |
- |
2 from Initial |
NI from 14 day |
2 |
NI from initial |
A B |
2 - |
3 - |
- 3 |
NI NI |
Fungi (yeast and mold) |
1 |
NI |
-
|
NI from Initial |
NI from initial |
NI from initial |
NI from initial |
A B |
- - |
- - |
2 1 |
NI NI |
Note:
The EP/BP criteria requires a reduction of bacteria at 2 days, this is the most stringent criteria for bacteria.
The CTFA criteria requires a reduction of fungi at day 7, this is the most stringent criteria for fungi.