Technical Information Bulletin

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CTFA[1]

USP

JP

EP/BP

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

Staphylococcus aureus, Pseudomonas aeruginosa

Yeast

Candida albicans or

Candida parapsilosis

Candida albicans

Candida albicans

Candida albicans

Mold

Aspergillus niger or Penicillium luteum

Aspergillus niger

Aspergillus niger

Aspergillus niger

Test Duration

28 or 56 days

28 days

28 days

28 days

Sampling times in days

For topical products

0, 2, 7, 14, 21 & 28

14 & 28

7, 14, 21 & 28

0, 2, 7, 14 & 28

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

Acceptance Criteria Cosmetics (Topical) [2]

Log Reduction

Log Reduction

Log Reduction

Log Reduction[3]

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
NI : No Increase

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.

[1] The CTFA 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.