PRESERVATIVE CHALLENGE TEST

Service Presentation
SPC Microtech Analytical and Testing Laboratory
PRESENTATION

OBJECTIVES: OUTLINE:

• To disseminate information regarding preservative efficacy • Overview

test to client. • Principle
• To set an agreement regarding the protocol and • Protocol
requirements of the analysis • Requirements
• Reporting of Results
PCT: An Overview
PRESERVATIVE CHALLENGE TEST

• a.k.a. Antimicrobial Efficacy Test

• use to determine the efficacy of the antimicrobial

activity of preservatives used in cosmetic products
PRINCIPLE
ASEAN
USP recommendation:
recommendation:

• The test consists of challenging a non-contaminated Staphylococcus aureus

product with a prescribed inoculum of suitable Pseudomonas aeruginosa
microorganismsand storing the inoculate product at a Enterobacter
Escherchia aerogenes
coli
prescribed temperature. Candida albicans
Aspergillus brasiliensis
• Using serial dilutions and plate counts, the number of
surviving microorganisms in the test product are
determined at specified time intervals.

• Products meeting the specified criteria will be

considered adequately preserved for manufacture and
consumers use.
PRINCIPLE

20 g

7 days

14 days

28 days
REQUIREMENTS

• 200g of sample

• A validated neutralization method against the cosmetic product

• 2 months turn-around time

REPORTING OF RESULTS
Reduction value = log(inoculum) – log(post count)

MICROORGANISMS
BACTERIA C. ALBICANS A. BRASILIENSIS
SAMPLING TIME 7D 14D 28D 7D 14D 28D 14D 28D
CRITERION A ≥3 ≥3 and NIb ≥3 and NI ≥1 ≥1 and N ≥1 and NI ≥0c ≥1
not not ≥0 and NI
CRITERION B ≥3 ≥3 and NI ≥1 ≥1 and NI ≥0
performed performed

b NI: no increase in the count from from the previous contact time
cR =
x 0 when log(inoculum) – log(post count), no increase from the initial count

Criterion A, whereby the formulation is protected against microbial proliferation that may present a potential risk for the user and no additional
factors are considered.

Criterion B, whereby the level of protection is acceptable if the risk analysis demonstrates the existence of control factors not related to the
formulation indicating that the microbiological risk is tolerable for the cosmetic product.