Preservative efficacy testing is required for the assessment of the antimicrobial preservation of multiple-use cosmetic and pharmaceutical products.

Antimicrobial preservatives are added to products to prevent or limit microbial contamination, which can occur under normal conditions of storage and use. Their efficacy can be compromised by formulation, container, or even the active pharmaceutical ingredient itself. This complexity poses a risk, not just to patient safety, but to compliance with stringent global regulations. 

We offer fully compliant preservative efficacy testing to assess antimicrobial preservation of pharmaceutical products. Microbial challenge testing can be conducted in accordance with the British Pharmacopoeia (BP), US Pharmacopoeia (USP), a combination of both, a client specific protocol or another nominated method.

Microbial challenge studies can provide critical insights into how long drug products can be held before patient safety is at risk.

These studies evaluate the effectiveness of preservatives and/or preservative ingredients, determine optimum storage conditions, and ultimately assess whether the drug product formulation can withstand low level contamination. If microorganisms can grow in the final drug product during the holding period, the intended hold time, product formulation, and storage conditions should be re-evaluated. Eurofins BioPharma Products Testing New Zealand can support your team in re-assessing and optimising these parameters through expert-led, regulatory-compliant testing.

Principle of test

Antimicrobial preservatives are added to products to prevent or limit microbial contamination, which can occur during normal conditions of storage and use. The efficacy of an antimicrobial preservative may be enhanced or diminished by the active constituent of the preparation, by the formulation in which it is incorporated, or by the container and/or closure being used as the final packaging material.

The test method must be qualified for the product under evaluation to ensure the correct diluent is used in assays for surviving microorganisms.

The product is inoculated with a specified number of each challenge organism and held at room temperature for 28 days. It is examined by the duplicate plate count method to determine the number of viable microorganisms which survive at each specified time interval.

All results are evaluated in accordance with the tabulated acceptance criteria of the relevant pharmacopoeia’s or test protocols.
 

Sample requirements

• Validation: 50g or 50ml
• PET: 150 – 200 g or 150 - 200 ml

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