The number of viable microorganisms - bacteria and fungi - present in or on a product defines its microbiological quality and safety. While non-sterile products are not required to be free from all microorganisms, they must be tested for bacterial and fungal counts, and the absence of specific pathogens. When manufacturing non-sterile pharmaceutical products, you must prove the absence of harmful pathogens, quantify microbial content accurately, and validate your processes in line with stringent pharmacopoeial standards. Microbiological examination of non-sterile products is therefore a vital part of ensuring product quality and regulatory compliance.

Eurofins BioPharma Product Testing network of laboratories offers a fully comprehensive microbiological examination of non-sterile products. We define the appropriate testing strategy based on your product type, assess the susceptibility of your product to microbial growth, and ensure compliance with regulatory requirements (USP, EP, FDA guidelines). Our global facilities have experienced scientists operating in compliance with GMP and ISO requirements, to deliver rigorous testing tailored to your specific product type and compliance requirements. 

Testing is conducted using standardised methods aligned with pharmacopoeial regulations or DIN EN ISO standards. Where needed, we develop client-specific test procedures, including method suitability testing in line with applicable guidelines, to ensure that complex formulations meet all relevant criteria. We offer both quantitative and qualitative microbial testing, designed to evaluate the microbiological quality of non-sterile products across industries.

Quantitative testing (Microbial Enumeration Tests) 

Quantitative testing determines the total number of viable microorganisms in or on the product. The aim is to quantify the total viable aerobic microbial count (TAMC) and total yeast and mold count (TYMC) in non-sterile products.

Methods:

• Plate Count Method: For counting colony-forming units (CFUs) using agar plates. The number of bacterial or fungal colonies is counted and expressed as CFU for TAMC and TYMC.
• Membrane Filtration: Used when the product can be filtered and is not suitable for direct plating.

Qualitative testing (Test for Specified Microorganisms)

Qualitative testing confirms the absence of microorganisms (defined by current pharmacopeial procedures) in or on the product. The aim is to ensure that nonsterile products do not contain harmful microorganisms that could pose a risk to patients or compromise product quality.

Target Microorganisms:

• Staphylococcus aureus
• Pseudomonas aeruginosa
• Escherichia coli
• Salmonella spp
• Candida albicans
• Clostridia (in some cases)

Testing is performed in accordance with the current requirements of the main international and national pharmacopeial chapters:

• Ph. Eur. 2.6.12 & 2.6.13
• USP <60> ; <61> ; <62>
• JP 4.05
• ISO 11737
• Water for Injections (Ph. Eur. 0169) and Water, Purified (Ph. Eur. 0008)