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.

Non-sterile pharmaceutical products are required to meet specific guidelines regulated by the Australian Therapeutic Goods Administration (TGA) under a specific Therapeutic Goods Order.

Therapeutic Goods Order No. 100 (previously TGO. 77, and TGO. 98) provides continuing clarity on the requirements for microbiological quality of medicines. This order requires medicines to comply with the harmonised methods of microbiological quality of non-sterile products (microbial enumeration tests) and the harmonised method for specified micro-organisms.  

The Australian TGA has taken the view that specified organisms should include Pseudomonads rather than just Pseudomonas aeruginosa.

Testing capability

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.

Testing of objectionable / indicator organisms is performed by an enrichment process. 

The product is suitably diluted and enriched by direct broth enrichment or membrane filtration. The enriched product is then streaked onto various selective agar plates to isolate Bile-tolerant Gram negative bacteria, Gram negative bacteria, Staphylococcus spp, Pseudomonads, Salmonella spp and Coliforms.

A confirmation process is performed if typical growth is detected by sub-culturing onto selective media agars. Further identification can also be performed using our phenotypic ID system (MALDI-TOF) or genetic sequencing system (comparison against our Eurofins IDmyk Comparative Sequence Index).

Products are also able to be tested by specific client methods provided we are given clear instructions and/or standard operating procedures are provided. 

Get in touch

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