Quality Control Testing

Comprehensive Microbial Quality Control Testing Services for Pharmaceuticals and Medical Devices

Expert Microbial Analysis for Total Aerobic Counts, Yeast & Mould Counts, Specified Microorganisms, Potable Water, and Environmental Swabs

Accurate microbial quality control is crucial for ensuring the safety and compliance of pharmaceutical and medical products.

High quality testing for microorganisms prevents contamination, protects consumer health, and meets regulatory standards. Our clients adhere to standards set by authorities like the FDA, MHRA, and international pharmacopoeias. 

As a GMP and GLP compliant lab, we offer precise testing methods that ensure product reliability and market credibility, minimising risks and safeguarding your brand’s reputation.

Quality Control testing

Your Partner in Microbial Quality Control Testing Services

Total Aerobic Microbial Counts

Determines the number of microorganisms (usually Bacterial) in a product quantity by either plate count method or membrane filtration method.

Total Yeast and Mould Counts

Determines the number of microorganisms (Yeast and Mould) in a product quantity by either plate count method or membrane filtration method.

Total Aerobic Microbial Counts

We can design the method of testing around the clients requirements. Usually medical devices and purified water samples are tested by membrane filtration methods and pharmaceutical products such as creams, tablets, API products and liquids are tested by plate count methods. 

Both methods are equally as accurate, however with a plate count method if you are expecting a count of some sort you can dilute the sample further and perform other dilutions so you have an accurate result.

Absence of Specified Microorganisms:

Determines the presence or absence of specified microorganisms
•    Escherichia coli
•    Salmonella spp
•    Pseudomonas aeruginosa
•    Staphylococcus aureus
•    Bile tolerant gram-negative organisms
•    Burkholderia cepacia complex
•    Candida spp
•    Clostridia spp

The tests listed above are not exhaustive, we can discuss further requirements of specific organism testing with the client. These tests are usually performed as a qualitative analysis, however with products that are known to have a high bioburden such as herbal products – they can be tested as a quantitative analysis.

The type of testing required will depend of the route of entry of the product. For example any topical creams or lotions would usually be tested for Pseudomonas aeruginosa and Staphylococcus aureus. Products that are going to be ingested are tested for E.coli, Salmonella etc as they will be digested inside the body and introducing these type of bacteria could make the consumer taking the product very unwell.

Potable Water Testing

We can conduct testing on water from manufacturing facilities either as part of routine Environmental Monitoring sampling at your site, or through client samples sent to our test facility. We are able to determine the levels of microorganism present and identify any microorganisms found.  We can also provide expertise in water systems, and management of water contamination and biofilm management as required.

The types of testing we can offer for these types of water samples are as follows:

  • TVC at 37C
  • TVC at 22C
  • Escherichia Coli
  • Total Coliforms
  • Pseudomonas aeruginosa
  • Enterococci and other Faecal organisms
  • Clostridium Perfringens
Enumeration of swab testing

Enumeration of swab testing

We can perform analysis of swab samples taken from a clients facility either from their routine Environmental Monitoring requirements or as a one off if they encounter a contamination issue and are swabbing their facility to establish the route of entry for the contamination. The swab is taken and placed into transport medium and sent to WML. WML will then perform a TAMC and TYMC plate count analysis.

enquiries

Scroll to Top