Pharmaceutical Microbiological Testing

Microbial Contamination Control in Pharmaceutical Manufacturing

Our pharmaceutical microbiological testing services are a critical component of safety and quality assurance during good manufacturing practice (cGMP) analysis.

GMP testing provides insight not only on long term environmental and manufacturing contamination hazards, but also sheds light on the microbial limits and preservative efficacy of new products for approval processes.

End-to-End Microbiological Testing for Pharma Safety

HMR Labs can help you uncover any harmful microorganisms present in finished products and validate the effectiveness of manufacturing processes. It’s important that microbiological testing be a part of a wider, end-to-end pharmaceutical solution, inclusive of method validation through to raw materials and finished product testing.

Regardless of whether our pharmaceutical microbiological testing is utilised as a stand-alone service or as a support function of the wider departments, we can assist with controlling microbial contaminations, including: bacteria, yeast, mould and more.

Develop formulations and good manufacturing processes that can withstand microbial challenges with our GMP testing services.

Dedicated In-house
microbiology unit

Expert guidance on process improvements

Identification of bacterial
and fungal isolates using a
range of techniques

Microbiological Identification & Testing

HMR Labs offers a consultative approach which allows us to work with customers to implement appropriate corrective actions based on all vital information gathered from our suite of pharmaceutical microbiological testing.

Through strategic partnerships, HMR Labs are able to offer the most advanced ID techniques available. This provides innovative characterisation methods for the specific microorganisms found in products, or manufacturing environments.

Microbial Limits Testing

Assess the total viable microbial count present in your products with the help of HMR Labs. Using pharmacopeial (BP, Ph.Eur., USP, JP) or customer-centric methodologies, we can determine quantity and specific species’ present in a drug.

Batch release and GMP testing are heavily reliant on microbial limits testing to ensure product safety, regulatory (including FDA and MHRA) compliance, process control, stability and sterility validation and batch to batch consistency.

Preservative Efficacy Testing

Pharmaceutical drug compounds require antimicrobial protection to ensure they can withstand potential contaminations during their intended shelf life. HMR Labs can test the effectiveness of the preservatives in your formulations, demonstrating the anti-microbial activity of a particular product offers adequate protection.

Endotoxin Testing Methods

Severe adverse effects that can affect patient safety may arise if bacterial endotoxins are identified in a pharmaceutical drug product. Regardless of whether it is an ingredient, water supplies used in manufacturing processes or the finished drug product, HMR Labs can determine the presence of bacterial endotoxins.

Limulus Amoebocyte Lysate (LAL) endotoxin test are essential for parenteral products which plan to be used in contact with the bloodstream, including injectable medications, IV solutions, vaccines, anaesthetics and pain management medications.

The LAL bacterial endotoxin test performed at HMR Labs accurately identifies and quantifies endotoxicity contaminant levels.

Bioburden and Environmental Testing

Broadening the scope of quantifying the microorganisms present during drug compound formulation leads to bioburden testing as well as environmental testing and residue testing.

HMR Labs offers the flexibility to help pharmaceutical manufacturers understand the potential threat of microorganism presence in their production environment as well as raw materials, residues and final pharmaceutical products.

Evaluation of Disinfectants and Biocides

Performed against BSEN, and other regulatory standards, HMR Labs also offers the capability to assess the bactericidal activity of disinfectants and biocides on a range of surfaces. As part of GMP testing, this service is principally used as a development tool for new R&D product assessment prior to final product formulation.

Complete Microbiological and Analytical Testing

Collectively, microbiological testing and our wider testing services can maintain compliance of raw materials, batch released products and manufacturing practices.

As a value-add provider, HMR Labs is committed to being a one-stop shop for pharmaceutical manufacturers. Our analytical testing portfolio allows our customers to take advantage of further services which ensure the quality, safety and efficacy of drug compounds.

Depending on dosage form and intended use, HMR Labs can advise on the most efficient and strategic testing timeline to validate methodologies and streamline batch release.