Pharmaceutical Microbiology Testing
Whether you need to ensure sterility, determine antimicrobial effectiveness, microbial contamination or bioburden, analyse endotoxins or identify flora from your environmental monitoring processes, Lucideon will be able to help.
We will work with you as part of your team to not only provide comprehensive quality data, but also timely and effective solutions to any challenges that you face.
We are fully GMP-certified for quality control testing of human and veterinary medicinal products. Our services are undertaken in compliance with EU guidance on GMP as it applies to contract QC testing laboratories.
Antimicrobial efficacy testing (AET)
We can perform antimicrobial effectiveness testing (AET or PET) to Ph. Eur. and USP on an array of products. The product is inoculated with a specified number of each challenge organism. Over a period of 28 days, the product is examined to determine the number of viable microorganisms which survive at each specified time interval.
Microbial limits testing
For non-sterile products, we can perform microbial contamination testing using harmonised pharmacopoeial or client-supplied methods to determine the bioburden within the sample. Microbial enumeration - Total Yeast and Mould Count (TYMC) and Total Aerobic Microbial Count (TAMC) analysis and tests for specified microorganisms are employed for this.
Endotoxin (LAL) testing
We can perform analysis of endotoxins using Kinetic Turbidimetric methodology. Limulus Amoebocyte Lysate (LAL) is used to detect and quantify bacterial endotoxins extracted from the products.
Bioburden testing is performed by Lucideon to ensure that your products comply with the associated standards. Lucideon offers assessment of the quality of your production processes and can work with clients to produce solutions and improvements.
Bioburden testing is used in several situations as part of:
- validation and revalidation of sterilisation processes
- routine monitoring for control of manufacturing processes
- assessment of the efficiency of cleaning processes
Environmental monitoring and identification
Our experts can incubate, enumerate and identify flora from your environmental monitoring processes. Using a VITEK® 2 system to complement traditional Gram stain and microscopy techniques we are able to identify a vast library of environmental and clinical organisms to aid in background environmental analysis, failure investigations, and contamination issues.
Whether it's analysing water quality to pharmacopoeial monographs (Ph. Eur., USP, BP, JP), HTM directives, microbiology of drinking water, or Total Organic Carbon (TOC) - at Lucideon, we can help.
Sterility testing is a key GMP microbiology testing requirement for sterile pharmaceuticals, medical devices, and materials, to ensure they are safe for use. We use two methods to perform sterility testing, each of which comply with USP <71> and Ph. Eur. 2.6.1.
Our direct inoculation method is performed in a Grade A Isolator (with optional VHP) to reduce risk of naturally occurring bacteria and fungi contamination delivering false positives and out-of-specification results, and is maintained for a period of 14 days with intermittent observations.
Our membrane filtration method uses enclosed sterile units, allowing two samples of equal volume to filtered simultaneously through two membrane filters.
Both of our methods inoculate in two types of media for detection of aerobic and anaerobic microorganisms. We test bulk and final drug products, as well as raw materials. We also perform bacteriostasis/fungistasis tests to assess if microorganism growth is inhibited.
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