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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, we are here 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 (full documentation is available to download on the right of this page). All Lucideon's services are undertaken in compliance with EU guidance on GMP as it applies to contract QC testing laboratories.
In the UK Lucideon is a UKAS-accredited testing laboratory (No. 0013) and our Pharmaceutical/GMP Laboratories hold an MHRA Certificate of GMP Compliance (No. UK GMP 43644 Insp GMP/IMP 43644/10698843-0005, Dated:28/07/2020) for contract QC Testing of Human and Veterinary Medicines. The Lucideon Pharmaceutical/GMP Laboratories also hold a current FDA Certificate of Registration and were successfully inspected by FDA in Sep-2019.
In the US Lucideon is Nadcap-accredited and has 10 CFR 50 Appendix B Quality Assurance accreditation.
» Our FDA registration certificate can be viewed here
We are also licensed to handle restricted products. Further details can be provided if required.
We have a state-of-the-art, purpose-built sterility test isolator incorporating a vaporised hydrogen peroxide (VHP) generator, minimising the potential of false positives associated with other types of sterility testing environments.
We use two methods to perform sterility testing:
- Membrane Filtration
- Direct Inoculation.
Antimicrobial Efficacy Testing (AET)
At Lucideon, 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.
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 a number of situations as part of:
- validation and revalidation of sterilization processes
- routine monitoring for control of manufacturing processes
- assessment of the efficiency of cleaning processes.
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.
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.