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Sterility testing is a key GMP Microbiology testing requirement for sterile pharmaceuticals, medical devices and materials, to ensure they are safe for use.
Our team work with you to support your quality control requirements, develop and deliver testing and analytical solutions. We use two methods to perform sterility testing:
- Inoculation in two types of media for detection of aerobic and anaerobic microorganisms
- Inoculation period of 14 days with intermittent observations
- 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.
Membrane filtration sterility testing
- Enclosed sterile units allowing two samples of equal volume to filtered simultaneously through two membrane filters
- Incubated in two types of media to facilitate 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.
Our test methods comply with USP <71> and Ph. Eur. 2.6.1
- Sterility Testing
- Antimicrobial Efficacy Testing (AET)
- Microbial Limits Testing
- Bioburden Determination
- Endotoxin Testing
- Environmental Monitoring and Identification
- Water Analysis
- Stability Storage and Testing and Accelerated Ageing Studies
- Extractables and Leachables
- Method Development and Validation
- QC (batch release) and Raw Materials Testing
- Residual Solvent Testing
- Water Analysis
- Heavy Metals Testing
- Cleaning and Sterilization Validation of Reusable Medical Devices
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.