Complete Laboratory Solutions
Pharmaceutical & Medical Device Microbiological Testing
Testing Services / Microbiological Testing / Pharmaceutical & Medical Device Microbiological Testing
At CLS we have a full range of microbiological testing, including sampling analysts who can take samples on-site or collect samples that clients have taken. Services include clean room testing ranging from bioburden, endotoxin, and IDs to developing test methods and validation to FDA and ISO standards.
As a long-established market leader in laboratory services, we have dedicated facilities to lead our centre of excellence to service the Pharmaceutical and Medical Device Industries. The cGMP approved testing facility works in partnership with leading manufacturers of medical devices and pharmaceutical products. CLS has invested in state-of-the-art facilities and technology to deliver the most up to date and appropriate solutions to our clients.
Our fleet of refrigerated vehicles is ready for sample collection and delivery, specialising in even the most time-sensitive work. We can customise a testing solution to suit your specific needs, combining out- and in-sourcing whichever suits your company growth cycle. All our analysts undergo continuous competency and proficiency measurement.
Routine Microbiological Testing
- Bioburden analysis
- Microscopic ID’s in supporting product and clean-room monitoring
- A range of bacteria identifications available, biochemical and Omnilog
- Endotoxin Testing (LAL), both gel clot and chromogenic methods available
- Preservative Efficacy Testing (PE Testing)
- Absence of specific organisms
- Media fill
Stability Testing & Storage
Our range of services includes ICH Stability storage facilities that are fully supported by our GMP operating Analytical Chemistry and Microbiology Laboratories. We have extensive experience in working with many dosage forms, drug substances and excipients.
- Testing delivered to you on your terms
- Capacity always available to you for planning and execution
- Depending on a company rather than your individuals, no sick time or holiday time required
- Allows you to focus on manufacturing – your value proposition not testing that’s ours
- Access to expediate results
- We manage the compliance of your testing and we host the audits
- We can manage your analyst recruitment screening, technical training, and succession planning and backfilling – no downtime.
WHO is this for
Medical Device Manufacturers
Hospitals and Sub Groups
Get in touch
Contact our Microbiological Testing department for a consultation on your requirements:
+353 (0) 91 574 355