Medical Device & Pharmaceutical Microbiological
Here at CLS, our laboratories have the capacity to in-source all your testing requirements including clean room environmental monitoring, raw and finished product testing.
We have a full range of micro-testing, including sampling analysts who can take samples on-site or collect samples that clients have taken. Our services range from bioburden, endotoxin and IDs to developing test methods and validation to FDA and ISO standards.
Our accreditations include FDA, HPRA, ISO 9001:2015, ISO 17025 (108T).
We offer a fleet of refrigerated vehicles 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 are on staff and return to commercial testing with us upon completion of projects. All our people undergo continuous competency and proficiency measurement.
- 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
- 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.