Complete Laboratory Solutions

Pharmaceutical & Medical Device Analytical Testing

Testing Services / Chemical & Analytical Testing / Pharmaceutical & Medical Device Analytical Testing

Our CLS Medical Device & Pharma Testing GMP approved laboratories support current products and next generation products through routine analysis, method development, stability testing, validations including process and cleaning.

Our Analytical Capabilities Include

  • Full range of raw material testing (API / Excipients) in accordance with USP, BP, EP, JP and to customers’ own specifications
  • Finished product /stability testing (chromatography, dissolution, spectroscopy, heavy metals, wet chemical analysis and physical testing)
  • Validation and subsequent routine monitoring of water systems
  • Analytical method validation as per ICH guidelines
  • Process and cleaning validation analysis
Technologies Used
  • Chromatography – (HPLC, TLC, GC-MS, GC-HS)
  • Spectroscopy – (UV-VIS, FTIR)
  • ICP-MS
  • AA
  • Dissolution Baths
  • HIAC
  • Karl Fischer
  • Polarimetry
  • Muffle furnace
  • Wet chemical techniques
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.

Validation Projects

CLS Pharma can conduct a wide range of customised validation projects. This can be an already prepared project that has been specified and scoped out by our client or in consultation with CLS. There is a valuable resource of expertise and knowledge that can be shared within our team and programmes can be drawn up and agreed. The following are examples of validation projects. An extended example of one of the areas ‘cleanroom validation’ is given below in more detail.

  • Method Transfers from client sites to CLS Pharma
  • Methods developed to client specification, international guidance or non specific
  • Process Validation
  • Process Simulation
  • Purified Water Systems e.g. Operational Qualification (OP) and Production Qualification (PQ) Purified to water for injectables
  • Various classification validations
  • Cleaning / Detergent efficacy
  • Training / Comparative validations
  • Pilot Validation studies
  • Material Integrity Validation
Cleanroom Validation
  • Design the validation programme in accordance with the clients requirements
  • Draw up specifications and compliance requirements
  • Specify testing requirements and accreditations
  • Compile a working document and report structure
  • Include interpretation and compliance discussion
  • Follow and design monitoring programmes and set up warning and action limits
  • Trained technicians conduct environmental sampling
  • Viable sampling and analysis of surfaces, air, personnel and water
  • Non viable sampling and reporting of non viable counts
  • On site recording of environmental conditions, number of personnel present, etc
  • Following through on over action results: Gram stains and Api identification
  • Setting up of a company library of strains identified
  • Troubleshooting for recurring issues

WHO is this for


Medical Device Manufacturers

Biotechnology Companies

Hospitals and Sub Groups


High-Risk Industries

Get in touch

Contact our MedTech and pharmaceutical testing department for a consultation on your requirements:

+353 (0) 91 781 690