CLS Medical Device & Pharma Testing Successfully FDA Inspected

10 Mar 2014

CLS Medical Device & Pharma Testing Successfully FDA Inspected

FDA

CLS Medical Device & Pharma Testing provides sampling, analysis and analysts on contract to the medical device and pharmaceutical sectors.

It has been FDA inspected successfully, GMP approved by the Irish Medicines Board and its microbiological facilities also includes an INAB accredited testing laboratory Reg. No. 108T

CLS Medical Device & Pharma Testing analysts are available on contract to client sites having under taken a broad range of techniques that we train analysts on and it can be very much customised to meet the exact operational needs from technology through to method execution. Our niche supply is analytical chemists and microbiologists.

CLS Medical Device & Pharma Testing performs ongoing tests and validation for both our Irish based and overseas clients. We have large scale capacities remaining to accommodate growth and new clients.

Our range of technology expertise includes but is not limited to:

  • Bioburden / Endotoxin Testing (LAL)‏
  • PET / Ingress / Integrity /barrier/ Environmental monitoring
  • Microbial limit testing / sampling
  • Verification / Validations / Simulations
  • Absence of specific Organisms
  • Detergent efficacy / challenge
  • Method Evaluation & development
  • Support contract R & D

Typical work would be clean room monitoring, compressed air testing, cleaning, product, process validation.

Our range of technology expertise includes but is not limited to:

Analytical:

  • HPLC
  • GC / FID GC / HS GC/ Liquid
  • MS
  • ICP / MS
  • KF
  • UV / Vis
  • Potentiometric titrations
  • Liquid Particle counter
  • Spectrophometry
  • TOC
    Typical testing
  • Compendial Testing
  • Potency ,UOC ,Related Substances
  • Raw materials and Finished products
  • Dissolution
  • Validation
  • Identifications
  • Heavy metals, solvent residues
  • Potentiometric titrations
  • Liquid Particle analysis
  • Residue on ignition, heavy metals, melting point etc
  • Uniformity of mass, disintegration

We are the only Irish providers of:

  • solvent residue testing
  • heavy metal testing as per USP 232 / 233 (ICP-MS)
  • and biocompatibility testing.

We deliver:

  • High-quality work and reliably fast turnaround times.
  • Online reporting and trending via our website for our clients.

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