Medical Devices

Medical Devices Testing and Analysis:

CLS offers the following services to the Medical Devices industry.                                                          

CLS MedPharma’s GMP approved testing facility works in partnership with the Medical Device sector to support current products and next generation products through routine analysis,method development ,stability testing and various process validations including process , cleaning etc .
Our state of the art facility includes the latest technology and a team of dedicated /experienced experts ensures CLS MedPharma delivers the most up current ,compliant and appropriate solutions to our clients thus ensuring CLS MedPharma continues to be the preferred contract laboratory facility

CLS provide a wide range of analysis and support in both our Microbiology and Chemistry Departments.
 

ANALYTICAL Testing and Analysis:

Our Analytical capabilities includes:

  • Full range of raw material testing (API / Excipients- including Cytotoxic Drugs) in accordance with USP, BP, EP JP and customer specific specifications
  • Finished Product /Stability testing (Chromatography , Dissolution, Spectroscopy, 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 
     

CLS MedPharma leading Technology offers a complete independent testing service to its clients including:

  • Chromatography –(HPLC, TLC, GC)
  • Spectroscopy – (UV Vis, FTIR)
  • Dissolution testing
  • Liquid Particulate analysis
  • Karl Fischer
  • Polarimetry
  • Muffle Furnace
  • Wet chemical techniques
  • Microbiological tests (Microbial limit test, Endotoxin, Bioburden)
  • Environmental Monitoring
  • Water testing as per USP /EP
  • Full generator and UPS back up

ANALYTICAL MICROBIOLOGY Testing and Analysis:

  • Microbial limit testing of Raw Materials and Finished Products
  • Endotoxin test method development, validation and subsequent testing using Gel Clot and Kinetic Turbidiometric methodologies as per FDA /AASMI Guidelines
  • Bioburden method development, validation and subsequent testing as per ISO 11737
  • Validation and subsequent routine monitoring of Water Systems
  • Identification of Micro Organisms (API, VITEK)
  • Detergent and Disinfectants testing as per USP

IDENTIFICATIONS:

  • API
  • Gram stains
  • Bbl crystals
  • Vitex

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. CLS Medpharma stability facility includes:

  • Fully qualified facilities with associated operation and control documentation
  • Trained and experienced staff
  • Standard reach in rooms operating at :

25 +/- 2 /60 % RH+/- 5%
30 +/- 2 /65 % RH+/- 5 %
40 +/- 2 /70 % RH +/- 5%

  • All conditions logged to provide continuous record of compliance
  • All temperature and humidity conditions alarmed with 24 hour /7 day call out response
  • Preparation of stability protocols as per ICH Guidelines
  • High security facility
  • Full generator back up in the event of power failure
  • Comprehensive preventative maintenance programme
  • An off site approved back up storage facility.

 Please see our Pharmaceutical  Department page for more detail.

Pipe Sterilisation:

In response to increased legislation and public awareness, pipe and tank sterilisation was established at CLS in 1998, utilising our vast experience in both microbiological and chemical analysis. CLS’s dedicated team of specialists liaises with our clients at every stage of the process, from Legionella Risk Assessments to analysis and interpretation of results.
 

Please see CLS Pipe Sterilisation page for more detail

Analysts on Contract:

Analysts on Contract allows our Medical Device clients to up skill their work force and capabilities, without the implications of recruitment and training.
CLS’s contract staff have a wide range of capabilities tailored to the medical device industry, Chemistry, Microbiology and Environmental Monitoring are all covered in great detail by CLS training programmes. These training programmes can be customised to CLS’s client’s specifications if requested.

Please see our Analysts on Contract page for more information.

Environmental chemistry Sampling:

CLS performs an extensive range of environmental sampling and INAB ISO 17025 accredited chemical and microbiological analysis delivering a professional service in all aspects of environmental monitoring from IPPC, Waste and Discharge license requirements to air & noise assessments. We monitor in compliance with regulatory requirements at landfill and waste facilities and treatment plants. CLS performs flow & load surveys and has extensive knowledge and experience in sampling from surface water, groundwater and drinking water sources. CLS’s state of the art laboratories are fully equipped with all necessary infra-structure to store, handle and analyse large numbers of samples. 

Exsamples Include the following:

  • IPPC
  • Dust
  • Noise & Vibration Monitoring
  • Waste
  • Discharge
  • Process Water 

 Please see our Environmental Monitoring page for more information

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