Pharmaceutical

Pharmaceutical Testing and Analysis:

CLS MedPharma’s GMP approved testing facility, works in partnership with leading manufacturers of pharmaceutical products to support current products and the next generation products through routine analysis, method development ,stability testing and various validation activities e.g.process ,cleaning etc .
Our state of the art testing facility includes leading technology and a team of dedicated analytical experts who ensure CLS MedPharma delivers the most current and compliant solutions to our clients thus ensuring CLS continues to be their preferred Analytical Partner .In addition, CLS MedPharma provides a nationwide collection service and a range of specialized sampling activities
 

ANALYTICAL Testing and Analysis:

Range of Analytical capabilities include:

  • Full range of raw material testing (API / Excipients- including Cytotoxic Drugs) in accordance with USP, BP, EP and JP
  • Finished Product /Batch Release /Stability testing (Chromatography, Dissolution, Spectroscopy, Wet Chemical Analysis and Physical Testing)
  • Validation and Subsequent routine monitoring of Water Systems including TOC and Conductivity
  • Analytical method validation as per ICH Guidelines
  • Process and cleaning validation analysis
  • Storage of retain samples as per GMP
     

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

  • Chromatography –(HPLC, TLC, GC)
  • Spectroscopy – (UV Vis, FTIR)
  • Dissolution testing apparatus
  • Liquid Particulate analysis
  • Total Organic Carbon (TOC)
  • Conductivity
  • Karl Fischer
  • Muffle Furnace
  • Polarimetry
  • 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
  • Cleanroom Validation and subsequent Monitoring as per ISO 14644
  • Utilities (Compressed Air, Nitrogen) qualification and subsequent monitoring
     

VALIDATION PROJECTS:

Because of its experienced Analytical team, CLS MedPharma can conduct a wide range of customised validation projects. This service includes protocol generation ,execution and report generation in compliance with relevanRegulatory requirements .Examples of such validation activities include :

  • Analytical test Methods developed and validated to current ICH Requirements
  • Process Validation as applied to a specific manufacturing process e.g. mixing ,coating ,filtering ,filling , depyrogenation, sterilization ,Cleaning ( detergent /API residual testing ) etc
  • Aseptic Process Simulation e.g. media/broth fills supported by growth promotion testing as per USP
  • Purified Water Systems
  • Cleanroom classifications (Class A –D) as per ISO 14644
  • Cleaning / Detergent efficacy as per USP
     

CLEANROOM VALIDATION (AN EXTENDED EXAMPLE OF A VALIDATION PROJECT):

  • Generate a Validation Plan in accordance with the clients requirements
  • Propose appropriate Specifications and Test Methods in compliance with the relevant Regulatory requirements
  • Introduce a working protocol for client approval prior to execution 
  • Prepare a Validation report including interpretation, discussion and conclusions
  • Propose an Environmental monitoring programme with appropriate alert and action
     

ENVIRONMENTAL MONITORING:

  • Non Viable air e.g. Particulate
  • Viable air
  • Surface /contacts
  • Finger swabs
  • dentifications of isolates – establishes root cause of out of specification results and identifies appropriate corrective /preventative actions

 PRODUCT TESTING:

  • Endotoxin – gel clot /kinetic turbiometric
  • Bioburden

WATER:

  • Endotoxin
  • TVC filtration

 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. We have extensive experience in working with many dosage forms- drug substances and final dosage presentations including tablets, capsules , drug coated stents ,liquids ,etc

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
• Full generator back up in the event of power failure
• Comprehensive preventative maintenance program
• Off site approved back up storage facility

Please see our Pharmaceutical 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 Pharmaceutical 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 pharmaceutical 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:

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.

Examples 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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