Eurofins BioPharma Product Testing Ireland Limited
IDA Industrial Estate
Clogherane, Co Waterford
X35 T628
Dungarvan
Ireland
Phone: +353 (0) 58 48300
pharma@eurofins.com
www.eurofins.com/biopharma
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Eurofins BioPharma Product Testing Ireland Limited facility provides microbial, chemical and biologics analysis to the biopharmaceutical, biotech and medical device industries throughout the US, Europe and Japan.
The company was originally founded in 1986 and has been successfully audited by US and European regulatory agencies. It currently employs 250 people in Dungarvan, County Waterford.
Eurofins BioPharma Product Testing in Ireland also offers PSS Insourcing Solutions. The PSS service provides managed, dedicated teams at client companies in Ireland and UK and a further 250 people are employed in this capacity.
Services:
Eurofins BioPharma Product Testing in Ireland has extensive experience in testing a full range of raw materials, intermediates and finished sterile and non-sterile products.
Microbiology and chemistry laboratories are fully equipped to offer complete testing services, including extensive chromatography facilities (HPLC, GC, TLC and GC-MS), spectroscopy (UV-VIS, AA and FTlR), metals analysis via AA,GFAA and ICP, dissolution testing, physical testing of tablets, full media preparation facilities, class A/B and C cleanrooms, isolator technology and Microseq genotypic bacterial and fungal identification.
Our biologics facility conducts a variety of assays, and analysis by CE.
Eurofins BioPharma Product Testing Ireland has broad experience using clients' methods and internationally recognised methods such as USP, BP or Ph. Eur. Alternatively, procedures can be developed in accordance with our clients’ requests.
Chemistry
- Compendial testing of raw materials
- Process validation
- Method development & validation in accordance with ICH guidelines
- Stability storage and testing
- Product Release Testing
- Cleaning validation studies
- Purified water and waste water testing
- Contaminant identification
Microbiology
- Microbial limit testing of raw materials and finished products
- Method development for sterility and bioburden analysis
- Validation and bioburden analysis according to the relevant pharmacopoeia
- Bacteriostasis and Fungistasis analysis
- Sterility analysis (Isolator and Clean Room)
- Identification of micro-organisms (Microseq)
- Preservative efficacy testing
- Use dilution and surface challenge testing of detergents and disinfectants
Biopharmaceutical
Eurofins BioPharma Product Testing Ireland can support all aspects of the biopharmaceutical drug development process with a comprehensive range of services from the biochemical characterization of biologicals to product specific cell and non-cell-based assays for drug potency.
The laboratory provides industry-leading experience in the development, optimisation, qualification and validation of biopharmaceutical products that meet regulatory guidelines for all phases of the development cycle.
Impurity Testing
- qPCR for Residual DNA impurities (CHO/E.coli)
- Host cell protein and Protein A contamination (ELISA)
Protein Analysis
- Capillary Electrophoresis (SDS/IEF)
- SDS-PAGE/Western Blot/IEF
- UV Spectroscopy
- ELISA (Potency)
- Biochromatography (UPLC/SEC/RP)
Medical devices
Eurofins BioPharma Product Testing in Ireland offers a comprehensive range of analyses and support functions to the Medical Device industry. Microbiological laboratory facilities include class A/B and C clean rooms and a microbial identification laboratory.
Experience in the validation of analytical methods and analysis of a wide range of medical devices, including prosthetic implants, ophthalmic implants, cutaneous adhesives and cardiac implants. Also provides contract facilities for the determination of API's associated with medical devices.
All data and results can be accessed via our LabAccess Web portal.
Accreditations:
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Good Manufacturing Practice (GMP) approval of contract laboratory is granted by the Health Product Regulatory Authority (HPRA) formally Irish Medicines Board (IMB). This approval is issued in accordance with Directive 2001/83/EC as amended by Directive 2004/27/EC for contract laboratory analysis of medicinal products and 2001/82/EC as amended by Directive 2004/28/EC for contract laboratory analysis of Veterinary products for the pharmaceutical industry.
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Operates in accordance with US-FDA Code of Federal Regulations (CFR) e.g. 21 CFR Part 210: cGMP General, 21 CFR Part 211: cGMP Finished Pharmaceuticals
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Inspected and registered by the FDA as a contract laboratory to serve the biopharmaceutical industry
- EPA approved laboratory for a range of environmental tests
