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Complete Laboratory Solutions (CLS)

HQ Gortmor

Galway, IE


GMP approved labs providing sampling, testing and analysis to the food, environmental, water, pharma & medical device industries. CLS MedPharma laboratories were successfully FDA inspected in 03-14.

The CLS group of laboratories is based in the capital of the medical device industry, Galway. Having been in business since 1994, it is the leader in its field in Ireland. Expert services include microbiological / analytical testing. Clients have an option to outsource testing requirements to CLS's modern laboratories & technology facilities or alternatively CLS analysts can work contractually at client sites. CLS has developed a bespoke in-house Laboratory Information Management System (LIMS) and an Enterprise Resource Planning System (ERP) and clients can access their quality checked results online. The company is proud to work in partnership with its clients, many of whom are leading global brands in the pharmaceutical and medical device sector. CLS supports current & next generation products through routine analysis, method development, stability testing and various process validations, including process, product, cleaning, etc. It has GMP (approved by the HPRA) testing facilities and performs microbiology testing in its INAB accredited testing laboratory Reg. No. 108T. In March 2014, CLS MedPharma was successfully inspected by the FDA.

CLS currently has a workforce of 101 employees, invests in leading technology, boasts a highly accomplished team of people and has both the vision and strategic plan to optimize growth with sustainability and innovation to place and hold CLS in a leading position making it attractive as a supplier both in Ireland and internationally.

Specialties

TECHNOLOGIES: ICP-MS, GC-FID, GC-MS, HPLC, cytotoxic containment

EXCLUSIVE Irish providers of: solvent residue checking and metal testing

Technical Information:

GMP approved labs providing sampling, testing & analysis to the food, environmental, water, pharma & medical device industries.
Analysis and support in CLS MedPharma's microbiology & chemistry depts include:
Full range of raw material testing (API/Excipients-including cytotoxic drugs) in accordance with USP, BP, EP, JP and customer specific specs
Finished product/stability testing (chromatography, dissolution, spectroscopy, wet chemical analysis & physical testing)
Validation; subsequent routine monitoring of water systems
Analytical method validation per ICH guidelines
Process & cleaning validation analysis

At CLS MedPharma's independent specialist testing facility, we offer clients:
GC-FID
GC-MS
ICP-MS
Chromatography-(HPLC, TLC, GC)
Spectroscopy-(UV Vis, FTIR KF)
Dissolution testing
Liquid particulate analysis
Karl Fischer
Polarimetry
Muffle furnace
Wet chemical techniques
Microbiological tests (microbial limit test, endotoxin, bioburden)
Environmental monitoring
Water testing per USP/EP

Specialist facilities include:
Cleanroom Suite for product testing
Cytotoxic containment laboratory for carcinogenic/cytotoxic products.
Basic testing & validation including all pathogen detection, LAL, PET, bioburden, simulation design & validation of products and processes.
Barrier testing, seal integrity, ingress, antimicrobial effectiveness

ANALYTICAL MICROBIOLOGY Testing & Analysis:
Microbial limit testing of raw materials & finished products
Endotoxin test method development, validation and subsequent testing using gel clot/kinetic turbidiometric methodologies per FDA/AASMI guidelines
Bioburden method development, validation and subsequent testing per ISO 11737
Validation and subsequent routine monitoring of water systems
Identification of microorganisms (API, VITEK)
Detergent & disinfectants testing per USP

IDENTIFICATIONS:
API
Gram stains
Bbl crystals
Vitex

STABILITY TESTING & STORAGE: Includes ICH stability storage facilities - fully supported by GMP operating analytical chemistry & micro labs.
GMP Approved Contract Laboratory
Method Development & Validation
Laboratory Design, Set up & Management
Contract R&D Support
Cleanroom Validation
Stability Studies
Sample Collection
CONTACTS: Anne O'Donnell aodonnell@cls.ie / Martin Dooley mdooley@cls.ie

The Environmental Services Department at CLS is recognised for interpretation and analysis of TPH in petroleum related incidences. We provide our clients with a wide range of services from sampling to analysis and reporting by our experienced team. CONTACT: cterloh@cls.ie for the full suite of hydrocarbon analysis carried out within our lab. Other services include:
Major Cations & Anions
Heavy Metals by ICP-MS
Nutrients,Minerals
Chloride, Sulphate, Total Hardness
Wet Chemistry Parameters
OFG, TSS, TDS
Detergent
PH, Turbidity, Colour
Dissolved Oxygen
Conductivity
TOC, COD, BOD, Phosphate, Ammonia
Sludge Anaysis,
Nitrate & Nitrite
Total Nitrogen, Phosphors
Suspended Solids
PAH 16
(TPH) Total Petroleum Hydrocarbons
(DRO, PRO, BTEX, MTBE)
Mineral Oil
Dustfall Analysis
Noise & Vibration Monitoring
TON
PCBs
VOCs
Pesticides
Organic/ Inorganic Chemistry

DISCLAIMER: This Laboratory Profile was provided by the company above.