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Laboratory Profile: Complete Laboratory Solutions (CLS)

Complete Laboratory Solutions (CLS) Services :

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

HQ Gortmor

Galway, IE