Regularly inspected by the MHRA
	UKAS accredited for many tests

The Ely laboratory was purpose built by a pharmaceutical company and has been acquired by Eclipse as a dedicated facility for supporting pharmaceutical clients who are outsourcing work.

It includes constantly monitored storage stability rooms, set up in compliance with ICH conditions, walk-in cold storage and freezer rooms and laboratories containing an extensive range of testing equipment.

Click here for details of our pharmaceutical testing services.

Testing areas covered by the Group include:

	Method development and validation: Analytical methods developed to ICH guidelines. Pharmaceutical analysis services covering all stages from raw materials through to finished products, with reference to the various Pharmacopoeias. Release testing and 'one-off' investigations.
	Storage stability testing: Facilities for ambient and accelerated storage stability trials, conducted in accordance with ICH guidelines. Choice of the appropriate method to be used to monitor stability and its validation. Performance of the tests at the required intervals and preparation of the final reports.
	Microbiological testing: Bioassays for the analysis of certain antibiotics and vitamins. Routine tests for undesirable micro-organisms - pathogens, yeasts/moulds etc. In products (bioburden testing) or in the manufacturing environment. Purified Water testing of waters used in pharmaceutical preparations. Sterility testing of pharmaceutical products.
	Physical testing: Dissolution; Tablet hardness, disintegration and friability; Uniformity of mass.
	Preservative efficacy testing, using a UKAS accredited method.

Our staff can assist in most aspects of your programme, from method validation through to generating data for regulatory submissions.The laboratories are equipped with a wide range of instrumentation including:

	HPLC (High-Pressure Liquid Chromatography) with various detection systems including UV (diode array), fluorescence, RI and electrochemical (linked to Dionex)
	GC (Gas Chromatograph) including mass selective detectors and GC/MS/MS (Mass Spectroscopy). Other detectors include: NPD (Nitrogen-Phosphorus Detector) , FID (Flame Ionization Detector) ECD (Electron Capture Detector) FPD (Flame PhotometricDetector )
	UV/VIS spectrophotometer (Ultra Violet / Visible Light)
	Physical testing
	ICP-AES (Inductively Coupled Plasma - Atomic Emission Spectroscopy)
	Automated Karl-Fischer moisture apparatus

Tests can be conducted using client's own methods, those specified from other sources, for instance BP/EP/USP (etc. Or we can assist in the development of a bespoke method.

Pharmaceutical: Regularly inspected by the MHRA (formerly MCA); UKAS accredited for many tests; Method development and validation; Storage stability testing; Microbiological testing; Physical testing.