There is 3,640m2 of laboratory space. The laboratory facility was built in 2004 and is divided between Quality Control (ground floor) and New Product development (upper floor). The laboratory has been purpose built with a specifically designed OEL < 10μg/m3 (low – medium containment) and OEL < 1.0 μg/m3 (high containment) laboratory for handling potent and cytotoxic compounds. The labs also contain the following key technologies:

• Glove box isolators and fume hoods
• Chromatography 15 x HPLC & 11 x GLC
• Spectroscopy FTIR, UV, X-ray diffraction
• Particle size (Malvern technique)
• Thermo gravimetric analysis & differential scanning calorimetry
• 4 x ICH stability storage chambers
• Physical & wet chemistry techniques to USP / EP
• All computerised lab equipment systems are validated and compliant with 21 CFR 11 requirements

Quality Operations

The plant has a strong quality system, as shown by the successful record of regulatory inspections. The most recent inspection was by the Irish Medicines Board (IMB) in April 2007.

The IMB approves the facility on behalf of the EMEA and the site has had 9 successful regulatory inspections by the FDA.

Technical Services
(New Product Introduction & Process Development)

The plant offering includes facilities to support technical services and development,including:

• Lab and pilot scale manufacture
• Process Development
• Process scale-up and optimization
• Risk assessment
• Analytical method development and validation
• Process and cleaning validation
• Piloting and testing of new technologies