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A centre of excellence for research, development and commercialisation of High Potency Oral Solid Dose medicines
Our facility
Located in Waterford, Ireland, our state-of-the-art and globally-accredited manufacturing environments were designed and constructed specifically for high potency manufacture and have capabilities to produce cytotoxic, genotoxic and moisture-sensitive drug products across multiple platforms.
40,000ft dedicated Hi-Potency Facility
2
Low Humidity capability (<30%RH)
ISO 14644 Class 8 Clean-room Standard
Full body Air-Suit Capability
Single-pass double HEPA filtered air
Fully-equipped Analytical Labs
Fully Segregated Processing Rooms
Equipment to support Oral Solid Dose Manufacture & Packaging
Our manufacturing suites support the manufacture of high potency finished product in multiple formats including film-coated tablets, soft-gel capsules and hard-shell capsules (powder/liquid-filled).
- The design of our suites is such that all areas use single pass, cascading negative air pressure systems back to dedicated handling areas to enhance in-room containment.
- Additional technology includes performance-qualified, closed-loop isolators; down-flow and powder containment booths and local exhaust ventilation (as required).
- Risk-dependent PPE (air suits, masks and so on) is used as a secondary cont
rol throughout processes.
R&D
Our dedicated research and development centre is staffed by a highly skilled team with decades of combined industry experience.
The team performs cutting edge research and development while consistently achieving the highest quality standards. It includes 53 Pharmaceutical Development professionals, including formulators and analytical chemists, Regulatory Affairs and Clinical Affairs. Formulators and Chemists bring extensive experience in handling teratogenic, cytotoxic, mutagenic and high bioaccumulation materials with OELs as low as 20 ng/m3. Our team is resourced and experienced to deliver high-value medicines in the OSD space. Capabilities in the formulation and analytical development are strongly focused on applying this experience on multiple platforms to development of innovative medicines as well as standard generics in the high containment space.
Because Accuracy Matters
Precision is everything — to that end we have invested heavily in market-leading technology that guarantees a level of accuracy that is second to none.
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