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SAFC Pharma™ – Gillingham, UK Facility
Experienced cGMP Manufacturing Provider
SAFC Gillingham – UK
SAFC Pharma's Gillingham, UK production facility provides complex, multi-step custom synthesis of APIs and manufacturing services from pre-clinical through phase III trials.
Fully validated, this 55,000 sq.ft. cGMP manufacturing facility was specially designed for complex, multi-step custom synthesis of APIs and key intermediates. Experienced development and production chemists ensure seamless operations for customer programs in all areas of scale-up, optimization and production.
The Gillingham facility hosts an on-site hazard evaluation laboratory and operates with comprehensive QC and QA procedures in place to help customers bring their products to market quickly and efficiently.
>> Gillingham Facility
Chemical Services:
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Laboratory-scale production |
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Scale-up expertise |
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Process optimization |
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Analytical reference standards and markers |
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Analytical methodology development and validation |
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Kilo scale to multi-ton manufacturing |
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Process validation |
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Stability studies programs |
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Regulatory filing experience and support |
| Capabilities:
Gillingham’s completely-segregated production trains were designed to eliminate the potential for cross contamination and maximize efficiencies in every customer program. Shift teams, supported by a chemist, around-the-clock to move projects through the plant in the most proficient manner. If required, on-site chemists coordinate with sister sites for projects that may be transitioning to other SAFC manufacturing facilities.
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Development through multi-ton manufacturing |
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Reactor range: 50 L to 1,600 L |
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Small quantity manufacturing in 3 fully-segregated HEPA filtered Class 100,000 (ISO 8) kilo labs |
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Temperature range: minus 85 °C to 220 °C |
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HEPA filtered and segregated Class 100,000 (ISO 8) isolation areas. The facility utilises a range of isolation technologies: C22 Hastelloy and stainless steel pressure filters and filter dryers along with a C22 Hastelloy centrifuge and agitated pan dryer. The unit also contains several stainless steel vacuum tray dryers. |
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Hastelloy® filter dryers, Stainless Steel Hastelloy® centrifuge, Hastelloy® agitated pan dryer |
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Fully equipped hazard evaluation laboratory with Mettler® RC1 (low temperature capability, Hastelloy® pressure vessel for hydrogenation) and DSC and ARC equipment |
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Ability to investigate desired reaction and potential thermal decomposition |
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Specific Technology Expertise in Hydrogenation with 2 L and 20 L hydrogenators (Hastelloy®, 150 °C, 50 Barg), allowing cGMP production to 20 L batch size |
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