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Provision of technical support for sterilised clean room and aseptic manufacturing facilities. The facilities consisted of:
class 10000/100 sterile manufacturing suites including extensive laminar hood ceiling areas and pressure differential control. Full performance testing and auditing of air, water, conditioning plant, DOP testing, airborne particulate, airborne pattern testing and reporting were carried out. |
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Provision of technical support and design services for large clean room manufacturing facilities.
Performance testing and auditing of air handling unit, ducting installations, terminal HEPA filter performance, DOP testing, airborne particulate testing and control of temperature and humidity and extensive pressure differential controls, performance testing and auditing of automatic control systems, (pneumatic and electronic) and class 100 capping/tableting facilities. |
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Provision of technical support and design facilities for tableting manufacturing plant including
class 10,000 air distribution systems, tight humidity controls, desiccant dryers, specific dust exhaust systems and full auditing and testing services. |
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Design and technical support services for large clean room manufacturing including
air distribution, direct expansion, chilling, terminal HEPA filters and exhaust systems, auditing and testing services. |
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Providing technical and design support services for the reappraisal of clean room manufacturing facilities to assist in obtaining FDA approval.
Work undertaken included
performance testing of complete air handling and air distribution /return air system plant, recalculating and rebalancing of air distribution system both supply and exhaust, rebalancing of pressure differential controls and a general audit/record testing for validation approval. |
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Providing design and technical support facilities for a clean room air distribution system consisting of heating, direct expansion chilling and desiccant drying to provide low ambient relative humidity. The plant was designed to provide general service corridor and pressure differential to manufacturing areas. |
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