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SAFC, a business unit of Sigma-Aldrich Corporation, has opened a new dry powder media (DPM) plant at its Irvine manufacturing facility in Scotland, UK, in January 2015.
The expansion adds dry powder milling and blending capabilities to the Irvine plant, which is an established centre of excellence for manufacturing liquid media, buffers and reagents for the biopharmaceutical industry.
In addition, the facility features dry powder cell culture media to produce large-scale bulk dry powder media and reagents. It is designed to cater to the growing biopharmaceutical industry in European and Asia-Pacific markets.
The validated new plant now serves as the European counterpart to SAFC’s centre of excellence for dry powder media, and reagent manufacturing in Lenexa, Kansas.
Facilities and technology at the dry powder media manufacturing plant
The new state-of-art DPM manufacturing facility features warehouses with temperature-controlled storage areas for raw material and finished goods. Warehouses will be continuously monitored using a Facility Monitoring System (FMS).
The facility has new formulation suites with humidity control to support product lot formulation from small to large scale. Rooms will be continuously monitored for efficient operation. All process rooms in the plant have dedicated heating, ventilation and air conditioning (HVAC) systems where appropriate, and are controlled environmentally.
All equipment hold validated cleaning processes, including clean-in-place processes for fixed equipment and pipe work, clean-out-of-place processes for wash room, and an automated intermediate bulk container washer.
The facility also features a purified water plant and distribution loop producing European / US Pharmacopoeia grade water. Clean, compressed air and clean nitrogen will be supplied and distributed throughout the plant.
Manufacturing facilities, processes and technology at the new plant are similar to those at the Lenexa facility to ensure consistency in production quality at both sites.
The entire construction work at the facility complies with US Food and Drug Administration (FDA) and EU current good manufacturing practice (cGMP) regulations, and also with local safety and environmental regulations.
Production at the new DPM manufacturing plant
The plant produces animal component-free (ACF) media, which is complementary to the liquid cell culture media, buffers and reagents already being produced at the site.
In addition, the plant features two separate manufacturing lines. Line 1 is a pin type mill with a conical, auger screw pre-blender and tumble post-blender, capable of producing ACF dry powder media batches from 750kg to 6,000kg.
Line 2 is also a pin type mill with tumble pre and post-blenders, capable of manufacturing dry powder media batches from 25kg to 750kg.
Irvine centre of excellence
The extended facility has been designed to meet increasing demand for integrated pharmaceutical development and commercial services.
SAFC’s Irvine facility is an 11,000m² cGMP manufacturing facility featuring liquid production facilities, quality control laboratories, and temperature-controlled warehouses.
Core technologies at the plant include automatic aseptic filling of bottles and bags, validated steam-in-place (SIP) clean-in-place (CIP) and flexible manufacturing systems, as well as disposable systems, and a wide range of testing capabilities for raw materials and finished goods.
The plant manufactures custom and catalogue formulations, liquid media, reagents and downstream purification buffers of pack sizes from 5ml to 500l,and batch sizes up to 10,000l (bags) and 6,000l (bottles).
SAFC, which provides products and services for use in regulated pharmaceutical and biopharmaceutical applications, is one of the world’s top ten chemical and biologics suppliers.
The company’s product portfolio includes high-purity inorganic materials for high technology applications, raw materials and biologics safety testing services for biopharmaceutical manufacturing, and high-potent APIs and key intermediates for pharmaceutical manufacturing.
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