11-Jun-2003

Self-contained booth for drug research unit

Abstract

Hosokawa Micron has installed a bespoke, stand-alone high containment facility for a key Schering-Plough research centre

The need for a special contamination-free "white area" to protect pharmaceutical formulations and staff at a key French development facility has been met by a purpose-built turnkey solution from Hosokawa Micron's Containment Division.

Schering-Plough's research centre in Dardilly, France, received an official recommendation from the French medicinal agency, the Agence du Medicament, requiring raw material weighing operations to be carried out in a separate, purpose-designed weighing area. The solution, developed in conjunction with the pharmaceutical group, centres on a high specification vertical downflow recirculation booth. In this high containment working area, a sophisticated air recirculation system ensures that air flows from ceiling to floor, pushing any chemical dust downward and away from the operator's breathing zone. Purged air is then passed through primary and secondary filters before third stage filtration through an EU13 HEPA filter prior to recirculation. The system provides around 700 volume air changes per hour. Chiller and heater controls are incorporated in the design to provide a comfortable air-conditioned working environment for staff who are required to wear full cleanroom protective workwear. The non-standard installation is unusual in having two entry airlocks one for personnel changing and one for raw material de-dusting providing a further guard against cross-contamination as well as safeguarding the health and safety of staff. The air in the entry airlock undergoes separate two-stage filtration, passing through a primary filter and HEPA filter before recirculation. The bespoke design of the Vitalair booth and air locks was developed following a Schering-Plough brief which detailed the work surfaces which were required, plus working practices and cross-contamination concerns. Schering-Plough specified a white epoxy finish for the airlocks, while brush-finished stainless steel was chosen for the interior of the booth itself. The unit has an exterior height of 2.7m with an inside working height of 2m and working area 2.6m wide by 1.8m deep.

"Plug-and-go" facility Currently installed in a warehouse, the Vitalair "plug-and-go" facility, which could easily be relocated elsewhere if required, is used by 10 of the facility's 40 staff for raw material weighing by the formulation group and for goods sampling by the quality control section. The development facility is involved in the manufacturing supply and packaging of clinical batches, formulation and process development and process improvement, and also produces stability batches. Just before commissioning, the installation was fully assembled for certification and warranty testing at Hosokawa's containment facility in front of Schering-Plough personnel. After successful trials the installation was shipped to France for assembly by a Vitalair team followed by commissioning, which included further certification testing. "Hosokawa brought forward many thoughts and skills and we are very satisfied with the equipment," said Olivier Michel, head of manufacturing and formulation development. "Hosokawa Micron's skills and costs for this customer-orientated specific design orientated the choice of supplier." The Pan-European contract followed earlier successful installations at several of Schering-Plough's facilities, including China, Mexico and Brazil.

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