A Hub Layout Concept for Oral Solid Dosage (OSD) Facilities

نویسنده

  • P. Mehta
چکیده

by M.P. Brocklebank, J. Lam, and P. Mehta This article describes a new configuration for the layout of an OSD facility that closely integrates all of the facility contents plus optional R&D and administration areas. It presents a number of operating and GMP advantages, as well as potential capital and operational cost savings. Introduction Oral Solid Dosage (OSD) facilities producing tablets and capsules use welldefined unit operations, regardless of differences in production volumes or usage of such facilities for single or multiproduct manufacture. The contents of such a facility typically include warehousing with receipt and dispatch areas, clean process rooms (which are conveniently called ‘white’ areas) containing process equipment, clean support process areas for items such as washing, movements, and staging, QA/QC laboratory, and black normal factory finish technical space for process ancillary equipment and ventilation, and basic utility supply equipment if it is a stand alone facility. To gain competitive advantage, companies aim to minimize capital and operating costs for such facilities, which primarily means reducing the size of such a facility, as well as improving the operational and internal logistics of the facility without compromising current good manufacturing and engineering practices.

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تاریخ انتشار 2006