Risk Assessment for Dispensing Booth

Dispensing booth is reverse laminar air flow (RLAF) and designed for ISO 4.8 requirements as per ISO 14644- Dispensing booth shall be facilitated with provision for connectivity of weighing balances. Filtration of air is arranged through pre filters (G-4, 15µm), intermediate filter (F-7, 5µm) and terminal HEPA filter (H-14, 0.3µm). The operation is based on VFD control to maintain desired pressure and velocity of air. The equipment is controlled by ON/OFF switches for blower and lights. For light sensitive products provision of sodium vapour lamp shall be provided with separate ON//OFF switch.

In this GMP risk assessment all critical components of the Dispensing Booth, based on the technical details, are listed and rated according to their influence of the product quality, EHS and operational requirements.