Abstract

ESTABLISHMENT OF CONTAMINATION FREE MATERIAL TRANSFER PROCESS THOUGH PASS BOX ADJACENT TO CLEAN ROOM OF PHARMACEUTICAL INDUSTRY

*Tushar Kanti Mondal, M. Pharm (Pharmacology)

ABSTRACT

Cleanrooms are designed to maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles. It is widely accepted for manufacturing of pharmaceuticals. A pass box is one of the sterile manufacturing cleanroom systems, which is used to transfer materials from one side to other side of clean rooms through controlled environment in order to avoid airborne cross contamination. Basically use to transfer material from high level clean room to lesser one without disturbing the cleanliness level of the both. The direction of transfer, the material hold time inside the pass box evaluated in terms of particle count data during the operation. Data assessed and transfer process time recommended based on the guideline specified particle count data limit.

Keywords: Clean room, pass box, ISO 5/ Grade A & B, material hold time, transfer method validation.