The use of pass through boxes (PTBs) for the transfer of materials is an absolutely essential part of any biopharmaceutical facility's controlled environments. To understand the types of PTB and the considerations for typical GMP application, read Saurwalt and Vissers' "The basics of PTB design and performance testing" in Cleanroom Technology's October issue. This article delves into a typical application for a GMP ATMP cleanroom situation. The design study, proof of concept tests and qualification tests of a 'continuous flow' pass through box in an actual project show it is capable of effectively recovering 100:1 within 2 minutes after opening. The all-important Annex 1, as part of EU GMP, applies to the manufacture of sterile products and its purpose is to 'prevent microbial, particulate and pyrogen contamination in final product'. These principles can be applied to other products such as certain liquids, creams, ointments, etc, where control and reduction of contamination is important.
展开▼
