Blow Fill Seal

Introduction

Blow Fill Seal (BFS) technology is an effective method of filling liquid pharmaceutical products. It involves the formation of the final container, filling and hermetically sealing in an uninterrupted sequence of operations. BFS is particularly suited to the aseptic manufacture of multiple pack or single dose units.

For aseptic manufacture, the liquid product pipe-lines, buffer tank, filter housings and other product contact parts are sterilised in-situ using clean steam (Steam in Place).

Approach

Along with the thermometric testing required for the steam in place process, we are also able to test the filling room background environmental conditions, the supply filter integrities, discharge velocities, room pressure differentials, air change rates and particle counts.

Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

Detailed validation reports are compiled that contain all of the real-time data generated as well as a concise summary, with a clear conclusion and details of any recommendations, as appropriate.

Experience

PEV staff are experienced in the validation of the SIP procedure on BFS machines. We are aware of the potential difficulties associated with sterilising multiple pathways (sometimes alternately on early models), filters, air shower etc.

We can provide operational resource and assistance with the generation of User Requirement Specifications (URS), through Factory Acceptance Testing (FAT) to Site Acceptance Tests (SAT) and Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.