A Blow-Fill-Seal machine, set to aseptically fill sterile liquid TSB medium into 20 ml plastic
containers, was subjected to a series of environmental microbial challenges in order to …

A programme of work has been initiated to further the understanding of the impact of the
environment surrounding a Blow/Fill/Seal (BFS) machine upon the microbiological quality of …

Fundamental investigations have been carried out into the effectiveness of aseptic fill using
Blow/Fill/Seal machinery. Techniques have been developed to generate and to maintain …

The routes of airborne contamination, during Blow-Fill-Seal (BFS) production, were studied
using tracer gas, particles and bacteria. The prevention of airborne contamination, by the air …

A new pharmaceutical aseptic vial filling system has been developed based on isolator
technology that is also well suited to use in conventional clean rooms. The results of …

Controlled microbial challenges, comprising air-dispersed spores of Bacillus subtilis var
niger, have been generated within a containment room (around 54 m'in volume) housing a …

Terminal sterilization and aseptic processing constitute the principal methods of
manufacture of sterile pharmaceutical products. Of the two methods, aseptic processing has …

Two biological indicators are routinely used by the Hospital Products Division to
demonstrate the sterilization of the closure-container interface. The use of a moist heat …

Designing a facility for the aseptic pro-duction of sterile products in their final containers
involves consideration of many different factors. Unlike some non-sterile product or active …

Barrier isolators that enclose aseptic filling equipment are being proposed as a means of:(1)
assisting in achieving a 10–6 sterility assurance level (SAL) in the filling area and (2) …