Settle plates play an important part in the environmental monitoring programme and for the
assessment of microbial settlement at key locations within cleanrooms, particularly when …

Active (volumetric) air-sampling is an important component of the environmental monitoring
of cleanrooms. It is important that the results of such monitoring are accurate. One aspect of …

This chapter reviews the primary utilities used in non‐sterile pharmaceutical manufacturing,
with a focus on good design principles and the testing undertaken to verify the status of the …

Compressed gasses are used at different stages of the pharmaceutical manufacturing
process. Applications include weighing of vials on process line or the removal of fallen vials …

A contamination control strategy is a system that considers all the integral elements of
pharmaceutical product manufacturing (1). This is best achieved using quality risk …

A contamination control strategy is a system that considers all the integral elements of
pharmaceutical product manufacturing (1). This is best achieved using quality risk …

Abstract Quality Risk Management has been an essential feature relating to the manufacture
of pharmaceutical and healthcare products for several decades, and its centrality is …

During biopharmaceutical manufacturing various stages in the manufacturing process
require hold stages. This can be for product formulation reasons, equipment issues, or …

This paper uses one example of a risk assessment approach to illustrate how risk
assessment can be incorporated into good manufacturing controls. The specific activity …

This paper uses one example of a risk assessment approach to illustrate how risk
assessment can be incorporated into good manufacturing controls. The specific activity …