This module focuses on microbiological topics specific to (bio)pharmaceutical and medical device manufacturing, with particular emphasis on the quality control of parenterals and other sterile products. The module also addresses environmental monitoring within manufacturing plants and includes a comprehensive introduction to cleanroom technology. Techniques pertinent to the batch release of sterile pharmaceutical products, e.g. endotoxin testing and sterility testing are covered in both theory and practice. The role of antimicrobial preservatives in non‑sterile and sterile products is addressed and pharmacopoeial methods for antimicrobial preservative effectiveness testing are performed. Procedures for the rapid identification of microbial isolates are also included.
‘Laboratory practical’s will be delivered/rolled out to students with a lecturer led emphasis on sustainability. Students will be asked to reflect on how they may incorporate sustainability into their practical work when preparing their laboratory reports’.
Understand the role and evaluate the efficacy of antimicrobial preservatives in pharmaceutical products.
Effectively participate in the validation of aseptic processing through Process Simulation Tests.
Design and undertake an Environmental Monitoring Programme - surface, air and personnel monitoring.
Perform pharmacopoeial sterility tests for validation of sterile products.
Understand the principles of cleanroom design and construction.
Summarise the personnel disciplines required for operation of cleanrooms and other controlled environments and apply same in practice.
Employ rapid methods for the identification of bacteria.
Explain the structure of Endotoxins, sources and significance in parenteral products.