Advanced Pharmaceutical and Healthcare Microbiology
Description
This module will provide learners with a sufficient knowledge to enable them to adopt responsible positions in the areas of industrial sterilization, cleanroom operations and developmental pharmaceutics (in the context of preservative systems). Learners should be able to evaluate the need for specific sterilization processes in pharmaceutical manufacturing and to effectively contribute to the design and validation of such cycles. The treatment of 'Cleanroom Technology' will enable learners to successfully participate in the design and operational management of cleanrooms and to choose appropriate testing and monitoring protocols for validation of such areas to prove continued compliance with international standards.
Learning Outcomes
Summarise the principles of the main industrial sterilization methodologies.
Design, validate and monitor industrial sterilization cycles.
Present a scheme for the rational development of suitable antimicrobial preservative systems for pharmaceutical and biopharmaceutical products.
Discuss the factors governing the action of antimicrobial agents, interaction between such agents and the associated safety and regulatory issues.
Analyse the factors pertinent to the commissioning, validation and management of cleanrooms for the pharmaceutical and healthcare sector.
Design the Environmental Monitoring programme required for cleanroom validation and routine monitoring.
Explore constructive arguments for investing in Isolation Technology and select appropriate systems.
Advise on the selection and validation of cleanroom clothing.