Contamination control in cleanrooms for Life Science production

– State-of-the-art for cGMPs and industry practice
(aseptic and non aseptic operations)

This training covers the necessary requirements (regulatory and technical) to control contamination in production or research operations in cleanrooms, in accordance with the requirements of the FDA and the EMA.

Course description

The means of contamination and cross contamination control are discussed in detail (cleanrooms, micro-environments, zone, flows, cleaning, hygiene and behavior, …). For each operation (aseptic, dry forms, terminal sterilization, etc..), requirements and expectations of US and EU authorities are systematically compared to the techniques available, and then compared and translated into practical recommendations. The application exercises allows the participants to apply the recommendations of the course instructor to real life.

Course outline

  • Review of cGMP’s in US and EU, in particular on clean and sterile operations
  • Recent FDA 483’s and “Warning Letters”, current expectations of the authorities
  • Contamination and cross contamination, definitions
  • The sources and vectors of contamination
  • Comprehensive approach activities against contamination
  • Cleanroom technology and controlled zones
  • The ISO cleanroom classes (US FS 209), GMP requirements in US and EU
  • Particulate and microbiological environmental monitoring
  • Material and personnel flow
  • Gowning and accessories
  • Hygiene and behavior, dressing
  • Personnel monitoring and microbiology
  • Aseptic techniques
  • Personnel qualifications
  • Cleaning and disinfection
  • Summary and conclusions

Learning objectives

The main objective of this session is to have an exhaustive overview of the contamination control management in a pharmaceutical plant.

Who should attend

This training is intended for personnel categories such as Quality Assurance, production, facilities, engineering, auditors, and all support functions involved in contamination controlled environments.