Contamination control in cleanrooms

- GMP requirements and industrial practice (US and EU)

Industry field:

Pharmaceutical production

Course description:

The 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. 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.

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.

Course content:

Day 1

• 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

Day 2

• 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:

At the end of this session the participants will have a full understanding of US and EU GMP references. Participants will have the knowledge necessary for a comprehensive approach to contamination control in the clean room, from design to operation. They will learn about the consistency of control methods to be implemented. They have acquired tools for auditing flows, and clean and aseptic operations.

Course facts

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