Contamination Control

Aims:
To develop a broad understanding of the types and sources of contamination; and to analyse and assess the major risks to pharmaceuticals and the practical control methods which are used to minimize and correct contamination problems

Outline Syllabus: 

• The types and sources of contamination found in pharmaceutical products, water and manufacturing environments
• The major sources of microbiological contamination and “objectionable” microorganisms
• Review of relevant WHO, EU GMP and FDA cGMPand guidelines
• Risk Assessment and Identification of Control Strategies
• Cleaning Validation
• Cleanroom Standards ISO 14644
• Cleanroom Conduct & Personnel
• Design and Validation of Cleanrooms
• Design and Validation & QA of Water Systems
• Sampling plans and techniques for environmental monitoring.
• Interpretation of environmental monitoring data

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• Identify the major sources of physical and chemical contamination
• Discuss the importance of personnel flow and materials flow, and their implications for facility layout
• State the GMP requirements for cleaning systems including CIP/SIP
• List the regulatory requirements for HVAC systems & environmental monitoring of controlled environments.
• Discuss the various environmental monitoring test methods
• List the critical design features of a water purification system for the pharmaceutical industry.
• List the three stages of water purification process.

(2) Discipline skills

• Conduct a risk analysis using FMEA or HACCP to identify contamination control
• Implement procedures to reduce the chance of material and product contamination.
• Audit current company cleaning & sanitation practices, & compare them with the cGMP requirements.
• Prepare monitoring procedures with particular focus on microbiological concepts, sample sites & frequency, and alert & action levels for sterile & non-sterile products.
• Prepare validation plans and protocols for Purified Water Systems