Contamination Control

Aims and Objectives

This subject aims to introduce students to the necessity for control of contamination in the storage, handling and processing of components, materials and products in both non sterile and sterile forms.

On the completion of this subject students will be able to:

• State why contamination control is critical.
• Identify the major sources of physical and chemical contamination
• Implement procedures to reduce the chance of material and product contamination .
• Audit current company cleaning & sanitation practices, & compare them with the cGMP requirements upon completion of this module.
• List the regulatory requirements for HVAC systems & environmental monitoring of controlled environments.
• Prepare monitoring procedures with particular focus on microbiological concepts, sample sites & frequency, and alert & action levels for sterile & non-sterile products.
• Discuss the various environmental monitoring test methods eg. Slit to Agar air Sampler, Settling Plates, Surface Swabbing & Contact (RODAC) Plate

Content

This subject consists of 6 modules or topics:

#1 Contamination Control

• Why contamination control is critical.
• Major sources of physical and chemical contamination
• Procedures to reduce the chance of material and product contamination.

#2 Microbiological Aspects of Pharmaceutical Manufacturing

• The types of microbes found in pharmaceutical products, water and manufacturing environments
• The major sources of microbiological contamination and "objectionable" microorganisms.
• The various (proposed) regulatory & pharmacopoeia standards, monitoring programs for raw materials, water systems & finished products.
• Examines closely the microbial/GMP issues relating to the control over environment, water, personnel & equipment.

#3 Cleaning & Sanitation

• Definition of cleaning and sanitation
• cGMP requirements for facility & equipment cleaning, sanitation programs & records.
• Basic requirements for good housekeeping, staff personal hygiene & pest control.
• Techniques for correct cleaning & sanitation
• Clean in Plan (CIP) Steam in Place (SIP)
• Cleaning validation

#4 HVAC and Controlled Environments - control and qualification

• Theory of particle filtration
• key design requirements for controlled manufacturing environments
• Regulatory requirements for HVAC systems & environmental monitoring
• Validation of HVAC systems

#5 Environmental Monitoring Programs

• This module discusses the requirements for environmental monitoring.
• The different classifications for controlled manufacturing environments.
• The environmental standards for controlled manufacturing environments.
• Sampling plans for environmental monitoring.
• Techniques for environmental monitoring.
• Interpreting environmental monitoring data.

#6 Water Systems - Design, Qualification & Operation

• The stages of a water purification process.
• GMP design considers for water purification systems.
• Qualification strategies for water systems.
• Ongoing control and monitoring of water systems.
• Transportation and Cold Chain Monitoring.