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HES6405 Contamination Control (3 days)

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

The module covers the advanced requirements for contamination control in non-sterile manufacturing. It identifies potential sources of contamination, issues regarding effective control and requires students to investigate case study examples. The module covers:

• 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

This module covers:

• 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

This module covers:

• 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

This module discusses the theory facilities design and operation, the standards for HVAC and how these protect the product.

• 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 Good Warehousing and Distribution Practices

This module covers:

• Key components - Good Distribution Practices.
• Stock Rotation, Stock Control, Inventory Record Accuracy and GMPs.
• How to achieve distribution chain traceability
• Returns and Rejects.
• Transportation and Cold Chain Monitoring.

Format

The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.

Out of Class Assignment

Participants are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants, and successful completion will be rewarded with additional certification.

There is no additional charge for this.