Course Offerings

This course provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharmaceutical/biotechnology manufacturing environment, including autoclaves and steam-in-place systems, by providing a thorough understanding of sterilization, sterile equipment design, the regulatory requirements associated with sterilization and the methods used to test and validate sterile processes. In addition, this course provides participants with an in-depth understanding of controlled temperature environments, as well as the current methods used to validate them in the biotechnology/pharmaceutical industry. Equipment covered includes validation of incubators, cold rooms, warehouses and freezers.

Course Objectives

The objectives of this course are to provide a thorough understanding of:
• sterilization
• sterile equipment design
• regulatory requirements associated with sterilization
• methods used to test and validate sterile processes
• controlled-temperature environments, including design
• associated regulatory requirements

Outline of Instruction

Day One
Morning session:
Introduction to Steam Sterilization
Autoclave Design
Regulatory Requirements
Acceptance Criteria
Autoclave Testing/Validation
Troubleshooting

Afternoon session:
Field Autoclave Cycle Analysis
Field Autoclave Validation Techniques for Liquid and Dry Goods Loads
Use of the Kaye Validator for Autoclave Validation

Day Two
Morning session:
Steam-in-Place (SIP) Design
Regulatory Requirements
Acceptance Criteria
Autoclave Testing/Validation
Troubleshooting

Afternoon Session:
Field SIP Cycle Analysis
Field SIP Validation Techniques
Use of the Kaye Validator for SIP Validation

Day 3
Morning session:
Control Temperature Unit (CTU) Design
Regulatory Requirements
Acceptance Criteria
CTU Testing/Validation
Troubleshooting

Afternoon session:
Field CTU Cycle Analysis
Field Validation Techniques
Use of the Kaye Validator for CTU Validation

Contact Hours

24

CEUs

1

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

Some validation experience or having taken the Basic Concepts of Validation course is preferred.

Learning Supplies Needed

All materials supplied by the Validation Academy

Clinical Site/Special Facilities

N/A

Requirements for Successful Completion

80% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Specific Industry or Business Support Needs

N/A

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to Training Outcomes for Employment

Related Courses

Course Contact Information

[email protected]