Workforce Continuing Education Course Catalog
Course
Sterilization and Controlled Temperature Enironment Validation
Name
SEF-103CL
Available Classes
Description
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 pharma/biotech manufacturing environment, including Autoclaves and Steam in Place (SIP) 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 biotech/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
• the regulatory requirements associated with sterilization
• the methods used to test and validate sterile processes
• controlled temperature environments including design
• the regulatory requirements associated with them
• the methods used to test and validate them.
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:
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
CEU's
2.4
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Some validation experience or having taken the Basic Concepts of Validation course is preferred.
Text and Supplies Needed
All materials supplied by the Validation Academy
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
- Attendance 80% or above
- Participation
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment