Sterilization and Controlled Temperature Environment Validation

Sterilization and Controlled Temperature Environment Validation

Scheduled

View available dates and register at the host college.

Starts: March 18, 2020
Register at Wake Technical Community College (Course #: 223304)
Class will be held at Capstone Center
Schedule
  • Wednesday, March 18, 2020 - 8:00am to 5:00pm
  • Thursday, March 19, 2020 - 8:00am to 5:00pm
  • Friday, March 20, 2020 - 8:00am to 5:00pm
Instructor: Russell Ciliento
Tuition: $272.00

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.

Audience

This course is designed for entry level process technicians, autoclave specialists, process engineers and those with responsibilities pertaining to component preparation, autoclave and SIP operations.

Topics Include

This three day, 24 hour course covers the following topics:

  • Introduction to Steam Sterilization
  • Autoclave and SIP Design
  • Regulatory Requirements
  • Acceptance Criteria
  • Autoclave and SIP Testing/Validation
  • Field  Autoclave and SIP Cycle Analysis
  • Controlled Temperature Environments
  • Field Validation Techniques

Learning Objectives

The objectives of this course are to provide a thorough understanding of:

  • Steam sterilization
  • Sterile equipment design
  • Regulatory requirements associated with steam sterilization
  • The methods used to test and validate sterile processes
  • Controlled temperature environments including design, regulatory requirements, testing, and validation

Portability

This course must be taught at a BioNetwork location.

Request this Course

Request this Course

Submit this form to request this course to be scheduled.

Sterilization and Controlled Temperature Environment Validation

Level: Intermediate

Lecture HoursLab HoursTotal

Instructor Pool

Russell Ciliento
Related Information
BioNetwork Capstone Center
Video
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone,... more
Golden LEAF Biomanufacturing Training and Education Center
Video
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top... more
NC Life Science
Video
This video surveys examples of life science-related training provided by NC Community Colleges for... more
Aseptic Gowning for the Cleanroom
Video
One of the primary safeguards that life science companies use to help prevent contamination in... more
  •  
  • 1 of 6
  • >