Sterilization Professional Certification


What Is a Sterilization Professional Certification and Why Do I Need It?

In its Guide to Sterilization Process Controls, the FDA listed five (5) important inspectional goals that the agency uses when performing routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls), which requires that manufacturers of products must manufacture products that meet defined specifications. Developing processes that are adequate to produce medical devices or other products that requires a defined Sterility Assurance Level (SAL) requirement, testing specifications, validating or fully verifying the results of those processes, including monitoring and controlling the processes are all steps that help assure that the result of the manufactured products meet the defined specifications.

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483’s that relate to Sterilization and Sterility Assurance processes show that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process. This can potentially lead to Product Failures (Sterility Failures), product Non-conformances, Product Recalls, FDA’s Warning Letters, Consent Decrees and discontinuance of commercial operations, which may negatively impact a company’s profitability. FDA regulated industries that produce products with a defined SAL are obligated to have adequately trained and knowledgeable staff, or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidance to the impacted systems.

CfPA's Sterilization Professional Certification program provides in-depth training on the key principles and tools needed to become a sterilization professional, beginning with the concept of understanding what a microorganism is and progressing through the various aspects of aseptic process requirements, different types of sterilization systems, and processes that are used within industries to achieve their unique or desired product SAL in conjunction with effective sterilization. This Certification Program offers professionals, like you, detailed and expansive training and development skills with a broader understanding of the area of sterilization, which is required in order to attain a certificate of accomplishment.

Who will benefit from a Sterilization Professional Certification?

All individuals working within or managing sterilization and Sterility Assurance processes that support sterile products requiring sterilization prior to release for use will benefit from the Sterilization Professional Certification.

Professionals in industries such as pharmaceutical, biotechnology, drug, biologics, medical device, and in-vitro diagnostics product manufacturing would benefit from obtaining the Sterilization Professional Certification, particularly those in the following departments:

  • Sterilization Engineers and Specialists
  • Sterility Assurance Personnel
  • Auditors and Quality Assurance Supplier Auditors
  • Quality Assurance Personnel and Management
  • Quality Control Personnel and Management
  • Laboratory Managers
  • Testing Analysts and Technicians
  • Manufacturing Personnel and Management
  • Suppliers and Vendors of Pharmaceutical Gas Systems
  • Validation Personnel and Management
  • Supplier Quality Assurance Auditors, Personnel and Management
  • Regulatory Affairs Personnel and Management
  • Shipping and Receiving Personnel and Management
  • Facility and Maintenance Personnel and Management
  • Microbiologist Personnel and Management
  • Engineering Personnel and Management
  • Materials Management Personnel and Management
  • Why become a Certified Sterilization Professional?

    A Certified Sterilization Professional is someone who has been trained to effectively interpret and execute regulations related to various sterilization and sterility assurance practices in order to ensure a compliant operation. They demonstrate techniques, tools, and knowledge of various aspects of ISO, AAMI, USP, 21 CFR Part 211, and FDA regulations, among others, that will be sufficient to guide, facilitate, and assist a company in avoiding regulatory issues and non-compliance with various national and international regulations.

    The Certified Sterilization Professional will be capable of the following tasks:

  • Interpret the various Sterilization and Sterility Assurance regulations, standards and requirements
  • Apply regulatory requirements to routine operational sterilization and sterility assurance applications
  • Plan and manage sterilization process controls to minimize product non-conformances and product sterility failures and investigations
  • Train and mentor internal sterilization, manufacturing, sterility assurance and other critical staff on various types of sterilization process requirements including the qualification and requalification requirement
  • Develop various types of Sterilization and Sterility Assurance Process Standard Operating Procedures (SOPs)
  • Prepare and Execute IQ, OQ and PQ protocols and draft reports for various sterilization processes and systems
  • Perform effective technical audits of Sterilization Process Suppliers and Vendors using key audit review requirements applicable to sterilization and cleanroom controls
  • Represent an organization as a Sterilization and Sterility Assurance Subject Matter Expert (SME) during FDA and other International Regulatory bodies’ inspections
  • Interact with management, regulators and other external auditors.

  • How to Earn Your Sterilization Professional Certification?
    Becoming a candidate is easy.

    Enroll: Register for the complete 10 course program. You will receive an email with instructions on accessing the courses.

    Learn: Attend each of the 10 courses and successfully pass the self-assessment with a score of 80% or higher.

    Earn: Once you have fulfilled all the program requirements, you will receive a certificate recognizing your achievement.


    What courses are included in the Sterilization Professional Certification:

  • Basics of Microbiology
  • Requirements for Aseptic Techniques and Practices
  • Basics of Electron Beam Sterilization Process Requirements
  • Basics of Gamma Radiation Sterilization Process Requirements
  • Basics of Ethylene Oxide Sterilization Process Requirements
  • Basics of Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices
  • Requirements of Aseptic Processing and Filtration Sterilization
  • Basics of Sterilization by Heat
  • Cleanroom, Microbiology and Sterility Assurance Practices for Sterilization
  • Cleaning, Sanitization and Disinfection Practices

  • Want to certify a group? Learn more about team certification by chatting with us now.