What is the Sterilization Professional Certification and why is it needed?
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during 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) requirements, 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 relates to Sterilization and Sterility Assurance processes shows 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 impacts 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 with the impacted systems.

CfPA’s Sterilization Professional Certification program provides detailed training on the key principals and tools required to become a Sterilization Professional which starts from the concept of understanding what a Microorganism is through the various aspects of Aseptic Process requirements, different types of sterilization systems/processes that are applied within the industries to achieve their unique or desired product SAL in conjunction with an effective Cleanroom Controls which is an integral part of the sterilization process controls. This Certification Program offers professionals a detailed and expansive training and development skills with a broader understanding in the area of sterilization which is required in order to attain a certificate of accomplishment.

Who will benefit from a Sterilization Professional Certification?
The Sterilization Professional Certification will be valuable to all individuals working within or managing sterilization and Sterility Assurance processes that supports sterile products requiring sterilization prior to release for use. Obtaining the Sterilization Professional Certification would be beneficial to professionals in various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially those within 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
  • Who is a Certified Sterilization Professional?
    The Certified Sterilization Professional is an individual trained in effectively interpreting and executing regulations associated with various sterilization and sterility assurance practices to ensure a compliant operation. They exhibit the techniques, tools and knowledge of various aspects of the ISO, AAMI, USP, 21 CFR Part 211 and FDA regulations amongst others which will be sufficient to guide, facilitate and assist a company in avoiding regulatory issues and non-compliance to various national and international regulations. The Certified Sterilization Professional will be able to perform the following:

  • 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.
  • Benefits to the Candidate
    The Sterilization Professional Certification recognizes that the Candidate has not only completed and demonstrated proficiency in each of the required series of online courses, but also, has achieved proficiency by mastering the overall comprehensive Certification Testing. The distinction of a Certified Sterilization Professional can differentiate the candidate from others within their specific industry

    The Sterilization Professional Certification Program consists of a total of 10 intensive courses, a total of 25 contact training hours. Candidates must complete and score at least 80% in the Learning Assessment* for each course.

    *Learning Assessment" is a means of testing that will be administered as part of each course. This resource will be used to verify that mastery of the subject has been achieved.

    How To Become Certified Sterilization Professional
    Becoming a Candidate for a CfPA Online Certification is easy. There are no additional fees beyond the standard course tuition.

    Simply sign up for each course one at a time or Enroll in the entire certification program. Pre-enrollment savings when you enroll in the entire 10 course program.

    Courses included in the 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

  • These courses are available from time to time in live format and are subsequently available on demand for your convenience. Check the CfPA website for the next live presentation or register at any time for the on demand course.

    Courses within this or any CfPA Certification Program may be taken individually for further career advancement.