Cleanroom Testing (CT) Exam

The Registered Certification Professional – Cleanroom Testing (RCP-CT) credentialing program will ensure that the certificate holders possess the fundamental knowledge required to evaluate a controlled environment as functioning properly and within required industry standards and/or facility protocols.  A successful candidate will be required to show an understanding of international standards and other regulatory guidelines; along with the ability to demonstrate the proper use of the equipment and procedures for evaluating the performance of controlled environments and document the results following cGMP documentation practices. The examination for the RCP-CT will be administered multiple times a year.

Exam Content:

The following chart provides the proportional makeup of the multiple choice and written practical portion of the exam that will be used for the CNBT's Registered Certification Professional for Cleanroom Testing.

Knowledge Domain

Both Multiple Choice and Written Practical 
Facility Assessment 11%
Contamination Control 3%
Equipment/Calibration 5%
Measuring Airflows 16%
Measuring Pressures 9%
HEPA Integrity Testing 17%
Particle Counting 18%
Room Recovery Testing 6%
Airflow Visualization 6%
Reporting 9%

 

Reference Materials:

  • CNBT Policy
  • 2004 FDA Aseptic Guidelines
  • CFR 21 Part 211 CGMP
  • EudraLex Vol 4 Annex 1
  • IEST RP-CC002
  • IEST RP-CC006
  • IEST RP-CC0013
  • IEST RP-CC0034
  • ISO 14644 Part 1 2015
  • ISO 14644 Part 2 2015
  • ISO 14644 Part 3 2005
  • ISO 17025

Exam Pricing:

CETA Member Pricing

  • $1250  CT Dual Exams                          
  • $  625  CT Multiple Choice re-test only       
  • $  625   CT Written Practical re-test only    
  • $1250   CT Re-Certification  (if you meet Section 4.1.1 of the CNBT Policy)
  • $1250   CT Re-Certification  (if you meet either Sections 4.1.3 and 4.4 of the CNBT Policy)  

Non-CETA Member Pricing

  • $1750  CT Dual Exams                          
  • $  875   CT Multiple Choice re-test only       
  • $  875   CT Written Practical re-test only
  • $1750 CT Dual Exam Re-Certification

Exam Dates:

Click here for exam dates.

Exam Application:

To register for Cleanroom Testing (ISO 14644) exams online, please click here.  

*Please ensure you review the CNBT Policy before submitting your application.

Cleanroom Testing Examination Subject Matter Experts:

  • Matt Smyers, Technical Safety Services, LLC
  • Wydell Fleming, Seqirus, Inc.
  • Nick Flynn, Boston University
  • David Luetkemeyer, Ace Lab Systems, Inc.
  • Les Miller, Micro Filtrations, Inc.
  • Chris Sperlein, TEC Services