Cleanroom Certification Process
We ensure your cleanroom is functioning within the specific parameters of USP and ISO 14644 that it was designed for. Cleanrooms may be unidirectional (laminar), non-unidirectional (turbulent), or mixed airflow. We can perform the following services:
- Particle Counts
- HEPA Filter Integrity Checks and Replacements
- HEPA Filter velocity/volume
- Room Air Change Rates
- Room Pressure Differential
- Temperature and Humidity Uniformity
- Fingertip And Media Fill Testing
- Cleanroom Cleaning Consulting
Industry Standards We Certify To
- IEST-RP-CC-006.3; Testing Cleanrooms
- I.E.S.T.-RP-CC002.3; Unidirectional Clean Air Devices
- IEST-RP-CC-007.1; Testing ULPA Filters
- I.E.ST.-RP-CC034.3; HEPA and ULPA Filter Leak Test
- ISO 14644; Cleanrooms & Associated Environments (supersedes FED 209E)
- USP 797; Pharmaceutical Compounding – Sterile Preparations
- USP 800; Pharmaceutical Compounding - Hazardous Drugs
Additional Services We Perform
BalCon's Lab Safety team can help with all of your lab certification and service needs. We can supply worry-free certification, warranty and onsite repairs for:
- Fume Hood Certification
- Biological Safety Cabinet Certification
- Critical Air Control Service, Installation and Repair
- Laboratory Consulting Service
- Compounding Aseptic Isolator Certifications
- Laminar Flow Hood Certification and Testing
- Hepa Filter Certification and Testing
- Viable Sampling
- Smoke Pattern Testing
Our Certifications
NSF Accredited Biosafety Cabinet Certifiers
NEBB Quality Certified
ASHRAE 110 Certifications
BSL-3 Certification
Why Validate My Cleanroom?
The National Environmental Balancing Bureau (NEBB) sets out standards you must meet for your clean room to qualify for use. It falls on the facility to either perform this testing themselves or contract out the testing to stay compliant.
What are clean room requirements?
This varies on the type and usage of the room. Typically, the room must be designed to supply sufficient HEPA filtered air to keep the design ISO Classification in both At-Rest and Dynamic Conditions. Other factors can be room pressurization, Clean Air Exchange Rate, and Sterility.
How frequently do I need a clean room certification?
This depends on the class of clean room you have. Generally, most companies will have their clean rooms inspected annually. Some industries, like the pharmaceutical industry, have their rooms tested every 6 months. Regardless of your frequency it is critically important to be consistent with your testing to ensure the safety of your team.
What are NEBB Testing and Certification Requirements?
- Have operated for a period of at least 12 months continuously with an employee as an engineering firm, mechanical contractor, plumbing contractor, fire protection contractor, electrical contractor, testing contractor, or an adjusting and balancing (TAB) contractor.
- Enjoy a reputation for responsible performance. Six letters of endorsement from building owners or contract awarding authorities in the firm's area are needed.
- Be a member in good standing of a local NEBB Chapter.
- Own the CPT instruments which are needed for NEBB certification in Cleanroom Performance Testing.
- Possess the current NEBB Standards for Cleanroom Performance Testing.
- Designate in writing the Certified Professional who will represent the firm and handle the supervision of Cleanroom Performance Testing.
