Clean Room Certification
For over 25 years, BalCon’s Lab Safety services team has been ensuring the safety of people, equipment, and lab environments. By exceeding all national standards, our Cleanroom Certification Team is the leader in comprehensive testing, certification and service.
Let our team of experts keep your cleanroom safe. Services include testing, certification, emergency repair and maintenance.
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
- IEST-RP-CC002.3: Unidirectional Clean Air Devices
- IEST-RP-CC-007.1: Testing ULPA Filters
- IEST-RP-CC034.3: HEPA and ULPA Filter Leak Test
- ISO 14644: Cleanrooms & Associated Environments
- USP 797: Pharmaceutical Compounding — Sterile Preparations
- USP 800: Pharmaceutical Compounding — Hazardous Drugs
Our Certifications
Accutrol Controls
Aircuity Controls
Antect Controls
Phoenix Controls
NSF Accredited Biosafety Cabinet Certifiers
NEBB Quality Certified
ASHRAE 110 Certifications
BSL-3 Certification
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
Frequently Asked Questions
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.
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.
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.
Have operated for a period of at least 12 months continuously as an engineering firm, mechanical contractor, or testing contractor.
Enjoy a reputation for responsible performance with six letters of endorsement from building owners or contract awarding authorities.
Be a member in good standing of a local NEBB Chapter.
Own the CPT instruments 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.