Cleanroom Certification

Filtech Testing Division

Cleanroom
Certification

Cleanrooms are engineered as controlled environments that use HEPA filtered air with airflow and positive or negative pressure differential parameters to reduce contamination and provide a level of control over airborne particulate and environmental controls in critical areas.

USP 797 USP 800 USP 825 GMP

Filtech technician performing cleanroom certification

Cleanroom Certification Services

Why Filtech

CNBT AccreditedCertification performed by CNBT accredited technicians.

ISO-9001 Quality ControlQuality control procedures follow ISO-9001 guidelines.

Facility SOPs HonoredWe follow Standard Operating Procedures as requested by the facility.

Reports in 11 DaysPreliminary report on site, final report mailed within 11 days.

Compliance With Industry Standards

Cleanrooms play a pivotal role in achieving compliance with pharmaceutical and healthcare industry guidelines. Our Testing division at Filtech underscores the reliability and trustworthiness of cleanrooms, meeting the highest standards of quality, safety, and compliance with industry guidelines.

USP 797

Sterile compounding: environmental control, personnel training, monitoring, and handling of compounded sterile preparations.

USP 800

Safe handling and containment of hazardous drugs in healthcare settings.

USP 825

Standards applicable to radiopharmaceutical preparation and compounding environments.

GMP

Good Manufacturing Practice requirements for controlled production environments.

Additionally, we adhere to Standard Operating Procedures (SOPs) to ensure precision and control as requested by the facility. With our CNBT accredited technicians and quality control following ISO-9001 guidelines, you can trust that your cleanroom and reporting will meet the highest standards.

Certification & Reporting Process

Our certification and reporting process aligns with current industry standards.

Standard Certification Services

Environmental Monitoring, Air & Surface
Non-Viable Particle Counting
Airflow Volume
Individual Room Air Exchanges
Individual Room Pressure Differential
Biological Safety Cabinet Certification, Class I, II, III
Isolator Certification
Robot Certification
Laminar Flow Cleanbench Certification
HEPA Filter Leak Testing
Dynamic Smoke Video Analysis
Temperature and Relative Humidity
Segregated Compounding Areas

Optional Testing Services

Monthly Sampling Program
Chemo Trace Analysis
Airflow Visualization
Room Recovery
Light
Sound
Vibration

As-Built & New Construction Certifications

At Filtech, we specialize in As-Built and New Construction certifications, leaving no stone unturned to ensure that manufacturers, contractors, and engineers have executed their roles to specification. This guarantees that your new cleanroom is fully compliant and ready for use and future certification, with meticulous attention to every detail.

Filtech's comprehensive certification process includes a thorough evaluation of key components, embodying our commitment to thoroughness and excellence. Whether you're certifying an existing cleanroom or ensuring the quality of a new construction, Filtech is your trusted partner for achieving the highest standards of quality, safety, and compliance.

Segregated Compounding Areas (SCA)

Segregated Compounding Areas are specialized environments designed to meet the strict standards outlined in USP 797 and USP 800 guidelines. These controlled spaces feature essential components such as a compounding hood within a room for USP 797, or meet USP 800's negative pressure differential requirements.

Filtech's Certification division specializes in certifying Segregated Compounding Areas, providing cost-effective and convenient solutions for facilities that require compliance with USP standards. We prioritize reliability, trustworthiness, and safety in these crucial environments, with CNBT accredited technicians guided by ISO-9001 guidelines.

SCA Certification Services

Environmental Monitoring, Air & Surface
Non-Viable Particle Counting
Individual Room Pressure Differential
Biological Safety Cabinet Certification, Class I, II, III
Isolator Certification
Laminar Flow Cleanbench Certification
HEPA Filter Leak Testing
Dynamic Smoke Video Analysis

Optional testing services such as airflow visualization, room recovery, light, sound, and vibration analysis are also available for Segregated Compounding Areas.

Reporting Process

Preliminary Report

We provide preliminary reports immediately following certification, so your team has results in hand before we leave the site.

Quality Assurance Review

Environmental sampling results are compiled and the full report is run through our ISO-9001 Quality Assurance procedures.

Final Report Within 11 Days

Your final report, including environmental sampling results, is mailed within 11 days. Digital copies are available upon request at any time during this process.

Schedule Your Certification

Ready to schedule cleanroom certification, or need help scoping the right set of services? Send us your facility type, the standards you certify to, and your preferred timing.