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Certification · 03

Cleanroom Testing

HEPA integrity, pressure cascades, particle counts, and full USP <797>/<800> suite certification for sterile and hazardous compounding.

ISO 14644USP <797>USP <800>
+15+5ISO 7ISO 8
Scope of work · 8 line items

What's included.

CR-01

HEPA Filter Integrity Test (per filter)

Aerosol challenge testing for HEPA filter leak detection and performance verification.

1 day
CR-02

Underdoor Pressure Differential Test (per door)

Precision pressure measurement for room segregation and airflow cascade verification.

1 day
CR-03

Room Pressurization & Balancing (per room)

Airflow balancing and pressure cascade optimization for controlled environments.

1–2 days
CR-04

Particle Count & EM Studies (full room)

Airborne particle classification and environmental monitoring for ISO classification.

1–2 days
CR-05

SCA Certification (Segregated Compounding Area)

Certification for segregated compounding areas per USP <797> standards.

2–3 days
CR-06

CSCA Certification (Contained Segregated)

Containment certification for contained segregated compounding areas per USP <800>.

2–3 days
CR-07

USP <797> Full Cleanroom Suite Certification

Comprehensive cleanroom suite certification for sterile compounding compliance.

3–5 days
CR-08

USP <800> Hazardous Drug Suite Certification

Containment and environmental certification for hazardous drug handling suites.

3–5 days