Is Your Cleanroom Prepared for USP<797> Inspection and Certification

USP<797> Compliance Overview

USP<797> establishes the minimum practice and environmental requirements for sterile compounding, including facility design, airflow performance, pressure differentials, environmental monitoring, and contaminationcontrol procedures. A cleanroom must demonstrate a validated state of control to ensure patient safety and product sterility.

Cleanetics supports facilities in achieving and maintaining full USP<797> compliance through engineering controls, certification testing, and lifecycle maintenance programs aligned with current regulatory expectations.

Key USP<797> Requirements Your Cleanroom Must Meet

1. Facility Design & Engineering Controls

- ISOclassified cleanrooms and segregated compounding areas

- Properly engineered pressure cascades (positive or negative depending on hazardous classification)

- HEPAfiltered unidirectional airflow in PECs (LAFWs, BSCs, CAIs/CAOs)

- Controlled temperature and humidity to maintain environmental stability

- Seamless, cleanable finishes and coved transitions to prevent microbial harborage

2. Airflow & Environmental Performance

- ISO5 PECs with validated unidirectional airflow

- ISO7/ISO8 buffer and ante rooms with documented air change rates

- Differential pressure monitoring with defined alarm limits

- Airflow visualization (smoke studies) demonstrating proper directional flow

- HEPA integrity testing (PAO/DEHS) at required intervals

3. Environmental Monitoring Program

- Viable air sampling (active) at defined frequencies

- Surface sampling using contact plates or swabs

- Nonviable particle monitoring aligned with ISO146441

- Trending, alert/action limits, and documented investigations

- Calibration and qualification of monitoring equipment

4. Certification & Qualification Requirements

- ISO146441 classification testing (asbuilt, atrest, operational)

- ISO146442 compliance verification

- Recovery time testing and containment verification

- Temperature, humidity, and pressure mapping

- Documentation supporting IQ/OQ/PQ of cleanroom systems

5. Operational Controls & SOP Alignment

- Gowning procedures aligned with risk level (Category 1/Category 2)

- Cleaning and disinfection schedules with approved agents

- Material and personnel flow designed to minimize contamination

- Defined beyonduse dating (BUD) based on risk category

- Training and competency assessments for compounding personnel

How Cleanetics Supports USP<797> Compliance

Cleanroom Construction & Engineering

Cleanetics designs and builds sterile compounding environments that meet the architectural, mechanical, and contaminationcontrol requirements defined in USP<797> and USP<800>.

ISO14644 Certification & Recertification

Our certification team performs all required testing, including:

- HEPA integrity

- Airflow visualization

- Particle classification

- Pressure differential verification

- Environmental mapping

Preventative Maintenance Programs

We maintain your cleanroom's validated state of control through:

- Scheduled filter replacements

- Mechanical system inspections

- Airflow and pressure recalibration

- Corrective actions and deviation support

21CFRPart11Compliant Monitoring

Cleanetics provides a validated monitoring platform supporting:

- 24/7 environmental data acquisition

- Secure audit trails

- Electronic signatures

- Alarm management and deviation capture

- Longterm data retention for regulatory review

US797 Cleanroom Pharmacy Renovation or New Construction?

If your facility is renovating an existing space or constructing a new pharmacy, Cleanetics offers comprehensive expertise to bring your cleanroom project to life. We specialize in the design phase, ensuring your cleanroom meets specifications for air changes, temperature, relative humidity, and particle counts.

With experience collaborating with leading hospitals worldwide, we have developed state-of-the-art USP <797> and USP <800> cleanrooms that adhere to all regulations and pass state inspections seamlessly. One highlight of our work includes a turn-key design-build project for a 2,000 sq/ft USP <797> and <800> hospital pharmacy. Cleanetics is your all-in-one provider for cleanroom design, construction, installation, and certification, ensuring your facility operates confidently and remains fully compliant with all applicable regulations.

I have been using Cleanetics for a few years now and I would highly recommend their services. Deric and his team are very reliable and knowledgeable and are always available whenever I have a question. I have worked with other companies in the past but none have been as responsive as Cleanetics. As they always tell me "It's my job to care for the patients and their job to take care of the cleanroom. -Salvatore R., New Jersey Pharmacist

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Partner with Cleanetics to Ensure Your USP797 Cleanroom is Compliant.

If your facility is renovating an existing sterile compounding suite or constructing a new pharmacy, Cleanetics provides fullscope engineering, commissioning, and qualification expertise to ensure your cleanroom is designed, installed, and validated in accordance with USP<797>, USP<800>, ISO14644, CAG003, and cGMP expectations. Our engineering team leads the design effort by developing detailed mechanical and architectural specifications that define required ACPH, supply and exhaust airflow balance, pressure cascade setpoints, thermal load calculations, and ISOclassified particle performance criteria.

During design development, Cleanetics performs HVAC load modeling, duct static pressure calculations, and pressurecascade simulations to ensure the buffer, ante, and hazardous drug rooms maintain stable differential pressures under all operating conditions, including dooropen transients. We specify HEPA filtration efficiency, terminal filter layouts, diffuser throw patterns, and PEC placement to achieve validated unidirectional airflow and minimize turbulence in critical work zones. All designs are aligned with URS/FRS requirements and incorporate proper material flow, personnel flow, and segregation of hazardous and nonhazardous operations.

Cleanetics has delivered complex sterile compounding suites for major hospital systems worldwide, including a fully turnkey 2,000sq/ft USP<797>/<800> pharmacy project encompassing design development, mechanical commissioning, TAB (Testing, Adjusting, Balancing), installation, and full lifecycle qualification. Our commissioning process includes:

- Prefunctional checks for HVAC equipment, controls, and monitoring systems

- Functional performance testing of supply/exhaust fans, terminal HEPA units, and pressure control loops

- Airflow balancing to achieve required ACPH and directional airflow

- Room pressurization verification under static and dynamic conditions

- Temperature and humidity stability testing across operational ranges

Following commissioning, Cleanetics executes a full qualification package:

Design Qualification (DQ)

Verification that the cleanroom design meets regulatory, process, and environmental requirements, including airflow modeling, pressure cascade logic, and PEC placement.

Installation Qualification (IQ)

Documentation that all architectural finishes, HVAC components, HEPA filters, PECs, and monitoring systems are installed per approved drawings, specifications, and manufacturer requirements.

Operational Qualification (OQ)

Execution of performance testing including:

- Airflow velocity and ACPH verification

- Differential pressure stability testing

- HEPA integrity testing (PAO/DEHS)

- Airflow visualization (smoke studies)

- Temperature and RH control response testing

- Nonviable particle counts per ISO146441

Performance Qualification (PQ)

Verification that the cleanroom maintains a validated state of control under dynamic, operational conditions with compounding personnel present.

Cleanetics also performs ISO146441/2 certification, recovery time testing, environmental mapping, and longterm preventative maintenance programs to ensure the cleanroom remains compliant throughout its lifecycle.

As a singlesource provider, Cleanetics integrates engineering, construction, commissioning, and certification into one coordinated process, ensuring your sterile compounding environment is fully compliant, operationally stable, and inspectionready from day one.

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Environmental Monitoring Experts

If you are operating a USP<797> cleanroom and require support with certification, recertification, or lifecycle maintenance, Cleanetics provides engineeringdriven services designed to maintain your facility's validated environmental state of control. Our team coordinates all work around active compounding schedules to ensure uninterrupted operations while maintaining compliance with State Board of Pharmacy, Department of Health, and Federal regulatory requirements.

Cleanetics manages the full suite of engineering and performanceverification activities required for USP<797> environments, including:

- HEPA/ULPA filter integrity testing (PAO/DEHS)

- Airflow velocity and ACPH verification based on mechanical design criteria

- Differential pressure stability testing under static and dynamic conditions

- Airflow visualization studies to confirm directional flow and PEC performance

- ISO146441 particle classification (asbuilt, atrest, operational)

- Temperature and RH stability mapping to validate HVAC control sequences

- Room pressurization cascade verification including dooropen transient response

- Mechanical system inspection of fans, terminal units, and control dampers

Our engineering team evaluates supply/exhaust balance, terminal HEPA resistance, fan curve performance, and control loop tuning to ensure the cleanroom maintains required pressure differentials and airflow patterns. We also assess the performance of PECs (LAFWs, BSCs, CAIs/CAOs) to confirm ISO5 unidirectional airflow and turbulencefree work zones.

Cleanetics provides proactive scheduling and automated alerts for certification intervals, filter replacement cycles, and preventative maintenance milestones. This includes monitoring trends in differential pressure drift, ACPH degradation, and environmental stability—allowing corrective actions to be implemented before compliance is impacted.

By assuming responsibility for the technical and regulatory management of your cleanroom, Cleanetics enables your pharmacy team to focus exclusively on patient care and compounded sterile preparations (CSPs). Our engineeringdriven maintenance programs eliminate the uncertainty associated with cleanroom performance, ensuring your facility remains compliant, stable, and inspectionready at all times.