Provide your site dimensions, required ISO class, and industry-specific needs (GMP, ESD, etc.) to our experts.
Receive a detailed design proposal within 24 hours, including airflow strategies, material lists, and transparent pricing.
We manufacture your modular panels, HVAC units, and FFUs with strict QC to ensure full compliance with ISO 14644 standards.
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For non-hazardous sterile compounding, the cleanroom uses HEPA-filtered supply air and positive pressure to reduce the entry of airborne contaminants from adjacent spaces.
For hazardous-drug compounding, the containment secondary engineering control, or C-SEC, maintains negative pressure to help prevent hazardous airborne material from migrating into surrounding areas.
Pressure direction is selected according to the compounding activity. USP <797> sterile preparation areas generally use positive pressure to protect the product, while USP <800> hazardous-drug rooms use negative pressure to support personnel and environmental protection.
HEPA filters remove airborne particles from the supplied air. Filter type, location, and coverage are selected for the required room classification and airflow pattern.
Hazardous-drug rooms can be connected to a dedicated exhaust system that discharges outdoors at a location evaluated by the project engineer.
Differential-pressure monitors provide continuous indication. Visual and audible alarms can notify operators when pressure moves outside established limits.
Sealed wall and ceiling interfaces, flush surfaces, and compatible finishes help support routine cleaning and disinfection procedures.
A positive-pressure configuration for non-hazardous sterile compounding.
A negative-pressure configuration designed to contain hazardous drugs and reduce occupational exposure.
Separate positive- and negative-pressure rooms within one coordinated compounding facility.
Room classification, pressure relationships, air-change rates, and exhaust capacity are finalized according to the compounding process, selected PECs, risk assessment, and site conditions.
Our cleanrooms are designed to support compliance with USP <797>, USP <800>, and applicable ISO 14644 requirements. Final compliance depends on installation, qualification, operating procedures, and ongoing facility control.
Testing is normally performed after installation, HVAC balancing, cleaning, and system commissioning. Typical qualification activities may include:
Qualification criteria should reflect the intended use and operating condition of each room.
The available turnover package depends on the contracted project scope. Typical documents may include:
Qualification reports should provide sufficient information for technical review and future reference. Each report should identify:
Initial qualification confirms performance only under the conditions documented at the time of testing. Continued control depends on scheduled certification, environmental monitoring, cleaning and disinfection, filter maintenance, HVAC maintenance, personnel practices, and documented change control.
The facility should define reassessment requirements after significant changes, such as HVAC modification, HEPA filter replacement, equipment relocation, room alteration, or a loss of pressure control.
Deiiang Hardwall Cleanrooms can be designed to support USP <797> sterile compounding and USP <800> hazardous-drug handling requirements. Each system is configured according to the intended compounding activities, risk assessment, facility layout and applicable local regulations. Final compliance depends on installation, operational procedures, certification and ongoing environmental control at the customer’s site.
A typical configuration includes an ISO Class 7 buffer room or containment secondary engineering control (C-SEC), an ISO Class 7 or 8 ante-room and an ISO Class 5 primary engineering control (PEC). Non-hazardous USP <797> buffer rooms are generally maintained at positive pressure, while USP <800> hazardous-drug C-SECs are maintained at −2.5 to −7.5 Pa relative to adjacent areas. Final pressure relationships are verified during site qualification.
The USP <800> Hardwall Cleanroom uses a sealed, non-shedding enclosure, controlled inward airflow and a negative-pressure cascade to help contain hazardous-drug contaminants. The C-SEC is externally vented through a dedicated exhaust system. Optional features include redundant exhaust fans, safe-change filter housings, room-pressure alarms and supply–exhaust interlocks, subject to the site-specific hazard assessment.
Qualification can include airborne particle counting in accordance with ISO 14644-1, HEPA filter integrity testing, airflow-volume and air-change measurements, room-pressure verification, airflow-visualization studies and temperature and relative-humidity checks. Alarm and interlock functions may also be tested. Calibrated instrument records, test reports and qualification documentation are supplied according to the agreed project scope.
Available controls include continuous differential-pressure monitoring, local or remote visual and audible alarms, temperature and humidity monitoring and status indication for supply and exhaust systems. Monitoring points, alarm limits and data-recording requirements are configured for the facility’s contamination-control strategy, standard operating procedures and applicable USP certification program.
Deiiang can provide approved drawings, material specifications, HVAC and pressure-balance information, HEPA filter test reports, particle-count results, equipment manuals and calibration records within the contracted scope. Preventive maintenance, replacement filters, troubleshooting, recertification support and onsite service are also available to help facilities maintain qualified performance and prepare for inspections or audits.
| ISO Class | ACH (Air Changes Per Hour) |
|---|---|
| ISO 3 | 360 - 540 |
| ISO 4 | 300 - 540 |
| ISO 5 | 240 - 480 |
| ISO 6 | 50 - 60 |
| ISO 7 | 30 - 40 |
| ISO 8 | 15 - 25 |
CE Certificate for Deiiang Air Shower and HEPA Filters
Electromagnetic Compatibility EMC Certification
Filter CE-Certification
Deiiang Hardwall Cleanrooms Quality Control Flowchart
+86 13638632902
Jason@cleanroomequips.com
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