1. Core Verification Instructions

• System Overview

The air conditioning and purification system consists of air handling equipment, ducts, and supply and return air vents. It delivers clean air to specific areas through processes such as fresh air pre-filtration, temperature and humidity control, medium and high-efficiency filtration, and is centrally controlled by a control cabinet.

• Verification Basis

Based on relevant sterile production management specifications and testing method standards for suspended particles, airborne microorganisms, and settled microorganisms in clean areas of the pharmaceutical industry.

• Verification Purpose

To verify whether the clean area environment, after the air conditioning unit is shut down and then restarted, meets the quality specifications required for production.

• Scope of Application

Applicable to Class 100,000 and Class 10,000 clean areas.

2. Verification Process and Standards

• Verification Prerequisites and Duration

Select a period without production or testing activities to shut down the air conditioning system in the clean area. The maximum shutdown duration is set according to the upper limit of the holiday period plus a safety margin. After shutdown, clean and disinfect the system and restart it for 30 minutes before conducting various tests.

• Test Items and Acceptance Criteria

Temperature and Humidity: The temperature in the main operating room should be 18-28℃, and the humidity should be 45%-65%.

Pressure Difference: The static pressure difference between rooms of the same clean level should be no less than 5 Pa, and the pressure difference between different levels and between clean and non-clean areas should be no less than 10 Pa.

Air Change Rate: The air change rate in Class 100,000 areas should be no less than 15 times/hour, and in Class 10,000 areas no less than 20 times/hour (calculated based on room volume and measured airflow). Suspended Particles: Monitoring of particles ≥0.5μm and ≥5.0μm. In Class 10,000 cleanroom areas, the particle counts should not exceed 350,000 particles/m³ and 2,000 particles/m³, respectively; in Class 100,000 cleanroom areas, they should not exceed 3,500,000 particles/m³ and 20,000 particles/m³, respectively. The 95% confidence upper limit of the average particle concentration at the sampling points must meet the standard.

Airborne Bacteria: ≤500 CFU/m³ in Class 100,000 areas, ≤100 CFU/m³ in Class 10,000 areas.

Settling Bacteria: ≤10 CFU/plate in Class 100,000 areas, ≤3 CFU/plate in Class 10,000 areas.

• Test Basis

Each test shall be performed in accordance with the corresponding standard operating procedures for airflow meter operation, suspended particle testing, airborne bacteria testing, and settling bacteria testing.

3. Supporting Documents

Record Documents: Records of the air conditioning system shutdown confirmation process shall be kept.

Report Documents: A special confirmation report shall be generated after the verification is completed and archived for future reference.

Suzhou Pharma Machinery Co.,Ltd.

2026/02/16

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