What is the acceptance standard of clean room after installation and design?

The acceptance of clean room is based on GB 50591-2010 Code for Construction and Acceptance of Clean Room, combined with design documents, contracts and industry-specific standards (such as GMP and ISO 14644), and three-dimensional acceptance of data+site+performance is implemented. If the core indicators are not up to standard, they will be judged as unqualified directly.

I. Core basis for acceptance

National standards: GB 50591-2010 (construction acceptance), GB 50073 (design) and GB/T 25915 (equivalent to ISO 14644).

Industry specialities: pharmaceutical GMP, food GB 14881, biosafety GB 50346 and electronic GB 50472.

Qualification requirements: The performance test shall be reported by a third party qualified by CMA/CNAS.

II. Mandatory core indicators (one-vote veto)

1. Air cleanliness (core)

Detection: concentration of suspended particles ≥0.5μm and ≥ 5μ m.

Decision: It must reach the design level (ISO 5–9/100–100,000).

2. Differential pressure control (pollution backflow prevention)

Clean area and non-clean area: ≥10 Pa

High cleanliness level and low level: ≥5 Pa

Negative pressure/dust producing room: the adjacent area is negative pressure.

3. Integrity of HEPA/ULPA

Methods: PAO leak detection (filter body+installation seal)

Judgment: zero leakage, and the leakage is directly unqualified.

4. Air volume/wind speed/ventilation times

Non-one-way flow: the air exchange rate reaches the standard (for example, ISO7 is about 50–60 times /h), and the deviation of air volume at the tuyere is ≤ 15%.

One-way flow: the average wind speed of the section reaches the standard, and the unevenness is ≤0.25.

5. Microbiological indicators (medicine/food/sterility required)

Planktonic bacteria, settling bacteria, surface microorganisms

Judgment: GMP/GB limit is met.

6. Temperature and humidity

Routine: 18–26℃, 45%–65% RH.

Medicine: 2℃/5% RH

7. Other key indicators

Self-purification time: ≤20 min

Noise: ≤60 dB (A)

Illuminance: ≥300 lx

Anti-static: grounding/surface resistance is up to standard.

Third, the installation quality acceptance (master control project)

Enclosure structure: color steel plate tongue-and-groove splicing, glue joint ≤ 2mm; Yin and yang angle r ≥ 50 mm; Ground flatness ≤1mm/2m.

Sealing: double sealing of wall-penetrating pipeline, with gap ≤ 0.5 mm; After the clean door is closed, the wind speed at the crack is ≤ 0.2m/s.

Air duct: argon arc welding+bite seal, no air holes in the weld; Air volume balance deviation ≤5%

High-efficiency filter: installed in clean environment, layering torque ≤ 10 nm; Compression ratio of gasket is 25%–50%.

Fourth, the acceptance process

Data review: as-built drawings, material certificates, hidden records, commissioning reports and third-party inspection reports.

On-site impression: no dust dead angle, intact seal and clear logo.

Performance test: the third party shall test all items according to GB 50591.

Rectification and reinspection: the unqualified items shall be rectified within a time limit, and can only be delivered after the reinspection is qualified.

V. Acceptance conclusion

Only when all the master control projects are qualified, the general projects conform to the specifications and the data are completely closed-loop, can the acceptance be judged.