Lighting Installation in Biopharmaceutical Cleanroom Engineering

Key Components and Installation Requirements

1. Lighting Layout

Lighting layout is a critical aspect of cleanroom engineering and must meet the following requirements:

· Plan lighting arrangement according to ISO 14644-1 cleanliness classification

· Ensure uniform illumination by proper luminaire spacing (refer to IESNA RP-36 standard)

· Avoid placing lights directly below HEPA filter air supply outlets

· Coordinate with HVAC systems to maintain proper airflow organization

Typical cleanroom lighting layout parameters:

Cleanliness Class	Luminaire Type	Installation Spacing (m)	Illuminance Standard (lx)
ISO Class 5	Recessed cleanroom luminaires	2.4-3.0	≥500
ISO Class 7	Surface-mounted cleanroom luminaires	3.0-3.6	300-500

2. Cleanroom Luminaire Installation

Key installation points:

· Must comply with EU GMP Annex 1 requirements for sterile products

· Luminaire surfaces should be smooth, dust-proof and easy to clean (meeting EN 60598-2-25 standard)

· Sealing treatment: Use medical-grade silicone for joints between luminaires and ceilings

· Electrical protection: Minimum IP54 rating (per IEC 60529 standard)

Critical installation steps:

1. Embedded parts installation (coordinate with structural engineering)

2. Luminaire hanger installation (vertical deviation ≤1‰)

3. Airtightness testing (pressure decay method)

4. Final leveling (horizontal tolerance ≤2mm/m)

3. Smoke Barrier Installation

Installation specifications:

· Must comply with NFPA 90A standards

· Minimum drop height ≥500mm (per GB 50016-2014)

· Minimum clearance ≥300mm from luminaires (to prevent heat accumulation)

· Fire resistance rating ≥0.5h (tested to UL 10B standard)

4. Smoke Damper Actuator Installation

Installation requirements:

· Actuators should be installed at least 150mm from cleanroom luminaires

· Comply with UL 555S smoke damper standard

· Conduct linkage testing after installation (refer to NFPA 92)

· Use metal conduits for cable routing (per NEC 300.22)

Relevant International Standards:

Standard No.	Standard Name	Application Scope
ISO 14644-1	Cleanrooms and associated controlled environments	Cleanliness classification
EU GMP Annex 1	Manufacture of sterile medicinal products	Clean environment requirements
IEC 60529	Degrees of protection provided by enclosures (IP Code)	Luminaire protection
NFPA 90A	Standard for the Installation of Air-Conditioning and Ventilating Systems	Smoke control systems