Reference for clean room management regulations of health care products clean room

Introduction

These regulations establish the standards for Clean room management in healthcare product manufacturing facilities. Compliance ensures product safety, prevents contamination, and maintains the integrity of the manufacturing environment.

Scope

Applies to all personnel, materials, and procedures within Class 100,000 Clean room environments for healthcare product manufacturing.

Objective

To minimize contamination risks and ensure consistent product quality through strict environmental controls and personnel protocols.

1. Use of Clean Room

1.1 Production Personnel Entering the Clean Room

1.1.1 Training Requirements

All staff must receive clean technology training covering the relationship between clean technology and preparation production. Personnel must understand and comply with all clean room regulations.

1.1.2 Personal Hygiene & Attire

Maintain strict personal hygiene
No makeup, watches, or accessories
Wear cleaned and disinfected area-specific work clothes
Follow "Standard Procedures for Personnel Entering and Exiting"

1.1.3 Cleanroom Garments

Low dust-collection materials
Non-shedding, anti-static, wrinkle-resistant
Cleaned and disinfected after each production cycle
Maintain detailed cleaning records

1.1.4 Personnel Control

Limit operators to the specified maximum number. Implement fixed-position operations for each process.

1.1.5 Operational Conduct

Move gently and minimize talking
Avoid unnecessary movements
Follow standard operating procedures strictly
Prohibit non-production activities
Avoid dust-generating actions (scratching head, fast walking, running)

1.2 Materials Used in Cleanrooms

1.2.1 Material Handling Procedures

All materials and utensils must comply with "Standard Operating Procedures for Materials Entering and Leaving Clean Areas".

1.2.2 Restricted Items

Prohibit dust-generating items: pencils, erasers, pens. Use ballpoint or signature pens for documentation.

1.2.3 Container Requirements

Raw material containers must be cleanable or disposable with sealed covers. Ensure contamination-free transportation.

1.2.4 Material Tracking

Collect materials according to production instructions
Seal leftover materials immediately with unsealing dates
Verify records before reusing unsealed materials
Maintain material balance cards for collection, consumption, and inventory

1.2.5 Production Setup

Before starting production, verify equipment and instruments are clean with no residue from previous batches.

1.2.6 Zone Restrictions

Operators must not cross between clean level areas without following proper changing procedures and garment protocols.

2. Hygiene Maintenance in the Clean Room

2.1 Surface Cleaning

Wipe doors, windows, walls, and equipment exteriors with drinking water
Scrub floors, waste containers, floor drains, and drainage systems
Remove production waste promptly

2.2 Comprehensive Cleaning

Fully wipe work surfaces, walls, ceilings, lighting, and Ventilation systems
Disinfect rooms based on bacterial inspection results
Establish disinfection cycles according to monitoring data

2.3 Disinfection Protocol

Rotate disinfectants every two weeks between:

0.02% Chlorhexidine

75% Ethanol

3. Cleanroom Cleanliness Management

3.1 Pre-Production Checks

Ensure facility and equipment integrity to maintain cleanliness standards before production begins.

3.2 Environmental Controls

Maintain HVAC operation to ensure proper temperature, humidity, and pressure differentials between clean zones.

3.3 Cleanroom monitoring (Class 100,000)

Parameter	Frequency	Tool	Location	Standard
Temperature & Humidity	1x per shift	Thermostat/Hygrometer	Indoor	18-26°C
Air volume & Speed	1x per month	Anemometer	Air inlet	±15% of target
Pressure	1x per month	Differential gauge	Indoor/outdoor	25MPa
dust particles	1x per quarter	Particle counter	Key points	≥5μm: ≤20,000/m³ ≥0.5μm: ≤3.5M/m³
Settling Bacteria	1x per month	Φ90mm plate	Key points	≤10 CFU/plate