Complete Construction & Operation Standard Of 100,000-Class Dust-Free Cleanroom For Medical Electrode Factories

Published: JULY 27, 2026 - Shanghai Zhichen Medical Technology Co., Ltd.

Disposable ECG, TENS and electrosurgical neutral plates are sterile medical consumables, all production, gel coating and packaging processes must be carried out in 100,000-class constant temperature & humidity clean workshop to avoid microbial contamination, which is a core mandatory requirement of ISO13485 quality system.

1 Core Definition & Mandatory Parameters Of 100k Cleanroom

1.1 Particle Concentration Standard

Maximum allowable dust particles ≥0.5μm ≤3,520,000 per cubic meter; ≥5μm ≤29,000 per cubic meter.

1.2 Temperature & Humidity Control Range

Temperature: 15℃~25℃; Relative humidity: 40%~60%. Humidity too high causes gel mildew; too low generates static dust pollution.

1.3 Microbial Limit Index

Planktonic bacteria ≤200 CFU/m³; Sedimentation bacteria ≤10 CFU/4h.

2 Cleanroom Functional Partition Layout Design

2.1 Personnel Access Buffer Zones

Air shower room, primary changing room, clean garment changing room, hand disinfection sink. All staff must complete two-stage dressing + air blowing dust removal before entering production area.

2.2 Raw Material Logistics Channel

Independent transfer window with UV sterilization lamp, raw materials cannot pass personnel passage to prevent cross-contamination.

2.3 Core Production Zone

Gel mixing station, carbon film printing, electrode assembly, EO pre-packaging area with high-efficiency filter ceiling.

2.4 Semi-Finished Product Transit Room

Isolated buffer space for temporary storage of assembled electrodes before sealing.

Waste & Finished Product Exit Channel

Dedicated outlet for defective products and finished cartons, one-way flow to avoid air backflow pollution.

3 Air Purification & Circulation System

Primary filter → Medium efficiency filter → HEPA high-efficiency three-stage filtration

Air change frequency: 10~15 times per hour for production area

Positive pressure design: production room > buffer > external workshop to block external dust inflow

Constant temperature & humidity air conditioning unit with dehumidification module

4 Wall, Floor & Ceiling Material Requirements

Whole room seamless epoxy floor, anti-static, easy to wipe and disinfect; color steel sandwich wall with sealed joint strips to avoid dust accumulation; suspended ceiling with integrated HEPA filter installation holes, no exposed gaps to hide bacteria.

5 Personnel Entry Standard Operating Procedure

Take off street clothes in general changing room

Wear clean underwear, cap and shoe covers

Enter air shower room for 30s high-pressure air dust blowing

Hand washing and alcohol disinfection before entering production line

6 Daily Environment Monitoring & Record Rules

6.1 Real-Time Recording Items

Temperature, humidity, indoor and outdoor pressure difference, air filter operation status recorded every 2 hours.

6.2 Regular Sampling Detection

Weekly sedimentation bacteria test; monthly planktonic bacteria and dust particle inspection.

6.3 Filter Replacement Cycle

Primary filter: 1 month; Medium filter: 3 months; HEPA high-efficiency filter: 12 months.

7 ISO13485 Audit Matching Requirements

Complete cleanroom construction drawing, filter replacement records, environment test reports and personnel training files shall be archived for audit, which are essential supporting documents for electrode export CE/FDA certification.

Summary

Standardized 100,000-class cleanroom construction and standardized daily management is the basic guarantee for medical electrode batch zero pollution, stable product yield and smooth overseas certification.