What should we pay attention to when installing the clean workshop project in the medical industry?

Matters needing attention in engineering installation of clean workshop in medical industry

Core principles for installation of medical clean workshop (GMP/aseptic workshop/operating room/IVD/medical equipment/consumables workshop): pollution prevention, crossover prevention, airtightness, easy cleaning, traceability and compliance.

First, preliminary preparation and drawing deepening

Clear cleanliness level

10,000/100,000/100, sterile area, D/C/B/A, negative pressure/positive pressure, separation of people flow and logistics.

Compliance standards must be preceded.

Medical devices: YY 0033, GMP Appendix "Sterile Medical Devices"

Drugs: GMP 2010

Laboratory: ISO 14644 and GB 50073 Code for Design of Clean Workshop.

Deepening drawings must be in place

Clean air conditioning, air duct, water supply and drainage, electricity, process piping, floor, wallboard, floor drain, transfer window, etc. are comprehensively arranged, and it is strictly forbidden to open holes or make holes at will in the later stage.

Closed management of construction area

Divide clean area, quasi-clean area and non-clean area, and people and materials flow in one direction.

Second, the structure and enclosure system (wallboard, roof, doors and windows)

material requirements

Color steel plate thickness, rock wool/glass magnesium core material, and fire protection grade A; Smooth surface, no dust, scrub resistance and corrosion resistance.

Installation key point

The angle of yin and yang adopts circular arc angle to avoid dead angle of dust accumulation.

Joint sealing and gluing between wallboard and roof and ground are full and continuous.

Doors and windows gaps and through-wall holes are all sealed to ensure air tightness.

It is forbidden to cut the plate in the clean area on site, and it must be processed outside.

Put an end to hidden dangers

Wooden keel, paper tape and dust-prone materials shall not be used inside.

Third, clean air conditioning and ventilation system (core)

Manufacture and cleaning of air duct

The air duct must be made in a closed manner and the production environment is clean.

The inner wall of the air duct is free of burrs, welding slag and oil pollution.

Finished air duct sealing protection, cleaning and leak detection before installation.

Installation requirements

High efficiency filter (HEPA/ULPA) finally installed.

The soft joint of the air duct is made of special materials that are antibacterial and do not produce dust.

Positive pressure control: clean area > buffer room > unclean area.

Reasonable arrangement of return air and exhaust air to avoid eddy current and dead angle.

Debugging focus

Air volume, air exchange times, pressure difference, temperature and humidity, and leak detection of high efficiency filter (PAO leak detection) must meet the standards.

Fourth, the ground engineering

Common ground

Self-leveling epoxy, homogeneous PVC and polyurethane floor require seamless, wear-resistant, antibacterial, corrosion-resistant and easy to clean.

Key points of construction

The base is dry and the strength reaches the standard.

The whole is seamless, and the corner is turned up in an arc.

It is forbidden to empty drum, crack and sand.

Medical special requirements

Sterile workshop and laboratory need disinfectant (alcohol, 84, chlorine-containing disinfectant).

V. Water supply and drainage system

Pure water/purified water pipeline

Adopt 316L stainless steel, electrolytic polishing the inner wall, quick assembly and connection, no dead angle.

Drainage and floor drain

Clean special water-sealed floor drain must be used to prevent odor, insects and backflow.

The slope of drainage pipeline is sufficient to avoid liquid accumulation.

Pipe through wall and plate casing sealing

Hygienic requirements

All valves and joints are easy to clean, and there is no dead angle.

Six, electrical and intelligent

lamps and lanterns

Clean lamp panel, integrated LED, sealed and dust-proof, easy to wipe.

Socket, switch and distribution box

Embedded, sealed, no dust.

Monitoring and automatic control

Pressure difference, temperature and humidity, dust particles and air volume are monitored online, and the data can be recorded and traced.

static control

Anti-static floor and grounding are required in the medical electronic/precision instrument workshop.

Seven, process equipment and auxiliary equipment installation

Transfer window, shower room, cargo shower room, clean workbench, laminar flow hood.

Install horizontally and seal in place.

Interlocking function is normal (door interlock)

Equipment positioning

It is easy to clean and maintain away from the wall, and the bottom can be used as a bracket or arc wrapping.

It is forbidden to produce dust equipment

Grinding, welding, sandblasting and other processes must be isolated independently and exhausted separately.

Eight, the construction process of health and pollution control

Construction personnel shall wear clean clothes and shoe covers, and smoking, eating and spitting are strictly prohibited.

Tools and materials must be cleaned and dusted when entering the clean area.

Garbage removal in time, daily cleaning and disinfection.

Cross construction shall be strictly controlled to avoid dust diffusion.

Nine, debugging and acceptance (the most important thing in the medical industry)

Third-party testing must be done

Cleanliness (suspended particles)

Sedimentation bacteria/plankton

Ventilation times, static pressure difference

Temperature and humidity, illumination and noise

High efficiency filter PAO leak detection

Completion acceptance data

Take cover engineering records, material certificates, cleaning and disinfection records, test reports and as-built drawings.

Verification (IQ/OQ/PQ)

Medical device/drug workshop must do installation confirmation, operation confirmation and performance confirmation.

Ten, late use and maintenance tips

Standardize the cleaning process and use special cleaning rags and mops.

Regular replacement of high efficiency filter and differential pressure monitoring.

Air conditioning system should be cleaned and disinfected regularly to avoid biological pollution.

It is strictly forbidden to open holes, transform or destroy the envelope at will.