Medical Material GMP Workshop Renovation
Decoration Material Selection
1. Wall and Ceiling Materials:
●Color Steel Plate (Rock Wool/Magnesium Oxide Core): Fire rating up to Class A, antibacterial surface coating, seams require sealing, suitable for Class B/C clean areas, corridors, etc.
●Stainless Steel Plate (304/316L): Acid and alkali resistant, no peeling, seamless weldable, higher cost, commonly used in high humidity areas and sterile core areas.
●Antibacterial Coating: Contains nano-silver ions, meets relevant antibacterial coating standards, suitable for auxiliary areas.
2.Floor Materials:
●Epoxy Self-Leveling Floor: Seamless, chemical resistant, anti-slip rating R10-R12, thickness ≥2mm, suitable for production areas and filling rooms.
●Polyurethane Mortar: High temperature resistant, impact resistant, suitable for areas with frequent steam cleaning, such as sterilization rooms.
●PVC Sheet Material: Food-grade certified, heat-melted welded seams, good elasticity, suitable for laboratories and packaging areas.
3.Doors, Windows, and Pass-through Facilities:
●Cleanroom Doors: Stainless steel frame + tempered glass viewing window, with automatic door closer; airtightness must meet relevant standards.
●Pass-through Windows: Generally 304 stainless steel liner, with UV/ozone sterilization function, double-door interlocking.
●Observation Windows: Double-glazed, aluminum alloy frame coated with epoxy resin to prevent condensation.
4.Other Materials: Corners must be rounded (R≥50mm), using stainless steel or PVC curved materials; sealant must be standard-compliant, low-volatile silicone sealant. If anti-static requirements are present, anti-static epoxy flooring or similar materials can be used.
Decoration Process
1.Preliminary Design: Determine the cleanliness level of the workshop based on the product category. For example, the production of implantable and interventional medical devices, final cleaning and assembly, etc., must be carried out in a cleanroom of at least Class 10,000. Simultaneously, follow the principle of "separation of personnel, materials, and airflow," rationally planning functional zoning, dividing clean areas, non-clean areas, and auxiliary areas.
2.Construction Preparation: Conduct a site survey and perform basic preparatory work on the factory walls, floors, and ceilings, including cleaning, leveling, and moisture-proofing.
3.Main Construction: Install the color steel panels for the ceiling and walls first, from the inside out and from top to bottom, followed by floor construction, such as laying epoxy self-leveling flooring or PVC rolls. During construction, ensure proper joint and sealing treatment, such as applying sealant to all joints of the color steel panels and sealing areas where equipment contacts the floor.
4.Equipment Installation: Install the air conditioning and purification system, water supply and drainage and disinfection system, electrical and lighting systems, etc. Air conditioning units must be compatible with the workshop area and cleanliness level. Air ducts should be made of stainless steel or galvanized steel, and connections must be sealed. Water supply and drainage pipes should be made of suitable stainless steel, and electrical equipment must be dustproof and waterproof.
5.Cleaning and Acceptance: After construction, the workshop must be thoroughly cleaned to remove dust, waste, etc. Then, conduct acceptance testing, including static and dynamic testing, measuring environmental parameters such as dust particle count, microbial count, air change rate, and pressure differential to ensure compliance with GMP requirements.
Functional Area Planning
●Personnel Cleanroom: Equipped with changing rooms, handwashing and disinfection facilities, and air showers. Personnel must enter the cleanroom according to prescribed procedures.
●Material Cleanroom: Separate entrances and exits for raw materials and finished products. Raw materials must undergo cleaning and disinfection upon entry, while finished products must be transported out through pass-through windows or similar facilities.
●Production Area: Divided into different operating areas according to product manufacturing processes, such as mixing, filling, and packaging. Each area must meet the corresponding cleanliness requirements.
●Auxiliary Area: Includes an air conditioning room, pure water preparation room, and waste storage room. The waste storage room must be sealed and maintain negative pressure from the cleanroom.