Medical-grade molds manufacture medical instruments, testing accessories and infusion supplies. Finished products directly contact human body fluid and wounds, hence mold cleanliness and disinfection effect determine product hygiene level. Production and maintenance shall comply with ISO 13485 and ISO 10993 standards, covering mold design, workshop management, graded disinfection, storage maintenance and pollution prevention.
1. Fundamental Sterile Design Specifications of MoldsInitial structural design avoids hidden dirt and microbial breeding gaps. Cavity and core components use 316L medical stainless steel with strong disinfection resistance and zero metal precipitation. Forming surfaces are polished to high smoothness to reduce microbial adhesion. Structures minimize blind holes and narrow slits, with precise parting surface assembly clearance preventing flash and dirt accumulation. Matching gaps of moving parts are controlled strictly to avoid trapped plastic scraps. Closed hot runner systems reduce exposed residual material areas, and round corner treatment realizes full disinfection coverage.
2. Standard Control of Sterile Production EnvironmentMedical plastic molding is conducted in ISO Class 6 to Class 7 clean workshops. Air purification systems operate continuously to keep suspended particles and settling bacteria within qualified limits. Indoor temperature and humidity remain stable to restrain microbial reproduction. Staff wear complete sterile protective equipment and are forbidden to touch forming surfaces directly. Production tools and turnover containers are disinfected specially and placed in separate areas to avoid cross contamination. Raw materials and waste scraps are sealed stored, keeping production sites clean and tidy without scattered impurities.
3. Graded Disinfection Modes and Operational NormsDisinfection work is divided into daily surface wiping, batch switching disinfection and deep sterilization after long downtime according to service frequency. 75% medical alcohol is used to wipe mold surfaces before and after each shift, waiting for full natural volatilization before production. Hydrogen peroxide atomizing disinfection is carried out during product replacement to eliminate hidden microbes inside gaps. Low-temperature plasma and ethylene oxide sterilization are adopted for deep maintenance. Strong acid and alkali disinfectants are prohibited to prevent mold corrosion. Disposable dust-free wiping cloths avoid secondary pollution. Microbial sampling inspection confirms disinfection effect before reuse.
4. Standard Control of Sterile Operation During ProductionMold opening time is shortened to reduce exposure to external air. Common release agents are banned, and non-toxic special coating is used for auxiliary demolding when necessary. Tiny scraps and dust attachments are cleaned regularly with disinfected tools. Screw and barrel carbon deposits are cleaned periodically to prevent impurity mixing. Defective flash products are isolated immediately without recycling. One fixed mold only produces medical products of the same grade to prevent cross contamination from different materials.
5. Sterile Storage and Maintenance Requirements of MoldsComplete cleaning and disinfection are finished before mold storage, and molds are closed after thorough drying. Medical molds are stored individually in sealed sterile warehouses away from damp and oily areas. Internal ventilation and regular disinfection are maintained in storage zones. Routine inspection checks surface rust, sealing part aging and internal dirt accumulation. Idle molds receive regular re-disinfection to keep qualified sterile state. Complete maintenance and disinfection records support whole-process traceability.
6. Pollution Abnormality Handling and Compliance AcceptanceProduction suspends once excessive bacteria or surface contamination are found on finished products. Molds are disassembled for thorough cleaning and disinfection, together with inspection on workshop environment and operational flows. Production resumes only after hidden risks are eliminated. Molds pass sterile test and biocompatibility recheck after manufacturing and overhaul before formal application. All management procedures meet medical quality system standards, ensuring safe and qualified medical plastic products for clinical use.
