The (Notice) Regulations of the "Implementation Rules for the Production of Aseptic Medical Devices": "Before issuing this notice, according to the relevant documents, one-time use of sterile medical device products (Notes, transmissions, etc.) for the implementation of the "Production Regulations for the Use of Sterile Medical Devices for Single Use (Notes, Instments)" (as amended in 2001) shall be implemented. ) Following the implementation of the "Specifications", the following requirements shall continue to be followed: All injection, extrusion, and blow molding parts produced by enterprises shall be produced in the plant area; the important parts and components shall be produced in the 100,000-class cleanroom area of ​​the plant (Homemade) Or the purchased single-product packaging bag is produced in the 300,000-class clean area. The production, final cleaning, assembly, and initial packaging of the zero, component, and protective cover that are in direct contact with the drug (blood) fluid must be The same building in the factory area of ​​100,000 clean room area. The above-mentioned important zeros and components are: single-use infusion (blood) drip bucket*, hose*, cork puncture device, barrel*, liquid filter*, air filter*, supporting self-use vein needle* One-time use of intravenous infusion needle holders, hoses*, needle handles; one-time use of sterile syringe jackets*, core rods*, supporting self-use injection needles*; one-time use of sterile needle holders. Among them, the "*" is a zero component that is in direct contact with the drug (blood) fluid. Purchased auxiliary syringe pistons, metal inserting needles, disposable injection needles, and disposable intravenous infusion needles must be products that hold medical device manufacturing enterprise licenses and product registration certificates. The company manufactures disposable syringes, infusion sets, and externally purchased needles (sharpened needle tips) for its own use of assembled injection needles or intravenous infusion needles. It must be a manufacturer of disposable sterile needles or intravenous infusion needles. License and product registration certificate for the company's products. †Regarding the range of disposable aseptic medical devices as stipulated in this notification, we refer to the annex to the "Regulations on the Administration and Administration of Disposable Aseptic Medical Devices" (Decree No. 24 of the State Administration) and the "Executive Production System for Partially Disposable Medical Devices". The Notification of Assessment Requirements (National Pharmaceutical Supervision [2002] No. 203) provides: Disposable sterile syringe; Single use syringe; Disposable blood transfusion device; Disposable burette infusion set; Disposable sterile needle; Disposable intravenous infusion needle (including indwelling needle); Disposable plastic blood bags; One-time use of blood collection device; Disposable insulin syringe Disposable self-destructive syringe Disposable dosing syringe One-time use of light-proof infusion device Disposable bag infusion set Disposable ultraviolet irradiation infusion device Disposable feeding infusion device Disposable transparent infusion set Disposable decompression material infusion set Disposable blood collection device (new style) Other disposable syringes and infusion products Regarding the reference to "others", reference is made to "any other disposable medical device subject to the production system assessment subject to the "Detailed Rules": (i) Single use medical devices whose basic structure is or can be attributed to an infusion set. (b) Single use medical devices whose basic structure is or can be attributed to a syringe. (c) disposable medical devices that come into contact with blood. Considering that the background and purpose of the above regulations were determined by the state at that time, it was to rectify the chaotic situation of the production of disposable medical devices in the country, and to restrict those enterprises with small scale, low level, and poor quality that only make product assembly. Zhejiang Sujing Purification Equipment Co., Ltd. is located in Daoshui Town, Shangyu District, Shaoxing City, Zhejiang Province and is an excellent manufacturer in the purification equipment industry in East China. Can provide professional air purification systems for industries such as microelectronics, biomedicine, hospital operating rooms, fiber optic cables, food and beverages, precision instruments, semiconductors, and new material applications in accordance with the ISO14644-1 standard, GB50073-2001 national standard, and national GMP specifications. Engineering design, construction, testing and technical services.
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Medical Device Packaging Cleanroom Specification