04, Production process requirements
(I) Relevant requirements for product manufacturing
The production process of medical glove products should be specified. Key processes and special processes should be noted in the process flow chart, and their process control points should be explained. Clarify the use of various processing aids and the control of impurities (such as residual monomers and small molecule residues) in the production process.
Medical glove production line generally includes: ingredients, mold cleaning (hand mold acid and alkali cleaning, hand mold water washing, hand mold immersion in hot water), hand mold immersion coagulant, drying, dipping, drying, curl , Leaching, isolating agent / chlorine treatment, drying, demoulding, vulcanization, drying molding, primary packaging, sterilization (if any), etc. The key procedures and special processes are: leaching, chlorine treatment, vulcanization, primary packaging, sterilization (if any), etc.
The production process of single-use sterile PVC medical examination gloves generally includes: batching, filtering, defoaming, dipping, plasticizing, powdering, sorting, demoulding, packaging, etc. Key processes and special processes include: defoaming, impregnation, plasticizing, packaging, etc.
Attention should be paid to the quality control requirements of raw materials for medical gloves, and the source and quality requirements of raw materials should be clarified. The raw materials should have relatively stable production processes and sources of supply to ensure product quality. The storage of raw materials should be protected from moisture, contamination and pests, especially latex and starch must be stored in an environment that can prevent the growth of microorganisms.
Medical Glove Production Line
(2) Sterilization process requirements
The sterilization process (methods and parameters) and sterility assurance level (SAL) of medical making machine china should be specified, and a sterilization confirmation report should be provided. For the products to be sterilized by the end user, the recommended sterilization process (methods and parameters) and the basis for the recommended sterilization method should be determined. If ethylene oxide is used for sterilization, the requirements for residues and the treatment methods adopted shall be clarified, and research data shall be provided.
(Three) product expiration date
The basis for determining the validity of medical gloves and the relevant verification data should be provided. Refer to EN 455-4-2009 "Requirements and Tests for the Determination of Shelf Life of Disposable Medical Gloves". And research data to maintain the integrity of the package during the stated validity period and transport and storage conditions.
05. Product instruction and labeling requirements
Product descriptions and labels shall comply with the "Medical Device Instructions and Label Management Regulations" (Order of the State Food and Drug Administration No. 6), "Symbols for the labeling, marking and providing information of medical devices for medical devices. Part 1: General requirements" (YY / T 0466.1-2009) and related standards.
(1) The inner packaging shall be clearly marked:
(2) "Left" or "Right" should be marked on the inner packaging;
(3) Powdered gloves should have “Note: Aseptic operation should be used to remove surface powder before surgery to minimize the risk of adverse tissue reactions.” Or “Once the gloves have been treated with any surface powder material, there should be a warning The surface powder should be removed aseptically before surgery. "Or equivalent;
(4) Gloves made of natural rubber latex should have “(product) contains natural rubber latex that can cause allergic reactions” or equivalent instructions;
(5) If the product is declared to contain protein, the specified process limits shall be given;
(6) "Hypoallergenicity" should not be marked.
(2) Unit packaging generally includes the following:
(1) the name or trademark of the manufacturer or supplier;
(2) Materials used;
(3) "Straight fingers" or "curved fingers", or similar words indicating the content of gloves design;
(4) the words "hemp surface" or "glossy surface", "with powder" or "no powder", or similar effects on the type of gloves;
(6) Production batch number, production date, use period or expiration date;
(7) Indicate the product status: "sterilized unless the package is opened or damaged" or "non-sterile";
(8) "One-time use";
(9) the words "surgical gloves" or "examination gloves";
(10) For category 1 gloves, the words "Products are made of natural rubber latex that may cause allergic reactions" are marked.
(11) During storage of the product, do not touch oil, acid, alkali, copper, manganese or other organic solvents. Avoid sunlight or artificial light containing ultraviolet rays. The warehouse should be free of ozone generating devices and kept away from radioactive materials.
(Three) multi-unit packaging
Multi-unit packaging is a box of products with a predetermined number of units of gloves of the same size. The purpose is to facilitate safe transportation and storage. Multi-unit packages are labeled as single packages, and the number of gloves and additional storage instructions should be indicated.