Chapter I? The model? Environs
Article 1? The medical oxygen described in this appendix refers to liquid oxygen and gaseous oxygen prepared by low-temperature separation of air.
Article 2? This appendix applies to the industrialized production process of medical oxygen, excluding the disposal of medical oxygen within the medical institutions.
Article 3 The requirements for the industrial production of other medical gases refer to this appendix.
Chapter II? Original? Rules
Article 4 The production, storage, transportation and sale of medical oxygen shall comply with the provisions of the relevant state departments and obtain relevant documents.
Article 5? Medical oxygen production and quality control shall meet the requirements of its quality and intended use, should minimize the risk of contamination, cross-contamination, confusion and error.
Chapter III? Personnel Personnel
Article 6? The person in charge of production management of the enterprise shall have college degree or above or intermediate professional and technical title in related majors (such as chemical engineering, pharmacy, chemistry, machinery and industrial engineering, etc.), and more than three years of experience in the production and quality management of medical oxygen, of which at least one year of experience in the production and management of medical oxygen.
Article VII of the enterprise's quality management and quality of the person in charge of the authorization should have a relevant professional (such as chemical engineering, pharmacy, chemistry, machinery and industrial engineering, etc.) college degree or above (including college) (or intermediate professional and technical titles), with more than three years of experience in the production and quality management of medical oxygen, of which at least a year of experience in the quality management of medical oxygen.
Article VIII engaged in the production of medical oxygen personnel should be regularly trained in medical oxygen-related knowledge, involving special equipment operators should be in accordance with national regulations to hold a valid and compatible with the production of medical oxygen qualification certificate.
Article 9? Employees should be equipped with appropriate work clothes and safety protection equipment as needed.
Chapter IV Plant and Equipment
Article 10? The production environment of medical oxygen production enterprises should be neat and clean. The overall layout of the production, quality inspection, administrative, living and auxiliary areas should be reasonable.
Article 11? The plant should be reasonable according to the requirements of the medical oxygen production process layout. The production area and storage area should have an area and space appropriate to the scale of production, and ventilation, lighting, fire prevention, explosion-proof, lightning, anti-static and other facilities.
There should be enough storage areas for empty cylinders and different stages of product cylinders (such as to be cleaned, to be filled, to be inspected, qualified, unqualified, etc.), the different storage areas should be differentiated by effective methods or obvious marking, such as: landmarks, partitions, fences and signage.
Article 12? Medical oxygen filling production workshop should be kept clean, the ground is smooth, wear-resistant and non-slip, and set up a special locker room; filling production workshop should be separated from the maintenance workshop.
Article 13 The equipment and instruments used for production and inspection should be confirmed and calibrated regularly.
Article 14 The production and inspection equipment should be regularly maintained. Maintenance and repair shall be recorded. Any maintenance and repair of production equipment shall not affect the quality of medical oxygen.
Article 15? Medical oxygen production process gas compression equipment is prohibited to use fluorine plastic material piston seal compressor and water lubrication compressor.
Article 16? Liquid oxygen gasification with gaseous oxygen filling, must use low-temperature liquid oxygen pump, pressurized gasification filling.
Article 17? Medical oxygen containers (tankers, storage tanks, cylinders, etc.) should be dedicated, and with other gas containers to distinguish the obvious signs. Containers should be numbered management, security period marking, including the establishment of safety verification data and other appropriate files.
Article XVIII of medical oxygen filling should use special equipment, filling fixture should be anti-error device.
Chapter V? Document management
Article 19? Each batch of cylinder filling records shall include:
(a) batch production instructions;
(b) product name, specifications, batch number;
(c) the date and time of the filling operation;
(d) the use of the equipment and its number;
(e) the number of cylinders, cylinder inspection before filling;
(f) the number and specifications of cylinders before and after filling;
(h) the number of cylinders and specifications of cylinders before and after filling;
(j) the number and specifications of cylinders before and after filling;
(g) The signature of the operator of each step, and if necessary, the signature of the reviewer;
(h) Relevant production operations or activities, process parameters and control ranges;
(ix) Necessary intermediate control processes such as leakage testing;
(x) The results of the quality test of medical oxygen before filling;
(xi) The results of the quality test of filled cylinders;
(xi) The number of cylinders and the number of cylinders before filling (xi) the results of inspection and confirmation of the filled cylinders;
(xii) a sample of the packaging label;
(xiii) a description of the deviation of the production process and its treatment, and signed and approved;
(xiv) the signature of the person in charge of the filling and the date of confirmation.
Article 20? Enterprises producing medical oxygen by cryogenic air separation shall have documents describing the purity of the gas, other components and possible impurity components in the purification process.
There should be flow charts describing the individual process steps.
Key process parameters should be documented, such as temperature control for the separation and purification process.
There should be complete batch production records for the relevant production process.
Article 21? The quality file of gas cylinders should be established, and according to the relevant provisions of the state to formulate the management system of gas cylinder scrapping and the establishment of gas cylinder scrapping processing records.
Chapter 6? Production Management
Article 22? All key steps of the production process should be verified.
Article 23? The production of liquid oxygen shall follow the following principles:
(1) The separation and purification process shall be validated and daily monitored according to the process requirements. For the maintenance and replacement of consumable parts (such as the cartridge of the purification filter), they shall be carried out regularly according to the results of validation and monitoring.
(ii) The production process should have continuous quality and impurity monitoring measures and monitoring records.
(C) used to monitor the process of computer systems should be validated.
(D) continuous production process batch division should be documented, and sampling and inspection by batch.
(E) liquid oxygen filling and transfer operations and other steps should be to prevent contamination measures, transfer piping should be equipped with check valves or other equivalent measures.
(F) to the liquid oxygen storage tank containing liquid oxygen to add liquid oxygen, must prove that the quality of liquid oxygen meets the requirements. Can be sampled before adding, can also be sampled after mixing.
Article 24? Medical oxygen filling production process shall comply with the following provisions:
(a) The division of production batch number should be the same continuous production cycle of medical oxygen filled as a batch.
? (B) The cylinders should comply with the relevant provisions, the recycled cylinders should be recognized, and shall not be filled with cylinders other than their own.
(c) Filling equipment and piping should be cleaned and replaced according to written procedures and checked and confirmed before use.
(d) The main factors affecting the quality of the product such as handling and cleaning of cylinders before use are verified, and the corresponding operating procedures are formulated.
(E) cylinder filling inspection, at least the following steps should be included:
1. The color markings on the outside surface of the cylinder and the specified markings of medical oxygen in line.
2. Check the residual pressure, make sure the cylinder is not completely empty, and the residual pressure of the cylinder equipped with residual pressure retention valve should be positive.
3. If the cylinder shows no residual pressure, it should be tested to make sure that it is not contaminated with water or other pollutants; contaminated cylinders should be cleaned using a validated method.
4. Verify that all labels on the cylinder that are not related to the batch have been removed.
5. Conduct a visual inspection of the appearance of each valve and cylinder, visually inspecting for dents, arc burns, debris, oil, and other damage, etc., and make any necessary repairs.
6. Inspect each cylinder or cryogenic container valve fitting to ensure that the type is suitable for medical oxygen filling.
7. Check the cylinder "test date" to confirm that the cylinder has been tested in accordance with the relevant provisions, and within the period of validity.
8. Confirm that the cylinder safety accessories are complete and meet the safety requirements.
(F) reuse of gas cylinders should be cleaned and disinfected before filling the bottle, and then replace the method or vacuum method to qualified, the vacuum should not be less than 15kPa. or each cylinder for the remaining gas full inspection.
(VII) should be used to check the appropriate method to confirm that the cylinder has been filled.
(H) medical oxygen filling, each cylinder is required to leakage detection, leakage detection failure is considered substandard, the leakage detection process shall not affect the quality of medical oxygen products. The leakage test is qualified to seal the mouth of the cylinder, and the cylinder is put into the area to be inspected with a cap and shock ring.
(ix) Each cylinder should be labeled with a product label, the label should indicate: name, company name, production address, production batch number, date of production, expiration date, the number of oxygen, pressure, and implementation of standards.