Hygiene Regulations for Disinfection Product Manufacturers
Nina Environmental Protection Technology Co., Ltd. Shanghai, October 27, 2008, 14:08:15
Chapter One: General Provisions
Article 1: In order to strengthen the hygiene management of disinfection product manufacturers and ensure the quality of disinfection products as well as the safety of consumers' use, these hygiene regulations are specially formulated.
Article 2: These regulations are formulated according to relevant provisions of the "Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases" and its "Implementation Measures", and the "Disinfection Management Measures".
Article 3: The disinfection products involved in these regulations include disinfectants, disinfection equipment, disposable medical and hygiene products, and indicator devices for evaluating the effects of disinfection and sterilization.
Article 4: Enterprises engaged in the production of disinfection products must comply with these regulations.
Article 5: Local health administrative departments at all levels supervise the implementation of these regulations.
Chapter Two: Production Environment and Layout
Article 6: Manufacturing enterprises should be built in clean areas without water accumulation, weeds, garbage, or breeding grounds for mosquitoes and flies.
Disposable medical product manufacturing enterprises should be located more than 500 meters away from sources that may affect product hygiene quality, and the surrounding environment of the factory area should be greened.
Article 7: The layout of manufacturing enterprises should be reasonable and meet corresponding hygiene requirements. The production area and non-production area should be set up to ensure the continuity of production and there should be no reverse crossing.
Article 8: The production layout must conform to the production process flow and should include raw material rooms, production workshops, finished product rooms, quality inspection departments, etc., with production processes reasonably connected.
Article 9: If toxic, harmful, flammable, or explosive substances are used or produced during the production process, corresponding hygiene safety facilities must be provided and comply with national hygiene safety regulations.
Article 10: Auxiliary buildings and facilities such as power, heating, air conditioning machine rooms, water supply and drainage systems, and wastewater, exhaust gas, and waste treatment systems should not affect production hygiene.
Chapter Three: Hygiene Requirements for Production Areas
Article 11: The production area must have a changing room equipped with lockers, shoe racks, and handwashing and disinfection facilities with running water.
Article 12: Toilets in the production area must be flushable and maintained in a clean and hygienic condition.
Article 13: The floor, walls, ceiling, and work surfaces of the production workshop should be easy to clean and disinfect. The interior decoration of the purification workshop should use materials that do not produce dust.
Article 14: Enterprises must have equipment suitable for the characteristics of product production, meeting production needs, and ensuring product hygiene quality.
Article 15: Enterprises should take disinfection measures in workshops based on the hygiene requirements of product production.
Article 16: Equipment, tools, containers, venues, and work clothes, hats, and shoes should be cleaned and disinfected before use according to the product characteristics.
Article 17: The quality of production water should meet the requirements of the production process.
Water used for producing contact lens care solutions and products with special hygiene requirements should be sterile water.
Water used for producing disinfectants should meet the standards for drinking water hygiene.
Water used for rinsing in the production of disposable medical products should meet the standards for deionized water and injection water.
Article 18: The production and packaging of disposable medical products entering sterile human tissues and organs, contact lens care solutions, and disinfection products with special hygiene requirements must be carried out in a purification workshop with a cleanliness level above ten thousand grades.
Article 19: The hygiene requirements for the production workshops of disinfection products shall be implemented in accordance with the provisions of GB 15979, GB 15980, and relevant national hygiene standards.
Chapter Four: Raw Materials, Product Packaging, and Storage Hygiene Requirements
Article 20: Raw materials used for producing disposable medical and hygiene products must be non-toxic, harmless, and pollution-free, with corresponding inspection reports or certification materials.
Article 21: Raw materials and finished products must be stored separately, with clear markings. Warehouses should have ventilation, dustproofing, rodent-proofing, and insect-proofing facilities. Stored items should be kept dry, clean, and tidy, and should meet the corresponding storage requirements of the products.
Disposable medical and hygiene products should be stored at least 10 cm off the ground and walls, and at least 50 cm from the ceiling.
Article 22: Products under inspection, qualified products, and unqualified products should be stored separately, with easily identifiable obvious markings. There should be registration and acceptance systems for product entry and exit from the warehouse, with records kept for reference.
Chapter Five: Hygiene Quality Control
Article 23: Enterprises should establish and improve the hygiene quality assurance system for product production. The hygiene indicators and testing methods in the enterprise standards or quality standards of products should meet the requirements of relevant national hygiene standards and technical specifications.
Article 24: Enterprises should establish self-inspection systems and have corresponding testing instruments and equipment. Measuring instruments used for production and inspection should be regularly calibrated as required, with records kept for reference.
Article 25: Personnel engaged in hygiene quality inspection must pass the assessment conducted by provincial health administrative departments and obtain an on-the-job certificate.
Article 26: Before each batch of products is put on the market, hygiene quality inspections must be carried out, and only qualified products can be released.
Article 27: Enterprises should conduct self-inspections of workshop environmental hygiene and product hygiene quality based on product characteristics. Self-inspection items for different product manufacturers:
(1) Disinfection equipment manufacturers should test the intensity of disinfection action factors or physicochemical indicators related to disinfection and sterilization effects for each product;
(2) Disinfectant manufacturers should test the physicochemical indicators of each batch of raw materials and products produced by each team. For products without specific effective content detection methods, such as plant and biological extracts, corresponding technical parameters, detection indicators, and methods should be established to ensure product quality;
(3) Indicator devices for evaluating disinfection and sterilization effects should establish corresponding technical parameters, detection indicators, and methods to ensure product quality;
(4) Disposable medical product manufacturers should test microbial indicators for products produced by each shift;
(5) Hygiene product manufacturers should test microbial indicators for products produced by each batch of raw materials added.
Article 28: Quality inspection records and reports should be complete, not arbitrarily altered, and legal measurement units should be used.
Article 29: All original records of the production process should be properly kept. The retention period should be three months after the expiration date of the product.
Chapter Six: Personnel Requirements
Article 30: Enterprises must be equipped with full-time or part-time hygiene managers who have received professional training. The list of managers should be reported to the provincial health administrative department for record.
Article 31: Operational personnel directly engaged in the production of disinfection products must undergo a health examination once before taking their posts and annually thereafter, obtaining a preventive health examination qualification certificate before starting work.
Persons suffering from active pulmonary tuberculosis, viral hepatitis, intestinal infectious diseases, carriers of pathogens, suppurative or chronic exudative skin diseases, and other infectious diseases shall not engage in the production of disposable medical and hygiene products.
Article 32: Personnel must receive training in disinfection hygiene knowledge and relevant hygiene standards before taking their posts and obtain a hygiene training qualification certificate before starting work.
Article 33: Staff uniforms should be worn neatly. Before operations, hands should be cleaned and disinfected according to product hygiene requirements.
Employees engaged in the production of disposable medical and hygiene products should not wear jewelry, watches, dye their nails, or have long nails during production.
Article 34: During production, staff should not engage in activities such as smoking or eating that could affect product hygiene quality.
Chapter Seven: Supplementary Provisions
Article 35: Definitions of terms used in these regulations:
Batch of products: For products finally disinfected or sterilized, the disinfection/sterilization batch is considered the product batch; for other products, those produced from the same batch of raw materials under identical production conditions are considered one batch.
Purification workshop with cleanliness grade of 100,000: Strictly divided into control zones and clean zones by design, using materials that do not shed dust, are easy to clean, and disinfect. Physical filtration and directional ventilation are used to achieve the following indoor microclimate requirements: temperature 18-28°C, relative humidity 50-65%, inlet air velocity not less than 0.25m/s, indoor-outdoor pressure difference not less than 4.9Pa, number of particles ≥0.5μm in the air not more than 3500/L, bacterial colony count in the air not more than 500cfu/m³, bacterial colony count on object surfaces not more than 10cfu/cm².
Article 36: These regulations are interpreted by the Ministry of Health.
Article 37: These regulations come into effect from January 1, 2001.