環境用藥工廠設廠標準

These Standards are determined pursuant to Article 13 of the Environmental Agents Control Act (herein referred to as “this Act”).

1The establishment of an environmental agent factory must comply with the following regulations.

2I. Those environmental agent factories manufacturing internal pressure aerosols shall have a surrounding wall or natural barrier, and may not obstruct environmental sanitation and safety.

3II. The manufacturing and storage areas of those factories engaged in the synthesis of highly flammable, highly explosive, or highly toxic technical grade environmental agents shall be a distance of at least 8 meters from the factory's outer wall. Necessary facilities shall be employed to separate manufacturing and storage areas from each other and from other working areas.

4III. Plant and warehouse structures shall be sturdy and clean. Walls and floors shall be made of concrete, terrazzo, or other easily washable materials.

5IV. Operating areas shall possess good ventilation and may not generate dust. Dustproof equipment shall be required in operating areas containing dust agents.

6V. The floors of those factories engaged in the synthesis of technical grade environmental agents and of operating areas where emulsions, liquid, suspensions, oils, and ultra-low capacity agents are manufactured (or processed) shall be made of impermeable material, may not allow puddling to occur, and shall be equipped with channels and pipes specifically for collecting wastewater and conveying it to a wastewater treatment facility.

7VI. Manufacturing and administrative areas within a factory shall be clearly delineated. All operating areas shall be clearly distinguished, and separation facilities shall be employed to prevent mutual contamination.

8VII. Environmental agent storage areas shall be clearly marked. Those factories storing technical grade environmental agents shall establish special storage areas subject to locking control and separated from other materials. Those environmental agent finished products and semi-finished products in storage must be clearly segregated from other materials.

1Those factories manufacturing microbial preparations used as environmental agents shall possess the following equipment.

2I. Microbial fermentation, culture, or preparation equipment

3II. Packaging equipment

4III. Storage equipment

5IV. Sterilization and disinfection equipment

6Structural equipment in operating areas containing microbial preparations used as environmental agents, including indoor ceilings, walls, doors and windows, and floors, etc., shall be convenient to wash and disinfect; areas where such agents are manufactured or processed shall be equipped with independent air conditioning systems.

1Areas where emulsions, liquid, suspensions, oils, and ultra-low capacity environmental sanitation agents are manufactured or processed shall posses the following equipment.

2I. Blending containers

3II. Mixing machines

4III. Storage tanks

5IV. Filling equipment

6V. Packaging equipment

7Those factories manufacturing internal pressure aerosols shall possess pressurized filling equipment and leak testing and inspection equipment.

1Those factories manufacturing and processing dust environmental sanitation agents shall possess the following equipment.

2I. Grinding machines or sifting equipment

3II. Mixing or smelting equipment

4III. Packaging equipment

1Those factories manufacturing and processing environmental sanitation agents in the form of granules, tablets, chunks, flakes, or gels shall possess the following equipment.

2I. Mixing or smelting equipment

3II. Molding, shaping, or filling equipment

4III. Packaging equipment

Equipment used for the production of rodenticide environmental agents may not be used interchangeably with equipment used to produce other environmental sanitation agents.

Except in the case of rodenticides and microbial preparations, the manufacturing, processing, and packaging equipment of those environmental sanitation agent manufacturing enterprises that concurrently produce pesticides must be used exclusively for specific purposes.

Environmental agent factories shall possess testing equipment or testing laboratories to test the quality of environmental agent finished products. However, if the environmental agent finished products at a factory are entirely identical with technical grade environmental agents in composition and contents, that factory shall not be subject to this restriction.

1Those environmental agent manufacturing enterprises that wish to apply for an environmental agent manufacturing permit shall first obtain a factory registration certificate in accordance with the law.

2When an environmental agent factory wishes to apply for an environmental agent manufacturing permit, the dosage form equipment of the agent in question shall comply with these Standards.

(deleted)

These Standards shall take effect on the date of promulgation.