Article 16
Factories that manufacture injectables (including dialysates) shall, as needed, install the following facilities:
(1) Facilities for the production of water for injectables;
(2) Ampoule cutting facilities;
(3) Container drying, sterilization, cooling and storage facilities; must effectively sterilize containers and prevent contamination;
(4) Injectable solution filtering facilities; must include cooling element and pathogen filter; for injectables in powder form, this requirement may be waived;
(5) Filling facilities with precise measuring capabilities;
(6) Injectables container sealing facilities;
(7) Sterilization facilities;
(8) Injectables container seal and leak testing facilities;
(9) Injectables foreign matter testing facilities;
(10) Distillation room (for employees’ washing and distillation);
(11) Changing room (for employees to changed into sterilized work clothes, caps, face masks, gloves and shoes);
(12) Drug solution preparation room;
(13) Drug solution filling and container sealing room;
(14) Animal experiment area, facilities and equipment, equipped with necessary animals and breeding and observation areas;
(15) Area, facilities and equipment necessary for conducting plate count, sterility tests and other tests;
(16) Freeze-drying facilities.
The rooms mentioned in Subparagraph 12 and Subparagraph 13 of the preceding Paragraph shall be strictly separated from other operation areas; they shall be equipped with double doors that seal tightly, air clean and sterilization facilities, and facilities for the regulation of temperature and humidity.
For pyrogen testing, priority shall be given to replacing testing on live animals with alternative techniques.