Introduction to Injection Water Equipment System:
The injection water equipment is purified water obtained by distillation, and its bacterial endotoxin and other indicators meet the requirements of the Chinese Pharmacopoeia for injection water. The injection water equipment system mainly includes the main modules of injection water preparation, circulation storage, dynamic distribution, and process control. The injection water equipment system adopts advanced two-stage reverse osmosis purified water and fully automatic multi effect distillation injection water treatment technology. The system adopts fully automatic control mode, humanized design, safety, reliability, and quality assurance.
Application industry: It can be used for water in industries such as medical devices, biomedicine, veterinary drugs, powder injections, in vitro diagnostic reagents, clinical analysis and testing instruments, large infusion solutions, and medical sterile water.
Standard specification for injection water equipment:
1. GMP regulations
(1) Implementation Regulations of the Drug Administration Law of the People's Republic of China
(2) Pharmacopoeia of the People's Republic of China (2010 edition)
(3) Good Manufacturing Practice (GMP) (2010 edition)
2. Industry standards
(1) JB/T20093-2007 Pharmaceutical Machinery Industry Standard
(2) TJ36-79 Hygiene Standards for Industrial Enterprise Design
(3) GB50591-2010 Code for Construction and Acceptance of Cleanrooms
3. National standards
(1) GB 9706.1-1995 Medical Electrical Equipment Part 1 General Requirements for Safety
(2) GB-52261-2002 Mechanical safety - Electrical equipment of machinery - Part 1: General technical specifications
(3) GB20801.1-GB20801.6-2006 Pressure piping specification - Industrial piping
Process flow of injection water equipment:
(1) Pre treatment+dual stage reverse osmosis+multi effect distilled water machine
(2) Pre treatment+single-stage reverse osmosis+electrodeionization+multi effect distilled water machine
(3) Pre treatment+Double stage reverse osmosis+Electrodeionization+Multi effect distilled water machine
(4) Pre treatment+single-stage reverse osmosis+electrodeionization+hot press distilled water machine
Optional disinfection methods: CIP cleaning system, activated carbon pasteurization, distribution system superheated water sterilization, distribution system pure steam sterilization.
Introduction to the performance of injection water equipment:
(1) Design and manufacturing standards: The system is designed according to the requirements of the new Chinese, American, and European pharmacopoeia standards, following CGMP and GAMP specifications, and complying with GMP and FDA certification requirements.
(2) 3D simulation manufacturing and installation, with full customer participation, showcasing detailed effects in advance to fully meet customer needs.