원산지: 인도.
인증 기준: ASME BPE 및 cGMP 지침에 따라 설계 및 제작되었으며, 생성되는 WFI는 USP, EP, BP, IP 표준을 충족한다. CFR 21 Part 11을 준수하는 PLC 제어반과 완전한 DQ/OQ/IQ/FAT/SAT 문서 패키지를 갖추었다.
용량/처리량: 시간당 5~6,000리터.
제작 소재: 보일러 증기가 존재하는 부위에는 이중 관판 구조의 무계목 열교환 튜브를 사용하여 100% 배수가 가능하도록 설계되었다.
용도: 단계적 낙하막 증발기 증류 공정을 통해 저전도도, 발열물질/엔도톡신 무함유 주사용수(WFI)를 생산한다.

기타 정보

추가 설명:

This multi-column distillation plant (Water for Injection generation plant) produces low-conductivity, pyrogen/endotoxin-free WFI through a staged distillation process based on falling film evaporator technology. Capacity ranges from 5 to 6,000 liters per hour, designed and built to ASME BPE and cGMP guidelines, with WFI meeting USP, EP, BP, and IP standards. It is specially engineered to remove pyrogens and endotoxins, uses seamless heat exchange tubes with double tube sheet construction wherever boiler steam is present, and is built for 100% drainability. It includes a PLC-based, CFR 21 Part 11-compliant fully automatic control panel with online printing, along with a complete documentation and certification package for regulatory compliance, and DQ, OQ, IQ, FAT, and SAT support with assistance for PQ development.