We offer turnkey solutions for design, installation, commissioning, and validation of clean utilities for life-science customers.
Clean utilities include the following:
· Pure Water (PW)
· Water for Injection (WFI)
· Pure Steam (PS)
· Process Gases
Our systems were designed in accordance with customer’s User Requirement Specification (URS) and conformance to current version of Chinese GMP, EU GMP and US FDA.
The site installation team strictly follow the welding standards as specified in latest ASME BPE standards for all our welds in term of decolorization and smoothness of welds by utilizing the latest endoscopic equipment available in the market.
Clean utilities system is not considered acceptable to customer without going through the vigorous qualification procedures. Our team will get ready the following reports to enable quick transition to production qualification for all projects undertaken by us:
1) Mechanical completion (MC)
2) Functional Specification (FS)
3) Hardware & Software Design Specification (HDS & SDS)
4) Factory Acceptance Test (FAT)
5) Site Acceptance Test (SAT)
6) Installation and Operation Qualification (IQ & OQ)