PW/WFI, Storage and Distributed Loop New Systems or revamping
New complete plant for storage and distribution of pure fluids such as purified water and water for injection.
From stand-alone or integrated PW or WFI generators to storage tank and loop distribution system equipped with heating and cooling system, ozone generator and UV reactor for disinfection, flow meters, pumps, valves, instruments, accessories and TOC control and sanitary piping to points of use.
Storage tanks with capacity from 100 to 50,000 litres, vertical or horizontal design, tri-clamp connections and control instrumentation; AISI 316L stainless steel and PED/ASME certification. Spray ball included for complete wetting of all internal parts of the tanks and mitigation of bio-film risk. Integrated heat exchangers, sanitary centrifugal recirculation pumps, in-line pressurisation and venting filters and conductivity control instrument. Ozone system and UV lamp for the sanitation process as an alternative to the superheated water sanitation process.
The storage and integration system is built with a SKID approach and an engineering design that allows for factory pre-installation and faster on-site installation.
The engineering provides for all design and functional aspects of construction and functionality requirements such as maximum flow, pressure and temperature, periodic consumption and sanitisation system.
The control system via PLC/HMI or PANEL PC is integrated to manage all phases, critical parameters and record all data according to CFR 21 Part 11 requirements. The complete system documentation provided consists of the mechanical booklet, electrical and software documentation, including all validation documents from design qualification, factory acceptance tests, site acceptance tests, installation qualification protocols, operational qualification protocols and performance qualification protocols.
The quality risk assessment document can also be provided for point-of-use assessment, sampling frequency, sampling procedure and risk reduction activities.
Revamping of existing qualified water production, storage and distribution system for additions or upgrades to GMP requirements.
System modifications for an additional point of use, connection of circuit extensions or quality upgrades and retrofits.
SEE ALSO
CIP-WIP-SIP SKID DISTRIBUTION LINES
N2, CA, PURE STEAM Distribution and modification of existing loop
COMPOUNDING PREPARATION SUITES with Fixed or Mobile Vessels
PROCESS AUTOMATION with PLC/SCADA/Panel PC control system
