Evoqua Purified Water System

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1.0 Purpose 
 
 This procedure describes the Evoqua water purification system and outlines procedures for its
 
 regular maintenance and performance monitoring. 
 
 2.0 Scope 
 
 This procedure applies to the Evoqua Purified Water System installed at Ion Labs.
 
 3.0 Responsibility 
 
 3.1 Operations and Facility management are responsible for the operation of the Evoqua
 Purified Water system. 
 
 3.2 Maintenance of the Evoqua water purification system is carried out by Evoqua Water
 
 Technologies, Tampa, Florida under a service agreement. 
 
 3.3 Quality Control is responsible for monitoring the Evoqua Purified Water system.
 
 4.0 Definitions 
 
 4.1 RO- Reverse osmosis, a process by which water passes through a porous membrane in
 
 the direction opposite to that for natural osmosis when subjected to a hydrostatic
 pressure greater than the osmotic pressure. 
 
 4.2 Ultraviolet — (UV); an electromagnetic radiation with a wavelength from 10 nm to 400
 
 nm. UV radiation constitutes about 10% of the total light output of the Sun, and is thus
 
 present in sunlight. UV light is used to kill residual bacterial in the water system,
 without using chemicals 
 
 4.3 PLC — Programmable Logic Control 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Evoqua Purified Water System F-502 2 Page 2 of 6 
 
 4.4 BOD — Biochemical Oxygen Demand; the amount of dissolved oxygen needed by
 
 microbes to break down organic matter present in water. BOD is a measure of the level
 
 of organic pollutants present in a water sample. 
 
 4.5 COD — Chemical Oxygen Demand; the amount of dissolved oxygen that can be
 consumed by reactions in solution. COD is a measure of the level of organic pollutants
 
 present in a water sample 
 
 4.6 ACF — Activated Carbon Filter 
 
 4.7 TDS — Total Dissolved Solids 
 
 4.8 UF — Ultra-Filtration 
 
 4.9 ISPE — International Society for Pharmaceutical Engineering 
 
 5.0 References 
 
 5.1 [OQ-FAC-17-140, Protocol, Reverse Osmosis Water System Installation/Operational
 Qualification 
 
 5.2 PQ-FAC-17-140, Protocol, Reverse Osmosis Water System Performance Qualification
 
 5.3 PRTCL-20-0006, Protocol, Evoqua Reverse Osmosis Water Purification System
 
 Performance Qualification 
 
 5.4 E-705, SOP, Water Use, Sampling, and Testing 
 
 5.5 E-705-F2, Form, Purified and Millipore Water Test Ticket — Microbial Limit/ pH/
 Conductivity/ TOC 
 
 5.6 E-705-F3, Form, Conductivity Stage 2 Test Ticket 
 
 6.0 System Performance Monitoring and Maintenance 
 
 6.1 Water purified by the Evoqua Water Purification System is monitored to ensure
 compliance with USP standards for Purified Water used in manufacturing processes.
 
 6.2 Purified water is tested regularly as outlined in SOP E-705 Water Use, Sampling, and
 
 Testing. 
 
 6.3 The water system is sanitized twice per year by Evoqua water systems.
 
 
 

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 Standard Operating Procedure SOP No | Rev 
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 6.3.1 | During sanitization, all Point of Use (POU) ports must be opened to allow
 solution to thoroughly flush these areas. 
 
 7.0 System Description 
 
 7.1. The Purified Water System purifies incoming city water and continuously distributes
 water that meets the requirements of the USP monograph for Purified Water (Error!
 
 Reference source not found.). 
 
 7.2 The water system has the following stages of purification, distribution and control:
 
 7.2.1 Pre-treatment System 
 
 7.2.1.1 The objective of pre-treatment is to treat city water in a manner that
 
 reduces the load on the final purification system and maximizes the
 efficiency of the final purification stage. 
 
 7.2.1.2 Softener Unit 
 
 T2A2.1 Two Softener units have been provided in the pre-treatment
 
 stage, in order to reduce the hardness of water to <Sppm.
 
 Tele These two softener columns work alternately, in order to
 provide a continuous flow of water, during regeneration of
 
 either one of the columns. Each softener column is
 
 regenerated in approximately 10 hrs. During regeneration
 of Softener - 1, the water is diverted to Softener — 2 by the
 
 operation of electrically operated valves. 
 
 fee eae The soft water, generated by the softener, is stored in a
 “Soft water Storage Tank”, in order to provide the
 
 necessary buffer required for the daily usage. 
 
 T2224 A brine tank is maintained for regeneration of the water
 
 softener tanks. 
 
 7.2.2 Generation system for Purified Water 
 
 
 

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 Standard Operating Procedure SOP No | Rev 
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 7.2.2.1 The objective of generation system is to provide water to the Purified
 
 Water Storage tank. 
 
 7.2.2.2 Soft water is passed through an activated carbon filter (ACF) for the
 
 removal of chlorine, color, odor, BOD and COD. 
 
 7.2.2.3. ACF filtered water is further passed through 5 micron filter for
 
 removal of suspended particles and microbial contamination to extend
 the performance and lifetime of the RO system. Pressure Gauges
 
 across the “5-micron cartridge filter” have been provided, in order to
 identify the choking of cartridge filter and facilitate its replacement.
 
 7.2.2.4 The pre-treated water is further passed through Reverse Osmosis (RO)
 
 module for reduction of salt content, suspended particulates, total
 organic carbon (TOC), and total dissolved solids (TDS).
 
 7.2.3 Storage and Distribution System 
 
 7.2.3.1 Purified water generated by system is fed to a glass reinforced
 polypropylene storage tank. The storage tank capacities have been
 
 arrived at, keeping in mind the peak load & buffer volumes to be
 maintained. 
 
 7.2.3.2 Water level controller in the storage tank prevents overflow and
 
 safeguards the pumps from running dry. 
 
 7.2.3.3 Two vent filters have been installed to filter air entering the tank to
 
 displace water as it drains. 
 
 7.2.3.4 The purified water stored in the purified water storage tanks is supplied
 to various usage points in the plant by means of a piping/distribution
 
 network, which is a closed loop system maintained at ambient
 
 temperature. 
 7.2.3.5 An ultraviolet (UV) system has been provided as an additional safety
 
 measure, to control the microbial load in the Purified water. The
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
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 germicidal lamps are monitored for performance and replaced as
 
 needed. 
 
 7.2.3.6 An Ultra-filtration (UF) system is used for removal of microbial
 
 contamination. The Ultra-filtration system consists of two 0.2 micron
 filters piped in parallel to insure the water flow is uninterrupted if one
 
 of the filters becomes clogged. Two pressure differential gauges are
 
 installed upstream and downstream of the filters to monitor
 performance of the filters. 
 
 7.2.3.7 A distribution loop for purified water has been provided for the liquid
 
 manufacturing and packaging block. It is constantly circulated and is
 designed with minimal dead legs. The only areas where the circulation
 
 is not present is at the POU ports. These ports must be thoroughly
 
 flushed (recommended 3 minutes) prior to use. A minimum velocity
 of water is maintained in the entire loop. Storage and Distribution
 
 system have been designed as per the guidelines of ISPE for minimum
 velocity in the loop as well as turn-over in storage tank.
 
 7.2.4 Control System 
 
 7.2.4.1. The control system is comprised of an enclosure housing a
 
 programmable logic controller (PLC) for integral control of the RO
 
 unit as well as discrete inputs and outputs for communicating with the
 pretreatment and post treatment equipment. The Control Panel also
 
 houses a contactor motor starter for each RO sub-system.
 
 7.2.4.2 The Control Panel is mounted to the RO’s aluminum frame to allow
 easy access to the conductivity monitor and control devices. The RO
 
 unit comes standard with a multi-function quality monitor. The
 
 monitor will display the system alarms and product conductivity. One
 alarm from the monitor will shut down the system on low quality.
 
 7.2.5 Monitoring System 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Evoqua Purified Water System F-502 Page 6 of 6 
 
 7.2.5.1 A monitor is installed immediately after the UF system to continuously
 measure TOC and conductivity of the purified water to ensure
 
 compliance with USP requirements for purified water. 
 
 Figure 1: Schematic of Evoqua Water Purification System 
 
 POU-LPI POU-LP2 POU-LP3 POU-LP4 POU-LPS 
 = = ss 
 POQU-LBI POQU-L82 POU-L83 POU-LBS 
 POU-LBS 
 Recircutating 
 Yéater Loop 
 - Reject 
 Yater RO 
 Conductiily Membrane 
 ResMiesttievri ty | 
 POU-GUt 
 ; rs f > Incoming 
 
 ; Disinfectant —— 5 a = — tai 
 = sa Mix Bed Storage Tank “Tank Pll et —— oe ‘* 
 L Deionization Circulation Pump Filter —_ 
 
 Filters 
 
 8.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/23/17 | New SOP, replaces all previous versions Re-write of procedure to simplify technical description of the water system. Add references to IQ-OQ-PQ protocols and associated l 07/27/20 procedures. Add section to describe required performance monitoring CC-20-0529 S. Sassman and maintenance. Remove second figure which provides the same information as the first figure. > 09/30/22 Per CAPA-22-0024, Added additional requirements for sanitization. CC-22-0396 1 Bassin Clarified dead leg areas. | 17-1203 | J. Coyle |