Millipore Water System

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1.00 Purpose 
 
 The purpose of this procedure is to provide instruction on the operation and maintenance oftthe
 Integral 5 Milllgarne Water System. 
 
 200 Scope 
 
 This procedure applies to the Milligore Milli-Q Integral Water Pumification System for use in
 
 the QG Laboratory at lon Labs, Inc. 
 
 300 Regpomsibility 
 
 811 itis the reqnonsitility of @C Laboratory Personnel to parfonm daily, or as needed
 inspections of the system, to change the cartridges during scheduled replacement, and to
 
 perform periodic system flushes. 
 222 Itis the respomsitility of @G Laboratory Management to implement this procedure and
 
 to ensure that the procedure is being followed. 
 
 833 It is the responsibility of @G Laboratory Management to keep this SOP current with
 latest lon Lalbs practices. 
 
 400 Definitions 
 
 411 QE = Quality Control 
 
 500 Referennes 
 
 511 Milligore User Manual, Milli-Q Integral 3/5/10/15 systems 
 
 &22 §E-705, SOP, Water Use, Sampling, and Testing 
 
 F3i3 EOSE2, Fonm, Purified add Millipore Water Test Ticket = Microbial
 Limit gHComathotwitiOtOg 7C 
 
 514 §£-705-3, Form, Conductivity Stage 2 Test Ticket 
 
 600 Procedure 
 
 try1 are me 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Milllipone Water System F-503 6 Page 4 of 4 
 
 6BELA4 Select “Memu" then “Samitize/Clear" amd them select “RO
 C12 Cleaning", the process will last anpronimatbly 19
 
 6.3.6.3 RO pHi Cleaning = anproximatdly evesy 6 months im place of CL2
 Cleaning, 
 
 6363311 Open the Sanitization port and place a ROClean pouch into
 the port. 
 
 636322 Put the cap back on and tighten it. 
 
 636333 Go into “Standby” mode 
 
 6363314 Select “Menu” then select “Sanitize/Clean” 
 
 636335 Select “RO pH cleaning”, the cleaning will last 742 minutes.
 
 6363H6 Remove the ROClean pouch the next time the Sanitization
 
 port is opened 
 Ne@te: Do not petfom CL2 and pH cleanings at the same time. fill
 
 Cleaning is used as a supplement to the CL2 cleaning
 
 644 Step-By-Step MRintemamceinsttuctionss 
 
 6411 Refer to the Milliq@ore User Manual, Milli-Q Integral 35/10/15 systems for step-
 by-step instructions on replacing cartridges and performing system maintenance
 checks and flustiess. 
 
 700 Revision History 
 
 Revision Date Descrition ofChany CCR # By 
 0 07/01/10 Original - - 
 | OvEDtO Removed conductivity testiDg requirementts, changed testing _ ;
 fiom each tank change to quarterly checks 
 O4/OIS | r U e p f d l a ec t t e t d h e S O Mi P l l f i o g r o m n a e t , w a n t a e m r e , s y a s o t d e m S OP number, changed SOP to = ~ B. Johos
 
 Biennial review: Updated! SOP fornratt. Added consumabie part
 3 ON/05/16 #s. Expanded information for routine inaimtemansse and dail) 16-0024 N. Zhang
 inspections. 
 4 @4i08119 | Scheduled review: added items to checklist. 19-O239 J. Maiigman
 Revise SOP to reflect current practioes and sdded sanitization ;
 . 2/23/19 steps per instrument manual 19-0964 I. Garett 
 Included Reference to SoP for Mille Water Testing and oOROD 
 6 oR26/20 removed speuifications ofsystem that are not needed — L. McWade
 
 CONFIDENTIAL; For ION Labs use only 

[SOP 

 Standard Operating, Procedure SOPNo | Rev 
 Millipore Water System F-503 6 Page 3 of 4 
 
 62229 ROCare A Pouches = Part# ZW AQIDOI2 
 
 633 Routinemainttanance 
 
 6311 The maintenamoe schedutte i§ autonmateti for the Millipore Integral 5 Water
 purification system. Alerts willl appear on the display when a cartridge change,
 lamp change or cleaning process is nearing the maintenance date. The indicator
 
 light will tum yellow when an alert is active. 
 
 63222 When the system is out of spavification and/or maintenance is due the indicator
 light vill tum red! amd! water prodwation willl be suspended umiil the alert is
 addressed. 
 
 63333 The system will need to be put into stamdby mode when a cartridge is changed
 or a clearihg procedure is being followed. The alert will need to be reset at the
 
 completion of the task before water production rvill resume. 
 
 63344 Document ail maintenance ant sewice, includimg cartridge chamges im the
 Milligane Water logbook. 
 
 62335 Consumable Replacement Schedule: 
 
 Consumable Replacement Intervals 
 Proguard Pak 
 
 aint oe Every 6 months or when the system check
 22 pm POD Filter 
 recommends a r 
 e 
 e 
 p 
 pl 
 l 
 a 
 a 
 c 
 c 
 e 
 ement 
 Tank Vent Filter 
 EDM Module Checked or r eplaced when alarm dictates th that
 cunent is not maintained at needed level
 UV Lamps Every 3 years or when the system check
 recommends a replacement 
 63%6 Sanitization of RO Cartridge 
 6.3.6.1 Perform RO Cartridge samitization in 3 and 6 month intervals
 6.3.6.2 RO CL2 Cleaning = approximately every 90 days 
 6862211 Open Samitizatiom Port and place a chlorine tablet in the poft.
 686222 Put the cap back on and tighten it 
 63223 Go into “Standby” Mode 
 

[SOP 

 Standard Operating Procedure ve No 
 Rev 
 F-503 
 _Mijllipore Water System 6 Page 2 of 4 
 “4411p; 
 61.1 Daily Inspections 
 6.i.ll Ready mode as indicated by a grean light should! be displayed om the Main
 Unit’s LED sereen when normal water production and delivery are required.
 
 61122 A yellaiw light will display as a caution to notify the user of impending serwice
 requirements such as a cartridge change or system flush. 
 
 61133 After turning on water flow at the @-BOB gun and check the indicator display
 
 on the @-POp during dispensing to ensure that no warnings are displayed and
 water metrics are within tolerance. 
 
 6.113311 The reservoir is represented by ten graphic bars, each bar represemting
 10% capacity ofpuified water in the tank. 
 
 6.11322 Resistivity should read > 18MQ. 
 
 6113233 TOC oxidizable carbon level <10 ppb. 
 
 6.113344 Water temperature should be near ambient. 
 
 6.113335 The Proguard Pak is in use as indicated by the symbol.
 
 6.1.866 The Quantum Cartridge is in use as indicated by the symbol.
 
 6.113377 No wamings or maintenance alerts are displayed. 
 
 6.14 Inspect the system for leaks. 
 
 22 Consumabies 
 
 62211 Proguard Pak = Pafi# PROGOTOS2US 
 
 62222 Bactericidal UV Lamp- Pant# ZLXUVYILIR} 
 
 62233 Photooxidation UV Lamp- Part# ZMQUVILPO1 
 
 62244 Quantum Cartricige - Part QTUMOTEX!! 
 
 6225 AlO TOC Monitor Lamp- Part# ZFAIOUVOI 
 
 6246 POD2Z24iM Filter- Part# MPOPOAGO 
 
 6277 Tank Filter- Part¥ TANKMPKOI 
 
 62248 Samitization Tablets (US)- Part# 5874316024 
 
 CONFIDENTIAL; For ION Labs use only