1、qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 1 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system1user requirements for awater for in

2、jectionsystemforinstallationatfirst approvalsecond approvalsignature:signature:print name:print name:print title:print title:qualification process solutions13406 blythenia rdphoenix, md 21131qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument num

3、berrevision numbera1date: 7 dec 2005page: 2 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system2table of contents1introduction .52overview.63operational requirements.73.1functions.73.1.1operation.73.1.2i/o streams.83.1.3process description:

4、.83.1.4cleaning and sanitization.103.1.5configuration (arrangement & materials of construction) .113.1.6operating parameters and quality requirements .193.1.7utilities required.203.1.8control system.213.1.9power failure and recovery.243.1.10“emergency stop” switch.243.1.11alarms and warnings .24

5、3.2data & security.263.2.1interfaces .263.2.2interface with operators.273.2.3the following shall be accessible only to supervisors .273.2.4interface with other systems.283.2.5data collection.283.2.6data collection and storage requirements:.293.3environment.293.3.1layout .293.3.2physical conditio

6、ns.294constraints.304.1milestones and timelines.304.2compatibility.304.2.1plc controllers.304.2.2utilities.314.2.3available drains:.314.2.4materials of construction.324.3availability.324.4procedural constraints.32qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is

7、prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 3 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system35life-cycle.335.1development.335.2testing.335.3delivery.345.4documentation.345.5support.356glossary .367references.378calc

8、ulations.388.1water consumption data sheet.388.2wfi tank simulation.398.3wfi flow rate calculations.408.4wfi distribution pressure drop calculations.418.5pump selection.428.6steam distribution calculations.43qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohi

9、biteddocument numberrevision numbera1date: 7 dec 2005page: 4 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system4revision historyrev.dateapprovalrevision summary05 dec 2005qualificationprocesssolutions, inc.proprietary information:unauthori

10、zed duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 5 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system51introductionproject no.:document no.:document description: this document constitutes the user requirem

11、ent document under gamp for a wfi-ps water system, distribution loop, and pure steam system. this document starts with the manufacture of distilled water and pure steam. a separate document describes the manufacture of purified feed water using reverse osmosis and deionization methods.qualificationp

12、rocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 6 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system62overviewthis is a critical utility system. major

13、 equipment included in this system includes:equipment descriptionp&id identification number1wfi-ps generator2wfi condenser3wfi storage tank4wfi tank vent filter5wfi circulation pump6pou heat exchanger7pou heat exchangerrefer to the p&ids for the interrelationship of the major equipment, as w

14、ell as the major utilities required for operation. p&id titledrawing number1wfi distribution p&id2pure steam distribution p&id3wfi condenser p&id4wfi-ps generation p&id5utility routing diagram6isometric wfi arrangement drawingthe storage tank and the hot circulation loop are self

15、-sanitizing at 80oc. operator intervention is required for periodic passivation and removal of accumulated rouge. the room temperature distribution sites require periodic sanitization with 80c water. the sanitization is performed semi-automatically, but requires operator intervention to properly con

16、figure downstream equipment.this specification does not include the ro/di system.qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 7 of 44author: narlin beatyrevision date: n/aequipment user requirem

17、entsequipment name:water for injection system73operational requirements3.1functions3.1.1operationthe wfi-ps generator shall produce 800 #/hr of pure steam and 25 gph of water-for-injection (wfi) as defined by the current united states pharmacopoeia (usp). the wfi system will store and circulate wate

18、r at 80c from a 400 gallon ss316l storage tank and through ss316l piping to three distribution points. distribution site 1: a vial washing station that will accept water at 80c.distribution site 2: a wash sink requiring wfi at 40c after passage through a heat exchanger.distribution site 3: a compoun

19、ding station that will require variable temperature delivery of water from a heat exchanger. temperature range will be 23c to 80c. the ps system will distribute pure steam through ss316l piping to three distribution points.distribution site 1: autoclave (200 #/hr)distribution site 2: lyophilizer (50

20、0 #/hr)distribution site 3: vial washer (50 #/hr)the system shall operate automatically. automatic operation shall be initiated locally through operator input. qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec

21、 2005page: 8 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system8the system shall have fault/alarm indicator automatic shutdown based on operator programming for the severity and type of fault.3.1.2i/o streamsinput streams:cold rodi water t

22、o the wfi-ps generation equipmenthot wfi makeup from the wfi-ps generation equipment.plant steam for wfi-ps generation, heating stored or circulating wfi, and for maintaining the vent filters in a non-condensing condition.chilled water for cooling (cold wfi drops and wfi generation).output streams:h

23、ot wfi (from hot wfi drops and wfi generation)cold wfi (from cold wfi drops)psvents tank and condensers are equipped with absolute rated 0.2 m hydrophobic vent filters to maintain vessel pressure at or near atmospheric. gas & vapor flow is in both directions, as required.steam condensate dischar

24、ged through steam traps to the process drain.warm chilled water returned from cold wfi drops and wfi generation.pure steam condensate / excess steam to drain.3.1.3process description:the elements of the wfi-ps generation and storage and distribution systems work together to maintain the quality of t

25、he wfi and ps from production through to delivery to end users at various locations in the facility. the key concept is the continuous circulation of hot wfi to maintain contacted surfaces in a sanitary and clean condition. the following process flow description follows the flow of wfi and ps from t

26、he wfi-ps generator through the wfi storage and distribution systems.qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 9 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipmen

27、t name:water for injection system9wfi-ps generatorrodi water is fed to the generator on a demand based on operating state of the equipment.the generator converts the rodi water through distillation into pure steam for distribution to the users.the pure steam is condensed into wfi at 80 2c based on t

28、ank level. wfi is diverted to drain until the proper temperature and conductivity levels are achieved.wfi storage tankwfi from the wfi-ps generation equipment is fed to the storage tank on a demand based on level. storage tank is maintained at 80 2c by plant steam through a tank heating jacket. the

29、tank temperature is used to adjust the set point of the temperature controller.wfi returning from the hot wfi circulation loop is sprayed into storage tank through a spray ball to ensure that the tanks internal surfaces are completely and continuously wetted by hot wfi and are thus maintained in a s

30、anitary and clean condition.the tank is maintained at atmospheric pressure by a steam-traced hydrophobic vent filter.hot wfi circulation loopwfi is continuously circulated through a single 1.5” od tubing supply header running through the building.the header is designed to maintain wfi velocity betwe

31、en 10 feet per second (fps) with no user loads and 3 fps during periods of high demand. this ensures that flow is kept fully turbulent in the header. these velocities correspond to circulation flow rates of between 13.78 and 45.95 gpm. this velocity range is maintained based on the hydraulic design

32、of the system; pump is not speed-controlled.qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 10 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injecti

33、on system10note: individual user drop flows vary widely depending on user requirements. drop usage is not coordinated and wfi demand can vary randomly.wfi returning to storage tank is throttled to maintain a minimum backpressure of 20 psig on the header. this maintains sufficient pressure at the use

34、r drops to ensure adequate wfi flow and to maintain positive pressure at all points in the loop. short periods of low end-of-header flow due to high wfi demand do not adversely affect the ability of the system to maintain a sanitary condition.header temperature is controlled by the heating jacket, w

35、ith the controller set-point adjusted based on the temperature in storage tank (cascade control).end-of-header water conductivity is monitored on-line.pure steam distributionps is continuously distributed through a single 1.5” od tubing supply header running through the building.the header is design

36、ed to supply ps at 45 psi with a pressure drop less than 10% of the supply value.the header is designed with sanitary steam traps to remove condensate on a continuous basis. 3.1.4cleaning and sanitizationthe wfi storage and distribution systems are effectively self sanitizing and self cleaning.on st

37、art-up, water from the wfi-ps generator is directed to waste until it meets specification. this feature is self contained on the condensing unit.the wfi storage and distribution systems are periodically passivated to reduce corrosion.the wfi storage and distribution systems are periodically de-rouge

38、d to maintain smooth, clean surfaces and reduce the potential for biological contamination.qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 11 of 44author: narlin beatyrevision date: n/aequipment us

39、er requirementsequipment name:water for injection system113.1.5configuration (arrangement & materials of construction)wfi -ps generatorthe wfi-ps generator is designed to produce water-for-injection (wfi) quality, pyrogen-free steam. the pyrogen-free steam produced, when condensed, meets all cri

40、teria for water-for-injection, as directed by the latest edition of the u.s. pharmacopoeia. the wfi-ps system is designed to produce sterile, pyrogen-free water-for-injection (wfi), as well. the distillate produced meets all criteria directed by the latest edition of the u.s. pharmacopoeia. the wfi-

41、ps system is configured to produce both pure steam and distillate concurrently.the wfi-ps generator is designed and constructed to meet all requirements of current good manufacturing practices (cgmps), as enforced by the u.s. food and drug administration. the separation of entrained impurities and p

42、yrogenic material is accomplished using gravity and centrifugal force.impurities collected in the separation process are continuously removed through the waste outlet.all surfaces in contact with feed water and pure steam are constructed of type 316l stainless steel for protection against carbide pr

43、ecipitation during the welding process.evaporator & separatorthe evaporator is a double-tubesheet, straight-tube, shell-and-tube heat exchanger, welded and constructed per asme, section viii, division 1, for unfired pressure vessels. all connections are sanitary-clamp type fittings.condenserqual

44、ificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 12 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system12the condenser is a u-tube shell-and-t

45、ube heat exchanger of double-tubesheet design, to ensure that coolant will not leak into the pure vapor and distillate. the tube side of the condenser is asme code stamped per section viii, division 1, for unfired pressure vessels.the condenser shell is mounted horizontally and pitched toward its ro

46、und end, with the distillate outlet at the lowest point to ensure full drainage.the condenser is vented to atmosphere in order to remove non-condensable gases and to equalize pressure during cooling. the vent is protected by a hydrophobic, pharmaceutical-grade, 0.2 m filter, preventing the passage o

47、f unfiltered air into the condenser and protecting the condenser from microbial contamination. filter shall be heat traced with isolation valves for maintenance purposes.the condenser is constructed of type 316l stainless steel. the connections for feed water, pure steam, and distillate are sanitary

48、-clamp type connections. coolant connections are npt fittings.feed water pump the feed water pump is contained entirely on the wfi-ps generator skid and includes all piping and wiring for automatic operation, contactor and overload, and alarm functions.all connections are sanitary-clamp type fitting

49、s.minimum feed water pressure to the pump is 2 psig.the pump is a sanitary, centrifugal-type, 316l stainless pump manufactured by _. it operates on 460 vac (or 208 vac), 3-phase, 60 hz, electrical current.table: wfi-ps generator & associated equipmentqualificationprocesssolutions, inc.proprietar

50、y information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 13 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system13design attributewfi-ps generatorwfi condensermanufacturer/sncapacity (working)

51、800 # / hr25 gphpressure rating_ psig _ psigtemperature rating132 c132 cmaterial316l316lwfi contact surfaces20 -inch ra, passivated20 -inch ra, passivatednozzles2:1 aspect ratio, free draining, sanitary fittingsn.a.overpressure protection_none installedqualificationprocesssolutions, inc.proprietary

52、information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 14 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system14wfi storage tank:the storage tank is a vertical, cylindrical tank of sanitary de

53、sign. all wfi contact surfaces are 316l stainless steel with a 20 inch ra or better surface finish. all internal surfaces on the tanks are kept wetted by spray balls on the circulation loop returns. the tanks are designed to be free draining. nozzles are designed for 2:1 depth to diameter ratio to e

54、nsure good spray penetration. the tanks are asme pressure vessels, although they are normally operated at atmospheric pressure, maintained through steam heated, hydrophobic aseptic filters. the following table summarizes the key characteristics of the one storage tank.table: wfi storage tank & a

55、ssociated equipmentdesign attributewfi storage tankwfi storage tank jacketmanufacturer/sncapacity (working)400 galn.a.diameter_” id_” idstraight side_” t/t_”headsasme f&dn.a.pressure rating45 psig & full vacuum100 psigtemperature rating132 c132 cmaterial316l304 (non-contact)wfi contact surfa

56、ces20 -inch ra, passivatedn.a.nozzles2:1 aspect ratio, free draining, sanitary fittingsn.a.overpressure protectionsanitary rupture discnone installedwfi tank vent filterqualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1da

57、te: 7 dec 2005page: 15 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system15the wfi tank vent filter is a sanitary design absolute rated 0.2m filter. the following table summarizes the key characteristics of the one filter.table: wfi tank v

58、ent filterdesign attributewfi tank vent filter cartrdigewfi vent filter housingmanufacturermillipore_model_typesanitarysanitaryutility side ratings125 c continuous150 psig / -20 to 350 futilityn/asteamwfi contact mocpvdf316lsealsvitonvitonwfi side surface finishn/a25 inch rafiltration surface area_

59、ft2wfi circulation pump:qualificationprocesssolutions, inc.proprietary information:unauthorized duplication is prohibiteddocument numberrevision numbera1date: 7 dec 2005page: 16 of 44author: narlin beatyrevision date: n/aequipment user requirementsequipment name:water for injection system16the wfi p

60、ump is a sanitary design centrifugal pumps. the following table summarizes the key characteristics of the one pump.table: wfi circulation pumpdesign attributewfi circulation pumpmanufacturer / model_serial number_inlet2”outlet1.5”impeller115 mmrated flow30 gpmrated tdh85 feetmaterial316linternal surface finish25 inch raseal typedouble, sic sic / c ceramic