注射用水用户需求（WFI URS）.doc

Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 1 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 1 USER REQUIREMENTS FOR A WATER FOR INJECTION SYSTEM FOR INSTALLATION AT FIRST APPROVALSECOND APPROVAL SIGNATURE SIGNATURE PRINT NAME PRINT NAME PRINT TITLE PRINT TITLE QUALIFICATION PROCESS SOLUTIONS 13406 BLYTHENIA RD PHOENIX MD 21131 Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 2 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 2 TABLE OF CONTENTS 1INTRODUCTION 5 2OVERVIEW 6 3OPERATIONAL REQUIREMENTS 7 3 1FUNCTIONS 7 3 1 1Operation 7 3 1 2I O Streams 8 3 1 3Process Description 8 3 1 4Cleaning and Sanitization 10 3 1 5Configuration Arrangement Pump is not speed controlled Note 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 user 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 with 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 Distribution PS is continuously distributed through a single 1 5 OD tubing supply header running through the building The header is designed 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 Sanitization The WFI Storage and Distribution Systems are effectively self sanitizing and self cleaning On start up water from the WFI PS Generator is directed to waste until it meets specification This feature is self contained on the condensing unit Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 11 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 11 The WFI Storage and Distribution Systems are periodically passivated to reduce corrosion The WFI Storage and Distribution Systems are periodically de rouged to maintain smooth clean surfaces and reduce the potential for biological contamination 3 1 5Configuration Arrangement pre fill rinse Wash Sink60 04xx21 gpm for 1 hour per cycle manual pre fill rinse Vial Washing1 260 xx80 1 gpm per nozzle for 10 seconds 20 40 psi 350 nozzles vial washing Formulation60 02xx2Batch use variable volumes WFI Pump Seal144 0Continuousx xxxxxx0 1Continuous may not use seal flush TBD Sampling30 01x2Each drop sampled once per week Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 39 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 39 8 2WFI Tank Simulation Based on the estimated water consumption a worst case model was developed to challenge the size of the generator and storage tank The following results show that the tank is properly sized Inputs 25 gph input continuous ish not to exceed 400 gallon tank capacity 120 gph usage between the hours of 10 00 and 12 00 UTC every day 60 gph usage from 14 00 to 16 00 UTC every day 9 gph usage continous over the work day 8 00 to 20 00 every day Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 40 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 40 Stainless Steel Tubing Pharmaceutical Grade 1 OD Tubing1 1 2 OD Tubing ID0 87 in 1 37 in A0 594468 sq in 1 474114 sq in A0 004128 sq ft 0 010237 sq ft Velocity ft s flow rate ft3 s flow rate ft3 m flow rate gpm flow rate ft3 s flow rate ft3 m flow rate gpm 10 0041280 24769491 850 0102370 6142144 59 20 0082560 49538993 710 0204741 2284289 19 Minimum30 0123850 74308485 560 0307111 84264213 78 40 0165130 99077987 410 0409482 45685618 38 50 0206411 23847479 260 0511853 0710722 97 60 0247691 486169711 120 0614213 68528527 57 70 0288981 733864612 970 0716584 29949932 16 80 0330261 981559614 820 0818954 91371336 76 90 0371542 229254516 680 0921325 52792741 35 Ideal100 0412822 476949518 530 1023696 14214145 95 110 0454112 724644420 380 1126066 75635550 54 120 0495392 972339322 230 1228437 37056955 14 130 0536673 220034324 090 133087 98478359 73 140 0577953 467729225 940 1433178 59899764 32 150 0619243 715424227 790 1535549 21321168 92 Maximum peak draw is 15 gpm for tank washing Assumes no other users Tank washing Tank washing 8 3WFI Flow Rate Calculations Select 1 1 2 Tubing 30 gpm normal flow rate If we reduce maximum draw due to tank washing 1 tubing might be a viable option There is no real cost savings between 1 and 1 1 2 tubing Tank spray ball will need a minimum flow rate typically 10 15 gpm can be designed special for low flow conditions Note For turbulent flow conditions v V A where V is flow rate Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 41 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 41 8 4WFI Distribution Pressure Drop Calculations Calculate Pressure Drop Flow rate 30 gpm 6 Full flow through tees 3 Zero dead leg valves 11 90 degree elbows 120 Tubing run includes risers and runs Friction loss ft per foot of tubing or ft per fitting 6 x 59 3 54 ft 11 x 07 0 77 ft 120 x 11 13 2 ft 3 x 2 31 6 93 ft true ZDL valve have much less head loss standard diaphragm valve CV values were used here 2 31 ft 1 psi Total loop drop 24 44 ft 10 58 psi Spray ball requires at least 20 psi on return Pump discharge 20 10 55 30 58 psi Table Pressure Drop in Sanitary Tubing Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 42 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 42 8 5Pump Selection Design 30 gpm 30 58 psi Analysis 30 gpm 30 58 psi is in between pump sizes Select smaller impeller 115mm and 3HP motor Loop will run faster and at a higher pressure but not significantly 3 HP motor will allow us to upgrade at some point in the future to a larger impeller without modifications to the electrical package Pump FP FPX 712 3500 rpm design set point actual pump Qualification Process Solutions Inc PROPRIETARY INFORMATION Unauthorized Duplication Is Prohibited DOCUMENT NUMBER REVISION NUMBERA1 DATE 7 Dec 2005 PAGE 43 of 44 Author Narlin Beaty Revision DATE N A EQUIPMENT USER REQUIREMENTS EQUIPMENT NAME WATER FOR INJECTION SYSTEM 43 Babcok formula For pressure drop when steam with a specific volume v flows in a pipe of diameter d is Pressure Drop 0 470 x d 3 6 x m 2x L x vStainless Steel Tubing Pharmaceutical Grade d 6 1 OD Tubing1 1 2 OD Tubing ID0 87 in 1 37 in d inches A0 594468 sq in 1 474114 sq in m lbm s A0 004128 sq ft 0 010237 sq ft L ft v ft 3 lbm Rules 1 If the pressure drop based on the entrance pressure is less than 10 the fluid can be assumed to be incompressible and the gas properties can be evaluated at any point known along the pipe 2 10 40 pressure drop Use mid point properties 3 40 or greater pressure drop Calculate using shorter sections cu ft lbBtu lbBtu F lb Specific VolumeEnthalpyEntropy CFP psi Sat Vapor ft 3 lbm Sat Vapor Sat Vapor Minimum121249 829 82513 82111641 6998 Maximum131267 840 50210 37611701 6753 Generator Pressure134 6889274 44459 40111721 6669 1 Btu778 26 ft lb Our generator will operate at a di