Storage & Distribution Systems

IDMA Workshop

1, 06.11.2002, Producer

Christ Water Technology Group

NaoH

SMBS

CI

FI

Christ Water Technology Group

3, 06.11.2002, Producer

Storage & Distribution Basics

4, date, SK

Design Objectives

? Maintaining the quality of water within acceptable limits. ? Delivering the water to the use points at the required flowrate and temperature. ? Minimising capital and operating expenses. ? Minimising the time the water is held at conditions which favour microbiological growth. ? Minimising changes to water temperature. ? Contacting all areas during sanitisation sterilization.

5, date, SK

Microbial Control Design Consideration

Conditions that aggravate the contaminations :
?Stagnant conditions and areas of low flow rates ?Temperatures that promote microbial growth (15-55C) ?Poor quality supply water

6, date, SK

Microbial Control Design Consideration

Measures that alleviate Microbial Problems :
Maintaining ozone levels of 0.02ppm to 0.2ppm ?Continuous, turbulent flow ?Elevated temperatures ?Proper slope ?Smooth, clean surfaces that minimize nutrient accumulation ?Frequent draining, flushing, or sanitizing ?Air breaks in drain piping ?Ensuring no leaks in the system ?Maintaining positive system pressure

7, date, SK

Distribution Design Concept Batch Operation (Rarely used)

?Utlizes at least two storage tanks ?One is in service to users while other is filled / tested ?Filled tank enters sevice after successful testing ?Water often drained after 24 hours ?Tank usually sanitized before refill.

8, date, SK

Distribution Design Concept Continous operation

?Off-sets peak demand with continious make up into single tank ?System supplies users continiously while maintining quality

9, date, SK

Distribution System Design Basis

?Water quality requirement ?QA release required before use ?Continous recirculation requriments ?Limiting hydraulics ?Hot users only ?Low temperature users only ?Combination of above

10, date, SK

Distribution System Design Basis

?Number of total low temperature users ?Hot storage desired ?Energy consumption critical ?Sanitization method ?Pressure requirements ?Future considerations

11, date, SK

Distribution System Basics

?No Use point filters . ?No filters in loop. ?Loop velocity- ISPE :3 ft/sec or 0.9 m/sec ?Slopes/ Gradient 1:100 standard paractice ?Dead Legs- <3d for ambient systems, <6d for hot systems ?Sanitary clamp connections , No threads ?Increasingly Orbital welding of SS tubes ?Complete drainablity ?SIP/CIP able.

12, date, SK

System Components

?Valves ?Gaskets ?Heat Exchangers ?Pumps ?Mechanical seals ?Connection types

13, date, SK

Regulatory Clarification to Common Industry Practices

14, date, SK

Dead Legs

There should be no dead legs

D
Flow direction arrows on pipes are important Deadleg section

If D=25mm & distance X is greater than 50mm, we have a dead leg that is too long.

<2D

Sanitary Valve Water scours deadleg

15, date, SK

Water System Design

1. Ball valves are unacceptable 2. Bacteria can grow when the valve is closed 3. The water is contaminated as it passes through the valve Stagnant water inside valve

16, date, SK

Water System Design

1. Sanitary pumps 2. Clamps and O rings versus threaded fittings 3. Heat exchangers 4. Side arm level measuring devices are unacceptable

17, date, SK

Disinfection

Heat ? One of the most reliable methods of disinfection of water systems Ozone ? Produced easily ? Leaves no residue

18, date, SK

Disinfection

UV
1. 2. 3. 4. UV does not sterilize Flow rate critical Post-irradiation recontamination may be an issue Lamps have finite life

Other chemicals
1. XO2 2. Halogen 3. Formaldehyde

19, date, SK

Electrolytical Ozone

Growth likely

Growth possible

No Growth

0.004

0.008

0.012

0.016

0.020

Ozone concentration (ppm)

Roche, Basel (Swiss Ph. 1983)
20, date, SK

Ozone Unit

ELECTROLYTICAL OZONE GENERATOR - Highest efficiency - Very low operational costs - Easy to retrofit systems - Proven Microbial Reduction - Guaranteed functionality (100s of references)

21, date, SK

Sanitisation - Ozone

Microbiological behaviour in ambient purified water loops with ozone ( ~20 ppb)
130 120 110 100

Action level purified water

Germ count [ cfu/ ml]

90 80 70 60 50 40 30 20 10 0
1

Continuous sanitisation by ozone < 10 cfu/ml

Action level water for injection

Operation time
22, date, SK

Sanitisation - Hot water

Microbiological behaviour in ambient purified water loops with periodic hot water sanitisation
130 120 110 100

Action level purified water

Germ count [ cfu/ ml]

90 80 70 60 50 40 30 20 10 0
1

Periodic sanitisation by hot water (>80C) Accepted contamination

Operation time
23, date, SK

Validation & Qualification

24, date, SK

Validation & Qualification

V model ensures the quality of your system throughout the Project

Working through the V-model

25, date, SK

Design Qualification
Water system Project execution steps
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 User Requirement Specification (Sales phase) Quality & Project Plan Design Purchasing Programming Software Review (office tests) Receiving inspections Manufacturing Commissioning & Start-up 1(Skids) Internal pre-FAT Factory Acceptance Tests Shipment Commissioning & Start-up 2 Site Acceptance Tests Hand over

Q U A L I T Y C O N T R O L

26, date, SK

Design Qualification
-Design phase, overview
Design P&ID and Functional Specification (FS) Detailed Design

Component list Functional Logics (FL) Software Design Specification (SDS) Hardware Design Specification (HDS) Hardware Plan, circuit diagram
27, date, SK

Welding Qualification

Mechanical installations according to Design specifications Complete Welding documentation for traceability Welding Procedure Isometric drawing with weld numbers Weld log Welders Certificates Material Certificates Orbital Machine print-outs Boroscoping Passivation Procedure
28, date, SK

FAT
- Factory Acceptance Tests at SUPPLIER Manufacturing sites
?The FAT is performed according to a customer signed protocol ?All tests are documented and witnessed by the customer ?When approved the system is shipped for immediate start-up P&ID Inspection

29, date, SK

FAT
The Factory Acceptance Tests are divided into four sections and contain the following tests
Mechanical & Documentation Inspections (IQ) Hardware Acceptance Tests (IQ) Hardware, electrical components Circuit diagram External cables Dead-legs Power on / off Manuals & Data sheets Digital inputs Certificates Digital outputs Analogue inputs Analogue outputs
URS

P&ID

Components

Functional Specification

System Acceptance Test

Hardware Design Spec

Hardware Acceptance Test

Software Design Spec

Software Integration Test

Software Module Design Spec

Software Module Test

Control system programming / Code review

30, date, SK

FAT

System Acceptance Tests (OQ)

Operation Tests (OQ)

Software Version

System Parameters

HMI Menus

Function of the pump, Program steps

Function of the loop system, Program steps

Alarms

Passwords

Back-up
URS

Functional Specification

System Acceptance Test

Hardware Design Spec

Hardware Acceptance Test

Software Design Spec

Software Integration Test

Software Module Design Spec

Software Module Test

Control system programming / Code review

31, date, SK

SAT
Site Acceptance Tests
Mechanical & Documentation Inspections (IQ) Hardware Acceptance Tests (IQ)

FAT Completion

Main switch

System Documentation Emergency stop P&ID External cables, Distribution system Components Analogue inputs, Distribution system Air gap to drain Analogue outputs, Distribution system

Dead-legs, Distribution system

Slope, Distribution system

Hardware operating environment

Drainability, Distribution system

32, date, SK

SAT

System Acceptance Tests (OQ)

Operation Tests (OQ) Calibration of Instruments (OPTION) Leak test

Software Version Function of the Distribution system, Program steps

Operation of the level transmitter Operation of the vent filter Operation of the loop pump Operation, uv unit Function Regulations

Back-up

The tests are always project specific to your system, which means there could be more tests for a larger system and tests could be deleted if not applicable.

Operation of the conductivity sensor Operation of the Ozone analyser Operation of the heat exchanger System Parameters Water quality, Distribution system Disinfection Sanitisation

33, date, SK

Validation
Validation Templates

? The templates should be developed in accordance with GMP, cGMP, GAMP and ISPE Baselines. ? Good Testing Procedure, Good Documentation Procedure and that documents are easy to follow and have a logical structure are very important. ? The templates are the base for each project, and are then worked through Project specifically to match your system exactly. ? All test protocols are sent to the customer for approval before test start

34, date, SK

Documentation
Name of test 2.4.6 Operation, NaOH dosing unit Test procedure 1. Check that the dosing unit is supplied with the correct chemicals. 2. 3. 4. Carry out the initial calibration for the pH meter QE/QICSA 270.12.1. Put the system into service according to the Operating instructions. Check that pump P 270.12.1 works correctly.

Test document format

? Name of test ? Test procedure ? Needed document(s) equipment ? Acceptance criteria

5. Check that the set-point for the pH value (measured at QE/QICSA 270.12.1) is maintained. 6. Fill in the results in the table below.

Needed document(s) / equipment Equipment manuals from sub-supplier. Acceptance criteria Description 1. Correct chemicals 2. Calibration QE/QICSA 270.12.1 3. System in service 4. Function of pump P 270.12.1 5. PH set-point QE/QICSA 270.12.1 Required NaOH % N/A N/A N/A Actual Result (Pass/Fail)

? Pass / Fail + Deviation nos

N/A N/A N/A

? Comment ? Tester, Date / Initials ? Witness, Date / Initials

Pass / Fail + Deviation nos

Comment

Tester, Date / Initials

Witness, Date / Initials

35, date, SK

Documentation
The complete documentation consists of the following sections
? Design documentation (Mechanical, Electrical Hardware, Software) ? Operating instructions ? Spare part list ? Equipment documentation (Manuals & Data sheets from sub-suppliers) ? Certificates ? Welding documentation ? Validation protocols ? SW Print-outs

36, date, SK

Current Trends-skids
Benefits for Skidded systems
? This offers a fast track project were the pre-validated system is easy to install and start-up on site

quick PQ start.

? Validation according to GMP, cGMP and GAMP. ? Customers can review the Validation protocol templates already during the sales phase. ? supplier has its own Validation engineers to work with Protocols and tests. ?Customers are invited for FAT and can witness all tests on supplier manufacturing site.

37, date, SK

Disinfection, distribution and monitoring unit LOOPO

38, date, SK

Standard Distribution, Monitoring and disinfection Compact Unit

Front side with ? Electrolytical ozone cell ? Ozone measurement ? Flow meters with contacts ? Conductivity measurement ? TOC measurement as option ? Control cabinet with remote I/O to PW plant or independent ? Completely pre-piped and pre-wired systems
39, date, SK

Standard Distribution, Monitoring and disinfection Compact Unit

Backside with ? Variable speed driven distribution pump ? UV ozone destruct ? Sanitary automatic takeoff valves for ozone measurement ? Cooling heat exchanger ? Waste water piping
40, date, SK

Documentation

All documentation included for full validation P&ids General assembly drawings Electrical drawings Layout of control panel Functional description Control system ladder logic Description of systems Manufacturers literature Operating instructions Maintenance procedures Commissioning data

41, date, SK

Thank you very much for your attention.

Any Questions ?

42, date, SK