1, 06.11.2002, Producer

Storage & Distribution Systems

IDMA Workshop

Christ Water Technology Group

3, 06.11.2002, Producer

Na

oH

SMBS

CI F I

Christ Water Technology Group

4, date, SK

Storage & DistributionBasics

5, 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.

6, date, SK

Microbial Control Design Consideration

Conditions that aggravate the contaminations :

?Stagnant conditions and areas of low flow rates

?Temperatures that promote microbial growth (15-55°C)

?Poor quality supply water

7, 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

8, 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.

9, 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

10, 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

11, date, SK

?Number of total low temperature users

?Hot storage desired

?Energy consumption critical

?Sanitization method

?Pressure requirements

?Future considerations

Distribution System Design Basis

12, 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.

13, date, SK

?Valves

?Gaskets

?Heat Exchangers

?Pumps

?Mechanical seals

?Connection types

System Components

14, date, SK

Regulatory Clarification to Common Industry Practices

15, date, SK

There should be no dead legs

Water scours deadleg

If D=25mm & distance X isgreater than 50mm, we havea dead leg that is too long.

Deadleg section

<2D

Flow direction arrows on pipes are important

Sanitary Valve

D

X

Dead Legs

16, date, SK

3. The water is contaminated as it passes through the valve

2. Bacteria can grow when the valve is closed

1. Ball valves are unacceptable

Stagnant water

inside valve

Water System Design

17, date, SK

1. Sanitary pumps

2. Clamps and O rings versus threaded fittings

3. Heat exchangers

4. Side arm level measuring devices areunacceptable

Water System Design

18, date, SK

Heat

? One of the most reliable methods of disinfection of water systems

Ozone

? Produced easily

? Leaves no residue

Disinfection

19, date, SK

UV 1. UV does not “sterilize”2. Flow rate critical3. Post-irradiation recontamination may be an issue4. Lamps have finite life

Other chemicals1. XO22. Halogen3. Formaldehyde

Disinfection

20, date, SK

Electrolytical Ozone

Growth likely

Growth possible

No Growth

0 0.004 0.008 0.012 0.016 0.020

Ozone concentration (ppm)

Roche, Basel (Swiss Ph. 1983)

21, date, SK

Ozone Unit

ELECTROLYTICALOZONE GENERATOR

- Highest efficiency

- Very low operational costs

- Easy to retrofit systems

- Proven Microbial Reduction

- Guaranteed functionality (100’s of references)

22, date, SK

Sanitisation - Ozone

0

10

20

30

40

50

60

70

80

90

100

110

120

130

1

Operation time

Ger

m c

ou

nt

[ cf

u/ m

l]

Action levelpurified water

Action levelwater for injection

Continuous sanitisation by ozone< 10 cfu/ml

Microbiological behaviour in ambient purified water loops with ozone ( ~20 ppb)

23, date, SK

Sanitisation - Hot water

0

10

20

30

40

50

60

70

80

90

100

110

120

130

1

Operation time

Ger

m c

ount

[ cf

u/ m

l]

Action levelpurified water

Microbiological behaviour in ambient purified water loops with periodic hot water sanitisation

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

24, date, SK

Validation & Qualification

25, date, SK

V model ensures the quality of your system throughout the Project

Working through the V-model

Validation & Qualification

26, date, SK

Water system Project execution steps

Hand over15

Site Acceptance Tests14

Commissioning & Start-up 213

Shipment12

Factory Acceptance Tests11

Internal pre-FAT10

Commissioning & Start-up 1(Skids)9

Manufacturing8

Receiving inspections7

Software Review (office tests)6

Programming5

Purchasing4

Design3

Quality & Project Plan2

User Requirement Specification (Sales phase)1

QUALITY

CONTROL

Design Qualification

27, date, SK

-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

Design Qualification

28, date, SK

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

Welding Qualification

29, date, SK

- Factory Acceptance Tests at SUPPLIER Manufacturing sites

P&ID Inspection

?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

FAT

30, date, SK

The Factory Acceptance Tests are divided into four sections and contain the following tests

Certificates

Manuals & Data sheets

Dead-legs

Components

P&ID

Mechanical & Documentation Inspections (IQ)

Analogue outputs

Analogue inputs

Digital outputs

Digital inputs

Power on / off

External cables

Circuit diagram

Hardware, electrical components

Hardware Acceptance Tests (IQ)

URS

Functional Specification

Hardware Design Spec

Software Design Spec

Software Module Design Spec

Control system programming / Code review

Software Module Test

Software Integration Test

Hardware Acceptance Test

System Acceptance Test

FAT

31, date, SK

Back-up

Passwords

Alarms

Function of the loop system, Program steps

Function of the pump, Program steps

HMI Menus

Software Version

System Acceptance Tests (OQ)

System Parameters

Operation Tests (OQ)

URS

Functional Specification

Hardware Design Spec

Software Design Spec

Software Module Design Spec

Control system programming / Code review

Software Module Test

Software Integration Test

Hardware Acceptance Test

System Acceptance Test

FAT

32, date, SK

Site Acceptance Tests

Drainability, Distribution system

Slope, Distribution system

Dead-legs, Distribution system

Air gap to drain

Components

P&ID

System Documentation

FAT Completion

Mechanical & Documentation Inspections (IQ)

Hardware operating environment

Analogue outputs, Distribution system

Analogue inputs, Distribution system

External cables, Distribution system

Emergency stop

Main switch

Hardware Acceptance Tests (IQ)

SAT

33, date, SK

Back-up

Function of the Distribution system, Program steps

Software Version

System Acceptance Tests (OQ)

Sanitisation

Disinfection

Water quality, Distribution system

System Parameters

Operation of the heat exchanger

Operation of the Ozone analyser

Operation of the conductivity sensor

Function Regulations

Operation, uv unit

Operation of the loop pump

Operation of the vent filter

Operation of the level transmitter

Leak test

Calibration of Instruments (OPTION)

Operation Tests (OQ)

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.

SAT

34, date, SK

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

Validation

35, date, SK

Description Required Actual Result (Pass/Fail)

2. Calibration QE/QICSA 270.12.1

N/A N/A

3. System in service N/A N/A4. Function of pump P 270.12.1

N/A N/A

5. PH set-point QE/QICSA 270.12.1

Witness, Date / Initials

Comment

Tester, Date / Initials

Pass / Fail + Deviation no’s

Equipment manuals from sub-supplier.

Acceptance criteria

2.        Carry out the initial calibration for the pH meter QE/QICSA 270.12.1.

3.        Put the system into service according to the Operating instructions.

4.        Check that pump P 270.12.1 works correctly.

5.        Check that the set-point for the pH value (measured at QE/QICSA 270.12.1) is maintained.

Name of test2.4.6 Operation, NaOH dosing unit

Test procedure1.        Check that the dosing unit is supplied with the correct chemicals.

6.        Fill in the results in the table below.

1. Correct chemicals NaOH %

Needed document(s) / equipment

Test document format

?Name of test

? Test procedure

?Needed document(s) equipment

?Acceptance criteria

?Pass / Fail + Deviation no‘s

?Comment

? Tester, Date / Initials

?Witness, Date / Initials

Documentation

36, date, SK

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

Documentation

37, date, SK

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.

Current Trends-skids

38, date, SK

Disinfection, distribution and monitoring unit – LOOPO ®Disinfection, distribution and monitoring unit – LOOPO ®

39, 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

40, date, SK

Backside with

? Variable speed driven distribution pump

? UV ozone destruct

? Sanitary automatic take-off valves for ozone measurement

? Cooling heat exchanger

? Waste water piping

Standard Distribution, Monitoring and disinfection Compact Unit

41, 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– Manufacturer’s literature– Operating instructions– Maintenance procedures– Commissioning data

42, date, SK

Thank you very much for your attention.

Any Questions ?