Millipore Exact-Air II Operator's manual

MILLIPORE Exact-Air II
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DOCUMENTATION OF THE SYSTEM
Reference: MSP008687
Description: Exact-AirTM II

MILLIPORE Exact-Air II
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TABLE OF CONTENTS
Volume Chapter Page
VOL. 1 I INTRODUCTION - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -I-1
I.1 Notice . . . . . . . . . . . . I-2
I.2 Safety recommendations . . . . . . . . . I-4
I.3 Glossary . . . . . . . . . . . . I-10
II BEFORE USING THE SYSTEM - - - - - - - - - - - - - - - - - - - - - - - - II-1
II.1 System description . . . . . . . . . . II-2
1. HydroCorr integrity testing - basic theory . . . . II-2
2. Manual vs. automatic filter integrity testing . . . . II-2
3. Functional description . . . . . . II-2
4. System overview . . . . . . . II-3
5. Operating Requirements . . . . . . II-5
5.1. Environment requirements . . . . II-5
5.2. Utilities requirements . . . . . II-5
5.3. Pressure setting . . . . . II-5
6. Description of test sequences . . . . . . II-6
II.2 Control panel description . . . . . . . . . II-7
1. Control panel. . . . . . . . II-7
2. HMI description . . . . . . . II-7
2.1. Welcome screen . . . . . II-7
2.2. Command screen . . . . . II-8
2.3. Main menu screen . . . . . II-9
2.4. Setup menu screen . . . . . II-10
2.5. P&ID screen . . . . . II-11
2.6. Alarm screen . . . . . II-12
2.7. Alarm history screen . . . . . II-13
2.8. Process parameters screen . . . . . II-14
2.9. Language screen . . . . . II-14
2.10. Screen utilities . . . . . II-15
2.11. Setup screen . . . . . . II-16

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II.3 Start-up instructions . . . . . . . . . . II-17
1. Precaution . . . . . . . . II-17
2. Start-up check list . . . . . . . II-17
3. Connection . . . . . . . . II-18
4. Instrument preparation . . . . . . II-20
5. Power-up . . . . . . . . II-20
6. Initial flushing procedure . . . . . . II-20
7. Initial start-up and leak test . . . . . . II-22
III OPERATION - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -III-1
III.1 Operating instructions. . . . . . . . . . III-2
1. Instrument set-up . . . . . . . III-2
2. Instrument preparation . . . . . . III-2
3. Power-up . . . . . . . . III-2
4. Starting a test . . . . . . . III-3
5. Draining of the system . . . . . . III-5
6. Cleaning in place (CIP) . . . . . . III-6
7. Security functions . . . . . . . III-7
III.2 Troubleshooting. . . . . . . . . . . III-8
III.3 System stopping . . . . . . . . . . . III-9
IV SYSTEM MAINTENANCE - - - - - - - - - - - - - - - - - - - - - - - - - - - IV-1
IV.1 General maintenance of the system . . . . . . . IV-2
1. Quarterly check recommendation . . . . . IV-2
2. Annual verification . . . . . . . IV-2
IV.2 Recommended spare parts list . . . . . . . . IV-3
VP&ID-FLOWSCHEMATIC
VI MECHANICAL DRAWING
VII COMPONENTS DATA SHEETS
VIII ELECTRICAL SCHEMATICS

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IX COMPONENTS DOCUMENTATION (ONLY AVAILABLE ON CD)
IX.1 Instruments documentation
1. Pressure
1.1. PI004
2. Level
2.1. LSH001
3. Temperature (Option)
3.1. TE001
IX.2 Other components
1. Valves
1.1. XV001, XV002, XV003, XV004, XV005, XV006, XV007
2. Tank
2.1. Tank TK001
3. Pressure relief valve
3.1. PRV001
4. Air supply kit
4.1. HV601, PSL001, PCV003, PCV001, PCV002
5. Filter
5.1. FLT001
6. Liquid trap
6.1. LTR001
7. Components of electrical box
8. Operator control touch screen
X MANUFACTURING RECORDS
X.1 ISO 9001, CE and certificate of quality
XI FACTORY ACCEPTANCE TESTS

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I. Introduction

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I.1. Notice
The information contained within this document is subject to change and therefore can
not be considered as a commitment on the part of Millipore s.a.s.
The document is considered complete and correct at the time of delivery.
This document can not be considered as legally binding. It is the sole responsibility of
the user for the use of the equipment and to verify that the equipment is used in
accordance with the recommendations contained within the document provided.
Copyright (2007), Millipore s.a.s. Printed in France. All rights reserved. These books or
parts thereof may not be reproduced in any form without the written permission of the
publisher.
MILLIPORE S.A.S
Hardware Systems Operations
Zone Industrielle de la Hardt
BP116 - 67124 MOLSHEIM
FRANCE
Tel: [phone]
Fax: [phone]
Visit us on Internet @ http://www.millipore.com
DOCUMENTATION REVISION CONTROL:
The documentation has a general revision code shown on the document named "notice".
Each documentation change is described on the notice and the revision code is increase
of one letter, i.e. from "-" to "A" for first revision, then from "A" to "B" for second revision.
Some specific documents (such as electrical schematics, drawings ...) have their own
revision code. This code can be different from the general revision code of the
documentation.

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System Ref. :
MSP008687
DOCUMENTATION CONTROL
Revision code
& date
(month / year)
Author Approved
by
List of changed paragraphs and changes
description
- 12/2007 R. Weber P. Scholz Initial doc.

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I.2. Safety recommendations
ANNEXE 4 , REV.B , SPEC N° 062 558 SO
GB
IRL ATTENTION
This user's manual includes important health and safety aspects, which
require a specific training. Please make sure that all operators before first
use of the equipment know the recommendations.
A
DACHTUNG
Manche Teile betreffen Sicherheits-aspekte die eine Schulung benötigen.
Bitte stellen Sie sicher daβalle diese Elemente von allen Benutzern vor
dem Einschalten der Anlage vollkommen verstanden sind.
B
NL ATTENTIE
Verschillende delen in de handleiding bevatten informatie over
onderwerpen als gezondheid en veiligheid, die een gerichte training
noodzakelijk maken. Overtuigt U ervan, dat al deze aanbevelingen
bekend zijn bij de gebruikers van de apparatuur voor het ingebruik nemen
ervan.
DK ADVARSEL
Flere kapitler indeholder vigtige oplysninger af sikkerhedsmæssig
betydning. Specifik træning af operatører er påkrævet. Venligst sørg for at
vejledningerne er kendt af operatørerne før opstart.
EATENCIÓN
Varios capítulos incluyen aspectos relativos a salud y seguridad en el
trabajo que requieren entrenamiento específico. Por favor, asegúrese de
que antes de comenzar a trabajar con el equipo los operarios conocen
estas recomendaciones.
F
LATTENTION
Certains chapitres traitent des aspects de sécurité et doivent faire l'objet
d'une formation. Veuillez vous assurer que ces points aient été compris
par tous les opérateurs avant toute utilisation la machine.
FIN HUOM
Monessa kohtaa käsitellään tärkeitä terveys- ja turvallisuuskysymyksiä,
jotka vaativat erikoiskou-lutusta. Varmistanette, että kaikki käyttäjät ovat
tietoisia näistä ennen laitteiston käyttöönottoa.
GR
Σε καποια απ τα κεϕαλαια, εμπεριεχονται σημαντικες
πληροϕορες που αϕορουν σε θεματα υγεας και ασϕαλειας, για
τα οποα απαιτεται ειδικη εκπαδευση. Βεβαιωθετε τι πριν απ
καθε χρηση της συσκευης, αυτες οι οδηγες εχουν γνει ηδη
γνωστες.
IATTENZIONE
Alcuni capitoli contengono informazioni riguardanti la sicurezza per la
quale è necessario un particolare addestramento. Occorre assicurarsi che
gli operatori abbiano preso conoscenza delle varie raccomandazioni
contenute prima di operare direttamente sulla macchina in oggetto.
PATENÇÃO
Vários capítulos incluem aspectos relativos à saúde e segurança no
trabalho que requerem formação específico. Por favor, assegure-se de que
antes de começar a trabalhar com o equipamento os utilizadores
conhecem estas recomendações.
SVIKTIGT
Flera ingående kapitel innehåller viktig säkerhetsinformation som kräver
specifik utbildning. Säkerställ att alla rekommendationer förstås och följs
av användande personal innan utrustningen tages i drift.
HFIGYELEM!
Ez az útmutató olyan fontos egészségügyi és biztonsági kifejezéseket
tartalmaz, amelyek speciális oktatást igényelnek. Kérjük, gondoskodjon
arról, hogy az elöírásokat a berendezés elsö használata eltt az összes
kezelö megismerje.

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EXEMPLE ANNEXE 11 , REV.- , SPEC 0 062 646 SO
Safety recommendations
Generalities
These general recommendations are provided by Millipore to assist in the safe and reliable
operation of the equipment. They do not relieve the client of the need to understand use and
maintain the equipment in a safe way.
The user must at all times satisfy himself of the safety of the equipment in his particular
circumstances. This will include the appropriate training of personnel, safety equipment and
local equipment environment and services.
• Before starting the system, verify the presence and good working condition of all
safety components (button test lamps/buzzer, protection caps...).
• Do not remove the intrinsic securities fitted.
• Place first-aid equipment at operator's disposal.
• Respect all the markings and symbols on the system, lines and tanks.
• MILLIPORE passes off its responsibilities for all inherent risks (toxicity,
contamination...) associated to the products to be filtered.
• Don't exceed the standard operating conditions.
• Respect the parameters of the utilities as defined on the flow schematic (product feed,
air inlet, steam, nitrogen...).
• Make sure that there is no pressure in the lines before any maintenance operation,
dismantling of connections, changing the filters, etc.
• Treat the effluents (drains, filtrate, retentate, cleaning and rinsing solutions) in an
adequate manner before rejecting them.

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EXEMPLE ANNEXE 11 , REV.- , SPEC 0 062 646 SO
Safety recommendations
Electrical risks
All electrical operation must be done by qualified personnel having the required accreditation.
Preventive Maintenance:
• Verify the good working condition of the emergency stops every day;
• Verify that the covers and electrical box doors are closed every day;
• Verify the state of the cables and electrical connections every month;
• Verify the continuity of earth grounding every month;
• Verify the good connection of the electrical connections every 6 months;
• Verify the water/dust tightness of the electrical boxes every year.

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EXEMPLE ANNEXE 11 , REV.- , SPEC 0 062 646 SO
Safety recommendations
Mechanical risks
All operation must be done by qualified personnel having the required accreditation.
Before any dismantling or maintenance operation, make sure that all the sources of energy are
shut down (fluid, gas, electricity).
Preventive Maintenance:
• Verify the state and the cleanliness of the footbridge, stepboard, ladders and the
circulation zone around the system every day;
• Verify the correct closing and tightness of all the tanks and vessels openings
(porthole, man-hole, drains, connection, lid...) every day;
• Make sure of the correct closing and tightness of all connections every day;
• Verify the state of all seals (connection, pump, valves...) every month;
• Verify the correct working conditions of the pressure regulators (low pressure and
high pressure);
• Verify the correct closing of the mechanical protections (covers, hides...) every 3
months;
• Replace all seals (connection, pump, valves...) every 6 months;
• Verify the state of the flexible tubing (tightness, distortion) every week;
• Replace the flexible hose of peristaltic pumps every second cycle of steam sterilization
or every 10-cycles of production;
• Replace all the flexible tubings every year.

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EXEMPLE ANNEXE 11 , REV.- , SPEC 0 062 646 SO
Safety recommendations
Chemical risks
The chemical risks are related to the different products used.
It is the responsibility of the client to ensure the adequate training of the operators and to put
individual protection equipment according to the products used at their disposal.
All operation must be done by a person duly informed about the chemical risks of the
products.
Use individual protection during manipulation of the chemicals in agreement with the existing
labelling.
Put safety and first-aid equipment such as shower, rinses eye, etc. at the disposal of the
operators.
Respect the recommended concentrations of chemicals to be used in the system.

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EXEMPLE ANNEXE 11 , REV.- , SPEC 0 062 646 SO
Safety recommendations
Thermal risks
It is the responsibility of the client to ensure the training of the operators and to put individual
protection equipment at their disposal.
All operations must be done by a person duly informed about thermal risks.
During of the system sterilization cycles, all the lines, valves, tanks, pump heads, etc. are
exposed to high temperatures and present some risks of burn. All manipulation should be
conducted with an appropriate safety equipment such as protection garments, integral mask,
isotherm gloves, etc.

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I.3. Glossary
CONVERSION TABLE
CIP (clean in place) Refers to procedures or equipment for cleaning membrane systems
without dismantling the equipment.
HydroCorr™ Millipore filter compression test for hydrophobic cartridge.
IT Abbreviation for Integrity Tester.
Length: 1 foot(ft. or ') =0.3048 m = 304.8 mm
1 inch(in. or ") =0.0254 m = 25.4 mm
Surface: 1 square feet (sqft or ft2) =0.0929 m2= 92903 mm2
1 inch² =6.45 cm2
1 m2=10.76 ft²
Pressure: 1 psi =0.0689 bar
1 bar =14.5 psi (pound per square inch)
Temperature: T°F =(9/5.T°C + 32)
T°C =5/9.(T°F - 32)
Weight: 1lb ( = pound) =0.454 kg
Volume: 1 gallon (UK, liq.) =4.546 l
1 gallon (US, liq.) =3.7854 l
1gallon/ft2(US) =40 l/m2
Flow Rate: 1 gallon per minute (GPM) (UK, liq.) =4.546 l/min=272.8 l/h
1 gallon per minute (GPM) (UK, liq.) =3.7854 l/min=227.1 l/h
1 gallon per day (GPD) (UK, liq.) =11.36 l/h
1 gallon per day (GPD) (US, liq.) =9.462 l/h
1 LMH/bar = 1 1/m2.hr.bar
Concentration: 1'000 ppm =1g/l
Torque: 1 in.lb =0.0115 kg.m=0.1130 N.m
1 ft.lb =0.133 kg.m=0.357 N.m

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II. Before using the system

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II.1. System description
II.1.1. HYDROCORR INTEGRITY TESTING - BASIC THEORY
The water based HydroCorr™ test has been designed and validated to evaluate the integrity
of hydrophobic vent filters. The HydroCorr™ test takes advantage of the fact that water does
not spontaneously wet hydrophobic membranes. Since the HydroCorr™ test only involves
upstream measurements and manipulations, it is recommended when on-line integrity testing
is needed.
The HydroCorr™ test consists of filling the filter housing with water until the upper level of
the filter cartridge. Subsequently, an automatic filter integrity tester is attached to the upstream
side of the housing. The tester measures the pressure drop in the gas headspace that is in
contact with water upstream of the filter. At the end of the test the HydroCorr™ value is
calculated and expressed in ml/min, which is directly proportional to the pressure drop
observed in the compressed air chamber.
Many parameters can influence and affect the HydroCorr™ test. The temperature in the gas
volume upstream of the water is a critical factor and must remain stable whilst testing to
produce reliable, accurate and reproducible integrity test results. The pressure in this required
gas volume undergoes dramatic variations when temperature changes. On the other hand,
water is less sensitive to temperature because its physical expansion and compression during
temperature changes is of low importance. Hence, Millipore has developed an automated
system designed with a remote volume, so that only water is present in the critical temperature
area. The filter housing and the connecting tubing are completely filled with water, and the air
volume is maintained at constant room temperature. The Exact-Air™ system allows
conducting automatic HydroCorr test under actual processing conditions and ensures reliable
test results under critical temperature conditions.
II.1.2. MANUAL VS. AUTOMATIC FILTER INTEGRITY TESTING
Advantages of using automated test equipment are that method variation is eliminated, and
reproducible filling conditions are observed. The Exact-Air™ system can be used to conduct
pre-use integrity testing even after the filter has been sterilized. This is accomplished without
compromising the sterility of the filtration system, because all connections are made upstream
of the filter, unlike alcohol-based test methods.
II.1.3. FUNCTIONAL DESCRIPTION
The Millipore Exact-Air™ system is a microprocessor-controlled unit designed to facilitate
filter integrity tests. The design boundaries for the Exact-Air™ system are that the unit can
conduct the test on hydrophobic filter systems ranging from 4” filters to 3 times 30”
cartridges. A Siemens PLC controls the filling and testing operations. The control panel starts
the draining, drying and cleaning procedures.

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The automatic filter integrity test instrument that is to be coupled to the Exact-Air™ system
is capable of producing a hard copy printout of the filtration system parameters and the
generated test data, and indicates if a filter has passed or failed its specified integrity test.
Performing the HydroCorr™ test with the Exact-Air™ system offers users a unique
opportunity to improve ease, reliability, accuracy, reproducibility and frequency of air filter
testing and to meet the increasingly demanding regulatory requirements.
II.1.4. SYSTEM OVERVIEW
The Exact-Air™ system is equipped with:
• Gas supply with low pressure alarm
• Pressure regulators
• Pneumatic diaphragm valves
• Liquid trap
• Aervent 50 hydrophobic filter
• Internal remote volume
• Water level sensor
• Water feed tank with pressure gauge and relief valve
• Operator control touch screen
• Electrical box
• Siemens PLC type S7-200
• Mobile frame with Staubli connections
All components are mounted on a mobile frame.

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Note:
The automatic filter integrity tester (like a Millipore Integritest® 4 instrument) is independent
from the Exact-AirTM system and has to be ordered separately.
LIST OF COMPONENTS
List of delivered accessories:
• 2 power cords
• Two tubing assemblies for Filter top and Filter bottom: a grey one and a blue one
• Bypass tubing assembly (filter top/bottom)
• All counter connectors (without tubing)
List of required equipment (not delivered):
• Inlet tubing (air inlet)
• Integritest® inlet tubing assembly
• Integritest® outlet tubing assembly
• Automatic filter integrity tester
Item n° Description and function
TK001 10 L feed water tank equipped with quick connectors for air inlet, water outlet,
venting and pressure relief valve.
The stainless steel water tank is removable and can be autoclaved.
Use WFI or RO water at 23°C +/- 3°C.
TK002 The remote volume must be maintained at constant room temperature.
LSH001 Level sensor located on TK002 to detect water level and control the filling
operation. This function is inactivated for the cleaning procedure.
PI004 Pressure gauge for TK001 (must be removed when autoclaving the tank).
LTR001 Liquid trap to protect integrity tester from potential water ingress.
PSL001 Low pressure alarm. Lock the system when inlet pressure is below 6 bar
XV001 to XV007 PP pneumatic diaphragm valves driven by PLC and electro-valves.
HV601 Manual shut off valve on air inlet connection.
PCV001 Gas supplies control unit for filling, draining and drying the system following
each HydroCorr test.
PCV002 Gas supplies control unit for automatic integrity tester.
PCV003 Gas supplies control unit for pneumatic valves.
PRV001 Safety relief valve for TK001.
FLT001 Aervent 50 hydrophobic sterilising grade air filter.
TI001/TE001
(option)
Temperature sensor located on TK002.

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II.1.5. OPERATING REQUIREMENTS
II.1.5.1. Environment requirements
Realising that Exact-Air™ system may be subjected to adverse environmental conditions in
the field, it was designed and constructed using internal components that function properly at
the following conditions:
II.1.5.2. Utilities requirements
The Exact-Air™ system requires a 240 V, 50 Hz electrical source. It is preferred to have the
electrical line isolated and protected from power surges. With respect to the gas inlet, it
requires a clean, dry and regulated compressed air or nitrogen source at an inlet pressure of at
least 6 bar. The pneumatic components of the system should be protected from possible
contamination in the gas source. Hence the gas filter in the inlet connection should be changed
on a regular basis. All required utilities are listed below.
II.1.5.3. Pressure setting
Three pressure regulators fitted with gauges are available for adjusting the required operating
pressures. The system is delivered with pre-set values that must be controlled during initial
start up. PCV001 is used to fill the filter housing and drain the system after testing. The initial
set pressure is 2.0 bar and can be lowered when small filter are involved, or when the filter is
located at a height below 2 m. PCV002 supplies the tester device and PCV003 is used to
actuate the pneumatic diaphragm valves via the coupled electro-valves driven by the PLC.
PARAMETER OPERATING STORAGE
Temperature + 4°to + 40°C0°to + 40°C
Humidity 20% to 80%
non-condensing
20% to 80%
non-condensing
Atmospheric pressure Stable during the test No specification
Utilities Specifications
Electrical 100 / 240 V, 50/60 Hz, 200 VA
Inlet Gas Pressure > 6 bar
Type Nitrogen or air
Condition Clean and dry
Item Required set pressure
PCV001 (feed water tank) 1 – 2.5 bar
PCV002 (Integrity tester) 5 – 7 bar
PCV003 (pneumatic valves) 6 – 7 bar

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II.1.6. DESCRIPTION OF TEST SEQUENCES
The filling operation and HydroCorr™ test is performed in an automatic sequence after
starting the integrity tester. Using the touch screen starts the draining operation. The valve
opening/shutting sequence is described in the table below.
Description of valve opening sequences:
Valve n° Stand-by Filling Testing
20 min
Draining
and drying
CIP
XV001-NC Closed Closed Closed Open Closed
XV002-NC Closed Closed Open Closed Closed
XV003-NC Closed Open Closed Closed Open
XV004-NC Closed Open Closed Closed Open
XV005-NC Closed Closed Closed Open Closed
XV006-NC Closed Open Closed Closed Open
XV007-NO Open Closed Open Open Closed
VA
PCV002
WATER
XV001-NC
XV004-NC
XV006-NC
VC
VD
VB
XV002-NC
XV003-NC
Integrity Tester
PCV001
XV005-NC
XV007-NO
DRAIN