GEA D-tec D Manual de usuario

Aseptic Valves

GEA D-tec® double-chamber valve type D/DV

Operating instruction (Translation from the original language)

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These Operating Instructions are the English translation of the original operating

instructions in the sense of the EU Machinery Directive. This document is

part, be copied, reproduced, translated or reduced to an electronic medium of

machine-readable form without the express permission of GEA Tuchenhagen

GmbH.

LEGAL NOTICE

Word marks

The D-tec® and TEFASEP® designations are trademarks of GEA Aseptomag AG

registered in Switzerland.

The designation T.VIS® is a protected trademark of GEA Tuchenhagen GmbH.

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TABLE OF CONTENTS

1 General Information 5

1.1 Information on the Document 5

1.1.1 Binding Character of These Operating Instructions 5

1.1.2 Notes on the Illustrations 5

1.1.3 Symbols and Highlighting 5

1.2 Manufacturer address 6

1.3 Contact 6

1.4 EC Declaration of Conformity for Complete Machines in accordance with the EC Machinery Directive

2006/42/EC, Annex II 1. A 7

2 Safety 8

2.1 Intended use 8

2.1.1 Requirements for operation 9

2.1.2 Pressure equipment directive 9

2.1.3 ATEX directive 9

2.1.4 Improper operating conditions 10

2.2 Operator’s Duty of Care 10

2.3 Subsequent changes 11

2.4 General safety instructions and dangers 11

2.4.1 Principles for safe operation 11

2.4.2 Environmental Protection 12

2.4.3 Electrical Equipment 12

2.5 Supplementary Regulations 12

2.6 Qualification of Staff 12

2.7 Safety equipment 14

2.7.1 Signs 14

2.8 Residual dangers 16

2.9 Danger zones 17

3 Description 19

3.1 Design of the valve 19

4 Transport and storage 21

4.1 Storage conditions 21

4.2 Transport 21

4.2.1 Scope of supply 22

5 Technical data 23

5.1 Type plate 23

5.2 Technical data 23

5.3 Resistance of the sealing materials 24

5.4 Pipe ends - General table of measurements 26

5.5 Tool 26

5.6 Lubricants 27

5.7 Weights 28

6 Assembly and installation 29

6.1 Safety instructions 29

6.2 Notes on installation 29

6.3 Control head 29

6.4 Valve with Detachable Pipe Connection Elements 29

6.5 Valve with welded ends 30

6.6 Pneumatic connections 31

6.6.1 Air requirement 31

6.6.2 Establishing Hose Connections 31

Hose connection diagram - double-chamber valve type D/DV with control top T.VIS 32

Hose connection diagram - double-chamber valve D/DV without control top 33

6.7 Electrical connections 34

6.7.1 Electrical connection with T.VIS control top 34

6.7.2 Adjusting the initiator 35

7 Start-up 37

7.1 Safety notes 37

7.2 Notes on commissioning 37

8 Operation and control 38

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8.1 Safety instructions 38

9 Cleaning 39

9.1 Cleaning 39

9.1.1 Cleaning Process Examples 39

9.1.2 Cleaning effect 39

9.2 Sterilisation 40

9.3 Passivation 40

10 Maintenance 41

10.1 Safety instructions 41

10.2 Inspections 42

10.2.1 Leakage outlet 42

10.2.2 Pneumatic connections 42

10.2.3 Electrical connections 42

10.2.4 Signs on the valve 43

10.3 Servicing intervals 43

10.4 Prior to disassembly 45

10.5 Disassembling the valve 45

10.5.1 Disassembling the main valve 45

Removing the control top 46

Disconnecting the valve from the housing 48

10.5.2 Disassembling the valve insert of the main valve 50

10.5.3 Disassembling the side valve 56

10.5.4 Disassembling the valve insert of the side valve 57

10.6 Assembling the valve 59

10.6.1 Assembling the valve insert of the main valve 59

10.6.2 Assembling the main valve 67

10.6.3 Assembling the valve insert of the side valve 70

10.6.4 Assembling the side valves 71

10.6.5 Torques for the Clamps and Clamp Connections 72

10.6.6 Checking the function 73

10.7 Maintenance 75

10.7.1 Cleaning valve / replacing worn parts 76

10.7.2 Note on seal replacement 77

10.7.3 Replacing the V-ring 77

10.7.4 Changing the stem diaphragm 78

10.7.5 Exchanging the O-ring (TEFASEP gold) 78

10.7.6 Lubricating seals and threads 81

11 Alarms 82

11.1 Malfunctions and remedies 82

12 Decommissioning 83

12.1 Safety instructions 83

12.2 Disposal 83

12.2.1 General notes 83

12.2.2 Valve Actuator Disposal 83

13 Parts list - D-tec double-chamber valve type D/DV 84

14 Parts list - D-tec valve insert D/DV-SV-NC/NO 90

15 Parts list - lift actuator _LB-DV 95

16 Dimension sheet - double-chamber valve type D/DV 98

17 Appendix 102

17.1 Lists 102

17.1.1 Abbreviations and terms 102

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1 General Information

1.1 Information on the Document

The present Operating Instructions are part of the user information for the

product. The Operating Instructions contain all the information you need to

transport, install, commission, operate and carry out maintenance for the product.

1.1.1 Binding Character of These Operating Instructions

These Operating Instructions contain the manufacturer's instructions to the

operator of the product and to all persons who work on or use the product

regarding the procedures to follow.

Carefully read these Operating Instructions before starting any work on or using

the product. Your personal safety and the safety of the product can only be

ensured if you act as described in the Operating Instructions.

Store the Operating Instructions in such a way that they are accessible to the

operator and the operating staff during the entire life cycle of the product. When

the location is changed or the product is sold make sure you also provide the

Operating Instructions.

1.1.2 Notes on the Illustrations

The illustrations in these Operating Instructions show the product in a simplified

form. The actual design of the product can differ from the illustration. For detailed

views and dimensions of the product please refer to the design documents.

1.1.3 Symbols and Highlighting

In these Operating Instructions, important information is highlighted by symbols

or special formatting. The following examples illustrate the most important types

of highlighting.

Danger

Warning: Fatal Injuries

Failure to observe the warning can result in serious damage to health, or

even death.

► The arrow identifies a precautionary measure you have to take to avoid

the hazard.

Warning: Explosions

Failure to observe the warning can result in severe explosions.

► The arrow identifies a precautionary measure you have to take to avoid

the hazard.

General Information

Information on the Document

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Warning!

Warning: Serious Injuries

Failure to observe the warning can result in serious damage to health.

► The arrow identifies a precautionary measure you have to take to avoid

the hazard.

Caution!

Warning: Injuries

Failure to observe the warning can result in minor or moderate damage to

health.

► The arrow identifies a precautionary measure you have to take to avoid

the hazard.

Notice

Warning: Damage to Property

Failure to observe the warning can result in serious damage to the

component or in the vicinity of the component.

► The arrow identifies a precautionary measure you have to take to avoid

the hazard.

Carry out the following steps: = Start of a set of instructions.

1. First step in a sequence of operations.

2. Second step in a sequence of operations.

®Result of the previous operation.

®The operation is complete, the goal has been achieved.

Hint!

Further useful information.

1.2 Manufacturer address

GEA Tuchenhagen GmbH

Am Industriepark 2-10

21514 Büchen

1.3 Contact

Tel.:+49 4155 49-0

Fax:+49 4155 49-2035

[email protected]

www.gea.com

General Information

Manufacturer address

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1.4 EC Declaration of Conformity for Complete Machines in accordance with the EC

Machinery Directive 2006/42/EC, Annex II 1. A

Manufacturer: GEA Tuchenhagen GmbH

Am Industriepark 2-10

21514 Buchen, Germany

We as the manufacturer hereby declare in sole responsibility that the

machine designated below, based on its design and type as well as in the

version brought to market by us, complies with the basic safety and

health requirements of the EC Machinery Directive.

This declaration will become invalid if any alterations are made to the

machine which have not been agreed with us.

Designation: Valve with actuator

Type: D-tec® stem diaphragm

Model: N/DV, W/DV, P/DV, D/DV

Relevant EC directives: 2006/42/EC EC Machinery Directive

Applicable harmonized

standards, in particular:

DIN EN ISO 12100 Safety of Machines -

General design principles

- Risk assessment and

risk reduction

Other applied standards

and technical

specifications:

Remarks: We also declare that the relevant technical documentation for

this machine has been prepared in accordance with Annex

VII, Part A, and agree to submit the documentation on request

by the market supervisory authorities.

Person authorised for compilation and

handover of technical documentation:

GEA Tuchenhagen GmbH

CE Documentation Officer

Am Industriepark 2-10

21514 Buchen, Germany

Büchen, 08/08/2018

Michael Wulle

Managing

Director

i.V. Matthias Südel

Senior Director

Product Development Flow Components

General Information

EC Declaration of Conformity for Complete Machines in accordance with the EC Machinery Directive 2006/42/EC, Annex

II 1. A

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2 Safety

2.1 Intended use

Aseptic double-chamber valves are mix-proof stroke valves for highly hygienic

and aseptic process systems and permit the safe separation of incompatible

media. The media separation is done via the integrated sterile chamber (ISB),

which is separated hermetically from the atmosphere with a seal each to both

product lines and via two side valves (inlet and outlet).

For safe operation, it is mandatory that the following points are observed in the

different process steps:

Transfer

During a media transfer through the main valve both side valves must be closed

completely.

Fig.1: Product transfer

Cleaning sterile chamber

After a media transfer the sterile chamber must be flushed at least with one

sterile medium. After the main valve has been closed, both side valves can be

put in the open position and thus permit the flushing of the sterile chamber.

Fig.2: Rinsing / sterilisation after transfer

CIP cleaning with seat lift

If seat lifting is activated for a CIP cleaning (preferably in cycles) no process must

be running in the opposite line. Furthermore, the outlet valve of the sterile

chamber to drain the CIP medium must be open.

Safety

Intended use

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Fig.3: Seat cleaning valve disk Fig.4: Seat cleaning double disk

The medium should preferably flow in the opening direction of the valve disk to

avoid pipe hammers when the valve is opened or closed. Should this not be

possible due to technical reasons related to the plant or process, it is

recommended to switch the valve without pressure. Both measures prevent

pressure hammers when the valve is opened or closed.

The valve is monitored, controlled and operated by the customer's installation.

Hint!

The manufacturer will not accept any liability for damage resulting

from any use of the valve which is not in accordance with the

designated use of the valve. The risk is borne solely by the operating

company.

2.1.1 Requirements for operation

The prerequisite for reliable and safe operation of the component is proper

transportation and storage as well as professional installation and assembly.

Operating the unit within the limits of its designated use also involves adhering to

the operating, inspection and maintenance instructions.

2.1.2 Pressure equipment directive

The component is a piece of pressure equipment (without safety function) in the

sense of the pressure equipment directive: Directive 2014/68/EG. They are

classified according to Annex II, article 4, section 3. In the event of any

deviations, GEA Tuchenhagen GmbH will supply a specific Declaration of

Conformity.

2.1.3 ATEX directive

In areas with an explosive atmosphere, only valves suitable for use in such areas

may be used.

Refer to and observe the additional operating instructions “ATEX version valves”.

For details regarding the marking of valves for potentially hazardous areas also

refer to the additional operating instructions “ATEX version valves”.

If these valves are used in areas with a potentially explosive atmosphere, you

must absolutely comply with directive 2014/34/EC with respect to all ignition

hazards.

Safety

Intended use

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2.1.4 Improper operating conditions

The operational reliability of the valve cannot be ensured under improper

operating conditions. Therefore avoid improper operating conditions.

Operating the valve is not permitted if

•Persons or objects are in the danger zone.

•Safety devices are not working or were removed.

•Malfunctions have been detected on the valve.

•Damage has been detected on the valve.

•Maintenance intervals have been exceeded.

•the position of the side valves is not adjusted to the process steps

Hint!

Negative pressure and switching under negative pressure in the

pipeline can lead to damage to the membrane.

2.2 Operator’s Duty of Care

In your capacity as operator of the facility you bear a particular responsibility for

the proper and safe handling of the valve in your facility. Only use the valve when

it is in perfect condition to prevent danger to persons and property.

These Operating Instructions contain the information you and your staff need for

the safe and reliable operation during the entire service life of the valve. Be sure

to read these Operating Instructions carefully and ensure that the measures

described here are observed.

The operator's duty of care includes planning the necessary safety measures and

monitoring that these measures are observed. The following principles apply:

•Only allow qualified staff to work on the valve.

•The operator must authorize the staff to carry out the relevant tasks.

•Working areas and the entire environment of the valve must be neat and

clean.

•The staff must wear suitable work clothing and personal protective equipment.

As the operator of the facility make sure that work clothing and personal

protective equipment are used.

•Instruct the staff with regard to any properties of the product which might pose

a health risk and the preventative measures to be taken.

•Have a qualified first-aider on call during the operation, who can initiate the

necessary first-aid measures in case of an emergency.

•Clearly define processes, lines of authority and responsibilities associated

with the valve. Everybody must know what to do in case of an emergency.

Instruct the staff in this respect at regular intervals.

•The signs relating to the valve must always be complete and legible. Check,

clean and replace the signs as necessary at regular intervals.

Safety

Operator’s Duty of Care

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