Equipment: 6000236 Confidential SAT Document | © Belimed Life Science

SAT Document

Product: Pharma Washer

Type: PH860.2L
Equipment: 6000236
Project-no: P-505156

Customer: PT Bio Farma

Place of Installation: Dirty Goods Handling
Plant Name: Building 37 Biofarma
Project Name: Bulk Rotavirus Production

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Approval Customer
Name Position Date Signature

Revision overview
Version Description Created Verified

Initial version (based on master 07 Feb 2024 07 Feb 2024

00
document 90144906, V08) Beat Messmer Boris Vukota

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Table of contents

1 General 4
1.1 Introduction and objective .............................................................................................................. 4
1.2 Overview of responsibilities ........................................................................................................... 4
1.3 Conditions for the tests .................................................................................................................. 4
1.4 IQ- / OQ- test documents ............................................................................................................... 4
1.5 Test procedure ............................................................................................................................... 4
1.6 Scope of testing ............................................................................................................................. 4
1.7 Deviation management .................................................................................................................. 4
2 Qualification 5
Test personnel .................................................................................................................................... 5
IQ-01.01 Initial cleaning ..................................................................................................................... 6
IQ-01.02 Pending issues from FAT .................................................................................................... 8
IQ-02.01 Technical documentation .................................................................................................. 10
IQ-03.01 Installation & preparation drawing ..................................................................................... 12
IQ-03.02 Mechanical installation ...................................................................................................... 14
IQ-03.03 Racks & transport trolley ................................................................................................... 16
IQ-04.01 P&I diagram....................................................................................................................... 18
IQ-05.01 Pneumatics........................................................................................................................ 20
IQ-07.02 Commissioning .................................................................................................................. 22
IQ-07.03 PLC in- and outputs .......................................................................................................... 28
IQ-08.01 Software ............................................................................................................................ 31
OQ-03.03 User administration external ............................................................................................ 33
OQ-03.05 PCS Interface .................................................................................................................. 35
OQ-04.01 Alarms ............................................................................................................................. 37
OQ-05.01 Calibration ....................................................................................................................... 39
OQ-06.01 Function sequences ........................................................................................................ 41
OQ-10.01 Tightness ......................................................................................................................... 43
3 SAT assessment / Deviation list 45
3.1 Deviations ....................................................................................................................................45
3.2 Approval .......................................................................................................................................45

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1 General
1.1 Introduction and objective
The SAT Document describes the scope of tests that have to be performed in the SAT phase.
SAT tests are subdivided into installation tests (IQ) and operational tests (OQ).
The performance and test results of the respective IQ and OQ tests are documented and evalu-
ated. This provides formal and systematic proof that the system has been built and installed
properly and in accordance with the specification.
1.2 Overview of responsibilities
Belimed Life Science
• Coordination, execution and logging of the IQ / OQ tests
• Recording of deviations, assessment of deviations, deviation tracking
• Release of the completed SAT Document
• Review and release of the deviation list
Customer
• Review and release of IQ/OQ test reports
• Review and release of the completed FAT/SAT documentation
• Review and release of the deviation list
1.3 Conditions for the tests
Approved test documents must be available for the tests.
Valid calibration certificates must be available for the measuring devices used for testing.
1.4 IQ- / OQ- test documents
The structure of the test documents is described in the associated masterplan.
1.5 Test procedure
The test procedure is described in the associated masterplan.
1.6 Scope of testing
Qualification is performed in two steps, installation qualification and operational qualification. The
scope of testing is specified in the associated masterplan chapter qualification matrix.
1.7 Deviation management
The deviation management is described in the associated masterplan.

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2 Qualification
Test personnel
Personnel involved in the qualification procedure enter their names on the following signature list.
Name Company Signature Initials

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IQ-01.01 Initial cleaning

Test Instruction

Purpose
Ensure that initial cleaning of the installation has been carried out before the start of the tests.

Reference document
• n/a

Procedure
1. Check all points listed in the test report.
2. Describe deviations in the «Comment» chapter and record them in the deviation list.

Acceptance criterion
The specifications from the test report are fulfilled.

Attachment
• n/a

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test Report

No. Specification Pass / Fail

1. The chamber is visually cleared of all remains of the assembly work.

2. The service area is visually cleared of all remains of the assembly work.

3. The chamber is visually free of dust and dirt.

4. The service area is visually free of dust and dirt.

5. The chamber is free of all packaging materials.

6. The service area is free of all packaging materials.

Name / Company Date / Signature

Tested

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IQ-01.02 Pending issues from FAT

Test Instruction

Purpose
Check whether all items from the «FAT Deviation List» have been processed.

Reference document
• n/a

Procedure
1. Check all points listed in the test report.
2. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.

Attachment
• 80125312 - Copy of the «FAT Deviation List»

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

1. All items listed on the «FAT Deviation List» are marked as completed.

2. All deviations have been corrected.

3. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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IQ-02.01 Technical documentation

Test Instruction

Purpose
Ensure that the binders are available and labeled correctly.

Reference document
• 6101012685- Order confirmation
• 80125319- Document structure

Procedure
1. Check by means of the document structure whether all binders of the documentation are availa-
ble.
2. For available and correctly filed documents, from the section «Operating manual» and «Design
documentation» the revision number must be recorded in the document structure.
Note: Material & weld seam documentation has been checked in IQ-02.02 during FAT.
3. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.

Attachment
• 80125319- Document structure; Revision ……………

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

1. All binders according to the document structure are available.

2. The numbering and names of the binders correspond to the document structure.

All documents listed in the section «Operating manual» are available, correctly
3.
filed and the revisions have been recorded in the document structure.

All documents listed in the section «Design documentation» are available, cor-
4.
rectly filed and the revisions have been recorded in the document structure.

5. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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IQ-03.01 Installation & preparation drawing

Test Instruction

Purpose
Ensure that the installation of the system corresponds to the installation & preparation drawing.

Reference document
• 80125284- Installation & preparation drawing
• 80125289- P&I diagram

Procedure
1. Check all points listed in the test report.
2. Mark the correct information on the installation & preparation drawing, checked according to the
test points, with a green highlighter.
3. Mark the incorrect information on the installation & preparation drawing, checked according to the
test points, with a red highlighter.
4. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.
• The installation & preparation drawing contains no red markings.

Attachment
• 80125284- Installation & preparation drawing; Revision ……………

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report
Pass / Fail
No. Requirement
/ n/a

1. The loading direction corresponds to the installation & preparation drawing.

2. The main operating side corresponds to the installation & preparation drawing.

3. The service accesses correspond to the installation & preparation drawing.

The Equipment-related dimensions on the installation & preparation drawing cor-

respond to the actual dimensions.
Tolerances:
4.

All utility connections are dimensioned in accordance with the installation & prepa-
5.
ration drawing.

6. The cladding is free of scratches and dents.

For each red mark it is clearly defined and recorded on the attachment whether it
7. is a deviation on the document or a deviation on the Equipment.
Note: If there are no red marks, this item is to be valued as <n/a>.

8. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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IQ-03.02 Mechanical installation

Test Instruction

Purpose
Ensure that the maintenance area of the system is freely accessible and that the mechanical installation
complies with the specifications in the test report.

Reference document
• 80125284- Installation & preparation drawing
• 80125289- P&I diagram

Procedure
1. Check all points listed in the test report.
2. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.

Attachment
• n/a

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

1. All utilities are correctly connected.

2. All pipes are installed as self-supporting units and connected tension-free.

All components requiring regular maintenance are accessible and removable

3.
(temperature sensors, pressure transmitters, steam traps).

4. Accessibility to the validation port is guaranteed.

5. Accessibility to the use of the sampler is guaranteed.

The cables of the sensors requiring calibration are long enough to be able to cali-
6.
brate them.

7. The drainability of the area in contact with the product is provided.

Name / Company Date / Signature

Tested

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IQ-03.03 Racks & transport trolley

Test Instruction

Purpose
Ensure that the racks & transport trolleys are available and can be loaded into the equipment or locked to
the chamber.

Reference document
• 6101012685- Order confirmation
• 80125285 - Operating instructions

Procedure
1. Check all points listed in the test report.
2. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.

Attachment
• n/a

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

1. Racks and transport trolleys are available in the specified quantity.

2. The racks can be securely locked and transported on the transport trolley.

3. The trolley is equipped with four swivel castors and parking break.

4. The trolley can be locked to the chamber for safe loading and unloading.

5. The equipment can be loaded and unloaded with the rack via the transport trolley.

When the rack is placed in the chamber, the coupling of the washing chamber
6.
matches with the rack connection piece.

Name / Company Date / Signature

Tested

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IQ-04.01 P&I diagram

Test Instruction

Purpose
Ensure that the piping of the equipment corresponds to the P&I diagram.

Reference document
• 80125289- P&I diagram

Information
Connection symbols (fittings, clamps, flanges, screwed joints) are not drawn in the non-product-con-
tacted part of the P&I diagram.

Procedure
1. Check all points listed in the test report.
2. Mark the correct information on the P&I diagram, checked according to the test points, with a
green highlighter.
3. Mark the incorrect information on the P&I diagram, checked according to the test points, with a
red highlighter.
4. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.
• The P&I diagram does not contain any red markings.

Attachment
• 80125289- P&I diagram; Revision ……………

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report
Pass / Fail
No. Requirement
/ n/a

1. The piping of the equipment corresponds to the P&I diagram.

2. The pipes are insulated according to the P&I diagram.

3. The components on the equipment correspond to the P&I diagram.

4. The components are labeled according to the P&I diagram.

5. All utility connections are labeled according to the P&I diagram.

For each red mark it is clearly defined and recorded on the attachment whether it
6. is a deviation on the document or a deviation on the Equipment.
Note: If there are no red marks, this item is to be valued as <n/a>.

7. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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IQ-05.01 Pneumatics
Test Instruction

Purpose
Ensure that the pneumatics of the equipment corresponds to the circuit diagram.

Reference document
• 80125290- Circuit diagram

Procedure
1. Check all points listed in the test report.
2. Mark the correct information on the circuit diagram, checked according to the test points, with a
green highlighter.
3. Mark the incorrect information on the circuit diagram, checked according to the test points, with a
red highlighter.
4. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.
• The circuit diagram does not contain any red markings.

Attachment
• 80125290 - Circuit diagram (+PNE section); Revision …..…; Pages ………..

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report
Pass / Fail
No. Requirement
/ n/a

1. The tubing of the pneumatic components corresponds to the circuit diagram.

2. The pneumatic components on the equipment correspond to the circuit diagram.

3. The pneumatic components are labeled correctly.

4. The pneumatic hoses are labeled correctly.

For each red mark it is clearly defined and recorded on the attachment whether it
5. is a deviation on the document or a deviation on the Equipment.
Note: If there are no red marks, this item is to be valued as <n/a>.

6. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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IQ-07.02 Commissioning
Test Instruction

Purpose
Ensure that the commissioning is correctly performed and documented.

Reference document
• 80125289- P&I diagram
• 80125290- Circuit diagram
• 80125288- List of measuring points

Procedure
1. Check all points listed in the test report.
2. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.

Attachment
• Copy of the calibration certificate of the reference measuring devices

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

Information
Serial- / ID-
Test device Type
number

Electrical connections

No. Requirement Pass / Fail

1. All electrical connections and terminals checked and tightened.

Motor protection

No. Test item Pass / Fail

Motor protection switches are set to nominal current as specified in the circuit dia-
2.
gram.

3. The rotating field of the input terminals must be clockwise.

Nominal voltage across the input terminals must be as specified in the circuit dia-
4.
gram (+/- 5 %).

5. The control voltage after the power supply unit must be 24 V (+/- 1 V).

6. The rotating field of the motors must be as specified.

Name / Company Date / Signature

Tested

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Current consumption motors

No. Test item Procedures Result / State Pass / Fail

The current consumption

L1: ………………A
must be evenly distributed
7. Circulation pump over all conductors and
P1 comply with the specifica- L2: ………………A
tions of the circuit dia-
gram.
L3: ………………A

The current consumption

L1: ………………A
must be evenly distributed
8. Fan over all conductors and
VL1 comply with the specifica- L2: ………………A
tions of the circuit dia-
gram.
L3: ………………A

Emergency stop

No. Test item Pass / Fail

The Emergency stop switching device is configured as specified in the circuit dia-
9.
gram.

No. Condition Procedures Result / State Pass / Fail

Machine is started. Machine stops.

10. Actuate an emergency-
<Program running> <Program: stopped> state
stop button
state

No reaction.
11. Emergency-stop Push the <open door>
The door UCS remains
actuated button UCS
closed.

12. Emergency-stop Try to open door UCS Door UCS cannot be

actuated manually. opened manually.

No reaction.
13. Emergency-stop Push the <Open door>
The door CS remains
actuated button CS
closed.

14. Emergency-stop Try to open the door CS The door CS cannot be

actuated manually opened manually.

The supply of the respec-

Check whether the digital
15. Emergency-stop tive outputs (see circuit di-
outputs for the media
actuated agram) is disconnected
valves are powerless.
(de-energized).

Name / Company Date / Signature

Tested

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No. Condition Procedures Result / State Pass / Fail

Check whether the digital

16. Emergency-stop output for valve <inflate
Output A1.0 is energized.
actuated door seal UCS> is ener-
gized.

Check whether the digital

17. Emergency-stop output for valve <inflate
Output A1.2 is energized.
actuated door seal CS> is ener-
gized.

18. Emergency-stop Acknowledge alarm. Machine is started.

unlocked Start machine. <Program running> state

Setting pressure regulators

No. Test item Procedures Result / State Pass / Fail

Set pressure according to

19. Module 0Z2 the specifications of the ………………bar
circuit diagram +PNE.

Set pressure according to

20. Module 0Z4 the specifications of the ………………bar
circuit diagram +PNE.

Set pressure according to

21. Module 0Z5 the specifications of the ………………bar
circuit diagram +PNE.

Set pressure according to

22. Compressed air purging ………………bar
the specifications of the
PI11
P&I diagram

Door safety

No. Condition Procedures Result / State Pass / Fail

Door unclean side:

The door must not ex- Start function <close door
23. ceed a force of 150N unclean side> and meas- FUCS max.: .................
when closing (F max. ≤ ure the maximum force of
150N). the door.

Door clean side:

The door must not ex- Start function <close door
24. ceed a force of 150N clean side> and measure FCS max.: .................
when closing (F max. ≤ the maximum force of the
150N). door.

Name / Company Date / Signature

Tested

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No. Condition Procedures Result / State Pass / Fail

A program start can only Push the <Start> button

25. be effected with closed with open door on the un- Program does not start.
doors. clean side.

Push the <Open door>

26. Doors cannot be open button on the clean side Door on clean side does
simultaneously with open door on the un- not open.
clean side.

A program start can only Push the <Start> button

27. be effected with closed with open door on the Program does not start.
doors. clean side.

Push the <Open door>

28. Doors cannot be open button on the unclean Door on unclean side
simultaneously side with open door on does not open.
the clean side.

The door seals are pro-

tected from over pres-
sure through a safety Adjust the pressure for
The safety valve opens if
valve (circuit diagram the door seals over 1bar
29. the pressure is higher
+PNE 0Z7). The safety (circuit diagram +PNE
than 1bar.
valve opens automati- 0Z5/0Z11).
cally, if the pressure is
higher than 1bar.

After program end or

program abort, the door Door cannot be opened.
Simulate the temperature
30. can only be opened probe WT with a value
when the temperature above safety temperature.
inside the cabin is below [Link]:...............°C
safety temperature.

Name / Company Date / Signature

Tested

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Safety level wash tank

No. Condition Procedures Result / State Pass / Fail

The valve V4 „draining

wash tank“ is locked via program is interrupted,
Simulate the safety level
31. LSA++3 „safety level valve V4 opens automati-
of the wash tank.
wash tank“ on hardware cally.
side.

General

No. Requirement Pass / Fail

32. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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IQ-07.03 PLC in- and outputs

Test Instruction

Purpose
Ensure that the assignment of the digital and analog inputs and outputs is carried out according to the In-
put / Output List.

Reference document
• 80125290- Circuit diagram
• 80125294- Configuration plan PLC

Procedure
1. Ensure that all necessary test equipment is available:
- Laptop equipped with the development software according to the configuration plan PLC
- Corresponding connection cable Computer-PLC
2. connect the laptop to the PLC and create the variable table in the TIA portal.
Digital Inputs
3. Manually operate the corresponding command devices and check whether the respective input
LED of the PLC lights up.
4. Check off all correctly wired digital inputs in the «Input / Output List» in the Test column.
Analogue Inputs
5. Manually disconnect the corresponding sensors electrically and check whether the correct indica-
tion on the HMI changes.
6. Check off all correctly wired analogue inputs in the «Input / Output List» in the Test column.
Digital Outputs
7. Control outputs via the variable table and check whether the corresponding actuator is controlled.
8. Check off all correctly wired digital outputs in the «Input / Output List» in the Test column.
General
9. Mark incorrectly wired inputs and outputs on the «Input / Output List» with a red highlighter.
10. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.
• The «Input / Output List» does not contain any red markings.

Attachment
• 80125290 - Input / Output List; Revision ……………

Comment

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Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

1. All in- and outputs are marked as tested in the «Input / Output List».

2. The «Input / Output List» is signed on each page with date and name.

3. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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IQ-08.01 Software
Test Instruction

Purpose
Ensure that the installed software complies with the specification.

Reference document
• 80125305 - Software Design Specification

Procedure
1. Transfer the program name of the PLC software from the PLC configuration plan to the test re-
port. The program name consists of the equipment number and the highest revision index (revi-
sion table at the end of the document).
2. Use the Info button on the control panel to call up the PLC version and enter it in the test report.
3. Transfer the program name of the operating software from the configuration plan HMI 1 to the
test report.
4. Call up the version of the operating software on the HMI 1 via the Info button and enter it in the
test record.
5. Transfer the program name of the operating software from the configuration plan HMI 2 to the
test report.
6. Read the version of the operating software at the upper edge of the HMI and enter it in the test
report.
7. Compare the software versions installed in the machine with the software versions specified in
the configuration plans.
8. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The versions specified in the configuration plans correspond to the versions installed on the equip-
ment.

Attachment
• 80125294- Configuration plan PLC; Revision ……………
• 80125295 - Configuration plan HMI 1; Revision ……………
• 80125296 - Configuration plan HMI 2; Revision ……………

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report
Specified in the Installed on
No. Software Pass / Fail
configuration plan the equipment

1. PLC

2. HMI 1

3. HMI 2

No. Requirement Pass / Fail

4. Sign the reviewed attachments with date and name.

Name / Company Date / Signature

Tested

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OQ-03.03 User administration external

Test Instruction

Purpose
To ensure that customer domain (Active Directory, AD) users can log in to the machine's HMI.
Note: This test requires support from a specialist from customers IT admin.

Reference document
• n/a

Procedure
Pre-condition: A valid HMI user group must be stored in the AD account of an AD user. The AD users to
be checked must not have a local profile (= users with the same name and password).
1. Check if AD users can log in to the HMI.
2. Disconnect from the domain server.
3. Check whether the AD users on the HMI can no longer log in.
4. Reconnect to the domain server.
5. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• Customer AD users can only log in to the HMI of the machine when the AD is accessible.
• When the machine is operating autonomously (AD cannot be reached), only local users (no AD us-
ers!) can log on to the HMI.

Attachment
• n/a

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Test item Requirement Pass / Fail

Transfer of the users of the domain Customer AD users can log in to the
1.
server HMI of the machine.
When the machine is operating autono-
mously (AD cannot be reached), only
2. Availability of users, if no access to AD
local users (no AD users!) can log on to
the HMI.

Name / Company Date / Signature

Tested

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OQ-03.05 PCS Interface

Test Instruction

Purpose
Ensure that the specified online data are exchanged between machine and a customer site, higher-level
system (PCS).
Note: This test requires support from a specialist from customers PCS.

Reference document
• 80125306 - Data specification PCS
• 80125305 - Software Design Specification

Procedure
1. Compare current online values on the machine with the ones in the PCS interface
(see attached data specification).
2. If the value in a source and destination tag is identical, mark the corresponding tag in the data
specification with a green highlighter.
3. If the value in a source and destination tag is different or does not exist, mark the corresponding
tag in the data specification with a red highlighter.
4. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The current data and measured values correspond to those on the PCS.
• The data specification does not contain any red markings.

Attachment
• 80125306 - Data specification PCS; Revision ……………

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

All online values in the data specification are correctly exchanged between ma-
1.
chine and the PCS system

2. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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OQ-04.01 Alarms
Test Instruction

Purpose
Ensure that the correct alarms are triggered in the event of faults.

Reference document
• 80125293- Alarm Specification
• 80125289- P&I diagram
• 80125290- Circuit diagram

Information
All alarms (errors and fault messages) are checked by simulating a fault.
The fault must not be simulated by intervening in the software.
Procedure
1. Simulation of the fault.
2. Check the alarm message (plain text display) on the HMI against the alarm specification.
3. When the simulated fault has been eliminated, check whether the alarm can be acknowledged.
4. Mark all correctly triggered alarms in the alarm specification with a green highlighter.
5. Mark all incorrectly triggered alarms in the alarm specification with a red highlighter.
6. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.
• The alarm specification does not contain any red markings.

Attachment
• 80125293- Alarm Specification; Revision ……………

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report
Pass / Fail
No. Requirement
/ n/a

1. All alarms listed in the alarm specification are triggered.

All alarm messages (plain text display) are displayed on the HMI and comply with
2.
the alarm specification.
For each red mark it is clearly defined and recorded on the attachment whether it
3. is a deviation on the document or a deviation on the Equipment.
Note: If there are no red marks, this item is to be valued as <n/a>.

4. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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OQ-05.01 Calibration
Test Instruction

Purpose
Ensure that all relevant measuring points (entire measurement loop) are calibrated and adjusted as nec-
essary.

Reference document
• 80125292- Maintenance manual
• 80125288- List of measuring points

Procedure
1. Calibrate the relevant measuring points by using the attached calibration protocols.
Note: The procedure for performing the calibration is described in the maintenance manual.
2. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.

Attachment
• 80125313 - Calibration protocols
• Copy of the valid calibration certificate of the reference instrument

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

The measuring points, in the «list of measuring points» defined as relevant for cal-
1.
ibration are calibrated / adjusted.

When calibration/adjustment has been performed, all measured values are within
2.
the specified tolerance.

The calibration certificate of the reference instrument was valid during the perfor-
3.
mance of the calibration.

4. Sign the reviewed attachments with date and name.

Name / Company Date / Signature

Tested

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OQ-06.01 Function sequences

Test Instruction

Purpose
Ensure the process steps of the machine are carried out properly

Reference document
• 80125303- Function specification
• 80125286- Process description

Procedure
1. Create a wash program.
2. Start the program.
3. Check chapter «Schematic process flow» from the document «Function specification» and mark
correct steps with a green highlighter.
4. Mark incorrect steps with a red highlighter.
5. Check the document «Process description» and mark correct information with a green high-
lighter.
6. Mark incorrect information with a red highlighter.
7. Check all points listed in the test report.
8. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.
• The attachments do not contain any red markings.

Attachment
• 80125303- Function specification, chapter «schematic process flow»; Revision ….…; Pages …….

• 80125286- Process description; Revision …..…; Pages ………..

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report
Pass / Fail
No. Requirement
/ n/a
The actual program sequence on the machine is in accordance with the schematic
1.
process flow in the «Function specification».

The function of the process steps correspond to the specifications from the docu-
2.
ment «Process description».

All tested functions have been documented in the documents «Function specifica-
3.
tion» and «Process description».
For each red mark it is clearly defined and recorded on the attachment whether it
4. is a deviation on the document or a deviation on the Equipment.
Note: If there are no red marks, this item is to be valued as <n/a>.

5. Sign the reviewed attachments with date and name.

Name / Company Date / Signature

Tested

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OQ-10.01 Tightness
Test Instruction

Purpose
Ensure that the Equipment has no leaks.

Reference document
• 80125289- P&I diagram

Procedure
1. Create and start a program, with a rinse step ≥ 1 hour
2. Visually check of the entire Equipment for leakages during the program.
3. Check all points listed in the test report.
4. Describe deviations in the section «Comment» and record them in the deviation list.

Acceptance criterion
• The requirements from the test report are fulfilled.

Attachment
• Printout of the batch report

Comment

Acceptance criterion fulfilled: ………………. (Yes / No)

Name / Company Date / Signature

Tested

Verified

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Test report

No. Requirement Pass / Fail

1. The rinsing time is ≥ 1 hour.

2. No leakages have been detected.

3. Sign the reviewed attachment with date and name.

Name / Company Date / Signature

Tested

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3 SAT assessment / Deviation list

3.1 Deviations
Specification Yes / No / n/a

Deviations have been detected.

Deviations are documented in the deviation list.

The deviation list is attached to the SAT Document.

3.2 Approval
The completed SAT Document with the attachments is confirmed as verified and accepted with
the following signatures.
Company Name Date Signature

Customer

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