Decagon Devices AquaLab 4TE, AquaLab 4TE DUO, AquaLab 4TEV, AquaLab 4TEV DUO Installation Qualification/operational Qualification Protocols And Instructions
Installation Qualification/Operational Qualification
Protocols and Instructions
AquaLab 4TE, 4TEV
4TE DUO and 4TEV DUO
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Table of Contents
Section 1
Section 2
Section 2.1
Section 2.2
Section 2.3
Section 2.4
Section 2.5
Section 3
Section 3.1
Section 3.2
Section 3.2.1
Section 3.2.2
Appendix 1
Appendix 2
Introduction
Installation Qualification (IQ)
Equipment Identification
Receiving and Unpacking
Visual Inspection
Environmental Conditions
Power Up Test
Operational Qualification (OQ)
Hardware testing
System information
Sensor Verification
Equipment Familiarization
Training Record
Deficiencies and Corrective Actions
Pg. 3
Pg. 5
Pg. 5
Pg. 5
Pg. 7
Pg. 8
Pg. 8
Pg. 10
Pg. 10
Pg. 10
Pg. 10
Pg. 12
Pg. 13
Pg. 14
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Section 1 – Introduction
This Qualification protocol is solely intended to be used with new or relocated AquaLab Water Activity
instruments. It is written to assist the end-user in validation of predetermined specifications.
The use of this document does not replace the need for the AquaLab Series 4 User’s Manual. Information
within the User’s Manual is required to complete this IQ/OQ Protocol. If the manual has been misplaced,
copies can be obtained from the manufacturer or downloaded from their website, www.aqualab.com.
Qualification of instrumentation is a formal process of documenting that an instrument is fit for its intended
use and that it is kept maintained and calibrated.
Responsibilities
The instrument qualification carried out onsite is the sole responsibility of the instrument owner/user.
However, Decagon Devices supports their customers in performing the qualification by providing the
instrument qualification dedicated documentation and offering a qualification service. In this regard, the
following responsibilities are defined:
Performance of Qualification
Execution of the instrument qualification and entire qualification of the installed system covered in
this document is performed by a Decagon Devices trained and authorized service personnel
when ordered from a customer.
Review and final qualification approval
Final approval for the qualification has to be completed after review of the qualification documentation
filled out during performance of the qualification procedures (IQ/OQ protocols). The customer representative then signs the approved form.
Installation Qualification (IQ)
Installation qualification is documented proof that the instrument was received as designed and specified by the manufacturer, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument. The IQ section therefore describes and
documents the instrument installation in the pre-determined environment. Further, the IQ verifies and
ensures that all ordered parts and documentation are in place and that all supplied items are in working
order and condition.
Operational Qualification (OQ)
The operational qualification serves as proof that the equipment operates as designed and intended,
as well as fulfills acceptance criteria defined and stated in the Operational Qualification documentation.
These criteria are defined and are based on the equipment technical specifications of the manufacturer.
Performance Qualification (PQ)
Performance qualification is documented proof that an instrument consistently performs according to the
specifications appropriate for its routine use. Monitoring of equipment during routine operation is essential
for ensuring that the ongoing performance is within specifications. The performance qualification, execution
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and frequency are solely under responsibility of the user. Performance validation should be designed to meet
the specifications and accuracy for a given application.
Equipment familiarization and operator training records
All equipment users are to be instructed in basic operation, functionality, instrument parameters, as well
as on basic hardware features of the installed system including routine maintenance and cleaning procedures. Please contact Decagon Devices to learn about available training and seminars.
Authorized support specialists perform the qualification services offered by Decagon Devices.
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Section 2 – Installation Qualification (IQ)
Initial Qualification and Requalification
The IQ protocols described below are dedicated to initial qualification and/or to requalification. Installation Qualification tests should be performed, 1) when the system is installed, 2) when the system is
moved to a new location, 3) prior to running OQ tests.
This section describes the procedure for receiving, unpacking, and installing a Series 4 AquaLab
Water Activity instrument.
The purchased AquaLab Water Activity instrument undergoing qualification is located at:
Company Name:
Department:
Address:
City: State:
Country:
Zip code/Postal Code:
Phone Number:
2.1 Equipment identification
Fill out this section after unpacking the AquaLab instrument and corresponding accessories.
4 4TE 4TEV 4TE DUO 4TEV DUO
Manufacturer: DECAGON DEVICES
Model Number:
Serial Number:
Decagon Devices Authorized Representative
Name:
Date:
Signature:
Initials:
2.2 Receiving and Unpacking
Verify that the external packaging was not damaged during shipment in a way that the internal package
content might be damaged.
External package condition Satisfactory Not Satisfactory
Remarks: N/A
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Compare shipment list with supplied items to ensure completeness of order.
Water Activity Instrument Complete Not Complete N/A
Quick Start Guide Complete Not Complete N/A
User’s Manual Complete Not Complete N/A
AquaLink 4 Software Complete Not Complete N/A
Certificate of Calibration Complete Not Complete N/A
Trial Verification Standards Complete Not Complete N/A
SDS Documents Complete Not Complete N/A
Power Cable Complete Not Complete N/A
USB Cable Complete Not Complete N/A
Filters (TEV only) Complete Not Complete N/A
Cleaning Kit Complete Not Complete N/A
LDPE Sample Cups and Lids Complete Not Complete N/A
DUO Quick Start Guide Complete Not Complete N/A
(DUO only)
Remarks: N/A
All parts were received as ordered and the delivery is complete. Yes No
Any parts that were missing at the time of this supply verification and reported as Not Complete must be delivered to complete the shipment. Any parts marked as Not Complete must be indicated below and reviewed
with the customer. Minor parts or accessories that do not impact the installation or qualification procedure or
the functionality of the instrument can be accepted, if agreed upon by the customer in order to complete the
remainder of the IQ/OQ process. Completed can be marked once the item has been received.
InitialsDate
Item:
Accepted Completed
Accepted Completed
Accepted Completed
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Date Initials
Accepted Completed
Accepted Completed
Accepted Completed
Remarks: N/A
Qualified by:
Date: Initials:
2.3 Visual Inspection
After unpacking, verify that there is no physical damage to the instrument, cables, and accessories.
Note all observed damage in the Remarks section. Minor defects that do not affect functionality can be
marked as accepted, if approved by the customer.
AquaLab Instrument Satisfactory Not Satisfactory Accepted
Documentation Satisfactory Not Satisfactory Accepted
Other Satisfactory Not Satisfactory Accepted
Remarks: N/A
Qualified by:
Date: Initials:
Severe damage to any of the delivered parts interrupts the installation qualification until the part is replaced. Completion of the installation qualification after replacement is documented below.
AquaLab Instrument Satisfactory Not Satisfactory N/A
Documentation Satisfactory Not Satisfactory N/A
Other Satisfactory Not Satisfactory N/A
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Remarks: N/A
Qualified by:
Date: Initials:
2.4 Environmental Conditions
Installation of the AquaLab Water Activity instrument includes placing the instrument on a level surface in a
location where the temperature remains fairly stable. This location should be well away from air conditioner
and heater vents, open windows, outside doors, or other items that may cause rapid
temperature fluctuation.
Location Satisfactory Not Satisfactory
Adequate Power Satisfactory Not Satisfactory
Stable Surface Satisfactory Not Satisfactory
Temperature Satisfactory Not Satisfactory
Remarks: N/A
Qualified by:
Date: Initials:
2.5 Power Up Test
After finding a good location for the AquaLab Water Activity meter, plug the power cord into the back of the
unit and a standard AC outlet. The ON/OFF switch is located in the lower left corner of the back panel.
Instrument is powered upon switching on Yes No
Remarks: N/A
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Completeness of Installation Qualification (IQ)
Installation Qualification was completed and documented according to manufacturer’s guidelines.
Initial Qualification Requalification
Decagon Devices Authorized Representative
Name:
Function:
Company:
Date:
Signature:
Initials:
Installation Qualification was reviewed by the representative of the system owner.
Reviewed and approved by:
Name:
Function:
Company:
Date:
Signature:
Initials:
Remarks: N/A
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Section 3 – Operational Qualification (OQ)
This section describes tests that are to be executed for Operational Qualification of the AquaLab Water
Activity instrument in order to prove proper operation of the installed instrument.
3.1 Hardware testing
Display is functional Yes No
Keypad is functional Yes No
Remarks: N/A
Qualified by:
Date: Initials:
3.2 System Information
AquaLab Water Activity Instrument Information
Manufacturer:
Model Number:
Serial Number:
Firmware Version:
3.2.1 Sensor Verification
The AquaLab Series 4 line of instruments contain a chilled mirror dewpoint sensor for
determining water activity. The 4TEV model contains both the chilled mirror sensor and a
capacitance relative humidity sensor. The performance of the sensors is verified by measuring
specially prepared calibration standards that have a specific molality and water activity.
Performance Verification Standards in four water activity levels are used for qualification:
0.250, 0.500, 0.760, 1.000 aw. The AquaLab dew point sensor will read each standard within
+/- 0.003 aw of the stated value. The capacitance (volatiles) sensor will read each standard
within +/- 0.015 aw of the stated value. To measure the water activity of the standards, follow
the instructions in the User’s Manual for taking a reading.
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Dew Point Sensor Volatiles Sensor (TEV only)
Standard @ 25°C Lot # a
±0.003 °C aw ±0.015 °C
w
13.41m LiCl 0.250
0.250
8.57m LiCl 0.500
0.500
6.0m NaCl 0.760
0.760
Steam Distilled H2O 1.00
1.00
Water Activity Verification Standards Within Specification Yes No
Remarks: N/A
If verification standards are out of specification, clean the instrument and follow the procedure in the
User’s Manual to perform a linear offset. Repeat the verification process with fresh standards.
Dew Point Sensor Volatiles Sensor (TEV only)
Standard @ 25°C Lot # a
±0.003 °C aw ±0.015 °C
w
13.41m LiCl 0.250
0.250
8.57m LiCl 0.500
0.500
6.0m NaCl 0.760
0.760
Steam Distilled H20 1.00
1.00
Water Activity Verification Standards Within Specification Yes No N/A
Remarks: N/A
Qualified by:
Date: Initials:
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3.2.2 Equipment Familiarization
This section ensures that the instrument operators receive appropriate equipment training to ensure proper
operation, maintenance, and generation of results with the AquaLab instrument. Product
familiarization covers instruction on basic operations, functionality and features of the instrument, and
routine maintenance including cleaning procedures.
Equipment familiarization and training
completed for the AquaLab. Yes No
Qualified by:
Date: Initials:
Completeness of Operational Qualification (OQ)
Operational Qualification was completed and documented according to manufacturers guidelines.
Initial Qualification Requalification
Qualifications met Vendor Acceptance Criteria Yes No
If any deficiencies are found, fill out the instructions for a corrective action on Pg. 14 of this document.
Decagon Devices Authorized Representative
Name:
Function:
Company:
Date:
Signature:
Initials:
Operational Qualification was reviewed by the representative of the system owner.
Reviewed and approved by:
Name:
Function:
Company:
Date:
Signature:
Initials:
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Appendix 1
Training Record
This training record is for instruction in basic operation, functionality, instrument parameters, as well as on
basic hardware features of the installed system including routine maintenance and cleaning procedures.
Please contact Decagon Devices to learn about available training and seminars.
Authorized support specialists perform the qualification services offered by Decagon Devices.
Name: Date:
Name: Date:
Name: Date:
Name: Date:
Name: Date:
Name: Date:
Name: Date:
Name: Date:
Name: Date:
Name: Date:
Decagon Devices Authorized Representative
Name:
Function:
Company:
Date:
Signature:
Initials:
Reviewed and approved by:
Name:
Function:
Company:
Date:
Signature:
Initials:
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Appendix 2
Deficiencies and Corrective Actions
If any deficiencies were found, they are to be followed with an instruction for Corrective Action. Once acceptable results are obtained, the deficiency is accepted by checking the “accepted” box under the deficiency.
Deficiency:
Corrective Action: Accepted Initial
Deficiency:
Corrective Action: Accepted Initial
Decagon Devices Authorized Representative
Name:
Function:
Company:
Date:
Signature:
Initials:
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