Service Note Number: CrossLab – Waters-009 Supersedes: False
Title: Acquity H-class QSM fails the gradient composition test
Summary:
The Agilent Enterprise Edition OQ LC Test Suite Gradient Composition Linearity test will frequently fail when performed on the Acquity H-class QSM.
Parts Required:
None
Situation:
When run on a Waters Acquity H-class QSM, the Agilent Enterprise Edition OQ LC Test Suite Gradient Composition Linearity test frequently demonstrates a slight inflection at the 100% to 95% transition. As a result, for some systems the 95% gradient linearity step may fail with a value less than the Agilent Recommended limit of 0.99900. The Acquity QSM is equipped with an electronically controlled inlet check valve. Similar behavior has been observed in other Liquid Chromatographic systems with electronically controlled inlet check valves, and adjustments made to the Agilent Recommended test limit.
It was determined after reviewing the results from a number of representative systems that a more appropriate value for the 95% gradient linearity step is 0.99500.
Operational Qualification is predicated on operational conditions representative of the regular use of a system across the complete duration of their lifecycle. It is ultimately the customer's PQ that proves the suitability of the instrument to the customer's application.
Solution/Action:
Agilent recommends changing the Agilent Recommended EQP limit for the 95% gradient linearity step from 0.99900 to 0.99500 for the Acquity H-class QSM.
Serial Numbers:
Serial Low Serial High
Attachments:
Additional Information:
It is advised that this limit be reviewed with the customer for the Waters Acquity H-class prior to delivery, and the limits change explained as described in this service note.
If required by the customer, this service note can be attached to the Agilent Enterprise Edition Equipment Qualification Report (EQR) using the following procedure:
1. Attach this service note (in Adobe *.pdf format) to the EQR.
2. The presence of this service note as an attachment page to the EQR makes it unnecessary to create a Deviation Correction form to manage the difference in testing limits as included in the Agilent Recommended EQP.
Related Products:
Date:10/13/2014 10:31:58 AM
Administrative Information:
Classification: Information Only
Author: PEARCE,DAN (A-PaloAlto,ex1)
Additional Information:
Copyright 2014 Agilent Technologies
Printed in U.S.A.
Service Note Number: CrossLab – Waters-009 Supersedes: False
Title: Acquity H-class QSM fails the gradient composition test
Summary:
The Agilent Enterprise Edition OQ LC Test Suite Gradient Composition Linearity test will frequently fail when performed on the Acquity H-class QSM.
Parts Required:
None
Situation:
When run on a Waters Acquity H-class QSM, the Agilent Enterprise Edition OQ LC Test Suite Gradient Composition Linearity test frequently demonstrates a slight inflection at the 100% to 95% transition. As a result, for some systems the 95% gradient linearity step may fail with a value less than the Agilent Recommended limit of 0.99900. The Acquity QSM is equipped with an electronically controlled inlet check valve. Similar behavior has been observed in other Liquid Chromatographic systems with electronically controlled inlet check valves, and adjustments made to the Agilent Recommended test limit.
It was determined after reviewing the results from a number of representative systems that a more appropriate value for the 95% gradient linearity step is 0.99500.
Operational Qualification is predicated on operational conditions representative of the regular use of a system across the complete duration of their lifecycle. It is ultimately the customer's PQ that proves the suitability of the instrument to the customer's application.
Solution/Action:
Agilent recommends changing the Agilent Recommended EQP limit for the 95% gradient linearity step from 0.99900 to 0.99500 for the Acquity H-class QSM.
Serial Numbers:
Serial Low Serial High
Attachments:
Additional Information:
It is advised that this limit be reviewed with the customer for the Waters Acquity H-class prior to delivery, and the limits change explained as described in this service note.
If required by the customer, this service note can be attached to the Agilent Enterprise Edition Equipment Qualification Report (EQR) using the following procedure:
1. Attach this service note (in Adobe *.pdf format) to the EQR.
2. The presence of this service note as an attachment page to the EQR makes it unnecessary to create a Deviation Correction form to manage the difference in testing limits as included in the Agilent Recommended EQP.
Related Products:
Date:10/13/2014 10:31:58 AM
Administrative Information:
Classification: Information Only
Author: PEARCE,DAN (A-PaloAlto,ex1)
Additional Information:
Copyright 2014 Agilent Technologies
Printed in U.S.A.
การแปล กรุณารอสักครู่..

Service Note Number: CrossLab – Waters-009 Supersedes: False
Title: Acquity H-class QSM fails the gradient composition test
Summary:
The Agilent Enterprise Edition OQ LC Test Suite Gradient Composition Linearity test will frequently fail when performed on the Acquity H-class QSM.
Parts Required:
None
Situation:
When run on a Waters Acquity H-class QSM, the Agilent Enterprise Edition OQ LC Test Suite Gradient Composition Linearity test frequently demonstrates a slight inflection at the 100% to 95% transition. As a result, for some systems the 95% gradient linearity step may fail with a value less than the Agilent Recommended limit of 0.99900. The Acquity QSM is equipped with an electronically controlled inlet check valve. Similar behavior has been observed in other Liquid Chromatographic systems with electronically controlled inlet check valves, and adjustments made to the Agilent Recommended test limit.
It was determined after reviewing the results from a number of representative systems that a more appropriate value for the 95% gradient linearity step is 0.99500.
Operational Qualification is predicated on operational conditions representative of the regular use of a system across the complete duration of their lifecycle. It is ultimately the customer's PQ that proves the suitability of the instrument to the customer's application.
Solution/Action:
Agilent recommends changing the Agilent Recommended EQP limit for the 95% gradient linearity step from 0.99900 to 0.99500 for the Acquity H-class QSM.
Serial Numbers:
Serial Low Serial High
Attachments:
Additional Information:
It is advised that this limit be reviewed with the customer for the Waters Acquity H-class prior to delivery, and the limits change explained as described in this service note.
If required by the customer, this service note can be attached to the Agilent Enterprise Edition Equipment Qualification Report (EQR) using the following procedure:
1. Attach this service note (in Adobe *.pdf format) to the EQR.
2. The presence of this service note as an attachment page to the EQR makes it unnecessary to create a Deviation Correction form to manage the difference in testing limits as included in the Agilent Recommended EQP.
Related Products:
Date:10/13/2014 10:31:58 AM
Administrative Information:
Classification: Information Only
Author: PEARCE,DAN (A-PaloAlto,ex1)
Additional Information:
Copyright 2014 Agilent Technologies
Printed in U.S.A.
การแปล กรุณารอสักครู่..
