Maintenance with OQ
Operational Qualification OQ within the scope of a maintenance for the
Atomic Absorption Spectrometer
ZEEnit 700
Contents |
|
|
1. |
GENERAL INFORMATION....................................................................................... |
4 |
2. |
DEFINITIONS ........................................................................................................... |
4 |
2.1 |
Validation .................................................................................................................. |
4 |
2.2 |
Verification ................................................................................................................ |
4 |
2.3 |
Qualification .............................................................................................................. |
4 |
3.ASCERTAINMENT OF THE TECHNIQUES AND ACCESSORIES TO BE TESTED
................................................................................................................................. 5
4.FUNCTION TEST OF BASIC FUNCTIONS OF DEVICE AND OF DEVICE
|
PERIPHERALS......................................................................................................... |
5 |
5. |
OPERATIONAL QUALIFICATION (OQ) .................................................................. |
7 |
5.1 Basic calibration of Graphite-furnace technique ....................................................... |
8 |
|
5.1.1 |
Calibration procedure ........................................................................................... |
9 |
5.1.2 |
Results of calibration ............................................................................................ |
9 |
5.1.3 Recovery of a quality control sample................................................................... |
10 |
|
5.1.4 Determination of detection limit ........................................................................... |
11 |
|
5.2 Basic calibration of flame technique........................................................................ |
12 |
|
5.2.1 |
Calibration procedure .......................................................................................... |
13 |
5.2.2 |
Results of calibration ........................................................................................... |
14 |
5.2.3 Recovery of a quality control sample................................................................... |
15 |
|
5.2.4 Determination of detection limit ........................................................................... |
16 |
|
5.3 Basic calibration of Flame technique in emission mode.......................................... |
17 |
|
5.3.1 |
Calibration procedure .......................................................................................... |
18 |
5.3.2 |
Results of calibration ........................................................................................... |
19 |
5.3.3 Recovery of a quality control sample................................................................... |
19 |
|
5.3.4 Determination of detection limit ........................................................................... |
20 |
|
6. |
FAULTS ASCERTAINED IN INSTRUMENT VALIDATION .................................... |
21 |
7. |
CONCLUSION OF MAINTENANCE WITH OPERATIONAL QUALIFICATION ...... |
21 |
Maintenance protocol standard ZEEnit 700 |
|
V: 1.0 |
2/ 22 |
Order no.: |
Customer no.: |
Date: |
performed by: |
Software version: |
Serial number: |
Company
User
Department
Street
Zip Code, City
Country
Phone
Fax
Maintenance protocol standard ZEEnit 700 |
|
V: 1.0 |
3/ 22 |
1.General information
The ZEEnit 700 is a fully automatic, sequential multielement atomic absorption spectrometer of the latest generation. It can be used both in absorption mode and, for specific elements, also in emission mode.
Being a compact AA spectrometer, it provides the performance of all AAS techniques.
The combination of graphite furnace and flame AAS allows the entire dynamic measuring range of atomic absorption spectrometry from ultratrace to principal component analysis to be covered by a single system.
The system complies with the requirements as laid down in EN ISO 9001.
The used control and analytical software operates on the principles of Good Laboratory Practice (GLP).
The ZEEnit 700 is particularly suitable for quality monitoring in pharmacy or, in general, for the control and monitoring of production processes, thus finding extensive applications in research and environmental care.
2.Definitions
2.1Validation
Described by FDA (Food and Drug Administration, USA) as follows:
Document furnishing proof, that a defined process with a high degree of reliability will continuously yield a product that meets predefined specifications and quality features.
2.2Verification
Defined in EN 45020: Examination of generally accepted performance data of a device or a method that are valid for all applications that can be performed with the device or method.
2.3Qualification
Term used by Pharmaceutical Manufacturers Association (PMA, USA):
The qualification deals with the testing of instruments and software products throughout the entire life cycle of the instrument system. It may be subdivided into different phases.
Specification Qualification (SQ)
Production Qualification (CQ)
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Maintenance protocol standard ZEEnit 700 |
|
V: 1.0 |
4/ 22 |
3.Ascertainment of the techniques and accessories to be tested
In this section, based on the existent order, those techniques shall be defined that are to be tested on the AAS ZEEnit 700 within the scope of the Operational Qualification.
Techniques and accessories that are not included in the supply shall not be subjected to OQ.
Graphite furnace technique
Flame technique
50 mm burner
100 mm burner
Flame technique (emission, 50 mm burner)
4.Function test of basic functions of device and of device peripherals
Functionality of hardware and software
On pressing the green power key, he AAS ZEEnit 700 starts with the automatic initialization of the spectrometer. The autosampler (if installed) also starts with the automatic initialization (sample tray, dosing device and injector arm are moving to their initial positions).
complies |
does not comply |
Date:
Initials:
|
Counter-read by: |
Date: |
|
|
|
|
Maintenance protocol standard ZEEnit 700 |
|
|
V: 1.0 |
5/ 22 |
|
|
|
|
|
|
Communication of hardware and software
The communication between the hardware and the control software of the device is checked by loading the control software (software for flame or graphite furnace technique). In the case of error-free communication, a method stored in the device memory will be loaded.
In the case of a communication error, the message „Time Out“ will appear.
By pressing the Print key on the PC keyboard, the communication with the printer is tested. The printer will print the current screen contents.
Date:
Initials:
Discovery of faults occurring in the functional check
Any faults occurring in the functional test are to be noted in writing on this page. If needed also dates for the rectification of faults that can not be realized within the maintenance shall be enter. If no faults occur in the functional check, this should be signed by the Analytik Jena AG specialist and countersigned from the competent head of laboratory or his/her representative.
Faults occurring |
Comment |
|
|
|
Initials |
Date |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repair of faults |
|
|
Comment |
|
|
Additional |
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
assigned |
|
|
|
||
|
occurring |
|
|
|
|
|
|
|
||
|
|
|
|
|
|
service date |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Initials Date
complies |
does not comply |
The ZEEnit 700 and the included components did not show any apparent faults in the function tests performed.
|
|
Date: |
|
|
Initials: |
|
Counter-read by: |
Date: |
|
|
|
|
Maintenance protocol standard ZEEnit 700 |
|
|
V: 1.0 |
6/ 22 |
|
|
|
|
|
|
5.Operational Qualification (OQ)
Prior to beginning with the OQ (and actual sample measurements), it is advisable to clean the atomizer systems provided and the sample-handling systems by clean-out (graphite furnace atomizer) or by thorough rinsing with nitric acid solution (approx. 1%).
Start-up and successful performance of OQ of the system requires the warm-up of all device components (hollow-cathode lamps, spectrometer, etc.) of at least 20 minutes.
Basic calibration of the AAS ZEEnit 600 / 650 is performed after instrument delivery at the customer's premises. Within the scope of OQ, basic calibration is performed by the analysis of elements that are characteristic for the respective technique or atomizer (graphite furnace.
Basic calibration of the graphite furnace system is based on the analysis of vanadium.
During the procedure, the analytical sensitivity of the spectrometer, expressed by the characteristic concentration C0, and the instrument detection limit (IDL) are determined.
After the calibration, additional tests are run for the precision of analytical determination (relative standard deviation in %) and the recovery rate of a quality control standard.
Maintenance protocol standard ZEEnit 700 |
|
V: 1.0 |
7/ 22 |
Loading...