IMPLEN NP80 NanoPhotometer Nano Volume and Cuvette Instructions

IMPLEN NP80 NanoPhotometer Nano Volume and Cuvette

Description of the Qualification

Objectives

This qualification is for the documented validation of the NanoPhotometer , to show that all is conform with the requirements, specifications of the installation and function.

Instrument Description

The NanoPhotometer measures sprectra in the range of 200 nm to 900 nm. Due to the integrated beam deflection and the use of fiber-optic light conductors, the sample can be measured in standard volumes
(cuvettes) and/or NanoVolumes. For the detection there is a 3648 pixel CCD array used. The instrument is maintainance and recalibration free due to sealed optics, the True Path and Sample Compression Technology™. This guarantees for a high accuracy and linearity over the entire life-time.
The following methods are available:

• single and multi wavelengths
• wavescan in the range of 200 nm – 900 nm (adjustable)
• concentration calculations (pre-programmed for nucleic acids and proteins)
• frequency of incorporation/degree of labelling of various fluorescent dyes (pre-programmed for nucleic acids and protein)
• cell density measurements
• colorimetric assays
• standard curves
• absorbance ratio calculations

General Data

System:| UV/Vis spectrophotometer|
---|---|---
Type:| NanoPhotometer
New device| YES
Used device| NO
Serial Number:| M80798
Operating System:| Windows10
Location:| Company:| Implen GmbH
Department:| Product Management
Person in Charge:| Dr. Helena Funk| if| +49 89 726 371 80
User:| Dr. Helena Funk| if| +49 89 726 371 80
Location:| Production

Adress:

|

Schatzbogen 52

City:| Munich
State/Province & Postal:| 81829
Country:| Germany

Validation Tools

The certified validation tools for the NanoPhotometer is a Didymiumglassfilter calibrated against a traceable NIST standard by an accredited supplier and a potassium hydrogen phthalate solution calibrated against a certified UV/Vis spectrophotometer. Calibration certificates can be furnished upon request.

Installation Qualification

Check of delivered items

Test description:
Verification of the delivery content by checking the delivery note.
Enclose a copy of the delivery note to the qualification report.

note

| YES|

Inspection of Documentation

–  NanoPhotometer User Manual

in digital version on USB flash drive

|

YES

|
Certificates| NanoPhotometer Operation

Certificate:

NanoVolume Application Cuvette Application

|

YES

|

Inspection of the Instrument

Test description:
Validation and approval of the NanoPhotometer installation in a technical correct manner according to the user manual of the supplier.

voltage: 90-250 V, 50/60 Hz, 90W, 19 VDC) and

load the battery pack at least for 3 hours prior to the first use

|

YES

|
By switching the instrument on a self-diagnostic check is automatically performed| pass all tests – no failure message appears – main display is shown|

YES

|
Integrated vortexer| Activated if NanoPhotometer is switched on and deactivated if the NanoPhotometer is

switched off.

|

YES

|

Installation of Software

Test description:
Validation and approval of the software installation in a technical correct manner according to the user manual of the supplier.

starting the instrument

| YES| N/A when no touch screen is

connected

computer (PC/MAC)| software can be opened and the home screen of the connected NanoPhotometer is shown|

YES

| N/A when using the built-in touch screen, a smart phone or tablet for controlling the NanoPhotometer.
Tablet| software can be opened and the home screen of the connected NanoPhotometer is shown|

YES

| N/A when using only the built-in touch screen, a computer or tablet for controlling the

NanoPhotometer.

Smart Phone| software can be opened and the home screen of the connected NanoPhotometer is shown|

YES

| N/A when using only the built-in touch screen, a computer or tablet for controlling the

NanoPhotometer.

Installation of Printer

| Installation of Printer| | |
---|---|---|---|---
| Test plan| Test report
Test parameter| Acceptance criteria| passed| remarks
Printer via USB

cable/network/WiFi network

| Print icon is shown on all

method screens.

| YES| N/A when no printer is

available

Printer is functional| Do a measurement and print

the results.

| YES| N/A when no printer is

available

| Printer installataion passed| YES|

Operation Qualification

Validation of the Calibration Standard

Test description Didymiumglassfilter:
As a validation tool, the Didymiumglassfilter is the secondary spectrometric calibration standard used. This filter is calibrated and checked against calibration- or control standards, which are NIST proven. For all validation tools which are used during the qualification, an actual and valid calibration certificate is necessary. Enclose a copy of the calibration certificate to the qualification report.

5.11.2021

|

YES

| recalibration of the Didymiumglassfilter every

24 months

Test description potassium hydrogen phthalat solution:
As validation tool a potassium hydrogen phthalat solution used. This solution is calibrated and checked against a certified UV/Vis spectrophotometer.

used for one hour.

Absorbance @ 280 nm

(10 mm path)

| 21,40| Absorbance entered| YES| The absorbance can be

found on the vial.

Validation of the Wavelength Accuracy – Cuvette

Test description:
Method: More Apps – Wavescan
Parameter Settings: Change to Cuvette, Pathlength 10 mm, Start Wavelength 200 nm, End Wavelength 900 nm, Baseline Correction Off, Smoothing 1
Blank: air
Sample: Didymiumglassfilter S/N E2343

Tolerance is +/- 2nm

YES

| Peak position must be visible in the graph, if not listed in the table please check manual for the corresponding peak

Validation of Absorbance Accuracy – Cuvette

Test description:
Cuvette mode
Method: More Apps – Wavelength
Parameter Settings: Change to Cuvette, Pathlength 10 mm, add 4 Wavelengths: enter wavelengths 270 nm, 280 nm, 321 nm and 341 nm, Baseline Correction Off, Smoothing 1
Blank: air
Sample: Didymiumglassfilter S/N E2343

| certified expected

absorbances:

| tolerance| measured values:
---|---|---|---
A270| 1,145| +/- 0.050| 1,140
A280| 1,143| +/- 0.046| 1,140
A321| 0,790| +/- 0.046| 0,790
A341| 0,495| +/- 0.034| 0,490
Test plan| Test report
---|---
Test parameter| Serial number| Acceptance criteria| passed| remarks
Didymiumglassfilter| E2343| The measured absorbances (270, 280, 321 and 341 nm)

have to be in the tolerance

range defined in the calibration certificate

| ****

YES

|

Validation of the Reproducibility – Cuvette

Test description:
Method: More Apps – Wavelength
Parameter Settings: Change to Cuvette, Pathlength 10 mm, enter wavelength 270nm, 280 nm, 321 nm and 341 nm, Baseline Correction Off, Smoothing 1
Blank: air
Sample: Didymiumglassfilter S/N E2343

| certified expected

absorbances:

| tolerance| measured values:| measured values:| measured values:| measured values:| CV%
---|---|---|---|---|---|---|---
A270| 1,145| +/- 0.050| 1,145| 1,144| 1,145| 1,145| 0,038
A280| 1,143| +/- 0.046| 1,143| 1,142| 1,144| 1,143| 0,062
A321| 0,790| +/- 0.046| 0,790| 0,790| 0,799| 0,790| 0,492
A341| 0,495| +/- 0.034| 0,495| 0,495| 0,495| 0,495| 0,000
Test plan| Test report
---|---
Test parameter| Serial number| Acceptance criteria| passed| remarks
Didymiumglasfilter| E2343| CV% = 0.75%| ****

YES

|

Validation of the Baseline – Cuvette

Test description:
Method: More Apps – Wavelength
Parameter Settings: Change to Cuvette, Pathlength 10 mm, enter wavelength 280 nm, Baseline Correction 377 nm, Smoothing 1
Blank: air
Sample: empty cell holder (air)

| tolerance| measured

values:

| measured

values:

| measured

values:

| measured

values:

| Absmax| � Abs
---|---|---|---|---|---|---|---
A280| +/- 0.002| 0,000| 0,000| 0,000| 0,001| 0,001| 0,001
Test plan| Test report
---|---
Test| Acceptance criteria| passed| remarks
Measurement against air / empty cell holder| Tolerance is +/- 0.002 A according to the technical specifications| ****

YES

|

Validation of Absorbance Accuracy – NanoVolume

Test description:
Method: More Apps – Wavelength
Parameter Settings: Dilution 15, Wavelength 280 nm, Baseline Correction 377 nm, Smoothing 1 Blank: water
Volume: 1.5 µl
Sample: vial with lot number 1606

| certified

expected absorbances:

| measured values:
---|---|---
A280| 21,40| 21,390
Test plan| Test report
---|---
Test parameter| Lot number| Acceptance criteria| passed| remarks
Potassium hydrogen phthalate solution (PHP)| 1606| The absorbance at 280 nm has to be in the certified range| ****

YES

|

Validation of the Reproducibility – NanoVolume

Test description:
Method: Protein UV
Parameter Settings: BSA, Volume 1 µl- 2 µl, wavelength 280 nm, Background Correction: On, Manual Dilution: Off Blank: water
Volume: 1.5 µl
Sample: water/pipette once and measure four times

| certified expected

absorbances:

| measured values:| measured values:| measured values:| measured values:| Absmax| ∆Abs
---|---|---|---|---|---|---|---
A280| 0,000| 0,000| 0,000| 0,002| 0,000| 0,002| 0,002
Test plan| Test report
---|---
Test parameter| Lot number| Acceptance criteria| passed| remarks
Water| 1606| Four repeated absorbance measurements tolerance is +/-

0.03 A (10 mm path) according to the technical specifications.

| ****

YES

|

Validation of the Baseline – NanoVolume

Test description:
Method: More Apps – Wavelength
Parameter Settings: Dilution 15; wavelength 280 nm, Baseline Correction 377 nm, Smoothing 1 Blank: air
Sample: air – no sample

| tolerance| measured

values:

| measured

values:

| measured

values:

| measured

values:

| Absmax| � Abs
---|---|---|---|---|---|---|---
A280| +/- 0.03| 0,002| 0,005| 0,000| -0,005| 0,005| 0,010
Test plan| Test report
---|---
Test| Acceptance criteria| passed| remarks
Measurement against air / empty cell holder| Tolerance is +/- 0.03 A (10 mm path) according to the technical specifications| ****

YES

|

Results and Release of Installation and Operation Qualification

The below listed persons confirm with their signature the succsessful installation and operation qualification of the NanoPhotometer .

Dr. Helena Funk

|

13.03.2020

|
Approved by:|

Dr. Michael Riepl

|

13.03.2020

|

Attachments

1. Copy of delivery note
2. Calibration Certificates for the NanoPhotomter
3. Calibration Certificate for the Didymiumglassfilter
4. Calibration Certificate for the Standard Solution

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