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.

Test plan		Test report
Test parameter	Acceptance criteria	passed	remarks
Check the delivery	Complete according to delivery note	YES

Inspection of Documentation

Test plan		Test report
Test parameter	Acceptance criteria	passed	remarks
User Manuals	–  Short Instructions NanoPhotometer NP80/N60/N50/C40 –  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.

Test plan		Test report
Test parameter	Acceptance criteria	passed	remarks
Installation of the NanoPhotometer	Power supply plugged in (operating 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.

Test plan		Test report
Test parameter	Acceptance criteria	passed	remarks
Built-in Touchscreen	home screen is shown after 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.

Test plan				Test report
Test parameter	Serial number	Acceptance criteria		passed	remarks
Didymiumglassfilter:	E2343	serial number correct		YES
Valid calibration certificate:		Next calibration:	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.

Test plan			Test report
Test parameter		Acceptance criteria	passed	remarks
Lot number	1606	lot number correct	YES	After opening a vial it can be 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

approx. position:	329 nm	472 nm	512 nm	681 nm
certified expected peaks:	328,71	472,06	512,86	681,29
measured value:	328	472	511	680

Tolerance is +/- 2nm

Test plan			Test report
Test parameter	Serial number	Acceptance criteria	passed	remarks
Didymiumglassfilter	E2343	Peak positions (see also calibration certificate)	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 .

Valuation	passed	remarks
All tests performed	YES
All acceptance criteria fullfiled	YES
System ready to use	YES

	Name (block letter):	Date:	Signature:
Performed by:	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

 

Documents / Resources

IMPLEN NP80 NanoPhotometer Nano Volume and Cuvette [pdf] Instructions NP80, NanoPhotometer Nano Volume and Cuvette

References

• User Manual