Implen NanoPhotometer®, Fully Compliant 21 CFR Part 11 #1 Alternative

Implen is a privately held corporation that is a leading supplier for spectroscopy instruments and consumables for the non-destructive analysis of ultra-low volume samples. The company focuses on biological, chemical, and pharmaceutical laboratories in industry and research. Implen has a strong focus on the customer taking pride in providing quality products and a high level of customer service to achieve total customer satisfaction.

Over the past years laboratories working in GMP / GLP / GxP regulated environments have been increasingly inquiring about the ability to add 21 CFR Part 11 compliance to their nanovolume UV/Vis spectrophotometer instruments. Since April 2019 eligible models from the Implen NanoPhotometer® product line can be upgraded with our CFR21 software package to help our users to become compliant with FDA requirements – Implen was again spearheading the market offering FDA 21CFR Part11 compliance for the NanoPhotometer® class of spectrophotometers – stand-alone with battery backup via the built-in computer and touch screen, through external computers or via Rest API with most LIMS systems.

Implen NanoPotometer® 21 CFR Part 11 Compliance

Fully Compliant!

In March of 1997, the United States Federal Drug Administration (FDA) issued final Part 11 regulations that provide criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records by the FDA as equivalent to paper records and handwritten signatures executed on paper under certain conditions.

21 CFR Part 11 became effective in August 1997 and since then has been constantly revised and narrowed to minimize the efforts for the industry whilst protecting the public health efficiently.
After several optimizations steps, the FDA today is intending to enforce provisions related to the following controls and requirements:1

Limiting system access to authorized individuals
Use of operational system checks
Use of authority checks
Use of device checks
Determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
Appropriate controls over systems documentation
Controls for open systems corresponding to controls for closed systems bulleted above
Requirements related to electronic signatures

1 Part 11, Electronic Records; Electronic Signatures – Scope and Application

Ideal 21 CFR Tool for GLP/GMP/GxP Laboratories

The Implen NanoPhotometer CFR21 software complies with the current FDA 21 CFR Part 11 requirements and is an optional software tool ideal for GLP/GMP/GxP laboratories, which require proper electronic record keeping. Implen’s CFR21 software includes

User management
Access control
Electronic signatures
Data integrity
Data security
Audit trail functionality

For a detailed list of CFR21 software features and the corresponding FDA requirements please refer to the following information

CFR21 Software Statement

Compare to Alternative Technologies

Installation and Operation Qualification (IQOQ)

The NanoPhotometer® IQOQ package consists of a liquid and/or a solid NIST traceable secondary standard and a corresponding Excel based software tool depending on the type of instrument. The liquid standard is based on a non-toxic compound absorbing at 280 nm to cover the area of most interest for Life Science Applications. All secondary standards come with a certificate of compliance. The Excel based software produces an automated report displaying all relevant data for an audit. The IQOQ procedure is fully described within the report documents and is simple and straightforward so that it can be carried out by a local lab technician to save time and cost.

Download Sample Report

LIMS Integration via REST API

implen nanophotometer 21 cfr part 11 compliance GLP lab

To add a variety of options and to increase efficiency to your workflow by integrating the NanoPhotometer® with your LIMS to control processes, eliminate errors and save time.

The NanoPhotometer® can be integrated with any LIMS software provider via our proprietary REST API allowing not only to obtain data from the instrument straight into the worksheet, but also to execute methods that have been established within LIMS. Please contact your local Implen support Team to learn more about the option and to get the integration process started.

Compare to Alternative Technologies

Compare Single Channel Spectrophotometers

The table below demonstrates a comparison of the NanoDrop™ One/One C vs. our NanoPhotometer® line of spectrophotometers

Features	NanoDrop™ One / One C	Implen NanoPhotometer® N60/NP80
21 CFR Part 11 Upgrade
Software Control	External control via Windows computer only	Stand-Alone and/or control via Windows and Mac OS
User Management	Yes	Yes
Audit Trail	Yes	Yes
Electronic Signature	Yes	Yes
Instrument Performance
Minimum Sample Volume	1 µL 2 µl sample size is recommended for protein measurements	0.3 – 2 μL
Pathlength	0.03 – 1 mm Auto-ranging	Utilizes two fixed path lengths 0.67 and 0.07 mm Fixed path lengths never change over the lifetime of the instrument
Measurement Time	8 seconds	2.5 – 4 seconds (full scan 200 – 900 nm)
Enclosed Sample Measurement Surfaces	NO Column is exposed to surroundings	YES Enclosed sample measurement surfaces No evaporation Accurate results independent from environmental conditions Ability to measure proteins with detergent buffers without sample build-up
Photometric Range Cuvette	0 – 1.5 A (with a 10 mm cuvette)	0 – 2.6 A
Analyze Organic Solvent Samples in a Drop	Cuvette only	The NanoPhotometer® Sample Compression Technology allows the analysis of organic solvent samples in a drop and in a cuvette
Detection Range*	dsDNA: 2 – 27,500 ng/µl BSA: 0.06 – 820 mg/ml	dsDNA: 1 – 16,500 ng/µl BSA: 0.03 – 478 mg/ml
Optical Specifications
Measurement Wavelength	Full scan from 190 – 850 nm	Full scan from 200 – 900 nm
Illuminated Read Head	N/A	Illuminated read head for an easy sample application
Light Source	Xenon Flash Lamp	Xenon Flash Lamp
Instrument Features
Built-In Vortexter	N/A	YES 2,800 rpm; tube size up to 2.0 ml
Reconditioning-free	NO The pedestal of the instrument may become unconditioned over time, especially when measuring proteins or samples that contain surfactants or detergents. This requires reconditioning of the unit’s pedestal.	YES Scratch-resistant inert quartz pedestal that requires no reconditioning
Quality Control Warnings	Acclaro Technology with contaminant calculations	Sample Control™: quality control technology identifies sample impurities, potential contaminants, turbidity and lint residue Blank Control™: prevents inaccurate readings caused by high background blanks or insufficient cleaning
Built-in Web Application Server	NO Limited Android-based internal computer only	Full Web Application Server with REST API
Processing Power, Compatibility, Data Processing
Operating System	Android	Linux based NPOS (NanoPhotometer Operating System) Open platform to connect to Windows, Mac OS, Android, iOS via web application interface
Internal Data Storage	32 GB	32 GB for storage of thousands of measurements
Software Compatibility	Compatible with Windows only	Compatible with Windows 7, 8, 10 (32 and 64 bit), Mac OS X, iOS and Android OS
Data Transfer and Connectivity Options	The unit includes 3x USB A, Ethernet, Bluetooth, WiFi	The unit includes 2x USB A, USB B, HDMI, Ethernet, WiFi
Data Output	Separate as .csv .tsv .sql	Complete data as PDF & Excel
Instrument Control	The device can be connected to a computer via Ethernet cable for operation, control and data storage.	Easy control of the NanoPhotometer is possible via Wi-Fi from tablets or smartphones (Android OS & iOS). Control from PCs via LAN, WiFi or USB (Windows & Mac). The HDMI port allows for presentations directly from the device.
WiFi Hotspot	Client possible	Built-in WiFi hotspot and with WiFi client capability
Instrument Dimensions	20 × 25.4 × 32.3 cm (8 × 10 × 12.7 inches)	20 x 20 x 12 cm (7.9 x 7.9 x 4.7 inches)

Compare Multi Channel Spectrophotometers

The table below demonstrates a comparison of the spectrophotometers 8-channel NanoDrop™ 8000 vs. 12-channel NanoPhotometer® N120

Features	NanoDrop™ 8000	Implen NanoPhotometer® N120
21 CFR Part 11 Upgrade
Software Control	N/A	Stand-Alone and/or control via Windows and Mac OS
User Management	N/A	Yes
Audit Trail	N/A	Yes
Electronic Signature	N/A	Yes
Instrument Performance
Number of Samples	Up to 8	Up to 12 Single sample mode available
Minimum Sample Volume	1 µL 2 µl sample size is recommended for protein measurements	2 – 3.5 μL
Pathlength	0.2 and 1 mm	Utilizes two fixed path lengths 1 and 0.125 mm Fixed path lengths never change over the lifetime of the instrument
Measurement Time	Less than 20 seconds 220 – 750 seconds for 8 samples	20 seconds for 12 samples (full scan 200 – 900 nm)
Enclosed Sample Measurement Surfaces	NO Column is exposed to surroundings	YES Enclosed sample measurement surfaces No evaporation Accurate results independent from environmental conditions Ability to measure proteins with detergent buffers without sample build-up
Analyze Organic Solvent Samples in a Drop	N/A	The NanoPhotometer® Sample Compression Technology allows the analysis of organic solvent samples in a drop and in a cuvette
Detection Range*	dsDNA: 2.5 – 3,700 ng/µl BSA: 0.15 – 100 mg/ml	dsDNA: 2 – 8,000 ng/µl BSA: 0.06 – 230 mg/ml
Optical Specifications
Measurement Wavelength	Full scan from 190 – 850 nm	Full scan from 200 – 900 nm
Illuminated Read Head	N/A	Illuminated read head for an easy sample application
Light Source	Xenon Flash Lamp	Xenon Flash Lamp
Instrument Features
Quality Control Warnings	N/A	Sample Control™: quality control technology identifies sample impurities, potential contaminants, turbidity and lint residue Blank Control™: prevents inaccurate readings caused by high background blanks or insufficient cleaning
Built-in Web Application Server	N/A	Full Web Application Server with REST API
Processing Power, Compatibility, Data Processing
Operating System	N/A Needs to be connected to a Windows computer	Linux based NPOS (NanoPhotometer Operating System) Open platform to connect to Windows, Mac OS, Android, iOS via web application interface
Onboard Processor	N/A	Built-in computer with high-performance Intel Celeron dual core 2.4 GHz processor
Internal Data Storage	N/A	128 GB for storage of thousands of measurements
Software Compatibility	Compatible with Windows only	Compatible with Windows 7, 8, 10 (32 and 64 bit), Mac OS X, iOS and Android OS
Data Transfer and Connectivity Options	USB	The unit includes 2x USB A, USB B, HDMI, Ethernet, WiFi
Data Output	Separate as .csv .tsv .sql	Complete data as PDF & Excel
Instrument Control	The device must be connected to a computer via USB cable for operation, control and data storage.	Easy control of the NanoPhotometer is possible via Wi-Fi from tablets or smartphones (Android OS & iOS). Control from PCs via LAN, WiFi or USB (Windows & Mac). The HDMI port allows for presentations directly from the device.
WiFi Hotspot	N/A	Built-in WiFi hotspot and with WiFi client capability
Instrument Dimensions	24 × 32 cm (89.4 × 12.6 inches)	20 x 20 x 12 cm (7.9 x 7.9 x 4.7 inches)

* dsDNA tends to precipitate/coagulate at concentrations above 10,000 ng/µl and should be diluted.

NanoDrop™ and NanoDrop™ One are registered trademarks of Thermo Fisher Scientific.
Implen® is not affiliated, sponsored or endorsed by Thermo Fisher Scientific or NanoDrop™.

Implen’s Overcoming 21 CFR Part 11 Limitations of Other Technologies

Have you experienced any of these difficulties finding the right technology?

No user management/21 CFR part 11 compliant software available
User management/21 CFR part 11 compliant software only available via external computer (no stand alone option)
No REST API interface available to connect to your LIMS System
Complex and pricy IQOQ procedures only offered with an expensive contract for onsite service
Long measurement times
Cumbersome software user interface
Costly recalibration/maintenance or decreasing accuracy over time
Instrument’s service and support discontinued and software not compatible with Windows10 or Mac OS
Low reproducibility (mainly caused by evaporation effects)
Getting results for more than 40 samples per run is time consuming
Waited for weeks to get instrument repaired

other-technologies-instruments-difficulties

How about trying a device that overcomes
all of these 21 CFR issues?

implen nanophotometers number one nanodrop alternatives N120 NP80 N60 C40

NanoPhotometer® Models Request a Quote

Implen NanoPhotometers® Reviews

“Excellent design and is easy to use“

Rating: 5.0 ★★★★★

Application Area: Neurosciences

“The photometer has excellent design, and is easy to use. Built-in vortex is one of the smartest decisions I’ve seen in lab equipment. Data manipulaton and interface decrease hand-on time, and are user-friendly.”

Olga Starkina
Organization: Melsytech LLC, Russia

“Really impressed with the accuracy, ease of use, and increased sample throughput“

Rating: 5.0 ★★★★★

Application Area: DNA Analysis

“I’ve really been impressed with the accuracy, ease of use, and increased sample throughput with this instrument. All this in such a small and sleek black box. The touch screen interface is a nice feature and very straightforward. You can easily navigate through the applications, load templates, access and analyze your data. I like that you’re given the option to run up to 12 samples at a time but you can also choose to run 1 or 2 samples, customizable to your experiments. Having options is always a plus and you get that with the N120. The pipette guide makes it really easy to apply your samples. I can see that a lot of time, expertise, and careful considerations went into developing the NanoPhotometer.”

Nam Che
Organization: UCLA Department of Medicine, USA

“Accurate Measurements, Solid Device“

Rating: 5.0 ★★★★★

Application Area: DNA Concentration Quantification

“My lab does a lot of molecular cloning work for synthetic biology projects. For the longest time we didn’t have any reliable and simple way of quantifying DNA concentration. This device has been a a life saver. It is accurate (checked samples against other similar devices), easy to use, has lots of extra features that the competitors lack and is cheaper.
If you are just needing to quantify DNA concentration the N50 is a solid choice. But it comes with so many other features you’ll be left wondering how other manufacturers get away with charging more for less. Overall the device is very sturdy and produces accurate results. But beyond just the basics you can do protein and kinetics assays and more. The touchscreen is easy an intuitive. Results are saved directly to the machine as a pdf or spreadsheet and can be retrieved remotely by a tablet/phone or a desktop computer. I prefer to simply copy the pdf directly to my laptop over the network. Another great feature is that the sample pedestal has a visible light shining through it while you load the sample which makes it easier to see what you’re doing. That is something I have not seen on any other microvolume spectrophotometer. My only complaint, if I have to come up with one, is that typing on the touchscreen with my arm extended out in front of my is kind of clumsy. But its a minor inconvenience. I just stick to short samples names.”

Cory Tobin
Organization: TheLab Inc, USA

“Best small volume spec on the market“

Rating: 5.0 ★★★★★

Application Area: Protein/nucleic acid quantitation

“The Implen NanoPhotometer N50 is extremely easy to use (intuitive menus and settings), accurate, and genuinely capable of measuring very small volumes repeatably. The touch screen works well even with gloves. Window configurations are adaptable so you can customize the information you’re looking at while working. The instrument is light and mobile, and since it’s all-in-one, you can literally move it to where you’re working as needed. It’s not stuck in a particular corner of the lab. In my opinion, it’s the best nano-scale measurement device on the market for routine lab sample quantification and spectral reading.”

David Rawling
Organization: Inflammatix, Inc., USA

“Easy use and accurate results “

Rating: 4.7 ★★★★★

“We are using it for nucleic acid quantification. It’s so easy to use, gives accurate results and easy to save data in organized way. Would recommend it.”

Dr. Assala Samad
Organization: University of Oxford, United Kingdom

#1 Alternatives from Implen

If you like to learn more about our technology and get an introduction into our range of cutting edge spectrophotometers and its advantages, please get in touch with one of our team or your local distribution partner.

Request a Quote

NanoDrop™ and NanoDrop™ One are registered trademarks of Thermo Fisher Scientific.
Implen® is not affiliated, sponsored or endorsed by Thermo Fisher Scientific or NanoDrop™.

Implen NanoPhotometer®, Fully Compliant 21 CFR Part 11 #1 Alternative

Implen NanoPotometer® 21 CFR Part 11 Compliance

Fully Compliant!

Ideal 21 CFR Tool for GLP/GMP/GxP Laboratories

Installation and Operation Qualification (IQOQ)

LIMS Integration via REST API

Compare to Alternative Technologies

Compare Single Channel Spectrophotometers

Compare Multi Channel Spectrophotometers

Implen’s Overcoming 21 CFR Part 11 Limitations of Other Technologies

Have you experienced any of these difficulties finding the right technology?

How about trying a device that overcomes
all of these 21 CFR issues?