The ideal solution for GMP environments
NucleoCounter® NC-200™ saves you time and optimizes workflow through automation. Compared to manual counting, the workflow is simpler, faster and easily standardized. Sample preparation is minimal and does not require sample pipetting out or adding dyes.
Figure 1: Comparison of time and procedure for a cell count and viability in manual vs. automated counting.
Key to the simplified workflow is the Via1-Cassette™: it is your pipette, your mixing apparatus, and your disposal container all in one. The Via1-Cassette™ eliminates time-consuming steps and provides more standardized counts with higher precision. Read more about the Via1-Cassette™ here
Precision and repeatability
All NucleoCounter® NC-200™ LEDs, optics and light profiles are adjusted to a common reference to ensure that all data is acquired under the same conditions. Consequently, all NucleoCounter® NC-200™ instruments are inter-comparable (see Figure 2).
LEDs are stable in their intensity over time which ensures consistency and durability. Read more about LED stability here. The optics are set during production and cannot be altered, ensuring consistency among users. For these reasons the NucleoCounter® NC-200™ does not need to be calibrated on an ongoing basis. Instead, scheduled IQ, OQ and PQ is used to verify instrument performance. The Via1-Cassettes™ are volume calibrated during production which ensures consistent sampling and cell staining. This is why the counting precision of the NucleoCounter® NC-200™ is unmatched in the market.
The unique design of the NucleoCounter® NC-200™ and Via1-Cassette™ combined with our unparalleled customer service has resulted in a broad recognition and adaptation by the world’s leading laboratories and companies.
Figure 2: Graph of Jurkat cells at 2 million cells per mL tested on 4 different NucleoCounter® NC-200™ instruments by four separate users.
Figure 3: Example locations of NucleoCounter® NC-200™ instruments (1-4). All of our instruments are calibrated to a master instrument and therefore perform the same.
Many NucleoCounter® users have successfully validated our equipment for their specific purposes in clinical applications or manufacturing. Application specific validation is necessary since the NucleoCounter® NC-200™ is intended for research use only.
IQ / OQ / PQ kits for validating instrument performance
Functional qualification of the NucleoCounter® NC-200™ is easily implemented using the available Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) kits. These kits are available from Chemometec to perform scheduled instrument performance validation.
Figure 4: NC Test Kit 3 used for PQ testing consists of three bead concentrations and a certificate defining the acceptable ranges and CV values for each test bead concentration.
NucleoCounter® NC-200™ data is saved locally or on a network in a secure file format. The NucleoCounter® NC-200™ can be used with a license for 21 CFR Part 11. Read more here: NucleoView™ – 21 CFR Part 11 ready software
Figure 5: Example of data management in a facility with multiple NucleoCounter® NC-200™ in multiple clean room suites.
The NucleoCounter® NC-200™ software, NucleoView™, features automatic generation of PDF reports in addition to electronic archiving. The report contains an abstract of the most critical information about the recorded data. The PDF reports can automatically be saved, opened and/or printed from a physical printer.
There is no limit to the number of IT systems that the NucleoView™ software can be installed on, allowing a variety of options for data management and analysis.
Cleaning and maintenance
The NucleoCounter® NC-200™ only requires cleaning on the outside in case of spillage. Accordingly, the exterior can be cleaned with 70% ethanol and a soft cloth or tissue. Dust are removed by pressurized air (spray). Dust and other spillages are be avoided by keeping the lid on the instrument when it is not in use. The NucleoCounter® NC-200™ is easily moved for daily or routine cleaning procedures as it only weighs 3 kg (6.6 lbs.).
Figure 6: Photograph of exterior cleaning procedure of a NucleoCounter® NC-200™ with a wipe saturated with 70% Ethanol.