Conductivity meter EzCon with Ezintegrity: The 21 CFR Part 11 compliant solution

In the pharmaceutical industry and other highly regulated fields, measuring the conductivity of water and solutions requires not only accuracy but also absolute data integrity. The EzCon multi-parameter conductivity meter with Ezintegrity software by Electrolab is designed to be the perfect solution, combining superior measurement performance with full compliance with 21 CFR Part 11 regulations.

Key features of the EzCon with Ezintegrity

This instrument is equipped with leading technologies to meet the most stringent requirements of a modern laboratory.

Comprehensive 21 CFR Part 11 compliance

This is the most critical feature, turning the EzCon into a powerful tool for the pharmaceutical industry. The integrated Ezintegrity software provides a full suite of security features, including multi-level user management, an unalterable audit trail, and electronic signatures, ensuring all data is secure, traceable, and legally valid.

Accurate multi-parameter measurement

The EzCon is a powerful analysis station, capable of measuring 5 critical parameters on a single device: Conductivity, Total Dissolved Solids (TDS), Salinity, Resistivity, and Temperature, saving valuable bench space and investment costs.

Smart and intuitive operation

With a 7-inch color TFT touch screen and an auto-ranging feature, operation becomes simple and efficient. The instrument automatically selects the most appropriate measurement range for the sample, from ultrapure water to highly concentrated solutions, eliminating errors and ensuring accurate results.

Comprehensive data management and connectivity

The device can store 1000 reports and allows for direct connection to printers, USB drives, mice, and keyboards. Network connectivity facilitates easy integration into LIMS systems and centralized data management, complying with both GLP and 21 CFR Part 11 principles.

Detailed technical specifications

• Model: EzCon with Ezintegrity

• Compliance: 21 CFR Part 11

• Parameters: Conductivity, TDS, Salinity, Resistivity, Temperature

• Conductivity Range: 0.02μS/cm to 2000mS/cm

• Conductivity Calibration: Up to 5 Points

• Display: 7-inch TFT touch screen

• Storage: 1000 reports

• Connectivity: USB (printer, drive), supports mouse and keyboard

Frequently asked questions (FAQ)

1. What is the main difference between this model and the standard EzCon?
The core difference is the software. This model is integrated with Ezintegrity software, making it fully compliant with 21 CFR Part 11 regulations for electronic records and signatures. The standard EzCon is GLP compliant only.

2. Why is 21 CFR Part 11 compliance important for a conductivity meter?
In the pharmaceutical industry, the conductivity of water (e.g., water for injection) is an extremely critical quality parameter. Ensuring that measurement data is accurate, secure, and unalterable is a mandatory requirement from regulatory bodies like the FDA.

3. How does the “Auto Ranging” feature help?
It saves the user from worrying about manual range selection. The instrument automatically determines the sample’s conductivity and displays the result in the most appropriate unit (μS or mS) and resolution, which speeds up the workflow and reduces errors.

4. Can this meter measure the conductivity of ultrapure water?
Yes, by using a probe (cell) with a cell constant of K=0.1, the meter can accurately measure very low levels of conductivity, making it suitable for ultrapure or distilled water.

5. Can I connect this instrument to my lab’s data management system (LIMS)?
Yes, with its network connectivity, data from the EzCon with Ezintegrity can be transferred to a computer and integrated into your LIMS, allowing for efficient and centralized data management.