Dedicated ion meter EzION with Ezintegrity: The 21 CFR Part 11 compliant solution

In highly regulated industries like pharmaceuticals, measuring ion concentration requires not only accuracy but also absolute data integrity and security. The EzION dedicated ion meter with Ezintegrity software by Electrolab is engineered to be the perfect solution, combining specialized measurement performance with full compliance with 21 CFR Part 11 regulations.

Superior features of the EzION with Ezintegrity

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

Comprehensive 21 CFR Part 11 compliance

This is the most critical feature, making the EzION an indispensable tool in a regulated environment. 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.

Dedicated and accurate ion measurement

The EzION focuses entirely on ion concentration measurement, allowing for precise determination using the corresponding Ion-Selective Electrode (ISE). Support for up to 5-point calibration ensures high linearity and accuracy across the entire measurement range.

Modern touch interface and smart operation

The 7-inch color TFT touch screen makes operation incredibly simple. The user-friendly graphical interface and built-in instructions allow users to easily perform calibrations, measurements, and data management without complex training.

Comprehensive data management and connectivity

With a large memory for 1000 reports and direct connectivity to printers, USB drives, mice, and keyboards, the EzION offers maximum flexibility in managing and archiving records in accordance with both GLP and 21 CFR Part 11 principles.

Detailed technical specifications

• Model: EzION with Ezintegrity

• Compliance: 21 CFR Part 11

• Parameters: Ion Concentration (ISE), Temperature

• ION (ISE) Range: 0 to 10000 ppm

• Concentration Units: ppm, Moles/Ltr, %W/V, mg/L, pX

• ION Calibration: Up to 5 Points

• Display: 7-inch TFT touch screen

• Storage: 1000 reports

• Connectivity: USB (printer, drive), Wi-Fi, Network

Frequently asked questions (FAQ)

1. What is the main difference between this model and the standard EzION?
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 EzION is GLP compliant but lacks advanced data security features like an audit trail.

2. Why is 21 CFR Part 11 compliance important for an ion meter?
In the pharmaceutical industry, the concentration of certain ions can be a critical quality attribute. Ensuring that measurement data is accurate, secure, and unalterable is a mandatory requirement from regulatory bodies like the FDA.

3. Does this meter measure pH?
No. This is a dedicated meter for measuring ion concentration only. If you need to measure both pH and ions, you should consider the EzpHION with Ezintegrity model.

4. What is an “Audit Trail”?
An Audit Trail is a secure, computer-generated, time-stamped electronic record that independently records all actions related to the creation, modification, or deletion of a record. This trail cannot be altered, which helps ensure data integrity.

5. Can I connect this instrument to my lab’s LIMS?
Yes, with its network connectivity (Wi-Fi/LAN), data from the EzION with Ezintegrity can be transferred to a computer and integrated into your Laboratory Information Management System (LIMS).