pH/ION meter EzpHION with Ezintegrity: The 21 CFR Part 11 compliant solution

For pharmaceutical laboratories and other highly regulated industries, measuring pH and ion concentration requires not only accuracy but also absolute data integrity and traceability. The EzpHION pH/ION Meter with Ezintegrity software by Electrolab is engineered to be the perfect solution, combining versatile measurement capabilities with full compliance with 21 CFR Part 11 regulations.

Superior features of the EzpHION 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 EzpHION 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.

Versatile measurement: pH and ion concentration (ISE)

The EzpHION provides two-in-one measurement capability, allowing for the accurate determination of both pH and the concentration of specific ions by using the corresponding Ion-Selective Electrode (ISE). This helps optimize laboratory space and investment costs.

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 EzpHION offers maximum flexibility in managing and archiving records in accordance with both GLP and 21 CFR Part 11 principles.

Detailed technical specifications

• Model: EzpHION with Ezintegrity

• Compliance: 21 CFR Part 11

• Parameters: pH, Ion Concentration (ISE), Temperature

• pH Range: 0 to 14.000 pH

• ION (ISE) Range: 0 to 10000 ppm

• Calibration: Up to 5 Points for both pH and ION

• 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 EzpHION?
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 EzpHION is GLP compliant but lacks advanced data security features like an audit trail.

2. Why is 21 CFR Part 11 compliance important for a pH/ION meter?
In the pharmaceutical industry, pH and ion concentrations (e.g., Sodium, Potassium, Chloride) are critical quality attributes. Ensuring that measurement data is accurate, secure, and unalterable is a mandatory requirement from regulatory bodies like the FDA.

3. 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.

4. Which ions can this meter measure?
The meter can measure the concentration of any ion for which a corresponding Ion-Selective Electrode (ISE) is commercially available. You simply need to connect the appropriate ISE to the instrument.

5. Do I need a computer to print my results?
No. One of the key advantages of this meter is its ability to connect directly to a printer via a USB port or over the network, allowing you to print GLP/21 CFR Part 11 compliant reports on the spot.