Standards Development

Scope

This document establishes procedures for measuring temperature, humidity and pressure tests on equipment critical to the sterilization process.

The document includes specifications for data collecting instruments, requirements for data protection, requirements for personnel involved in the qualification, maintenance and calibration of data collecting systems, standard instruments for calibration, sensors for measurement of temperature, pressure and other variables, periodicity of test equipment qualification, and guidance on the number and position of the sensors for each piece of equipment.

Purpose

The Technical Validation Standards require submission of the equipment to thermometric challenges to meet the defined requirements. Without these, it is not possible to validate the equipment in all its requirements.

In order that thermometric measurements results represent the correct functioning of the equipment, it is essential to select an adequate procedure, the personnel performing the activity has specific skill and training, and the data collecting equipment used is suitable for the purpose of the activity. The protocol and report are necessary to perform the qualification of the equipment.

The processing of primary data also has a great influence on the results of the tests, so it is necessary to adopt procedures aiming that the exploratory analysis of the data leads to the correct result of the measurements performed on the equipment.

The ABNT NBR 16328:2023 standard was developed based on standard requirements and equipment characteristics. The intent of this standard is to provide users who want to validate their equipment according to standards, a procedure that allows them to complete the task of thermometric measurements with a procedure that can be replicated and ensure that the final results correctly represent the operation in which the equipment is being validated.