Validation scheme for measuring procedures for gases/vapors

Status:

completed 05/2021

Aims:

Measuring procedures for determining the concentration of hazardous substances present in the form of gases/vapours in the atmosphere of working areas must satisfy requirements set out in prEN 482:2020 and EN ISO 22065. These requirements had to be specified in a schema for validating procedures for measuring hazardous substances. Further requirements set out in the TRGS technical rules for hazardous substances (including TRGS 402, TRGS 900, TRGS 910) applicable in Germany had also to be taken into account and implemented. Against this background, a validation schema was to be developed which:

• provides the user with information on the form and scope of validation tests based on the assessment standard applicable to the hazardous substance under consideration, and
• specifies the boundary conditions and the evaluation of the tests to be carried out.

The validation schema must state the required documentation both of the preliminary considerations for selection of the validation tests, and of their results. The processes for interpreting the measured values must be comparable. This is to be ensured by a harmonized process employing a calculation file set up for the validation schema.

The validation schema must be comprehensible to all users to permit a harmonized, transparent procedure. It must be available in its latest version to all users at all times. It has therefore to be integrated into the Q.wiki quality management platform, as is the Microsoft Excel calculation program (process data sheet). Responsibility for maintenance and in the event of queries has to be defined by way of responsibility for the website.

Activities/Methods:

All units whose tasks include the analysis of hazardous substances in gaseous form were to be involved by project management in design of the validation schema. Consideration had to be given to the facilities available at the IFA for the practical performance of validation tests (test gas stream, controlled environment).

A user-friendly Microsoft Excel calculation program for interpretation of all validation tests and other relevant process data was to be designed.

The validation schema and the Excel calculation program were to be made available through Q.wiki.

Users were to receive training in use of the validation schema and the Excel calculation program.

Results:

The validation schema for gases and vapours was developed according to the objectives formulated at the beginning of the project and made available in Q.wiki to all staff of the IFA´s Chemical and Biological Effects Department. The Excel calculation program for determining validation data was revised, and also made more user-friendly. A checklist will be used for formal assessment of the measuring procedures. The checklist is coordinated with the two working groups (at the DFG and BG RCI) also responsible for publishing recommended procedures for workplace measurements in accordance with TRGS 402. The checklist is intended to ensure consistent assessment of the scope of validation and the identified performance characteristics of the recommended measuring procedures.

The staff of Chemical and Biological Effects Department were informed about the new developments at two events and were able to contribute experience gained during previous validation activity. This process will be continued.

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