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«Innovation expert clean rooms»®

hamburger Risk assessment technological processes

INEX specialists within the framework of a comprehensive risk assessment during the operation of cleanrooms, carry out work to assess and manage risks at all stages of their technological processes. A process risk assessment should be performed during any type of validation. Essentially, this process defines the final results as well as the validation parameters for the entire equipment or system and the required functions.

Along with the pre-design analysis of technological risks, giving the customer an understanding of the possibility of certain emergency situations, INEX engineers offer a range of optimal options for technological approaches and, accordingly, the selection of equipment that is as reliable as possible and corresponding to the tasks and needs of the customer.

In order to ensure high quality of technological processes in clean rooms, INEX develops and documents a system of operating instructions. For areas where there is a risk of contamination of technological processes, the main risk factors are indicated, taking into account the purpose of the cleanroom. For these factors, control methods should be determined in case the necessary actions are taken in case of violations of the requirements for cleanliness. The conclusions drawn from the process of assessing technological risks can be included in the project validation plan, in separate protocols or in a separate document.

INEX provides a full range of recommendations for organizing the monitoring of technological processes of a cleanroom during its operation, conducts systematic training of personnel at the required level in accordance with their responsibilities.

At the request of the customer, the development of situational models of technological risks and basic schemes of personnel actions in the event of emergency situations is carried out.