Risk assessment

In the design of cleanrooms, a key role is played by risk management methodology, which facilitates the development of sound and acceptable solutions made to achieve regulatory requirements related to industrial cleanliness.

One of the risk factors affecting the quality of cleanroom operation is the potential hazard of microbial contamination. Sources of such contamination can include technological media (air, water, inert gases), dust particles, equipment used, personnel, cleaning tools, incoming raw materials, and components. The very evolution of the cleanroom concept is largely aimed at reducing the risk of microbial contamination specifically.

Biocontamination Control and Standards

In accordance with the requirements of the international standard ISO 14698, "Cleanrooms and associated controlled environments — Biocontamination control," cleanroom operations must include a documented policy for ongoing biocontamination control, a sampling plan for risk zones, and a primary and periodic training program for the personnel involved.

The biocontamination control system required by the standard is designed to assess and control factors that may influence the microbiological cleanliness of the process and the manufactured products. Accordingly, such a system must be implemented taking into account the specific field of cleanroom application and existing technologies. This forms the basis of the risk management system, which, in turn, is an integral part of the enterprise's quality system.

Implementing a Documented Control System

When creating a documented control system in accordance with ISO 14698-1:2003 protocols, it is necessary to:

• Identify risk zones and potential hazards, assess the probability of each occurrence, and select appropriate preventive actions;

• Determine critical control points with acceptance criteria that allow for the elimination of hazards or the minimization of their occurrence probability;

• Establish the procedure for actions to be taken when any deviations are detected;

• Maintain the suitability and relevance of the associated documentation;

• Organize an effective personnel training system.

At the design stage, INEX specialists create the most detailed assessment possible of potential risk sources. This assessment is aimed at minimizing and eliminating risks through the refinement of technologies and all cleanroom operation systems, construction logistics, and the mechanism for implementing and maintaining the risk management system.