Purpose Of The ISO 14698-1

Behind The Purpose Of ISO 14698-1

The International Organization for Standardization (ISO) is a global federation of national standards bodies that develops international standards. Neslo Manufacturing adheres to ISO standards when manufacturing cleanroom wall systems.  This is done through ISO technical committees in which member bodies with interest in the subject sit on. The organization also partners with other international organizations, government institutions, and non-governmental organizations to carry out its mandate. For example, ISO collaborates with the International Electrotechnical Commission (IEC) for electrotechnical standardization. 

The technical committees prepare drafts of international standards then circulate them to member bodies for voting. A 75% threshold is required for a draft to be published as an international standard.

The ISO 14698-1 was first published in 2003. It describes the basic methodology and principles needed in a formal system to assess and control biocontamination for cleanrooms. This helps in monitoring biocontamination in risk zones in a reproducible way and putting in place the necessary control measures to mitigate the risk.
The aim of ISO 14698-1 is to promote hygienic practices.

In order to assess and control biocontamination, formal systems rely on the following principles:

• Identification of potential hazards to the production process or the product and assessment of the likelihood of their occurrence. Prevention or control measures also have to be identified.
• Designation of risk zones and the determination of controllable factors such as procedures and conditions that eliminate or reduce the chances of the hazards occurring.
• Establishment of control limits.
• Establishment of a schedule for monitoring and observation.
• Establishment of corrective actions when certain trigger conditions are met.
• Establishment of procedures, including supplementary procedures and tests, to verify the effectiveness of the system.
• Establishment of procedures for training personnel.
• Establishment and maintenance of appropriate documentation for the laid-down guidelines and procedures.

Establishing A Formal System

For biocontamination control to be possible, there’s a need for facilities to establish a formal system that allows for the timely detection when conditions deteriorate. The formal system should be tailored to the facility’s needs, the field of application, and specific conditions. It should also include a proper training program for cleanroom personnel besides establishing monitoring guidelines that can be easily implemented to minimize the risk of contamination.

Examples of sources of bio-contaminants include liquids, textiles, surfaces, and air.

Furthermore, facilities are required to put in place biocontamination alerts and action levels depending on the classification of the risk zones and field of application. The facility should rely on data to establish and periodically review alert and action level baselines. When the alerts are triggered, a facility will need to undertake immediate intervention. This includes investigations on the cause and performing corrective action.
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While the ISO 14698-1 addresses viable biocontamination, it isn’t as widely used as the ISO 14644. This is because it doesn’t give specific requirements for application and is quite vague. Other monitoring guidance offers great detail for performing environmental monitoring. The ISO 14644 is more specific and covers most of the physical aspects of cleanroom operations, including counting of particles. There’s no mention of ISO 14698 in any GMP guidance but a review of the standard has already been initiated by the technical committee.