Cleanzone 2019

National societies in cleanroom technology and contamination control often make guidelines that fit the needs of the industries in their country. These guidelines often contain new knowledge. Sometimes these guidelines are used in the development of new standards or the revision of existing standards. In an ISO or CEN standards working group the knowledge of the participating countries is shared, combined and put as a common denominator into a new standard. Through the international standard the knowledge becomes available in the countries that adopt the new standard.In the ISO TC209 recent examples are the standards on cleanroom suitability (ISO 14644-14 and 15), energy efficiency (ISO 14644-16) and particle deposition rate (ISO 14644-17). As an example the monitoring and application of particle deposition rate, the key parameter in contamination control, will be discussed.

National societies in cleanroom technology and contamination control often make guidelines that fit the needs of the industries in their country. These guidelines often contain new knowledge. Sometimes these guidelines are used in the development of new standards or the revision of existing standards. In an ISO or CEN standards working group the knowledge of the participating countries is shared, combined and put as a common denominator into a new standard. Through the international standard the knowledge becomes available in the countries that adopt the new standard.

Participants will get an overview on current status of ISO 14644 clean rooms standards, discussions on content for standards under revision and an future perspective.

The current version of ISO 14644-4 dates back to 2001. Within ISO Technical Committee (TC) 209 working group (WG) 4 has been assigned the task to review and update this part of the 14644 and 14698 set of standards.

Participants will get an overview of the current standard on biocontamination control, ISO 14698:2003 and some of the limitations in its practical application. Experts from 10 European countries, working in Cleanroom Microbiology and Engineering, across many industries have been collaborating since 2016 in working group, WG-05 CEN TC243 on this important subject of biocontamination control. The result of this CEN activity is out for final ballot at present, FprEN17141, This revision adopts the principles of QRM and is written to be more usable in terms of practical applications for Pharmaceuticals, Medical Devices, Hospital and Food industries. The result of the ballot will be discussed and plans to integrate this standard within the wider ISO 14644 family of cleanroom standards.

Every two years a member society of the ICCCS (International Confederation of Contamination Control Societies) organizes the International Symposium on Contamination Control and Cleanroom Technology. Under the able guidance of Hasim Solmaz and his team at Cleanroom Technologies Society of Turkey, ISCC’2020 is being held in Antalya, Turkey from 12 to 15 of October 2020.

Project sequence: EVERYTHING HANGING TOGETHER !!!Planning processes and contentsQualification Who, How, What, When?Qualification measurements OQ, PQCommunication with the authority

Why is light more than just brightness?Shapes and colors - and no end ...Recognize and understand connections!Light can and must be used as a tool!The light of the future ...

Particle counter calibration in accordance with ISO 21501-41. Functioning of a particle counter2. Influence of the particle properties on the measured particle size3. Quality characteristics of a particle counter4. Calibration of a particle counter

For the implementation of tailor-made system solutions for clean rooms and measuring rooms, the air conditioning unit is a crucial component. Space requirements and flexibility in the planning of equipment are key influencing factors in the functionality of the overall system and in the planning and investment process. The differences of the device systems and their modular extension, such as Chillers for compact air conditioning units determine the areas of application (clean rooms, laboratories, production rooms, process rooms and measuring rooms).

May the force be with us!Anyone who fights daily in cleanrooms against the dark side of power (microorganisms and particles) must be well prepared. But how? The newly published practice book "Cleanroom in the Pharmaceutical Industry" provides the necessary tools and covers everything from planning through qualification to the everyday use of cleanrooms, with a view into the future not too short.The book presentation is supplemented by a discussion round with the writing team.