Cleanroom Staff Training
Quality assurance of the production process
A significant factor in quality assurance of the production process is the qualification of your personnel.
Facility Managers, maintenance personnel and those working in the cleanroom, must constantly adapt themselves
to the requirements and circumstances of cleanroom operation, and must be regularly trained in
this respect. The training is not merely a matter of echoing the specific work content and guidelines on
behavior, but specialist knowledge must also be conveyed und refreshed. This motivates and simultaneously
increases the efficiency of your staff.
Cleanroom controls, monitoring sensors, utility systems, and filtration systems need to be monitored and maintained on a
regularly scheduled maintenance program.
ISO Standards on Cleanroom Operation:
ISO 14644-1, Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness covers the classification of air cleanliness in cleanrooms
and associated controlled environments. Classification in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particles. Furthermore,
the only particle population's consideration for classification purposes are those that have cumulative distributions based on threshold (lower limit) sizes ranging from 0.1 µm to 5 µm.
- ISO/DIS 14644-2 (2010) Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination
to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include aerospace,
microelectronics, pharmaceuticals, medical devices, healthcare, food, and others. Many factors besides airborne particulate cleanliness must be considered in the design,
specification, operation, and control of cleanrooms and other controlled environments.
- ISO 14644, Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
specifies requirements for the design and construction of cleanroom and clean air devices, as well as requirements for start-up and qualification.
This International Standard also provides guidance on the basic elements of design and construction.
- ISO 14644-5, Cleanrooms and associate controlled environments - Part 5 Operations The scope of Working Group 5 is to provide
those basic requirements for operating and maintaining cleanrooms and associated controlled environments to meet the standards of the particular cleanroom as designed,
built, and used.
ISO 14644-7, Cleanrooms and associate controlled environments - Part 7 The scope of the WG 7 shall be to define performance requirements in areas of minienvironments
and isolators. These requirements will focus on ways that minienvironments differ from cleanrooms in the area of monitoring, design, testing, molecular contamination, material compatibility,
integrity, and microbial contamination.
ISO/FDIS 14644-9, Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration applies to all solid surfaces in
cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment, and devices. The surface particle cleanliness (SPC) classification is
limited to particles between 0,05 µm and 500 µm.
Cleanroom training can be accomplished by online courses, customized cleanroom training classes at your facility, or seminars at cleanroom trade shows. As part of the construction close out
procedure Quality Engineered Structures
will supply training and manuals on the installed air handling systems, filtration systems, control systems, and monitoring systems through the installing subcontractor. These training sessions will cover the operating
and maintenance requirements of the equipment installed.