Displaying items by tag: cleanroom

ISO-5 cleanroom classification is a common high level of the cleanroom classes. The ISO cleanroom standards are set by the International Organization for Standardization. They are a private international organization with a membership of 167 national standards bodies.

ISO Standards for cleanroom are a set of guidelines established by the International Organization for Standardization (ISO). They focus on the design, construction, and operation of cleanrooms in various industries, including pharmaceuticals, biotechnology, electronics and medical devices. The purpose of these standards is to ensure that cleanrooms meet specific requirements for cleanliness, air quality, and environmental controls.

Clients often come to us specifically requesting an “ISO 7 cleanroom” or an “ISO 8 cleanroom.” What they often fail to realize is that the ISO class does not define the layout of the cleanroom. It only defines the cleanliness level that needs to be met. In fact, the ISO classification actually corresponds to a specification of how clean the cleanroom must be. The ISO 14464-1 standard doesn’t say how to design the cleanroom, it only specifies the maximum quantity of air particles allowed.

There are seven critical items to get right when designing your new cleanroom. Be sure to get these right to make your new cleanroom a success.

Planning a cleanroom construction project can feel overwhelming. From ISO classifications and material selection to regulatory compliance and budget considerations, the process demands meticulous attention to detail.

Designing a cleanroom requires careful consideration of various factors to ensure the highest level of cleanliness and contamination control.

Cleanrooms are specialized workspaces for critical processes and operations. They are designed to maintain strict standards of cleanliness for certain types of manufacturing and product preparation. Cleanrooms are commonly used for some applications in the manufacture of electronics, semiconductors, pharmaceuticals, medical devices, and aerospace equipment, as well as in labs and research settings.

Cleanroom design is a critical component of maintaining a sterile and contaminant-free environment. The design of a cleanroom is essential to ensure that the required level of cleanliness is achieved and maintained. Cleanroom design requirements and best practices vary depending on the industry and application.

Our experienced cleanroom design teams can support you with all aspects of the design and specification requirements of your cleanroom project, bringing experience and knowledge of traditional and specialist cleanroom panel systems. We can assist from project conception to facility handover and validation, with feasibility studies, Capex / budget costs, design for tender process or as part of a design and build project.

In the United States, ISO 14644-1 is regarded as the gold standard for cleanroom construction. Cleanroom standards help define and measure expected outcomes but do not always provide a clear roadmap on how to achieve them. In parallel, GMP, IEST, USP, EU, and ASHRAE standards may provide more specific methodologies for air quality classification, testing equipment, and validation methods.