Cleanroom standards, technical guides, GMP manuals and sectoral documentation center.
Expert answers to the most wondered topics in the cleanroom sector
A cleanroom is specially engineered areas where the amount of particles in the air is kept under control, compliant with ISO 14644 standards. It is used in critical production processes in pharmaceuti…
Cleanroom systems include HVAC filtration, LAF cabinets, panel systems, special doors, pass box units. These systems work integrated to provide contamination control.
According to ISO 14644 standard, there are classes between Class 1-9. Class 100 (ISO 5) is widely used in pharmaceutical, Class 1000 (ISO 6) in electronics sector.
GMP (Good Manufacturing Practice) are international regulations that determine quality standards of pharmaceutical products.
GMP certificate is an official certificate documenting that production facilities comply with Good Manufacturing Practice standards.
GMP document is an official document showing that quality management systems of pharmaceutical and food production facilities comply with standards.
ISO 14644 is the international standard for classification, performance testing and monitoring of cleanrooms and controlled environments.
ISO 14644-1 is the main standard that determines cleanroom classification according to airborne particle concentration.
Sterile areas are controlled environments where microorganisms are completely eliminated, specially designed for aseptic production.
Modular cleanroom are flexible and scalable cleanroom solutions that offer fast installation with pre-manufactured panel systems.
Cleanroom regulation is the legal legislation that regulates design, installation and operation requirements of cleanroom facilities in Turkey.
Cleanroom audit is performed with particle counting, air flow measurement, pressure difference tests and microbiological controls.
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