Our standards
Laboratory cleanroom standards
ISO 14644-1 (Cleanrooms and associated controlled environments)
Both pharmaceutical and medical device manufacturing require specific environmental systems and processes to ensure that finished products are free from contaminants like dust, airborne microbes, and aerosol particles.
ISO 14644-1 is a series of international standards that specify the classification and requirements for designing, operating, and monitoring cleanrooms and controlled environments to ensure contamination control.
ISO 14644-1 specifies air cleanliness levels in terms of airborne particle concentration.
Liber’s devices are assembled in a facility certified and maintained to ISO Class 8 cleanroom standard, and Liber’s cartridges are filled in a facility certified and maintained to ISO Class 7 cleanroom standard.
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