Regulatory Compliance
AWST supports its customers with product compliance to the standards or laws of several regulatory authorities.
ISO 9001:2000
Alfa Wassermann itself was recertified to ISO 9001:2000 early in 2006. The comprehensive application of the Quality ethic ensures the closest attention and response to customer expectations and an iterative approach to continuous quality improvements.
FDA
The AWST SMARTSYSTEM™ control system complies with the FDA standard 21 CFR part 11 and use of the AWST ultracentrifuges assists users to comply with other FDA regulations.
cGMP
The design of the KII and PKII continuous flow ultracentrifuge systems enables processing in compliance with current Good Manufacturing Practices, as applied to the field of bioprocessing.
GAMP 4
To assist you in achieving the highest standards in automated processing, the ultracentrifuges from AWST comply with the rigorous demands of GAMP 4.
CE
Fully compliant with the legal requirements of the European Union, the machines from AWST provide the highest levels of electrical and mechanical safety.
CSA
Responding to the stringent requirements of the North American market, the KII and PKII ultracentrifuges have been certified by the Canadian Standards Authority in all aspects of safety.
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