Equipment Qualification

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Do you use your equipment in regulated areas (FDA, GMP)and need equipment qualification (IQ/OQ) within the scope of your standard operating procedures ? HACH LANGE performs certificates according to pharmaceutical international standards, e.g. FDA (Food and Drug Administration), GMP (Good Manufacturing Practice).



IQ/OQ: Installation Qualification/Operational Qualification
 
Do you use your equipment in regulated areas and need equipment qualification (IQ/OQ) within the scope of your standard operating procedures.
We can performed and deliver certificates according to international standards, e.g. FDA (Food and Drug Administration), GMP (Good Manufacturing Practice)
 

Orbisphere instrument:
  • O2 and O3 probes.

Particle counters:
  • HIAC, Metone

Anatel TOC analyzers:
  • A600 and A643.
 
 
 

Do you use your equipment in regulated areas (FDA, GMP)and need equipment maintenance within the scope of your standard operating procedures

Certificates according to pharmaceutical international standards, e.g. FDA (Food and Drug Administration), GMP (Good Manufacturing Practice)
 

Anatel TOC analyzers:
  • A643.

Particle counters: HIAC
  • 9703 and 8103

Do you need your particle counters to be qualified in accordance to the ISO 21501-4 specification?
We can perform this service on-site and in our facilities.
 
  • Particle counters:  Metone
  • Metone