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HVAC systems

According to GMP / ISO 14644
  • Installation review
  • Measurement of air flow and air renewal calculation
  • Measurement of differential pressure between chambers
  • Particle counts in clean rooms
  • Measuring of temperature and relative humidity in chambers
[ult_ihover thumb_height_width=”250″ gutter_width=”30″ align=”left”][ult_ihover_item title=”Gometrics” thumb_img=”1475″ desc_font_color=”#bbbbbb” info_color_bg=”#001d35″ block_border_color=”rgba(255,255,255,0.2)” block_border_size=”20″ spacer_width=”100″ spacer_border_width=”1″ title_responsive_font_size=”desktop:22px;” title_responsive_line_height=”desktop:28px;” desc_responsive_font_size=”desktop:12px;” desc_responsive_line_height=”desktop:18px;”]HVAC system qualification, compressed air, purified water…[/ult_ihover_item][/ult_ihover]

Compressed air systems

ACCORDING TO GMP / ISO 8573
  • Installation review
  • Particle counts
  • Temperature and dew point measurement
  • Hydrocarbon review
  • Viable particle counts

Purified water and pure steam systems

ACCORDING TO GMP
  • Installation review
  • Slope verification
  • Dead points verification
  • Material certification check
  • Running tests
  • Instructions and alarms check
  • Water physico-chemical and microbiological results check

Clean in Place systems

CIP
  • Installation review
  • Slope verification
  • Dead points verification
  • Material certification check
  • Running tests
  • Measuring of temperature and relative humidity in chambers

Production equipment qualification

  • Solid mixture pumps
  • Shaking screens and crushing rolls
  • Turbo mixers
  • Fluidized beds
  • Coating pumps
  • Liquid and semi solid fabrication reactors
  • Qualification of dosification systems and primary and secondary packaging lines for solid, semi-solid and liquid forms