Cleanroom Manufacturing

SteriPack has expertise in cleanroom contract manufacturing services ISO 13485 compliant for medical devices and pharmaceutical products under primary and secondary authorisation due to cGMP. Project management and process validation procedures comply with FDA requirements.

ISO Class 7 Cleanroom

  •  Maximum permitted particles per cubic meter: 352 000

ISO Class 8 Cleanroom

  •  Maximum permitted particles per cubic meter: 3 520 000

Class D Cleanroom (cGMP)

  •  Maximum permitted particles per cubic meter: 3 520 000

Cleanroom standards depend on the process – the more susceptible the product is to contamination, the higher the standard of cleanliness required. Upon receiving a classification, the room must be maintained to meet the specifications for:

  •  Cleanliness
  •  Temperature
  •  Humidity
  •  Pressure
  •  Number of air changes/hr
  •  Flow rate

SteriPack's expertise:

ISO class 7 & 8, grade D & C cGMP medical devices and pharmaceutical products cleanroom manufacturing services.

cleanroom contract manufacturing

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