Sterile Operations including Lyophilization

QPS is experienced in aseptic operations, including guidelines for FDA, EMEA and ISO. Our capabilities include the following.

  • Design and build clean rooms
  • Remodel existing suites to meet current standards
  • Perform aseptic process validations
  • Advise about equipment selection
  • Perform installation and commissioning
  • Train personnel
  • Write Master Plans
  • Write SOP's
  • Perform Engineering Assessments
  • Specify and install RABS
  • Sterile Operations

    The principles at QPS have a combined 35 years of experience in sterile operations. We also give aseptic processing seminars and are up to date on the latest regulations for the US and Europe.

    Available Document: STERILE FILL FUNCTIONAL MANAGEMENT OUTLINE