//Sterile Operations//
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Commissioning Control Systems FMEA Scale-Up Validation FAT
Lyophilization High Purity Utilities Standard Operating Procedures Sterile Operations Pipe Calculations

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.

Sterile Fill
Functional Management
Outline
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