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This forum is available to suggest additional topics to include in the forum list.  Please provide your input and suggestions.

Steam in Place (SIP)

The Steam in Place (SIP) topics forum is for questions and content related to SIP qualification.  Please share your best practices, greatest challenges, or leave a question for the forum so other users can provide their input.

Process Validation Forum

The Process Validation forum is for questions and content related to Process Validation.  Please share your best practices, greatest challenges, or leave a question for the forum so other users can provide their input.

Equipment Qualification

The equipment qualification topics forum is for questions and content related to equipment qualification.  Please share your best practices, greatest challenges, or leave a question for the forum so other users can provide their input.

Autoclave Qualification

The Autoclave qualification topics forum is for questions and content related to autoclave qualification.  Please share your best practices, greatest challenges, or leave a question for the forum so other users can provide their input.

Computer Systems Validation

The Computer Systems Validation topics forum is for questions and content related to Computer Systems Validation.  Please share your best practices, greatest challenges, or leave a question for the forum so other users can provide their input.

Data Integrity

The Data Integrity topics forum is for questions and content related to Data Integrity.  Please share your best practices, greatest challenges, or leave a question for the forum so other users can provide their input.

Control System Upgrade: Lyophilizers

Control System Upgrade for Production Lyophilizers

Duration- 6 months

Overview:

Upgrade the existing control system for production lyophilizers at a large biotech company.

Scope of Work:

The project scope included:

  • PLC and HMI Upgrade for Multiple Lyophilizers
  • ControlLogix and iFIX
  • Programming
  • Design Documents (DDS, SRS, FRS)
  • Functional Testing
  • Protocol Development and Execution
  •  FTBatch HMI/SCADA

The Mangan team collaborated with the onsite automation staff and business users to perform design reviews to optimize HMI displays and screen navigation.

Outcome:

Project was completed successfully on time.

Bulk Manufacturing Process Cleaning Validation

Bulk Manufacturing Equipment Train Cleaning Validation

Duration- 8 months

Overview:

Developed and performed cleaning validation of a new manufacturing process implemented at a international pharmaceutical site to improve process yields.  A full evaluation of their cleaning process on the existing equipment was required.

 Scope of Work:

The cleaning validation scope included: 

  • Bioreactors
  • Various Vessels
  • Buffer Distribution/supply skids
  • Parts Washer for new equipment train parts  

In addition, the Mangan team collaborated with onsite SME’s to determine worst case residues and sites, then utilized a family approach to perform cleaning validation on all the manufacturing equipment used during the process.

 

Outcome:

Project was completed successfully on time.

Process Development Laboratory CQ&V

Process Development Laboratory Commissioning, Qualification and Validation

Duration- 14 months

Overview:

Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new PD laboratory, within an existing biopharmaceutical commercial/clinical manufacturing facility.  The PD laboratory is approximately 500 SF.

 Scope of Work:

The CQ&V included Design Qualification, FAT, IQ, and OQ for the following equipment/utilities/systems:

  • Biosafety Cabinet
  • Laminar Flow Hood
  • Bench Scale Incubator Shaker
  • Bench Scale Fermentors
  • Bench Scale Temperature Control Units
  • Bench Scale Autoclave
  • Glass/Parts Washer
  • -70°C Freezer
  • Water for Injection
  • Purified Water
  • Process Air
  • Clean Steam
  • Oxygen
  • Nitrogen
  • HVAC / BAS
  • Elpro Temperature Monitoring System