Aseptic Technology & Design
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Isolator Technology
Project Management

 

 
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We offer a full project management service from original concepts through to production including all aspects of design, operation and qualification to FDA and EU standards.

We can manage the entire project allowing the client time to make both well informed and incisive decisions or we can execute all or any of the stages within a project (both Pre-installation and Post-installation) to assist the client in meeting project deadlines.

We have a wealth of experience in aseptic manufacture and are able to assist with or manage all production activities. We know that the real success of a project is determined by the output of the process and we have the unique ability to maximise the efficiency of a process to best suit the clients objectives.

 
Pre-installation: Post-installation:
  • Front End Study
  • User Requirement Specifications
  • Bid Analysis
  • Validation Master Plan
  • Detailed Design
  • Design Qualification (DQ)
  • Equipment Build
  • Criticality Review
  • Factory acceptance Test (FAT)
  • Installation / Commission
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Process Optimisation
  • Standard Operating Procedures
  • Performance Qualification (PQ)
  • Operator Training
  • Handover