Quality

Off-site manufacturing 

Increases quality and safety

 

With our quality management system, we also have standard procedures and instructions used for all projects. The quality management system covers the complete project, from design, through procurement and manufacturing, to commissioning and qualification. Relevant, GMP-compliant documentation facilitates our clients’ validation, operations and maintenance.

Modular manufacturing offsite obviously minimizes such variables as differing materials, building codes, construction quality standards, and labor force quality. This streamlines regulatory approval, with positive effects on budget and timeline. Fabrication in a factory also makes the facility less dependent on labor quality, leading to higher productivity and better control of cost and schedule.

Safety also improves because so much of the work is carried out under highly controlled factory conditions instead of out in the field.

Replication and relocation

Offsite manufacturing also means that if you decide you want another facility built in another part of the world, we can make a duplicate copy for you; the only variables are site preparation and the labor force building the external shell. You also gain maximum flexibility to change the location of a planned facility in response to event.

For example, one client had planned a facility to be placed in Latin America. But while the modules were being fabricated, political instability in the target country caused concerns. The client therefore decided to place the site in southeast Asia instead.

Modular manufacturing Sweden

Caption: Our modular manufacturing takes place in Sweden.

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Quality Control & Testing

We develop a project quality plan (PQP) for each delivery. Throughout the manufacturing process, systems are subject to stringent quality checks.

Customer-specific factory acceptance tests (FAT) can include:

  • Riboflavin test
  • Heating/cooling test
  • Surface roughness measurement
  • Ferrite content determination
  • Documentation
  • Electrical testing
  • Control system

GMP-Compliant Documentation

We support our delivery with relevant and GMP-compliant documentation to facilitate our clients’ validation, operations and maintenance.

  • Receipt Verification and full traceability of all material included in delivery
  • Automation according to GAMP
  • Function Specification and Testing Specification
  • Full welding and manufacturing documentation
  • Component list with data sheet of all components
  • Operation Manuals
  • Test Control Plan
  • FAT Protocols
  • Commissioning Protocols (SAT)
  • Qualification Protocols

Our quality management system ensures the full traceability of all materials used, including the provision of certificates.

Off-site fabrication – in a worksop

  • Less dependent on labor quality
  • Quality – cleanliness
  • Improves safety
  • Allows for substantial testing off-site
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Learn more about Modular Solutions

Expanding production? Launching a new product? The KeyPlants team has decades of proven, worldwide experience building modular, turnkey facilities for the world’s leading pharmaceutical and biotech companies. Our modular and POD agile design solutions meet the demanding requirements of today’s business needs in the production of therapeutics.

We’d love to hear from you!

Contact us today – we will help you to master your specific challenge.

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