Greenfield Expansion for Solids Dosage Form Medicines

Greenfield Expansion for Solids Dosage Form Medicines

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Our customer, a leading pharmaceutical manufacturer required a significant increase in capacity of solid dosage form medicines.
 

Key Results

  • Significant expansion to the client’s tablet and capsule handling capacity
  • Innovative containment solutions to handle highly potent API’s
  • Successful commissioning and qualification of process modules, utilities and laboratories
     

Key Project Features

  • State of the art process module design to permit handling of highly potent drug substances
  • Specification, vendor management and qualification of state-of-the-art coating, granulation and mixing process equipment
  • Facility planning including new QC laboratories and utilities systems
     

Our Delivery

  • Design of major pieces of secondary manufacturing process equipment including coaters, wet granulators, mixers and isolators
  • Development of engineering specifications, tender process and vendor management  for the process & media equipment, including controls and instrumentation
  • Installation coordination of the installation of process equipment and media systems
  • Commissioning lead for process and media systems
  • Coordination and execution for the full qualification process
     

Value to Our Customer

  • Delivery of cutting edge containment technologies, including novel process equipment design and delivery
  • Innovative, lean laboratory process design
  • Intelligent consumption analysis and utilities capacity design
  • Successful qualification of process and utility systems to a challenging schedule
     

Key Applied Capabilities

  • Facility Design

    We specialise in full facility design, integrating complex functional processes and laboratories throughout their entire life cycle.

  • Process Engineering

    We understand our clients’ operational and quality process needs, applying industry leading ideas from some of the best minds in our field.

  • Project Management & Controlling

    With our hands-on approach to project delivery strategies, our experienced project managers and their teams define and manage schedules, budgets and deliverables throughout the project lifecycle.

  • C&Q / QA / QP / MDR

    We support our clients in efficient and integrated commissioning and qualification, quality assurance, qualified person and medical device regulation activities.

  • Construction Management & HSE

    Our robust CM tools and skilled teams enable us to develop specific plans that deliver projects safely and to scope, time and budget.

  • Functional Safety Management

    We ensure our clients meet their regulatory safety obligations. We offer complete lifecycle functional management; bringing process and operational expertise together with the latest analysis tools.

  • Laboratories

    Intelligent environments and smart processes. Innovative integrated laboratory solutions delivered by our expert engineers, scientists and architects.

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