Sterile Liquid Fill

Injectable Filling Line for Isolation Technology
Toronto, ON, Canada

SAGE Engineering was engaged as the lead Equipment Engineers to provide a new sterile injectable liquid fill line for small glass vials in 5 sizes using isolation technology. The expertise provided by SAGE included the following:

Design and Room Layout
Material & People flow from ISO Class 100,000 to ISO Class 10,000 filling room with a Class 100 Isolator
Airlock and cleanroom qualifications from ISO Class 100,000 to ISO Class 10,000
Forecast Analysis
Business interruption planning
Installation and commissioning
Compliance
Isolation technology
Spatial design
Integration with other suites
Integration with warehouse
Project management
Equipment design and specification
Scheduling/budget control
Equipment start up
Complications were overcome through close vendor management of the isolator vendor and the filling line vendor resulting in the final line as a cohesive system.

Project Details

Key Features:

Isolation technology incorporating VHP
Room / Equipment designed for washing, sterile filling, stoppering and oversealing of glass vials
Designed to meet FDA and HPFBI regulatory requirements for sterile processing
Processing speeds up to 150 vials/min

Project Size:
3,000 sq.ft

Project Value:
Confidential

Client Reference:
Available Upon Request

 

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New Contruction of an Aspetic High Potency Liquid Filling Suite
Toronto, ON, Canada

SAGE Engineering was selected as the Engineering Firm representing the Client through the Front End Design & Engineering, Build, Start-up and Validation phases for a new Aseptic High Potency Filling Suite. The newly designed clean room manufacturing suite provided for an efficient flow of material and people, incorporating production, packaging and in-process testing.

SAGE Engineering dedicated a team which integrated with the client team from initial design through to construction, handover and manufacturing of product. The SAGE team provided Project Management, Procurement, Vendor Management, Validation support, and Production Engineering support. The Engineering services provided by SAGE included:

  • Design of room layouts
  • Equipment & utility requirements matrix
  • Sourcing & evaluating new equipment options with client for vial washing, depyrogenation, sterile filling, and
    lyophilization
  • Material & personnel flow from ISO Class 100,000 to ISO Class 10,000 filling room with a Class 100 Isolator
  • Environmental classification
  • Gowning requirements and procedures
  • Mechanical submittal reviews
  • Scheduling/budget control
  • Facility design reviews against GMP/GLP requirements
  • Airlock and cleanroom qualifications from ISO Class 100,000 to ISO Class 10,000
  • Equipment installation, startup, SAT, and Qualification support

Complications were overcome through close vendor management of the isolator vendor and the filling line vendor resulting in the final line as a cohesive system.

Project Details

Key Features:

  • 1500 sq.ft state of the art manufacturing suite
  • Facility designed for dispensing, compounding, sterile filling, lyophilization and packaging
  • Compliant to FDA and HPFBI regulatory requirements for sterile processing

Project Size:
1,500 sq.ft

Project Value:
Confidential

Client Reference:
Available Upon Request

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New Ophthalmic Filling Line
Toronto, ON, Canada

SAGE Engineering was engaged as the lead Equipment Engineers to procure and install a new Ophthalmic Filling Line within an isolator, followed by an integrated Packaging Line for bottles in 3 sizes. SAGE provided expertise in the following Engineering services:

  • Prepared a detailed URS outlining the required equipment specifications
  • Applied subject matter expertise to Technical and Commercial evaluation of equipment proposals
  • Created workable line layouts, incorporating high volume material handling into the room while considering material
    and people flow
  • Conducted vendor management to ensure seamless integration between equipment, as the primary and secondary
    equipment items were purchased from different vendors
  • Provided project management to ensure integration with existing suites, mechanical and electrical consultants,
    architects, clients’ facility and warehouse throughout the design phase of the project
    Overall Responsibility for equipment installation, startup and SAT execution
  • Prepared and executed commissioning and validation protocols for the new line.

Successful completion of this project allowed the new product to launch on time and on budget.

Project Details

Key Features:

  • Ophthalmic filling within an isolator integrated with a Packaging Line
  • Component handling at 150/min
  • Successful completion on time and on budget

Project Size:
4,000 sq.ft

Project Value:
$9 Million

Client Reference:
Available Upon Request

 

 

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