Pharmaceuticals

The pharmaceutical industry is highly regulated as manufacturers who produce the highest quality, potentially life-saving products that are consumed by patients.

SAGE consultants are  well-equipped with the knowledge and experience required to complete Equipment & Facility Engineering, Compliance & Validation, and overall Project Management projects for clients. We are deeply versed in the processes, rules and regulations of a broad range of pharmaceutical types, including: Solid Dose, Liquid Dose, Topicals, Radiopharmaceuticals, and Biopharmaceuticals.

 

Solid Dose

Solid dose products make up a large portion of the pharmaceutical market. SAGE has experience in the full life cycle of manufacturing and packaging for products, primarily in the tablet and capsule formats. SAGE has also completed projects that involved hazardous powders requiring additional levels of personnel safety measures and greater degrees of containment.

SAGE can provide the following services to support your Solid Dose projects:

  • Process Design
  • Equipment Procurement
  • Facilities Modifications
  • Commissioning and Qualification of equipment
  • OEE studies and Continuous Improvement projects

Key Projects

Equipment & Facility Engineering

Facilities

Capacity and Spatial Analysis, GMP Concept design, throughput calculations and equipment specification for new allergen facility, including greenfield and brownfield layouts

Equipment

URS development, equipment sizing, vendor selection and qualification for solid dose manufacturing production including unit operations for tablets and capsules

Compliance & Validation

Equipment

Installation, commissioning and qualification of production equipment for solid dose manufacturing, including granulation, fluid bed dryers, encapsulators, and tablet press machines.  Fully integrated packaging lines from tablet counters to end-of-line equipment.

Project Management

Equipment

Full project management and vendor coordination for a new encapsulator for development work of high potency product, including temporary decommissioning of an OEB 3 containment suite to complete construction activities

 

Liquid Dose

Liquid dose pharmaceutical products present different challenges to solid dose products. SAGE is knowledgeable in those differences, and the activities required for liquid dose project execution. SAGE has experience in liquid products including, but not limited to: Oral Liquid Dose, Nasal Sprays, Sterile Ophthalmic Solutions, and Injectibles. SAGE liquid dose projects can include the full life cycle of manufacturing and packaging operations.

SAGE can provide the following services to support your Liquid Dose projects:

  • Equipment Procurement
  • Facilities Modifications
  • Commissioning and Qualification of Equipment

Key Projects

Equipment & Facility Engineering

Process

Ophthalmic solution filling suite layout and equipment specification for filling and closing machines enclosed in an aseptic isolator, integrated with a secondary packaging line in adjacent unclassified area

Project Management

Review

Asset Management Master Plan review with Failure Modes and Effects Analysis (FMEA) to develop risk-based Preventative Maintenance (PM) tasks lists for both sterile and non-sterile liquid filling lines

 

Topicals

Topical drug products require a complex, multi-phase process with strict controls on critical process parameters (CPP), including temperature, mixing and transfer rates.  SAGE has experience in implementing well-validated, control systems for batch or in-line processes to ensure that the correct viscosity, homogenization, and yield is achieved for the finished product.

SAGE can provide the following services to support your Topicals projects:

  • Process Design and CPP Mapping
  • Specification of mixing tanks, heating and cooling skids, transfer pumps, in-line dispersers etc.
  • Specification of packaging equipment: tube fillers, sealing, cartoning, labeling, case packing, and palletizing
  • Equipment and Utility schedules

Key Projects

Equipment & Facility Engineering

Process

Large-scale project for a topical pain medication scale-up, including infrastructure, manufacturing and packaging readiness to develop capacity of 30 million tubes annually

Facilities

Large-scale project for Topical Aerosol Foam products with flammable liquid, including dispensing of OHC Category 4 and 5 compounds within a containment isolator

Compliance & Validation

Equipment

Vision system for automated inspection of tubes to verify quality attributes, including contamination, tube diameter, crimp seal, and Lot/Exp presence

Project Management

Equipment

Clinical batch project for topical medication, including new mixing tanks, in-line powder disperser, and tube filler

 

Radiopharmaceutical

Radiotherapeutics are difficult to produce, highly regulated, and require customized facilities and equipment. SAGE has the specialized knowledge and experience to successfully complete projects for these radioactive, sterile and short shelf-life products.

SAGE can provide the following services to support your Radiopharmaceutical projects:

  • Facility Concept Design
  • Equipment Layouts
  • User Requirement Specifications
  • Quality & Compliance
  • Vendor Management
  • Procurement, Commissioning, Qualification, and Validation of:
    • Hot cells
    • Shielded isolators
    • Shielded biosafety cabinets
    • Clean rooms

Key Projects

Equipment & Facility Engineering

Process

Development of equipment and facility concept for brown field construction project; clean room user specifications, room data sheets, equipment schedule (MEP) and CQV Gantt

Logistics

Gap Analysis and Risk Assessment of Good Distribution Practices for cold chain logistics of radiotherapeutics manufacturer

Project Management

Facility

Renovation of High Level laboratory to clean room space for synthesis and dispensing operations; vendor management and owner’s representative during construction phase, responsible for room and equipment validation

 

Biopharmaceutical

The Biopharmaceutical industry is a complex niche sector of the Pharmaceutical industry, transforming microorganisms by means of fermentation, separation/purification and lyophilization into recombinant proteins.  SAGE has extensive direct industry experience within plant operations, capital projects, and validation.  Our expertise exists in process and packaging equipment, the associated material and people flows, and integration with utilities and building fabric.

SAGE can provide the following services to support your biopharmaceutical projects:

  • Greenfield Design
  • Facilities Refurbishment
  • User Requirement Specifications
  • Quality & Compliance
  • Vendor Management
  • Procurement, Installation, Commissioning, Qualification, and Validation of Manufacturing and Packaging Equipment
  • Process Improvement

Key Projects

Equipment & Facility Engineering

Operations

Integrated with client process engineering design team to provide support for biopharma facility scale-up with equipment optimization, with focus on downstream operations (UF, fractionation and chromatography skids, vessels)

Compliance & Validation

Equipment

FAT execution for upstream and downstream equipment, review of vendor turnover package in accordance to user requirements and to ensure regulatory compliance

Process

Process Validation execution to meet batch production scheduling and sample collection requirements, root cause investigation for process validation non-conformances, deviation investigation

Project Management

Support

On-site integration of SAGE resources over a multi-year period, supporting client manufacturing teams and facilitating capital projects, process improvement and maintenance activities

CMO Management

Project management and technical leadership for the fill/finish activities of a COVID-19 therapeutic at 4 CMOs to supply finished product for 30,000+ patient treatments