Barry-Wehmiller Network
Regulatory Compliance

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Please see the below Project Profiles representing Design Group Regulatory Compliance.

  • Regulatory Compliance - Process Development_cGMP Compliance Remediation

    cGMP Compliance Remediation

    Evaluate business and production practices throughout cGMP cosmetics manufacturer to develop a joint action plan for 483 remediation. Developed documentation systems, developed SOPs for corporate policies, worked with contract manufacturers to ensure all GMP products were manufactured according to 21CFT Part 211. Provided product and process development studies, improving product processes and developing new product manufacturing processes. Built complaints investigation, stability, and cleaning procedures.

    Design Group Scope of Work:

    • Product/Process Development
    • Validation – Product, Process
    • Line Integration/Automation
    • SOP Development 
    • 3rd Party Manufacturing Remediation
    • Complaints Investigation
    • Quality Management System Development

  • Utility Commissioning Services

    Utility Commissioning Services

    Provide commissioning services for facility and utilities in new commercial production space.

    • Generate user requirement specifications, commissioning documents and turn over packages (TOPs) for modified utilities (plant steam, pure steam, O2, CO2, N2, Compressed Air (CDA), WFI, chilled water, waste, HVAC and Facilities).
    • Reviewed TOPs, field verified all installed utilities, resolved any variations between design and as built conditions, executed commissioning documents and modified URS’s as required.
  • Continuous Manufacturing

    Continuous Manufacturing

    Commissioning and Qualification of all utilities and equipment that convert a traditional batch process to continuous, single-use. Continuous manufacturing reduces waste and decreases footprint (eliminates centrifuges).

    Design Group Scope of Work:

    • Paperless Commissioning
    • 50L SUB/ATF/VAC
    • Chromatography Skids
    • Wave Mixers
    • SUMV
    • TFF
    • VI
    • Tube Sealers
  • reg-comp-body-wash

    Body Wash Production Reformulation

    New Process Area for production of a starch based ingredient for use in body wash formulations.

    Project Scope

    • New Process Area for production of a starch based ingredient for use in body wash formulations
    • Three batch tanks
    • Raw ingredient dosing into batch mixers 
    • Three new balance tanks and streams for high velocity mixing systems 

    Design Group Scope of Work

    • Electric Design for MCC and Distributed I/O Panels 
    • PLC Programming, HMI, and Batch Development for S88 standard process control on new process systems
    • Instrument and Operational Qualification of new systems
  • reg-comp-cap-ex-vaccines

    Capacity Expansion for Vaccine Production Facility

    Capacity Expansion, new, ground up, full scale vaccine production facility

    Project Scope

    • Building Construction
    •  Production Support Clean Utilities
    •  Complete Production Scale Purification Train
    •  Aluminum Salts Production
    •  Wash Area

    Design Group Scope of Work
    •  Automation for Buffer, Clean Utilities, and Wash Areas
    •  GMP Batch Automation Design and Implementation
    •  OEM FATs
    •  Area Start Up and Qualification
  • reg-comp-haccp

    HACCP Metal Detection Compliance

    Metal detection compliance to meet HAACP standards.

    Project Scope

    • Incorporate new metal detection head
    • Integrate belt tracking encoders for positive product tracking and identification
    • Integrate photo-eyes to: 
      • Confirm reject into bin
      • Confirm negative line space
      • Add locking reject bin
      • Controls and interlock integration

    Design Group Scope of Work

    • Global QA Standards Compliance
    • Mechanical Design
    • Electrical Design
    • Component Specification and selection
    • ACAD plan and elevation view drawings
    • Electrical schematics
    • Project Management
    • Schedule Development
    • Installation Specifications
    • Budget Development
    • Mechanical Scope of Work
    • Electrical Scope of Work
    • Mechanical and Electrical Bid Packages
    • Bid Evaluation
  • reg-comp-bag-in-box

    Bag in Box Line and Foam/Gel Puck Line Installation

    Validation and Engineering Services for Bag in Box (BIB) Line and Foam/Gel Puck Line

    Validation and Engineering Services for BIB Line

    • WinPak Form Fill Seal: FAT, SAT, SOP’s, OQ
    • Videojet Coder: SOP, OQ
    • Fox IV Labeler: SAT, SOP’s, OQ
    • RA Jones Cartoner: FAT, SAT, SOP’s, OQ
    • Domino Laser Printer: SOP’s, OQ

    Validation and Engineering Services for Foam/Gel Puck Line

    • PCM Filler: FAT, SAT, SOP’s, OQ
    • PSA Torquer: FAT, SAT, SOP’s, OQ
    • Accraply Labeler: FAT, SAT, SOP’s, OQ
    • Domino Laser Printer: SOP’s, OQ
  • reg-comp-commissioning-qual-relo

    Commissioning, Qualification, and Relocation

    Plan, organize and manage the commissioning, qualification, and release of new production areas following completion of construction and relocation activities.

    Project Scope

    • Provide quality and validation resources for the assessment, planning and management of relocation.
    • Compile schedules, documentation and vendor service agreements for successful inspection and release of the new facility.