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Honeyman Group
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Water System Design and Build |
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Having experience and
expertise in Purified Water, Water Highly Purified and Water for
Injection, we take full responsibility for the design, build,
commissioning and
validation of pharmaceutical water systems delivering
these compendial waters which may subsequently be used in the
manufacture of pharmaceutical
products.
Our specialist in-house expertise is independent of equipment suppliers,
manufacturers and installers and we can offer a service of the highest
integrity, quality and technical excellence without commercial
influence.
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In designing, building,
commissioning and validating new pharmaceutical water systems, or when upgrading existing ones, we ensure that all basic elements are correctly
applied:
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Design Brief & Project
Requirements
Production of a concise, detailed design brief culminating in the
production of the Purified Water / Water For Injection system User Requirement
Specification (URS)
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Detailed Process Design/Specification
Development of a detailed design file reflecting the spirit and
intent of the User Requirement Specification
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Life Cycle Validation Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification is carried out ensuring the design file intent is
reflected in the Purified Water / Water For Injection system build
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Procurement, Subcontractors and Project
Programme
Ensuring that all component and in particular, critical
components, match the requirements of the design file
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System Build & Project
Management Control To ensure that the intent of the design file is achieved in the
Purified Water / Water For Injection system build
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Commissioning Setting the limits of the Purified Water or Water For Injection system to match the
system design
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Handover Ensuring an inspection readiness, compliant Purified Water / Water For Injection
system
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As a result, our systems perform exactly to specification, optimise
capital and maintenance costs and avoid over-compliance and unnecessary
re-validation.
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In addition to providing a
turn-key design and build service, we also provide an extensive menu of
specialist services to support existing teams and their projects,
including:
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Feasibility Studies and Budget
Cost Assessments
Our ability and experience is used to review, comment and recommend
system design and reconfiguration to suit the clients requirements
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Development of a User Requirement Specification (URS)
Our knowledge of compendial requirements will be reflected in a
robust dependable User Requirement Specification
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System Process Design and Specification (DQ)
We are able to produce a design file reflecting the URS which is
capable of being challenged by a Design Qualification protocol
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Operation and Control Philosophy
Honeyman Group can produce operation and control philosophies used
to control modern systems
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Control System Design
and Validation
GAMP4 capability in producing and validating system controls
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Vendor Appraisal and Selection
In depth audits of vendors result in the correct selection for each
individual project
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Installation
The execution and control of installation by Honeyman will produce
compliant, inspectable systems
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Project Co-ordination and Management
Management and control of the project installation
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Validation - Package Compilation (DQ/IQ/OQ) & Commissioning
Honeyman Group are able to produce full validation protocols to any
design
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PQ Planning and Implementation,
Including Biological and
Chemical Water Analysis
Assistance with the planning, organisation and control of the PQ
phases
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System Handover - Operator Training
Honeyman Group can provide comprehensive training in the use,
implementation and control of the completed system
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On-going System Support & Continuous Compliance Assurance (CCA)
Inauguration of water committees and the provision of initial advice
to the committees
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Our strength is the range of
specialist in-house expertise we bring to each project - design,
engineering, technical, regulatory and project management - essential to
meet quality, time and cost criteria..
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