ROBUST AND INTELLIGENT CQV

In the Life Sciences sector, CQV or Commissioning, Qualification and Validation services will play an important role in both process design and engineering projects. With a heavy focus on compliance and regulation in the industry, Dolmen Engineering understands the landscape and can offer you a complete range of lean CQV services.

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OUR APPROACH

On any project, it is important to remember that the more you validate, the longer your programme will become. We believe in deploying lean methodologies so that all CQV work is limited to ensuring that when a particular element of work is designed and built, it operates as intended. This ensures all CQV programmes are run efficiently, saving time and costs where possible.

Like so many aspects of industrial engineering, a successful approach to CQV lies in collaboration and clear communication. CQV can generate plenty of paperwork and continuous correspondence, so close working relationships are crucial to help deliver the best outcome possible.

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COMPLETE CQV SERVICES

From testing and assessment to reporting and documentation, our understanding of the compliance and regulatory environment means we can offer you a full range of CQV services.

  • Commissioning, Qualification and Validation (CQV) Consulting

    Our expert teams from across the industry from compliance and regulation will provide you with a full range of CQV services.

  • Factory Acceptance Testing (FAT)

    Factory Acceptance Testing (FAT) generation and execution by our expert consultants.

  • Site Acceptance Testing (SAT)

    Site Acceptance Testing (SAT) generation and execution by our expert consultants.

  • Quality risk assessments

    Quality risk assessments and reporting are carried out throughout the project lifecycle. Every new design must undergo rigorous testing and assessment to meet industry standards.

  • Validation master plan creation and management

    Expert senior engineering team creating validation master plan and strict management.

  • Validation documentation writing

    Expert senior engineering team creating and reviewing all validation documentation.

     

     

  • Subject Matter Experts (SME) – Bioservices, Sterilisation (Steam, Eto, VHP), Cleaning, Packaging, Shipping

    We work with trusted partners with a proven track record, covering a range of disciplines, including:

    • Environmental, Health & Safety
    • Mechanical & Electrical
    • Civil, Structural, Architectural
    • Fire Engineering, Assigned Certifiers
    • Cleanroom Manufacturers
    • Process Equipment Manufacturers
    • Quantity Surveying & Budget Control

COMMISSIONING, QUALIFICATION & VALIDATION SPECIALTIES

Every industry is faced with regulatory challenges but the Life Sciences sector requires an ongoing awareness of compliance to enable development and growth. Every inch of infrastructure and every new design must undergo rigorous testing and assessment to meet industry standards. And it’s our insight in the sector and the crucial role of CQV which allows us to tackle the most demanding CQV programmes with you.

cOur focus on lean methodologies ensures we remain focused on providing the most cost-effective and consistent service possible.

dolmen engineering

CASE STUDIES

MANUFACTURING & CLEAN UTILITIES SKIDS

Duis Aute Irure Dolor In Reprehenderit In Voluptate Velit Esse Cillum.

MANUFACTURING & CLEAN UTILITIES SKIDS

Duis Aute Irure Dolor In Reprehenderit In Voluptate Velit Esse Cillum.

MANUFACTURING & CLEAN UTILITIES SKIDS

Duis Aute Irure Dolor In Reprehenderit In Voluptate Velit Esse Cillum.

MANUFACTURING & CLEAN UTILITIES SKIDS

Duis Aute Irure Dolor In Reprehenderit In Voluptate Velit Esse Cillum.

MANUFACTURING & CLEAN UTILITIES SKIDS

Duis Aute Irure Dolor In Reprehenderit In Voluptate Velit Esse Cillum.

MANUFACTURING & CLEAN UTILITIES SKIDS

Duis Aute Irure Dolor In Reprehenderit In Voluptate Velit Esse Cillum.

Driving Innovation in Purification and Filtration Manufacturing Skids

Redefining process design and project delivery by providing Purification and Filtration Manufacturing Skids to the highest standards for a major pharma manufacturer. Based in Dublin, Ireland our client is a leading global biopharmaceutical company delivering innovative health solutions through its medicines, vaccines, biologic therapies and animal health products. With the development of a cutting-edge facility the requirement for seven new process vessels and skids was identified.

Sterile Pharma Facility Designed and Delivered in 18 Months

By taking a collaborative and agile approach, Dolmen Engineering delivered a novel sterile manufacturing environment within 18 months from inception to qualification. Our client, a new Pharmaceutical start-up, identified an existing factory in Ireland to house a new ophthalmic production site for their product range. With no previous manufacturing experience, they needed a sterile facility to make products in a laboratory setting on a manufacturing scale.

Major Manufacturing Capacity Expansion in Live Production Testing Environment

Understanding client needs, Dolmen Engineering delivered a fully robust, multi-faceted plan to increase production capacity and meet organisational goals. Our client is a world leader in diagnostic testing systems that helps in the prevention, diagnosis and treatment of a range of health conditions. With its superior systems and continued growth expansion was required to fulfil customers’ needs and the Long Rang Plan for the next 5 years.

Automation Of Powder Handling Process

By designing a customised engineering solution batch turnaround time improved by 20% for a dedicated product line. A leading pharmaceutical manufacturer based in the south of Ireland deploying manual methods for chemical additions in their manufacturing process, for products designed to treat kidney diseases and other chronic and acute medical conditions.