Machinery Directive Compliance & Functional Safety Validation: Leading Global Manufacturer

Learn more about our PUWER Inspection & Assessment Services and Machinery Safety & Compliance Services at Bureau Veritas.

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SectorPharmaceutical & Nutrition

ServiceConformity & Safety Validation

Duration2 Years

The UK pharmaceutical sector

Is a major global player, contributing over £43 billion annually to GDP and employing over 250,000 people, with significant hubs in London, Cambridge, and Oxford.

4

Sites Covered
2 Year

Automation Project
7+ Year

Partnership

CLIENT CHALLENGE

A leading global manufacturer of nutritional and pharmaceutical products embarked on an ambitious series of production line upgrades and automation projects, including the installation of advanced X-ray inspection systems. The introduction of equipment incorporating sophisticated robotics and radiation sources presented multiple unique hazards requiring careful consideration and robust control measures.

These complex systems necessitated functional safety protective measures in accordance with technical standards such as ISO 13849, creating significant compliance challenges.

With safety being a fundamental principle for the organisation, the client required a partner capable of providing high-competency, impartial and independent support for their equipment integration into manufacturing lines. They needed assurance that all systems would comply with legislative and technical standard requirements under the Machinery Directive 2006/42/EC, whilst maintaining operational efficiency and supporting a safe, secure workplace for employees across multiple production facilities.

Documentation deficiencies in functional safety design and specification are commonplace in such projects, often leading to conformity invalidation and costly delays. The client needed early-phase involvement from specialists who could drive supplier engagement, identify potential issues proactively, and prevent expensive on-site rectification works.

The project's scope extended across multiple sites over a two-year period, requiring consistent application of safety standards and methodologies whilst accommodating site-specific variations and operational requirements. The client's commitment to employee wellbeing demanded rigorous validation of all safety systems and functions.

OUR SOLUTION

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BENEFITS

Through Bureau Veritas' comprehensive functional safety expertise and proactive compliance approach, the manufacturer achieved seamless automation integration whilst maintaining the highest safety standards across all production facilities.

Compliance Without Delays:

Successfully delivered automation projects with no compliance-related delays, maintaining project timelines whilst ensuring full regulatory adherence across all installation phases.

Enhanced Safety Assurance:

Demonstrated unwavering commitment to high standards and employee wellbeing through independent validation of potentially hazardous equipment, providing confidence in operational safety measures.

Proactive Risk Management:

Early involvement at design phase identified potential issues before implementation, avoiding costly delays and on-site rectification works through pragmatic industry expertise.

Comprehensive System Integration:

Drove overall system safety concept ensuring equipment design considered additional requirements such as interlocks, sensors, and emergency stops for seamless site integration.

Long-term Partnership Value:

Established ongoing relationship spanning seven years across four sites, providing consistent expertise and support for continued compliance and safety validation requirements.

Jared

James

Principal Machinery Specialist

Bureau Veritas

Our early involvement at the design phase, combined with our certified functional safety expertise, enabled us to identify potential compliance issues before they became costly on-site problems. The client's dedication to safety standards aligned perfectly with our mission to create safer working environments.

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Learn more about our PUWER Inspection & Assessment Services and Machinery Safety & Compliance Services at Bureau Veritas.