• Safety of Machinery and CE Marking

    Safety of Machinery and CE Marking

    Process equipment used for biopharmaceuticals, pharmaceuticals, and fine chemicals frequently needs to be CE marked. We are very familiar with the CE marking requirements in these industries.

CE Marking in the Process Industries

CE Marking in the Process Industries

We have been particularly active in the CE marking of process equipment in relation to the European ATEX, Machinery and Pressure Equipment Directives along with other CE marking directives that are relevant to the process industries.

By making use of machinery and Ex non-electrical equipment risk assessments we have been able to assist our clients with the CE marking of partly completed machinery, machinery assemblies and ATEX assemblies. We are fully familiar with requirements for global assessments for ATEX and Pressure Equipment Directive (PED).

This assistance has allowed our clients to overcome CE marking problems in a cost efficient and timely manner and ensure that their process equipment is compliant with the relevant CE marking regulations.

ATEX and Non-Electrical Equipment

ATEX and Non-Electrical Equipment

Where a hazardous area exists it is usually ecessary to carry out a detailed assessment of the potential ignition sources.

Statistics show that for gas, vapour and dust explosions the vast majority of ignitions arise from non-electrical equipment. Non-electrical equipment used in potentially explosive atmospheres is subject to the ATEX 100a directive and needs to comply with relevant EN standards. Category 2 and 3 non-electrical equipment do not require certification by a notified body, so are only subject to self-certification. We are familiar with the requirements of self-certification.

We have a detailed understanding of these ignition sources and can efficiently carry out the required risk assessment in compliance with EN ISO 80079 Part 36, thus assisting are clients to comply with the regulations and CE mark their equipment.

Partly Complete Machinery and Global Assessments

Partly Complete Machinery and Global Assessments

Process equipment is frequently “partly completed machinery” as defined by the EU Machinery Directive. This is frequently because it cannot achieve its specific application since it has been supplied without its control system. Alternatively, the completed machinery has been supplied by several manufacturers.

We assist our clients to incorporate the partly completed machinery thus forming a single item of completed machinery. We can then ensure that this completed machinery conforms to the required regulations by carry out a machinery risk assessment and a conformity assessment and by generating a Technical File. Finally, we assist our clients to CE mark this completed machinery.

Process equipment that is “machinery” as defined by the EU Machinery Directive is also frequently an assembly with respect to the ATEX, EMC and PED and and frequently requires a global assessment. Our approach is to include the relevant global assessment in the Technical File so that it visible to all relevant parties. Carrying out the global assessments allows the equipment to be CE marked for ATEX, EMC and PED as well as the Machinery Directive.

If you are looking for safety, environmental, processing or equipment solutions please get in touch

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Testimonials

What our clients say about us

Catalent Micron Technologies

I certainly know where to come for any future HAZOP’s, I know DEC have also been very impressed. Peter Line, Facilities & Capital Projects Manager

Customer #2

Further testimonials coming soon.

Customer #3

Further testimonials coming soon.

We can help you improve your effectiveness by working with you to:Push your projects to completion, Start up your equipment on time, Solve processing problems,Keep to that tight budget, Meet the time frame that your management require.

Get In Touch

Contact Us

  • 01270 664747
  • 07714 167707
  • keith.plumb@integpharma.com
  • Address

    Integral Pharma Services
  • Brookbank,
  • 7 Hardy Close,
  • Wistaston,
  • Crewe,
  • Cheshire,
  • CW2 8DY