For pharmaceutical engineering buyers, CE marking is often treated as a simple compliance requirement, a familiar mark on a piece of equipment confirming that it can be placed on the EU market. But CE marking is much more than a nameplate. For pharmaceutical equipment such as process skids, bespoke machinery, sampling systems and access platforms, the CE mark is the visible result of a wider process involving risk assessment, applicable legislation, engineering standards, testing and technical documentation. At Premech, we treat CE compliance as part of the engineering process from the outset. Our pharmaceutical and process equipment is designed, fabricated and documented with compliance built in, rather than added at the end of a project.
So, what is actually behind the CE mark, and why does it matter so much in a pharmaceutical manufacturing environment?
What Does CE Marking Mean for Pharmaceutical Equipment?
CE marking demonstrates that the manufacturer has assessed the equipment against the applicable European Union requirements and, where required, completed the appropriate conformity assessment process. For pharmaceutical manufacturers, this is particularly important because equipment often forms part of complex production environments where safety, traceability, hygienic design and documentation all need to be considered together. A CE mark should therefore be viewed as the visible endpoint of an engineering and compliance process, not simply a sticker added when a machine is finished.
Which CE Directives Apply to Pharmaceutical Equipment?
CE marking is not based on one single piece of legislation. Different EU legislation can apply depending on the design, function and operating conditions of the equipment. For pharmaceutical and process equipment, three areas are particularly important.
Machinery Directive 2006/42/EC
The Machinery Directive is relevant to a wide range of machinery incorporating moving parts, controls, operator interfaces and safety functions. It establishes Essential Health and Safety Requirements that machinery must meet before it can be placed on the market. For bespoke pharmaceutical machinery, this means safety needs to be considered during the design process rather than treated as a final inspection exercise.
Pressure Equipment Directive (PED) 2014/68/EU
The Pressure Equipment Directive (PED) becomes relevant where equipment contains pressure equipment within its scope. This can be particularly important for pharmaceutical process skids and systems handling pressurised liquids or gases. Determining whether PED applies, and establishing the correct classification, should happen early in the engineering process. Getting this wrong can create significant problems later in the project.
ATEX Directive 2014/34/EU
ATEX can apply to equipment intended for use in potentially explosive atmospheres. This can be particularly relevant within pharmaceutical manufacturing environments involving solvents, powders, flammable materials and potentially explosive atmospheres. ATEX requirements need to be considered at system level rather than simply by selecting individual certified components.
Machinery Regulation (EU) 2023/1230
The Machinery Directive is being replaced by the Machinery Regulation (EU) 2023/1230, which will apply from 20 January 2027. For pharmaceutical manufacturers specifying equipment with a long operational life, it is worth discussing this transition with suppliers during the design and procurement stage. The new regulation introduces updated requirements, including provisions relating to areas such as digital technologies, cybersecurity and safety-related software.
What Standards Are Used to Demonstrate Compliance?
EU legislation establishes the legal requirements. Engineering standards provide recognised methods and specifications that can be used to help demonstrate conformity.
EN ISO 12100 and Machinery Risk Assessment
EN ISO 12100 provides a fundamental framework for machinery risk assessment and risk reduction. The process involves identifying foreseeable hazards, assessing risks and determining appropriate measures to eliminate or reduce those risks. For bespoke pharmaceutical equipment, this should influence the design from the beginning rather than being completed as an administrative exercise after fabrication.
Type A, Type B and Type C Machinery Standards
Machinery safety standards are generally organised into three categories. Type A standards establish fundamental concepts and general principles applicable to machinery. Type B standards address particular safety aspects or types of safeguards and can apply across different categories of machinery. Type C standards provide detailed safety requirements for specific types of machinery. Where an applicable Type C standard exists, it can take precedence over more general requirements.
ASME BPE and Pharmaceutical Hygienic Design
For pharmaceutical and bioprocessing equipment, ASME BPE can be equally important from an engineering perspective. ASME BPE sits outside the CE framework, but it provides important guidance for hygienic and sanitary equipment design.
Depending on the application, this can include considerations such as:
- Surface finishes
- Weld quality
- Drainability
- Dead-leg control
- Materials
- Product-contact surfaces
- Fabrication and inspection requirements
CE compliance and hygienic design are not the same thing. Equipment can meet applicable CE requirements while still failing to meet the hygienic design expectations of a pharmaceutical process.
What Documentation Should Come With CE-Marked Pharmaceutical Equipment?
A properly compliant machine should not arrive with nothing more than a CE nameplate. The supporting documentation is an important part of the equipment handover and can provide valuable information for engineering, quality, maintenance and future modification work.
EU Declaration of Conformity
The EU Declaration of Conformity identifies the applicable legislation and standards against which the equipment has been assessed.
Technical File
The technical documentation can contain important engineering evidence such as:
- General arrangement drawings
- Electrical and control diagrams
- Risk assessments
- Applicable standards
- Design calculations
- Inspection and test records
- Relevant certificates and reports
Operating and Maintenance Documentation
Operating instructions should provide the information required for the safe use, operation and maintenance of the equipment.
For pharmaceutical sites, clear maintenance documentation can also be important for long-term asset management.
Equipment Nameplate and CE Marking
The CE marking and equipment nameplate provide identification and traceability information and should correspond with the supporting documentation.
Material Certificates and Traceability
For pressure-retaining and product-contact components, material traceability can be particularly important. Depending on the specification, this may include certificates such as EN 10204 3.1 material certificates.
Inspection and Test Documentation
Inspection and testing records provide evidence of the checks carried out during manufacture and before equipment is released. For pharmaceutical projects, having this information organised and available at handover can make future engineering and quality activities significantly easier.
ATEX Compliance: Why Certified Components Aren’t Enough
ATEX is an area where equipment specifications can become particularly complicated. One common misconception is that if every individual component within a machine is ATEX certified, the complete machine is automatically ATEX compliant. It isn’t that simple.
Why Individual ATEX-Certified Components Don’t Guarantee System Compliance
A complete machine or assembly needs to be assessed in the context of its intended application.
This can involve considering:
- The hazardous area or zone
- Potential ignition sources
- Equipment categories
- Electrical and mechanical components
- Operating conditions
- Interfaces between components
- The complete assembled system
Assessing the Complete Machine
A cabinet containing correctly rated components does not, by itself, demonstrate that the complete machine has been appropriately assessed. The complete system needs to be considered and the relevant assessment and technical documentation completed. For pharmaceutical projects involving potentially explosive atmospheres, this system-level approach is particularly important.
CE Compliance and RAMS: What Happens During Installation?
CE compliance relates to the equipment itself. It does not replace the need to plan and manage the safe installation, commissioning and integration of that equipment on site. This is where a Risk Assessment and Method Statement (RAMS) becomes important. A RAMS provides a documented approach to how installation or other site activities will be carried out safely.
In a pharmaceutical manufacturing environment, this can involve working around:
- Live production areas
- Controlled environments
- Existing process equipment
- Other contractors
- Restricted access areas
- Planned shutdown windows
At Premech, we see RAMS and equipment risk management as complementary parts of the wider engineering process.
Why Single-Vendor Engineering Can Reduce Compliance Risk
Pharmaceutical equipment projects can involve multiple suppliers, contractors and engineering disciplines. Design may be completed by one company, fabrication by another, and compliance documentation assembled separately. Every additional handover can create an opportunity for information to be lost or interpreted differently.
Design and Engineering
Compliance requirements can be considered from the first design decisions.
Fabrication
The equipment can then be manufactured against the agreed design and specification.
PED and ATEX Considerations
Where relevant, pressure equipment and hazardous area requirements can be incorporated into the engineering process.
Testing and Inspection
Inspection and testing can be coordinated with the equipment specification and documentation requirements.
Technical Documentation
The supporting documentation can then be developed alongside the equipment rather than being chased after fabrication is complete. When engineering, fabrication and compliance activities are managed together, there is a clearer line of accountability from the initial design through to final handover.
What CE Compliance Looks Like at Premech
At Premech, CE compliance is part of how we approach the engineering and fabrication of pharmaceutical and process equipment. From bespoke machines and process skids to sampling systems and access platforms, compliance considerations are incorporated into the project rather than treated as a final-stage addition. Depending on the equipment and its application, this can involve risk assessment, applicable machinery standards, PED considerations, ATEX assessment, inspection and testing, material traceability and supporting technical documentation. For pharmaceutical manufacturers, the goal is not simply to apply a CE mark. It’s to deliver equipment that has been properly engineered, assessed, documented and built for its intended environment.
Questions to Ask Your Pharmaceutical Equipment Supplier
When specifying pharmaceutical equipment, don’t stop at the question: “Is it CE marked?”
Consider asking:
- Which EU legislation applies to the equipment?
- Has a machinery risk assessment been completed?
- Does the Pressure Equipment Directive apply?
- Does the equipment or installation require ATEX assessment?
- Which engineering standards have been applied?
- Is hygienic design to ASME BPE or another specification required?
- Will the technical documentation be provided at handover?
- Are material certificates and inspection records traceable?
- Who is responsible for overall equipment compliance?
- How will installation and commissioning risks be managed?
These questions can help establish whether compliance has genuinely been built into the project or simply addressed at the end.
CE Marking Is the Start of the Conversation, Not the End
For pharmaceutical equipment, a CE mark should represent much more than a nameplate. Behind it should be a considered process covering engineering, risk assessment, applicable legislation, standards, testing and documentation. For pharmaceutical manufacturers and engineering teams, the right question is therefore not simply:
“Is the equipment CE marked?”
It is:
“What engineering and documentation sits behind that CE mark?”
At Premech, we build compliance into the engineering process from the outset, helping pharmaceutical clients deliver equipment that is designed, fabricated and documented for its intended application.
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