Our CE/UKCA Marking Services Include
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Selection of Directives
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Determination of Regulations
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Inspections
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Assessments
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Testing
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EU Examinations
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Compliance
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Regulatory Consulting
The CE/UKCA Marking and Routes to Compliance
Legislation
Identify which legislation applies to your product.
CE Mark Requirements
Show that your product satisfies the legal requirements.
Conformity
Sign a legal Declaration of Conformity.
Application
Apply the CE marking.
Pharmaceutical equipment used in manufacturing has powered moving parts, so the Machinery Directive addresses the safety aspects (2006/42/EC). EMC aspects are addressed by the EMC Directive (2014/30/EU) and substance restrictions by RoHS (2011/65/EU). Depending on the equipment size, it may be exempted from the requirements of RoHS.
Why Choose Technology International
- Understanding of the laws & regulations
- Experienced staff to lead the CE process
- On-site assessments and testing
- ATEX assessments and testing
- Full CE documentation and support
- Global regulatory compliance support
Pharmaceutical Production Equipment
Pharmaceutical equipment used in the EU requires CE Marking. If the equipment is intended for the market in Great Britain, it will also need to be UKCA marked. This is similar to CE marking in the conformity assessment procedure, with the main differences in the Declaration of Conformity.
CE Marking is mandatory for nearly all pharmaceutical production equipment, including:
- Mixing equipment and agitators
- Coaters
- Centrifuges
- Sorting and grading equipment
- Inspection equipment
- Packaging and labeling equipment
- Blister packing equipment
- Bottling equipment
- Filling equipment (tubes and containers)
- Conveying equipment for bulk materials and finished products
- Ovens
- Presses
- Industrial washing machines
- And many others
Other Industries We Serve
- Packaging
- Rail
- Warehouse Automation
- Recycling
- Aerospace
- Semiconductor
- Food Processing
- Production
- Defense
- Energy
- Pharmaceutical
- Electronics
- Automotive
- Robotics
- Agricultural
- General Manufacturing
What is CE Marking?
The Conformité Européenne, or CE Marking, is a symbol that shows an item complies with the European laws governing health, safety, and environmental protection.
Unlike other certification marks applied to an item once it passes tests administered by a particular organization, no group grants permission to use a CE Marking. As a manufacturer, you must understand and comply with European law and use the CE Marking if necessary.
It is illegal to affix a CE Marking improperly or to use it on an item that does not require a CE marking.
What is UKCA Marking?
After the UK left the EU, they dropped the CE Marking requirement and instead adopted UKCA Marking. All manufacturers must affix a UKCA Mark instead of a CE Marking to indicate product conformity with the relevant UK Product Safety Regulations. The technical requirements of the new UK Regulations came into effect on January 1st, 2021, and were identical to the EU Directive requirements that they replaced.
Is CE/UKCA Marking Mandatory?
In short, yes, if the equipment falls within the scope of several of the above directives and UKCA legislation.
Annex I of the Machinery Directive lists the Essential Health and Safety Requirements (EHSRs) which need to be addressed in your equipment before it can be considered safe. Six sections cover general remarks common to all products in scope.
There are supplementary Essential Health and Safety Requirements for pharmaceutical machinery within Annex I.
Machinery intended for use with pharmaceuticals must be designed and constructed in such a way as to avoid any risk of infection, sickness, or contagion.
In particular, these aspects need to be addressed:
- Cleaning
- Surfaces in contact with materials to be smooth
- Adequate disinfection processes
- Design should not allow insects or other forms of contamination
- No contamination possible by the equipment
As a manufacturer, you have to assess your equipment against these EHSRs to ensure that under all conditions of use the safety is maintained.
While its use is not compulsory, the harmonized standard BS EN ISO 12100:2010 Safety of machinery – General principles for design – Risk assessment and risk reduction provides fundamental guidance and an overall framework for designers making decisions during the development of machinery to enable them to design machines that are safe for their intended use.
Each piece of equipment should follow the Type B standards for industrial machines.
As the machinery is intended for manufacturing pharmaceuticals, the appropriate EU legislation is Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
Looking at the Type C standards for machinery, there are standards for wrapping, packaging, bulk materials storage/handling, food processing (may be relevant in terms of hygiene), extruding, and conveying, to name a few.
If RF heating is part of the process, then the EMC standard EN 55011 should be used:
BS EN 55011:2016+A11:2020 Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement.
For the general EMC compliance requirements, you should use the EN 61000-6-X family of standards, depending on the environment you intend the equipment to be used in.
In addition to conforming to all of the CE conformity requirements, pharmaceutical equipment has other issues to consider.
You need to ensure that the correct standards have been selected, designed to, and shown that the equipment is safe. There will have to be two Declarations of Conformity produced, one for CE and one for the UK.