CE Marking Audit on a Pharmaceutical Packaging Machine
Background
A leading pharmaceutical manufacturer planned to purchase a high-speed blister packaging machine for a new production line. Given the stringent requirements of EU Machinery Directive 2006/42/EC and pharmaceutical GMP standards, the company’s Quality & Engineering team decided to conduct a pre-purchase CE compliance audit at the manufacturer’s facility.
The objective was to ensure that the machine met all legal obligations under CE marking before it was delivered and commissioned on site.
Purpose of the CE Audit
The CE audit was carried out to:
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Verify the machine complied with all essential health and safety requirements (EHSRs) of the Machinery Directive.
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Check that the Technical File, Declaration of Conformity, and risk assessments were complete and accurate.
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Identify any gaps in compliance early, avoiding costly delays or modifications after delivery.
Audit Findings: Areas of Concern
The audit team, comprising internal safety engineers and an external CE consultant, reviewed the design documentation, technical file, and physical prototype.
Key issues were highlighted:
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Incomplete Technical File
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Risk assessment under EN ISO 12100 lacked sufficient detail on maintenance activities.
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Electrical schematics were not updated to reflect the latest design revision.
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Guarding and Safety Distances
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Certain removable guards did not have tamper-resistant fasteners.
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Safety distances around access panels did not fully comply with EN ISO 13857.
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Control System Validation
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Emergency stop circuitry did not meet the required Performance Level d (PL d) under EN ISO 13849-1 for critical stop functions.
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Corrective Actions Implemented by the Manufacturer
Area of Concern
Incomplete Technical File
Corrective Action
Updated risk assessments to cover all operational and maintenance tasks; revised electrical schematics
Outcome
Complete and compliant documentation ready for CE submission
Area of Concern
Guarding & Safety Distances
Corrective Action
Added tamper-proof fasteners and adjusted access panel clearances
Outcome
Guards now meet EN ISO 13857 safety distance requirements
Area of Concern
Control System
Corrective Action
Upgraded E-stop system to Category 3 (PL d) and added fault detection logic
Outcome
Ensured reliable emergency stop performance
Results of the CE Audit
The proactive CE audit delivered significant benefits:
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✅ Legal Compliance Ensured – Machine delivered with a valid Declaration of Conformity and CE mark, meeting the EU Machinery Directive.
✅ Risk Reduction – Early detection of guarding and control issues prevented potential operator hazards and regulatory penalties.
✅ Cost Savings – Identifying issues before purchase avoided expensive on-site modifications and production delays.
✅ Supply Chain Assurance – Manufacturer demonstrated transparency and commitment to EU safety standards, strengthening long-term supplier relationship.
Conclusion
By conducting a pre-purchase CE audit, the pharmaceutical company ensured that its new blister packaging machine fully complied with the Machinery Directive before entering service.
This early intervention allowed the manufacturer to correct documentation and safety deficiencies, guaranteeing legal conformity, operator safety, and smooth integration into the production facility.
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