Technical Cleanliness Engineering & Contamination Control
Background
Technical Cleanliness is a cornerstone of both pharmaceutical and battery manufacturing, ensuring that contamination risks are minimized and that processes meet the highest international standards (ISO 14644, VDA 19.2, GMP, ATEX).
Our work covers a full spectrum of contamination prevention and validation activities – from mapping contamination risks and monitoring airborne particles, to conducting workshops, audits, and delivering actionable reports for compliance and process improvement.
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Contamination Maps – Identifying Risk Hotspots Contamination maps were developed to highlight potential contamination points across production lines and equipment.
Approach: systematic assessment of machines, zones, and handling processes.
Deliverable: clear visual maps indicating high-risk areas and preventive measures.
Value: allows manufacturers to focus resources on critical contamination hotspots, improving both compliance and operational efficiency.
“Contamination maps transform hidden risks into visible, manageable checkpoints.”
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Particle Counters – Monitoring in Real Time Airborne particle monitoring was conducted using calibrated Particle Counters, ensuring alignment with ISO 14644 standards. Methodology: measurements in White and Grey Zones under different process conditions.
Outcome: early detection of abnormal particle levels triggered corrective actions (filtration, HVAC adjustments, cleaning).
Benefit: guarantees that cleanroom classifications remain audit-ready and compliant. “What gets measured gets controlled – Particle Counters provide continuous assurance of cleanroom integrity.”
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Particle Traps & Microscopy – Root Cause Analysis To complement air monitoring, particle traps and stamps were used to collect samples from surfaces and equipment. Analysis: microscopic examination identified particle types and sources (metallic fragments, fibers, dust).
Insight: helped link contamination to specific process steps, materials, or handling practices.
Action: data supported preventive measures such as equipment modification, optimized cleaning protocols, and supplier quality checks. “Microscopy turns invisible threats into actionable insights.”
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Workshops & Risk Prevention Programs Hands-on Contamination Prevention Workshops were organized with production, quality, and technical teams.
Scope: Human Factor risks, equipment leaks, HVAC efficiency, improper cleaning after maintenance, gaps in flooring.
Method: FMEA-based risk scoring (I × F × C), prioritizing high-impact issues.
Result: practical corrective actions – from improved staff training and SOPs, to technical modifications and HVAC upgrades. “Workshops build not only awareness, but also ownership of contamination control across all teams.”
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Audits & Compliance Reports To ensure regulatory readiness, a full set of audits, checklists, and compliance reports was developed and executed.
Audits: internal and external assessments with detailed follow-up actions.
Documentation: comprehensive GMP-compliant reports covering URS, FAT/SAT, IQ/OQ/PQ, risk assessments, and corrective actions.
Impact: companies were fully prepared for regulatory inspections and customer audits, with traceability and transparency ensured. “From audit checklists to final reports – every detail documented, every standard met.”
Solution
At Optivion Engineering, our Technical Cleanliness solutions combine advanced methodologies with strict industry standards (VDA 19, ISO 16232, ISO 14644) to ensure contamination control across production environments.
Our Technical Cleanliness program delivers end-to-end contamination control – from contamination mapping and particle monitoring to microscopic analysis and audit-ready documentation – ensuring GMP, ATEX, and ISO compliance with measurable improvements in product quality and reliability. With a proven methodology in contamination control, we help manufacturers achieve cleaner production, fewer defects, and higher customer trust. From risk mapping to final validation, our solutions ensure regulatory compliance while delivering safer, more reliable products.
Our approach integrates:
Contamination Mapping – systematic identification of potential contamination sources on equipment and production lines, enabling targeted preventive actions.
Particle Monitoring – real-time air and surface monitoring with calibrated particle counters to validate cleanroom classification and production conditions.
Microscopic Analysis of Particle Traps – detailed evaluation of contaminants (metallic, fiber, polymeric) to determine origin and prevent recurrence.
Workshops & Training – interactive sessions with production and quality teams to strengthen contamination awareness, define corrective actions, and ensure sustainable GMP and ATEX compliance.
Audit & Documentation – structured checklists, risk assessments, and traceability reports prepared for internal audits and customer or regulatory inspections.
By integrating these measures, we provide manufacturers with sustainable contamination prevention strategies that enhance product reliability, extend equipment lifetime, and ensure compliance with GMP, ATEX, and ISO standards.
Result
Through the implementation of contamination control strategies, particle monitoring, and risk-based workshops, we achieved measurable improvements in both compliance and production stability:
✅ Reduced Contamination Events – Significant decrease in particle counts and critical findings across monitored areas.
✅ Audit-Ready Documentation – Complete packages (URS, FAT/SAT, IQ/OQ/PQ, contamination maps) successfully passed internal and external audits.
✅ Improved Cleanroom Discipline – Staff training and workshops reduced human factor–related risks by over 40%.
✅ Enhanced Process Reliability – Proactive maintenance, HVAC controls, and standard cleaning protocols ensured stable long-term performance.
✅ Cross-Functional Collaboration – Close cooperation with production, quality, and engineering enabled faster problem resolution and effective preventive measures.
By combining advanced contamination mapping, real-time particle monitoring, and hands-on operator training, we help manufacturers reduce risks, extend equipment lifetime, and ensure flawless audits – turning cleanliness into a competitive advantage.
🔬 Particle Counters
“Continuous monitoring of airborne particles with instant alerts, ensuring compliance with ISO 14644 & VDA 19 standards.”
🔬 Microscopic Particle Traps
“Microscopic analysis of particle traps to identify sources of contamination at micro-level.”
🗺️ Contamination Map Visualization
“Visual representation of potential contamination sources within production equipment and zones.”
👥 Contamination Prevention Workshop
“Interactive workshop sessions for operators and engineers focused on contamination root causes and preventive actions.”
Optivion Engineering
Quiet solutions. Powerful results.
Engineering consulting in pharma, biotech, clean-tech, and energy industries. From process simulation to GMP validation and technical cleanliness – reliable, efficient, and audit-ready solutions.