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Design and Function of Packaging Lines
Addressing the Risk of Cross Contamination
L. A. Goff, Director of Quality Assurance
Pharma Packaging and Labeling Conference Feb. 2017
Addressing Cross-Contamination in
Packaging
Agenda
1. Pre-existing cross contamination risks
2. Cross-contamination risks during
renovations
3. Final design to address cross-
contamination risks
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Pre-existing Challenges: • Bulk/component
staging area • Common hallways • Product exposure • Fit & Finish • Lack of full
segregation btw/Pack Lines
• Shared wash/clean rooms • Material flow (dirty/clean) • Wood pallets
Renovation Nation: Design Objectives & No Drug
Shortages
• Meet or exceed ISPE guidelines for Fit & Finish
• Deliver fully segregated packaging lines • Identify and Mitigate risks from cross
contamination • Deliver solution to address future
Serialization and Aggregation requirements • DO NOT ADVERSLY IMPACT ON-GOING
PACKAGING AND MANUFACTURING OPERATIONS
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The Challenge – renovate while continuing to pack, analogous to living in your house while completely renovating the kitchen
Mitigating Cross-contamination Risks during
Construction
• Containment Plans
o Hard containment walls vs. plastic
o Negative pressure to keep particulate matter inside construction area – directly exhausted to outside
o Magnehelic gauge to confirm airflow
o Monitored by QA daily for compliance to plan
o Air-monitoring for VP and NVP
• Gowning requirements for construction zones
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Major demolition
Containment plans designed to mitigate risks associated with construction activities.
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International Society of Pharmaceutical Engineers (ISPE) Area Designations
Design & Functionality of Packaging Lines
• Fully segregated packaging lines • Fill Rooms and Secondary Pack separated by PALs and
MALs • Use of “Bubble” Airlocks • Fill rooms w/dedicated HVAC systems single pass
w/appropriate ACH • Product exposure – only in Fill Room • Gowning changes when transitioning from Grey to White
zones • Gowning changes when transitioning to new Product Family • Smooth walls, ceilings and solid color floor for ease of
cleaning • Local extract at Case Packer to mitigate corrugate dust • Filler upgrades for the detection of foreign tablets • Elimination of wood pallets in GMP space • Submitted for ISP Facility of the Year Award
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Blister suite prior to packaging line installation
Kanban
• Improved capabilities to confirm tablet quality
• Fill room (Primary Pack) enhancements mitigates risk of cross-contamination
Finished goods leaving line in cases
Central Palletizer
PA-5: new Formulation Suite
Questions???