Using new 3D and fly through tools to visualise contamination...Using new 3D and fly through tools...
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Using new 3D and fly through tools to visualise contamination risks Presented by Mairead Kennedy 4 July, 2016
Transcript of Using new 3D and fly through tools to visualise contamination...Using new 3D and fly through tools...
Using new 3D and fly through tools to visualise contamination risksPresented by Mairead Kennedy
4 July, 2016
Slide 2 © PharmOut 2015
Case Study - Client brief
Modify and upgrade a pharmaceutical compounding facility and apply for a TGA manufacturing licence.
Provide a risk assessment on potential facility layouts that will accommodate the compounding of both cytotoxic and antibiotic products within the facility
Prepare a facility User Requirements Specification
Prepare a proposed HVAC schematic
Prepare a formal set of layouts, showing material and personnel flows
Slide 3 © PharmOut 2015
Plan View
Slide 4 © PharmOut 2015
3D
Slide 5 © PharmOut 2015
Fly Through
Slide 6 © PharmOut 2015
Cross Contamination Regulations
Operations on differentproducts should not be carriedout simultaneously or consecutively in the same roomunless there is no risk of mix-upor cross contamination.
Eudralex Volume 4, Chapter 5 - 5.9
Slide 7 © PharmOut 2015
ISPE Baseline Guide Vol 4 Logic Diagram
Slide 8 © PharmOut 2015
Routes for Cross-Contamination
Mix Up
Retention
Mechanical Transfer
Airborne Transfer
ISPE Baseline Guide Vol. 7 – Risk Based Manufacture of
Pharmaceutical Products, Section 6.3
Slide 9 © PharmOut 2015
Facility Design
Mix Up
“The contamination at unsafe levels of one product with another via inadequate plant and process design or human error.”
• Most commonly occurs through labelling, receipting, line clearance type problems – human error
How do we prevent mix-up through facility design?
• Considerate design
• Eg. Line clearance, mentalstimulation
• Physical segregation
• even in multi-product facilities
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Slide 10 © PharmOut 2015
Mix Up Prevention
Slide 11 © PharmOut 2015
Facility Design
Slide 12 © PharmOut 2015
Facility Design
Retention
“Carryover of material on product contact surfaces from one productto another in the same equipment used in a sequential or campaignmanner; the residue or accumulated product on product contactsurfaces”
• Most commonly caused by inadequate cleaning
How do we prevent retention ?
• Cleaning process development
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Slide 13 © PharmOut 2015
Facility Design
Mechanical Transfer
“includes all routes by which material can be transferred from contaminated non-product surfaces into the product”
• PPE is a common source of mechanical transfer
Factors which affect the risk are those that influence:
• Transfer of material to a surface
• Association of the surface withthe product at risk
• Release of material from the contaminated surface to theproduct
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Slide 14 © PharmOut 2015
Case Study – Multi Product Facility
Slide 15 © PharmOut 2015
Fly Through
Slide 16 © PharmOut 2015
Benefits of 3D and fly through
• Transforms CAD data into compelling imagery and movies to support conceptualisation of design
• Improve the factory design review process
• Multiple models or scenarios aids decision making
• Assists communication across boundaries (discipline, language and location)
Taking a real-time, virtual tour of your design provides:
• insight into your design intent while;
• demonstrating how it works
3D design avoids costly mistakes when designing multi floor facility
Slide 17 © PharmOut 2015
• Measures to prevent cross-contamination and their effectiveness should be reviewed periodically according to set procedures.
Eudralex Volume 4, Chapter 5 - 5.22
Periodic Review
Slide 18 © PharmOut 2015
Thank you for your time.Questions?
Mairead Kennedy
Lead Consultant
www.pharmout.net
