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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
!
?
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
