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Exclusive Webcast Event
Ensuring Sterile
Barrier System
Success
May 25, 2010
Moderated by:
Daphne Allen, Editor
Pharmaceutical & Medical
Packaging News
Today’s Speakers
Alison TylerTechnical DirectorBeacon Converters Inc.
Ed WoodDirector of Sales,Medical-Consumer-Industrial Div.,Multivac Inc.
Kevin ZachariasEngineering Program ManagerOliver-Tolas Healthcare Packaging
Jason CrosbyMedical Business ManagerPlastic Ingenuity
Today’s Sponsors
Customer Driven
Innovation
Alison Tyler
Technical Director
Beacon Converters, Inc.
Case Study #1
Nurses input-
•AORN Nurses survey feedback presented at HealthPack.
•Contain devices better.
•Aid in presentation to sterile field.
•Prevent drops or parts falling on floor.
•Quick access, less waste, and visibility.
•74% nurses respond clear packaging was important.
•Discussion of multiple component devices falling.
•Discussion of packaging issues with tubing coils.
Device Manufacturer Inputs
•Tubing coils most problematic.
•Packaging must keep the coil unitized in package to reduce
stress on package seals.
•Packaging must be easy to remove in the OR/ER.
•Easy to load product into.
•Cost effective.
Solution
•Beacon Converters worked with a device manufacturer to create a unique packaging solution that addressed the requirements of the product and met the needs of the end user.
•Tie wraps were developed specifically to meet these needs.
Beacon Converters Tie
Wraps
Solution
•100% Tyvek®.
•No adhesives.
•“Belt and loop.”
•Easy application in production.
•Easy removal at the time of use.
•There is nothing to cut or break that could introduce particulates into the sterile field.
•Completely customizable for any length or size.
•Very cost effective and user friendly.
Beacon Converters Tie
Wraps
Case Study #2
Customer Input
•Product had multiple drill bits.
•Sharp edges.
•Thermoformed trays were evaluated but footprint was too large in
order to accommodate all the cavities with snaps.
•Product needed to be secured to protect packaging from
compromise.
•Product needed to be organized – multiple components different
sizes and materials.
•Cost effective.
•Stable for multiple sterilization methods.
Challenges
•Sharpened metal edges.
•Multiple components of differing materials.
•Heavy cylindrical components.
•Small footprint restriction.
•Containment and unitization required for presentation.
•Beacon Converters worked with the customer and created a wallet-style die-cut insert that secured each component securely within the structure.
•The die-cut insert cards are made entirely of 100% high-density polyethylene and can be embossed with a company logo or recycling symbol.
Custom Die-Cut Insert Card
Solution
The card folded creating a wallet like insert. The ends of the drill bits are protected with an end wall of material to prevent damage to the primary packaging from the drill bits. The assembly is placed in a Tyvek® film pouch.
The die-cut insert cards are made entirely of 100% high-density polyethylene and can be embossed with a company logo or recycling symbol.
The design successfully met all the criteria and subsequently passed the customer’s ship testing protocol.
Learnings
•Take on difficult-to-package products with an open
mind.
•Communication between supplier and device
manufacturers is critical for success.
•Listen to end users to improve your packaging
functionality – it matters.
Opening Features for
Sterile Medical Packaging
Ed Wood
Director of Sales, Medical
Multivac, Inc.
Step Down
Short Sheet
Folded Tyvek / Paper
Hot Formed Peel Bumps
Cold Formed Peel Bumps
Embossed Peel Bumps
Tear Notch
Star Notch
Human Factors Considerations in Sterile Medical Device Packaging
By Kevin Zacharias
Engineering Program Manager
Oliver-Tolas Healthcare Packaging
Oliver-Tolas™ Healthcare Packaging• Markets Served:
Medical
Pharmaceutical/Biotech
Combo Drug/Device
• Products:
Pouches
Lids
Rollstock
• Locations:
USA: Michigan, Pennsylvania, Ohio
Europe: The Netherlands
Far East: China
Human Factors in Package Design• There is a complexity in the interaction between a package design and
the user.
• Design elements not only have an effect on ease of use, but more importantly, can address and minimize potential user errors that may result in medical errors or noncompliance (legibility), with an ultimate focus on patient safety.
• Important due to:
Aging of nursing professions.
Increase in medication and medical errors misuse.
Possible tampering or counterfeiting of devices.
Liability.
Design Considerations (the Basics)
• Aseptic Presentation - introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination (ISO 11607).
“Knuckle Peel” – Peel and curl both sides of package and present device to sterile field.
“Flipping”/”Dumping”/“Bombing” – Peel one side of package and dump device into sterile field.
Consider seal strength when designing peel systems.
– Nurses want low peel strength because they open many packages per day…but this needs to be balanced with keeping the seal integral to point of use!
Design Considerations (the Basics)
• Peel Tabs
Put more thought into the design of peel tabs.
Make it obvious how to open a package (use graphics).
Peel tabs should be large to accommodate all hand sizes.
Include thumb notches, debossing in film to aid gloved hands
in grasping tab.
Consider left-handed versus right-handed users.
• Legibility of Print
Appropriate font size for eyes of all ages.
Expiration date clearly marked.
Check legibility after sterilization and distribution testing.
Design Considerations (the Basics)
• Peel Open Characteristics - shall be continuous and homogenous, without delamination or tearing of the material that can affect aseptic opening and presentation (ISO 11607).
Adhesive coatings reduce occurrence of tearing and delamination.
• Seal Integrity - characteristics of the seal, which ensures that it
prevents the ingress of microorganisms under specified conditions
(ISO 11607).
Consider adding color to adhesive and or film to aid in
verification of seal integrity.
Design Considerations (the Basics)
• Disposal - complaints about bulky packaging filling up waste
disposal containers.
Less is better (from a disposal viewpoint) though not always
achievable.
Can packaging materials be recycled?
• Storage - understand how the end-user stores and moves the
package.
Is the package stacked on shelves? (COF considerations,
slip additives).
Is it dispensed automatically?
Does it need to fit in bins, racks, or carts of certain sizes?
Example: Header Bags
• Negative feedback from Voice of the Customer Nurses focus group.
• Problem: Product can come in contact with
non-sterile portions of the seal.
• Solution: Chevron seal incorporated into
Header bag design to facilitate aseptic presentation.
Example: VisiSeal
• Problem:
Nurses have difficulty verifying whether seal is integral during visual examination prior to opening the package.
• Solution:
Color shift in seal allows for easy visual inspection of seal integrity.
Verification is possible without peeling open pouch.
Provides clinician quick verification of integrity and evidence of tampering.
The Best Way to Gain Perspective on Your Package Design is with the End User
• The best way to optimize the package design facilitation between the user and the package is to study the important elements of the interaction subjectively and objectively--thus the immersion experience.
• Immersion in a real or simulated healthcare setting offers realistic, engaging, multisensory learning experience to increase clinical proficiency and decrease medical errors and costs.
• Traditionally not easy for packaging engineers to gain access to clinical setting.
Privacy regulations (HIPPA).
Vaccinations required and other hurdles.
• Some MDMs have relationships with local hospitals that allow for some access.
• Suppliers are even further removed from the end user, yet are often responsible for generating design ideas.
• Simulated immersion environments may be the best method to develop data to support your design in a controlled but realistic healthcare environment.
• Collaboration between Oliver-Tolas and MSU Schools of Nursing, Medical, Osteopathy, Veterinary, Packaging, and Anti-Counterfeit/Product Protection Program
• Working together on:
• Package testing
• Systems solutions for medical device and pharmaceutical manufacturers.
• Educational opportunities.
Opportunity to “Fill the Gap” Via the
Learning & Assessment Center at
Michigan State University
Healthcare Packaging Immersion Experience
• Provide an immersive educational experience in a simulated operating room and emergency department.
• Observe and interact with doctors and nurses using packaged devices.
• Gain a better understanding of how package design can impact the end-user.
• Screen new package designs.
Thank You!
Improving the End User
Experience
Jason R. Crosby
Medical Business Manager
Plastic Ingenuity
May 25, 2010
Utilizing Design in
Medical
Thermoforming
Goal: Improved End User Experience
“ When packaging becomes transparent, we as packaging
engineers know we have done our job.”
- Packaging Manager, Medical OEM
End User Analysis
Package Engineering
ManufacturingMarketing
Medical Device Company Correct Finished Product
Healthcare Provider
Understand the Following:
OEM manufacturing processes and package specifications.
Package validation testing requirements.
Distribution system (full value chain).
Point of use: Clinic, OR, ER, Surgical Suite, or General
Hospital setting.
Medical device function, handling, orientation, and potential
ergonomic issues.
Critical Step: End User Analysis
Focus Groups: If focus groups are held and packaging is
analyzed, invite your packaging supplier.
• Second hand feedback is never as clear.
Package designers are very good at developing
solutions; however, they need to be at the table.
Feedback is often relayed incorrectly or critical details are
often times left out.
• Outcome:
•Better solutions.
•Faster solutions.
Huge Missed Opportunity
Critical Step: End User Analysis
End User Overview
Presentation into Sterile Field.
Single or Double Barrier.
Function of Device/Patient Interaction.
Sequence of Use.
Storage in Hospital.
Design Overview
Sterilization Method.
Device Containment Strategy.
Sterile Barrier – Pouch or Tray/Lid.
Automated System / Hand Loaded.
Part Denesting Strategy.
Design Functionality.
Current Problems / Challenges.
End User Analysis: Design Assessment
Material Selection
MVTR Requirements.
UV Light Requirements.
Sterilization & Heat Sealing Process.
Cold or Hot Applications.
Gauge Targets.
Silicone or Denesting Agents.
Process Control / Quality / Testing
Validation Requirements.
Critical Design Features.
Defined Testing Protocols.
Clean Room Processing.
Target or Established Specifications.
Supply Chain / Distribution Process.
Practical Examples: Improving the End User
Experience
Market Examples:
• Handling Tray while Removing Tyvek.
• Label Viewing.
• Package Integrity.
Market Example: Improve Grip for Gloved
Nurse
Ear Tab – Grip Pull
Pretty Standard.
Provides gloved nurse ability to lift Tyvek Lid.
Grip Hand Hold
Designed tray with a rib feature located on the cavity.
Rib feature provides gloved nurse area to grip and secure tray.
Width of cavity to accommodate ergonomic grip.
Grip feature located on both sides of cavity.
Market Example: Improve Label Identification
Issue:
Package stacked in hospital.
Hospital staff has end view of package.
Label located under plastic lid - unable
to read label easily.
Difficult to select correct product.
Market Example: Improve Label Identification
Design Improvement:
Create a pocket for the label to drop into when
folded.
This will allow for end viewing of the label.
Hospital staff will easily be able to view label and
make product selection.
Market Example: Improve Label Identification
Design Improvement:
Large label pocket created.
Allows label to easily fit inside pocket.
Clear material (PET or PETG) was
utilized for easy viewing by healthcare
personnel.
Market Example: Package Integrity
Issue: Rigid Tray in Pouch
Potential Pouch Puncture.
Sharp Tray Edge and Pouch
Interaction.
Market Example: Package Integrity
Design Improvement:
Round soft edge – trim edge hidden.
Reduce pinhole potential from abrasion.
Reduce puncture potential from sharp
flange.
Market Example: Package Integrity
SafeEdge
Flange
Standard
Flange
Hitting the Target: Key Take-Aways
End User Analysis – critical to project
success.
Include package designers and suppliers in
focus groups or design reviews.
Challenge suppliers to help solve problems.
Listen, Listen, Listen to the end user.
Questions for our speakers?
Alison TylerTechnical DirectorBeacon Converters Inc.
Ed WoodDirector of Sales,Medical-Consumer-Industrial Div.,Multivac Inc.
Kevin ZachariasEngineering Program ManagerOliver-Tolas Healthcare Packaging
Jason CrosbyMedical Business ManagerPlastic Ingenuity
Thank you to our speakers!
Alison TylerTechnical DirectorBeacon Converters Inc.
Ed WoodDirector of Sales,Medical-Consumer-Industrial Div.,Multivac Inc.
Kevin ZachariasEngineering Program ManagerOliver-Tolas Healthcare Packaging
Jason CrosbyMedical Business ManagerPlastic Ingenuity
Thank you to our sponsors!
For more details . . .
www.beaconconverters.com
www.multivac.com
www.oliver-tolas.com
www.plasticingenuity.com
