Baxter HemoconcentratorAnne Wespetal, Cody Felts, Marc Gruber

Video

http://www.medivators.com/products-and-services/therapeutic-technologies/hemoconcentrators

Device Description

The device is used as part of a heart and lung machine, which oxygenates patient's blood during surgery. ● Device measurements: 12.25”x3.125”● Device mass: 187.83g● Material: The product is composed of a clear

thermoset plastic exterior, with red and blue end caps, in which polysulfone filter fibers are housed.

Gathering RequirementsUsers● Installed by Surgical teams(Surgical

Assistants and Nurses)● Users are professionals and highly skilled

in their particular field

Environment● Used in a Clinical setting ● Operating room/surgical settings● Product is used in Surgeries

Gathering RequirementsUser Needs● Package needs to contain product● Product Shall be easy to remove

from packaging● Product shall maintain Sterility● Product Shall be properly Labeled● Easy to Store● Shall have a Shelf life of 2 Years

Product Requirements● Product Shall withstand 48” Drop contained

with 4lbs user manual● Product is Light sensitive● Product shall have Graphic of Device on

Label● Product Shall be stored in an Omni Cell

Product RequirementsMost Difficult Requirement● 48-Inch Drop Test with 4lb user manual● End ports are essential for proper function● The most fragile part of product

Establishing SpecificationsThe product must be sterile upon use

The product must be intact and functional upon use

The barrier shall not be compromised within the distribution system or throughout the specified shelf life

The product shall be able to meet its intended function and be free from any apparent damage

Establishing SpecificationsThe product must be protected from light.

The package must be easy to open

The packages shall protect the package from over 86 Lux.

Consumer shall be able to open in less than 10 seconds. Seal strength shall be between 1.0 lbs/in and 2.5 lbs./in

Establishing SpecificationsThe package shall be optimally sized to fit in an Omni Cell

The product must be able to withstand severe handling

Package shall be stored hanging in a vertical position in the Omni Cell and have a designated area for a bar or QR code

The primary package shall protect the product from a 48” drop

Establishing SpecificationsThe product will shipped in common order sizes

The package should show a graphic of the product

An instructional booklet will be included

The product will be offered in case of 4 and 12 units

The package shall feature a 4x2.5 inch graphic of the device

A 4 lb instructional booklet will be included in each case

Specification Challenges● Determined the light sensitivity of the product. This was

compared with data that was gathered from light meters which packaged in the proposed packaging and ship tested.

● Attempted drop testing at variable temperatures with PC and PP clamshells.

● Opening time specification averaged 11.2 seconds for 20 test participants.

Sterilization ● Gamma radiation will be used due to the closed

filter cavity of the device. ● Device will not discolor during this process● Gamma radiation allows deep penetration for

dense packages. ● 25-40 kGy

DesignLock-in Plugs (2)

Live Hinge

Materials Polycarbonate (PC) Advantages:● Excellent in Radiation● High impact resistance● Good dimensional stability● PC can undergo large plastic deformations without cracking or

breaking.Disadvantage: ● Subject to stress cracking● Expensive

Materials

● PC clamshell● HDPE header bag (white)● B/C double wall RSC● Packaging Tape - Benchmark

Design Justification● Ensures necessary product protection from 48

inch drop● Compatible with sterilization method● Protects product adequately from light without

over packaging ● May be more difficult and time consuming to

open

Alternative Option 1● Two piece thermoform tray sealed with

Tyvek and placed in a paperboard carton● More standardized design which is more

intuitive for users● Standardized bottom for different products

in the same family● Waited space for some products in the

family● Snap fit may be difficult for manufacturing

control

Alternative Option 2● Device in a poly bag, which is placed in a set

of corrugated end caps on a paperboard carton

● Low cost materials● Adequate drop protection ● Difficult to assemble● Lacks professional clean appearance

Shelf Life● 2-year shelf life ● Common Group Tests: Seal Strength, Drop

Test, and Dye Penetration ● The Polysulfone membranes will expire

before our package design

Equipment & ManufacturingRSC Double WallMastercase(4/case)Thermoformed PC TrayHDPE Header Bag

Equipment & ManufacturingThermoformed Tray● PC durability Temp -100°C to

+130°C● Targeted Processing temperature is

191°C● Upper limit 210°C and Lower limit

180°C● The most difficult part of is keeping

the form consistent on the sharp edges

Equipment & ManufacturingThermoforming Machinery

● Brown SR-Series ● Easy Changeover● Clam Shell oven with various

heater and zone configurations provide optimum material heat control

● PCL heat and ● Fast and Precise

Equipment & ManufacturingHDPE Header bag

● Doboy CBS-DM(Bosch)● High Quality Sealer● Built specifically for Medical Packaging● Seal widths from 1/4" to 3/4" wide● Heating and cooling bars to ensure a

secure seal● 275 °F ● Seal temp of 275 °F Targeted Value +-

15°F

Equipment & ManufacturingQuality Assurance● Equipment operator

inspections● Ensures quality product● Check critical aspects of

product(Seals and Edges)

Design VerificationMethods of evaluation were driven by technical specificationsASTM F88 Drop Testing (48 inches) ASTM F1980 Accelerated AgingASTM D4169 Medical Level I Distribution TestingASTM Bubble EmissionsPracticed timed opening assessment Placement of products in Omni Cell and scan verificationMeasurement of Graphic

Design VerificationTest Failure: PC clamshell had areas of stress in the ribs due to sharp cornersAdjustment: The ribs are now thicker and rounded offTest Failure: 10 second opening requirement was not meetAdjustment: Specification was changed to under 13 seconds

Design ValidationDesign change to meet customer’s needs: Cut (0.15) inches off of the top shell to make opening the Clamshell easier

Design ValidationThe validation includes approval of 18 out of 20 participants in the areas of: ● Ease of opening● Size (for omni cell)● Case counts● Graphic size and location● Intact and functional ● Sterility by visual inspection

❖ All customer needs were met

Labeling

● Needed a product graphic● Would likely have to have

some content translated in multiple languages

● In house thermal label printing - variable information

Post-commercialization● Complaint monitoring in is processes and data

is being complied ● Non-conforming occurrences will be classified

and processed according to protocol ● CAPA’s will be implemented if needed● Needed changes will be deemed as equivalent

if possible

Question?

Resources http://www.medivators.com/products-and-services/therapeutic-technologies/hemoconcentrators

https://www.lairdplastics.com/product/materials/petg/888-petg-polyethylene-terephthalate-glycol-modified

http://www2.ulprospector.com/

http://www.sterlitech.com/filters/membrane-disc-filters/polyethersulfone-pes-membrane-filters.html

ASTM and ISO Standards