1. Molded Rubber & Plastic components and Assemblies
Solving Critical To Function Problems

2. Worldwide Facilities Mason City, IA (55,000 Ft²)
Extrusion and Mixing Facility
Reynosa, Mexico
Custom Molded Shapes and Assemblies
Plymouth, MN
(56,000 Ft²)
Corporate Offices
Litchfield, MN
(70,000 Ft²)
Rubber & Plastic Molding and Assembly
Clean Rooms
FDA Registered
River Falls WI
(46,000 Ft²)
Plastic Molding and Assembly
Suzhou, China
(60,000 Ft²)
Rubber & Plastic Molding
Engineering & Development
Clean Room
Pacy-sur-Eure, France
(50,000 Ft²)
Distribution Facility
European Sales & Technical Support

3. Medical Customers
Confidential

4. Core Capabilities Product Design and Development Program Management
Design Group
Material Development
Advanced Materials Group staffed with PhD Chemists
Custom Molded Rubber and Plastic Components
Integrated Components & Assemblies

5. Design Group Early Involvement - “Member of the Team”
Full Complement of Design Tools
Ideation, DFM, FEA, Prototypes
Components, Assemblies, Tool Design and Machine Design
200+ Projects a Year
I-DEAS NX
Siemens NX
AutoCAD 2010
Pro Engineer
Solidworks
Abaqus Finite Element
Sigmasoft Mold Flow Analysis
Alias Visualization Software
Confidential

6. Material Development
Over 1,000 rubber formulations in portfolio – all types – custom formulations to suit market & customer needs.
Proprietary formulations – QunitonTM and QmonixTM
Blends
Colors
Market Specific Approvals
Agency Certifications – Global
Testing and Analysis
Dissimilar materials
Interfacial chemistry expertise
Bonding, coating, surface modification

7. High Performance Plastics
PEEK, Torlon® PAI
TPE and many other engineering resins
Compounded as needed

8. Micro-Molding Plastic anchors, staples and other securing devices.
Liquid silicone rubber parts for glucose meters.
EPDM rubber
o rings and quad rings.
Qmonix EPDM for defibrillator seal application.
PEEK heart implant wires and valves.

9. High Volume Application
Duck Bill
20 M/Yr, LSR Injection, Slit, In Mold Inspection

10. Controlled Environments
& Clean Rooms
Confidential

11. Packaging ISO 7 / Class 10,000 Clean Room Blister Pack, Fill and Seal
Tyvek Bagging, ESD Protective Pouches
SBS Boxing and Kit Assembly of Sterile Components
Confidential

12. Vertical Market Focus
WATER
TRANS
MEDICAL & PHARMA
POWER

13. Medical & Pharma MEDICAL & PHARMA Drug Delivery Diagnostics Surgical
Treatment

14. Drug Delivery Applications
Syringe caps, plunger seals, vial seals and seals for large bore syringes and plungers.
Market Trends
Strong growth of pre filled syringes with long shelf lives.
Pre Filled Syringe CAGR >11.3%, Injectable oncology drugs, 6.5% CAGR.
Increasing regulatory scrutiny of silicone oil.

15. Diagnostics Applications
In Vitro Diagnostics, Sample Collection, Seals & Diaphragms for Dx equipment
Market Trends
Highly fragmented market with large global companies
Largest segment Immunochemistry
Global CAGR 7.3%
M&A continue to be a critical strategy to enter new markets and / or increase market share

16. Surgical Instruments Applications
Over Molded Surgical Instruments (OMSI), plastic handles for instruments & devices
Components and sub assemblies for minimally invasive surgeries.
Endoscopes and other imaging and positioning devices for MIS
Trocar Seals
Single use devices for cardiovascular and orthopedic and general surgical procedures that combine rubber & plastic.
Market Trends
US CAGR of 3.6%. APAC CAGR is 13.2%
Cardiac and Neuro markets are poised to increase significantly with new technologies.

17. Specialty Treatment Applications
Cardiovascular and interventional devices.
Cardiology: Pacemakers, defibrillators, heart valves and vascular access & closure devices
Respiratory & Anesthesia delivery systems.
Home health care devices for monitoring and treatment.
Market Trends
US CAGR is 6.5%.
Significant increase in home health care initiatives and products to lower medical costs.

18. Integrated Components
& Assemblies
Automated Pill Dispenser
Confidential

19. Quniton™ – An Innovative Surface Modification for Elastomers
Quniton is a trademark of Minnesota Rubber & Plastics / Quadion LLC

20. Requirements of a surface modification
Conventional methods for modifying a surface
Rubber Elastomer families

21. Comparison of Elastomers
Most commonly used in Medical Applications
IR – synthetic polysioprene
EPDM – ethylene propylene rubber
xIIR – clorobutyl and bromobutyl
VMQ – silicone
FKM - fluorocarbon

22. Conventional methods to produce a lubricious elastomer surface
Coatings
Siliconization
Urethane
Powder coatings of talc, graphite, MoS2, PTFE, etc
Conformal coatings – Parylene, Vapor Deposition Coatings

23. Medical Device surface & performance requirements
Longer life – reduced friction and wear
Consistent performance
No delamination, flaking, or decomposition
Biocompatibility
Low (no) outgassing,
Minimal extractables and leachables
Stable to all methods of sterilization
Moisture barrier and low WVTR

24. Development of Quniton
A low friction surface modification for elastomers
A surface modification. Not a coating
Reduces coefficient of friction to as low as 0.20
Resists adhesion to a variety of substrates
Can be achieved on FKM, EPDM, HNBR, NBR, and IR
Retains all of the performance characteristics of the base elastomer
VMQ (silicone) & Polyurethane - Quniton is under development

25. Comparison of Elastomers (classification according to ASTM 2000)4
325
FFKM
300
275
FKM
250
Heat resistance
Temperature (°C)
225
VMQ
200
175
FVMQ
AEM & ACM
150
EPDM
CSM
HNBR
CPE
125
ECO CR
URE
NBR
100
IIR
SBR 70 IR B C D E F G H J K
140
120
100 80 60 40 30 20 10 A
not required
Oil Resistance Class (% volume swell in ASTM No. 3 Oil)
5/20/2014
Chemical resistance

26. Polymer Types Thermoplastic Thermoset Melt - form - re-melt
Does not melt - forms irreversible 3D network
Chemical cross-link

28. Coefficient of Friction is
measured with the use of
a sled on an anodized
aluminum surface.
Glass and plastic surfaces
have also been tested.

29. CoF comparison of typical elastomers (lower values are preferred)

30. Quniton surface modification significantly reduces CoF

31. Among dipolymer fluorocarbon elastomers, modification is relatively similar between Bisphenol AF and Peroxide cure

32. Little to no difference in material properties are noted between Standard and Quniton FKM-70
Tensile, psi
2033
1858
Elongation, %
249
229
psi
648
743
Hardness, Shore A 72 74 SG
1.84
Immersion - Fuel C, 70/23°C
hardness change, Shore A -2 -1
volume change, %
3.8
1.8
Immersion - SF 101, 70/200°C -8 -7
13.7
11.8
FKM-70
Quniton FKM-70
Immersion - Water, 70/100°C
hardness change, Shore A -2
volume change, %
3.7
4.0
Immersion - Steam, 168/200°C -6
14.9
Compression Set, 22/200°C, %
11.0
11.9

33. Among high fluorine terpolymers and specialty FKM types modification is dependent upon covalent bond availability

34. For medical applications Quniton FKM-70 offers a significant reduction in CoF

35. Quniton EPDM performs similar to conventional coatings
Not a coating

36. Quniton ™ 914M (FKM) is cited in DMF 28143 containing the following documented test results
ISO MEM Cytotoxicity
USP Class VI
USP Acute Systemic Injection
USP Intramuscular Irritation
USP Intramuscular Implantation

37. Ensures that seals and components exhibit minimal adhesion to mating components throughout the life of the product (low CoF)
As a surface modification, it will not flake, peel, or transfer, unlike coatings of PTFE or polyurethane
Exhibits bio-compatibility
Exhibits minimal extractables and leachables

38. A family of high performance EPDM elastomers designed for use in Water, Beverage, and Food applications. Some of the Qmonix elastomers have specialized use in medical applications
Qmonis is a trademark of Minnesota Rubber & Plastics / Quadion LLC

39. Features & Benefits Ozone and oxidative resistance
Sterilization and disinfection resistance
UV, Steam, ETO, Gamma
Chlorine, Chloramine
Excellent sealing force retention
Continuous use at 150°C
High dielectric strength – Compound 912T
Regulatory compliance
FDA 21 CFR
NSF/ANSI Standard 61
EU EC 1935:2004
KTW (Germany), ACS (France), WRAS (Great Britain)
DMF (Compound 912T)
ISO (non-cytotoxic)

40. Original and Aged Properties
Property / Material
559PE
558EC
912T
560CF
559GT
Hardness, Shore A 70 75 60 90
Tensile, psi
1500
1800
1600
Elongation, %
135
160
400
350
100
100%, psi
900
950
500
450
1850
Specific Gravity
1.12
1.11
1.08
1.04
1.20
Compression Set, % 8 6 12 7

41. Medical and Pharma Water Defibrillators & Pacemakers
Implantable pulse generators
Electrosurgical Instruments
Water
Water distribution and point-of-use
Beverage dispensing
Food contact

42. Visit our Booth # 2251
Confidential