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March 2020
Focused Global Leader in Contract Services
650+Employees
36%of indirect employees holdEngineering degrees
20+yearsServing medical and pharmasectors
Asia Europe USAGlobal Presence
55+ Quality audits per year
PartnersExisting globaltop ten Pharma and Device Partners
OwnershipPrivately held without outside debt
Locations
USA IRELAND IRELANDHeadquarters
POLAND MALAYSIA
SteriPack Ireland HQ (2017)Facility : 110,000 sq. ftISO Class 7 cleanroom: 20,000 sq. ftAdditive manufacturing capabilities for rapid prototyping and small batch volumes 3 x Carbon 3D Printing Machines
SteriPack Poland (2006)Facility: 140,000 sq. ftISO Class 8 cleanroom: 40,000 sq. ft
SteriPack USA (2012)Facility: 43,000 sq. ftISO Class 7 and 8 cleanroom: 20,000 sq. ft
SteriPack Malaysia (2008)Facility: 86,000 sq. ftISO Class 7 and 8 cleanroom: 22,000 sq. ft
Our Global Presence
Poland 140,000 sq. ft.since 2006
Malaysia 86,000 sq. ft.since 2008
USA, 43,000 sq. ft.since 2012
Global Locations & Cleanroom Contract Manufacturing Capabilities
Ireland 22,000 sq. ft.since 2013
• Ireland
• Liquid, Creams & Gel Formulation/Filling
• Poland
• Combination product assembly (Drug & Device)
• ISO Class 8 Injection Molding
• Microbial Barrier Testing
• Contract Assembly/Packaging
• Malaysia
• Pharmaceutical Blister Contract Packaging
• ISO Class 8 Injection Molding
• Class 3 Burn Dressing Manufacture
• Contract Assembly/Packaging
• USA
• Contract Assembly/Packaging/Kitting
• ISO Class 8 Injection Molding
• Ultrasonic Cleaning
• Liquid/Powder Filling
• Tray/Pouch filling & sealing
• Form Fill Seal
• Sterilization Management
Ireland New HQ 110,000 sq. ft.since 2017
Quality& Compliance
o ISO 13485: 2016
o Compliant to MDD 93/42/EEC, Annex II
o FDA registered and audited21 PART 820 Quality System
o Regulation compliant
o Accredited to JPAL and CAN/CSA
o CAN/CSA
o Accredited to MHLW Japanese Ministerial Ordinance No. 169
o CE marking
o 510K submission
o ISO 17025 Accredited Laboratory
o ISO Class 7 and 8 Cleanroom production
Quality & Compliance
o Pharmaceutical Manufacturing Authorization for primary and secondary packaging (cGMP).
o Pharma Cleanroom Class D.
o Controlled temperature and humidity environment.
Business Contingency Planning at SteriPack
Global Quality SystemGroup Wide Harmonization of Equipment & Processes
Interchangeable ToolsEnglish Speaking Management Group Wide
Cleaning and RinsingULTRASONIC CLEANING, RINSING, DISINFECTING
Assembly and KittingMANUAL AND AUTOMATED
Sterile Barrier Packaging and LabellingMANUAL AND AUTOMATED
Sterilization and Sterile Barrier TestingGAMMA, E-BEAM, X-RAY, EO, STEAM
For prototyping and highly complex partsmanufacturing
Excellent mechanical properties, resolution and surface finish
o MPU – Medical Polyurethane: bio compatible, sterilizable and durable
o EPU – Elastomeric Polyurethane: highly elastic, tear resistant and resilient
o SIL – Silicone: soft touch, bio compatible and tear resistant
o RPU – Rigid Polyurethane: versatile, tough and rigid
o FPU – Flexible Polyurethane: impact resistant
o CE – Cyanate Ester: high temperature resistant and stiff
o EPX – Epoxy: temperature resistant, strong and tough
o UMA – Urethane Methacrylate: manufacturing jigs and fixtures
o Other polymer materials
Polymer AM technology
SteriPack Additive
Bringing a new manufacturing technology to scale
Production grade Additive Manufacturing
M2 printer build volume(189 mm x 118 mm x 326 mm)
Programmable Liquid Resins
UV Light Cured Green Part Thermally Cured Strong PartLiquid Programmable Resin
CLIP
BAKE
Cross-Linked UV system with an unreacted thermal system
Post-bake an interpenetrating network of UV System and thermal system forms
CLIP
Liquid resin with no cross-linkage
1 2 3
BAKE
TRADITIONAL AM DIGITAL LIGHT SYNTHESIS
TRADITIONAL AM DIGITAL LIGHT SYNTHESIS
Isotropic Mechanical Properties
Materials
RPU Rigid PolyurethaneSimilar to ABS
Tough + abrasion resistant, stiff
EPU Elastomeric PolyurethaneSimilar to TPU
Highly elastic, resilient
CE Cyanate EsterSimilar to GF Nylon
High temperature resistance, strength, stiffness
EPX EpoxySimilar to GF PBT
Temperature resistant, strong, accurate
UMA Urethane MethacrylateSimilar to Polystyrene
Rigid, fast prints
FPU Flexible PolyurethaneSimilar to Polypropylene
Tough, impact + abrasion resistant, moderate stiffness
SIL Silicone-UrethaneSoft touch, biocompatible, and tear resistant
Dental productionPrints fast and accurately
MPU Multi-purpose PolyurethaneSimilar to Polypropylene
Mechanical strength, biocompatibility, and sterilisability
Materials
ResinUltimate Tensile Strength (Mpa)
Elongation at break (%)
Tensile Modulus (Mpa)
Shore Hardness
Impact Strength
(J/m)
Heat Deflection Temperature (C)
Biocompatibility
Comparable Thermoplastic
Cyto
toxic
ity
1
Irrita
tion
2
Sensi
tisa
tion
2
CE 221 92 3.3 3870 92D 15 231 Glass filled nylon
EPU40 10.2 310 - 68A - - x x x Thermoplastic polyurethane (TPU)
EPU41 6.2 130 - 73A - - x x x Thermoplastic polyurethane (TPU)
EPX82 82 5.9 2800 89D 44 115 20% glass-filled PBT
FPU50 29 280 831 71D 40 78 x x x Polypropylene
RPU70 45 100 1900 80D 22 70 x x x ABS or PC ABS
SIL30 3.4 330 - 35A - - x x x Silicone or TPE
MPU100 38 25 1200 - 29 48 x x x Polypropylene
Materials
1 ISO 10993-5, Biological evaluation of medical devices – Part 5: Test for in vitro Cytotoxicity2 ISO 10993-10, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitisation (GPMT)*Sensitisation testing for EPU 40 specifically used the Closed Patch Sensitisation Study rather than the GPMT.
ACCREDITED LABORATORY
Capabilities
CLEANROOM
Injection molding
24
Services scope
○ Concept design
○ Design development
○ Design review
○ Injection molding validation
○ Cleanroom injection molding
○ Cleanroom value added contract manufacturing services
○ Grey zone value added contract packaging services
25
WHAT?
○ Medical devices and combination
products cleanroom injection molding
○ High complexity components with
medium to low quantities focus
○ Molding as a part of complete device
manufacturing process with other value-
added services such as welding, printing,
assembling, packaging and sterilization
WHERE?
○ In SteriPack’s facilities in Ireland, Poland,
USA and Malaysia
○ In ISO 7 and ISO 8 controlled cleanroom
environment
HOW?
○ Scientific molding
○ eDart system
○ CT and X-ray scanning
○ Global validation standards
○ On Arburg and Boy machines (10-150
tons)
○ Dryer with molecular sieves with Dev
point -30 (calibrated every year)
28
I. Commodity II. Engineered III. Exotics
ABS Acrylonitrile Butadiene Styrene
LDPE Low Density Polyethylene
PA Polyamide (Nylon)
PC Polycarbonate
PE Polyethylene
POM Polyoxymethylene (Acetal)
PSU PolySulfone
SBC Styrene Butadiene Copolymer
SMMA Styrene Methyl Methacrylate
PP Polypropylene
PS Polystyrene
HDPE High Density Polyethylene
PMMA Polymethylmethacrylate
COC Cyclic Olefin Copolymers
TPE Thermoplastic Elastomer
TPO Thermoplastic Polyolefin
PEEK Poly Ether Ketone
Plastic material recommendation
28
29
Molding capabilities across SteriPack sites
SteriPackIreland HQAdditive manufacturing for
prototyping and small batch volumes
3 x Carbon 3D Printing Machines
SteriPack PolandArburg / Boy Machines: 1 x 150,4 x 100, 2 x 40, 1 x 10 tons
SteriPack USAArburg Machines: 1 x 220, 1 x
120, 3 x 100, 2 x 50, 1 x 38 tonsSteriPack MalaysiaArburg / Boy Machines: 2 x 150,1 x 60, 1 x 55, 1 x 35, 1 x 10 tons
30
3D printing for prototyping of highly complex parts manufacturing
We utilize breakthrough Carbon© technology that uses digital light projection, oxygen permeable optics, and programmable liquid resins to produce parts with excellent mechanical properties, resolution and surface finish. We support R&D activities with design for manufacturing, design verification, test method development and process development as end-to-end solution provider.
Materials that we are using:
MPU Medical Polyurethane: bio compatible, sterilizable, durable
EPU Elastomeric Polyurethane: elastic and tear resistant
SIL Silicone: soft touch, bio compatible and tear resistant
RPU Rigid Polyurethane: versatile, tough and rigid
FPU Flexible Polyurethane: impact resistant
CE Cyanate Ester: high temperature resistant and stiff
EPX Epoxy: temperature resistant, strong and tough
UMA Urethane Methacrylate: manufacturing jigs and fixtures
32
Scientific molding (RJG Platform)
Scientific molding is a machine-independent process that provides certain basic parameters to optimize the molding process.
Scope:
○ Materials, molds, machines
○ Hydraulics and instrumentation
○ Polymer behavior
○ Process development using DECOUPLED MOLDING
○ Process documentation
○ Data interpretation
33
eDART System
The eDART System is the process monitoring and control system for plastic injection molding applications.
Scope:
○ In-cavity pressure sensors to see what's in the mold
○ Minimize the impact of process variation
○ Reduce scrap and processing time
○ View historical data on every shot of your process
○ Automatically divert rejects to stop shipping short shots
○ Eliminate costly and time-consuming manual parts inspection
○ Gate sequencing for the ultimate processing control
34
CT scanning -High resolution CT & X-Ray System
A versatile high-resolution system for 2D X-ray inspection and 3D computed tomography (micro ct and nano ct) and 3D metrology.
Scope:
○ Internal defect analysis
○ 3D quantitative porosity analysis
○ Assembly control
○ Materials structure analysis for small high-absorbing castings
○ Precision 3D metrology
○ CAD Data nom/act comparison
○ Non-destructive measurements
○ No operator influence
○ Reproducible precision 3D metrology with CT
○ Process control and validation
CLEANROOM INJECTION MOLDING
CASE STUDIES
36
Orthopedic surgical device
Challenge
Full design of the product, starting from „napkin sketch” with no measurable requirements. Additional features and functionalities, non-existing in current solutions in the market, which had to be incorporated.
Solution
Set of molded, adjustable to human anatomy components was introduced. Additional features, such as easy and intuitive mounting were implemented.
Scope
○ Defining requirements (CAD labs)
○ 3D printed and vacuum casted prototypes
○ 3D & 2D drawings
○ Engineering calculations and molding tools
○ Validations (molding, sterilization, shelf-life, package design)
○ Vendor & BOM management
○ CE marking
37
Life saving auto-injector
Challenge
Design and build a highly sophisticated tooling solution that addressed and minimized a very complicated assembly.
Solution
Successful project management required many engineering changes and iterations during the development process, with the outcome of a very robust product that was transformed from a “low” volume product to a semi “high” volume product.
Scope
○ Develop and build 15 plastic injection molding tools utilizing
semi-automated equipment for assembly of a combination
product
○ Process validations & verifications
○ Serialization
○ Sterilization
CLEANROOM INJECTION MOLDING
FROM CONCEPT DESIGN TO MOLDING
39
SteriPack’s One stop shop Concept ideas
CAD
Tool design and build
Validation
DFM /Robust design
Mould flow and
simulations
Production
40
Product development
INP
UT
/ O
UT
PU
T
MA
TR
IX
3D model(if possible)
AN
ALY
SIS
OF
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vs D
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SE
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•In
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isci
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team
s le
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esi
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ngin
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•1 f
inal co
nce
pt
Report
Workshop with Customer
Product concept phase layout
Customer final approval
SE
LE
CT
ION
vs P
RO
BA
BIL
ITY
OF
SU
CC
ES
•In
terd
isci
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team
s le
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•1-2
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BR
AIN
ST
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MIN
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SIO
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Team
1 /
Team
2•
Inte
rdis
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ary
team
s le
d b
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esi
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•Cle
ar
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•4-5
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Requirements Analysis
Team led by Design Engineer. The team includes members of different departments relevant
for the product
Product Benchmarking
Design Engineer supported by the team, which includes
members of different departments relevant for the
product
Input
• Product functionality and usage conditions and
requirements• Product & packaging
requirements• Latest URS (if available)• Latest drawings and prototypes (if available)
NEW INQUIRY
Not sufficientrequirements
No No No
Negative review
41
Standard design review
TRANSFER INTO PRODUCTION
AP
PR
OV
ALDrawing/SpecificationAnalysis
Design EngineerDocuments:
First drawing analysis Process flowProcess Engineer
Documents:Process flow (draft)
Quality inspection planQC SpecialistDocuments:
Process Flow (draft)
Robust design reviewDesign Engineer
Documents:Robust design report
Usability study*Design Engineer
Documents: Ïnput/Output Matrix
Input
• Current 3D models• Current 2D drawings with critical tolerances
• Product and packaging
specification• DFMEA• Samples
No No
No
Risk analysis: DFMEADesign Engineer
Documents:DFMEA Report
Design for manufacturing
Design Engineer/ToolmakerDocuments:DFM Report
Risk analysis PFMEAProcess Engineer
Documents:PFMEA Report
Design review workshop with
CustomerDesign Engineer
Documents: Final report
DE
SIG
N R
EV
IEW
STERIPACK hands-on experience in services for Medical Devices:
+20,000,000 devices assembled/inspected/packed at SteriPack annually
+150,000 devices batches released annually
+4,000 SKUs handled annually
+25 year experience
STERIPACK Facilities and utilities devices assembly | packing | sterilization services:
o ISO CLASS 7 & 8 cleanroom production
o IN-HOUSE ENGINEERING TEAM process integration, molding, validation and testing done by SteriPack in-house Engineering Team
o STERILIZATION by our third party and fully managed by SteriPack
o CUSTOMIZED EQUIPMENT access to complete sets of customized equipment (including presses, gauges,jigs and fixtures) for assembly processes
o REVERSE ENGINEERING proven track record for production transfers including reverse engineering (re-engineering) for cost reduction improvements
o MES manufacturing execution system based batch release
o LEAN lean programs on corporate and manufacturing line levels
Current projects - tubes assembly & packing
PRODUCT EXAMPLE
Sterile pressure monitoring kits to relay blood pressure information to a patient monitoring system. Assembled to multiple configurations to meet clinical needs.
SCOPE:
1. Full line transfer of existing production line
2. Supply chain management
– Extruded tubes sourcing
– Locally sourced and manufactured components
3. Assembly with gluing
4. Packing & E-beam sterilization
PRODUCT EXAMPLE
A fluid management device used during arthroscopic surgery to flush away blood & toxins, expand the operating area, compress damaged capillaries and increase field of vision.
SCOPE:
1. Reverse engineering and production transfer
2. Extruded, DEHP free, tubes sourcing
3. Assembly with gluing
4. 100% quality inspection and testing
5. Packing & ETO sterilization
PRODUCT EXAMPLE
Arthroscopic surgery disposable pump set
SCOPE:
1. Reverse engineering
2. Injection moulding of polycarbonate cassette
3. Supply chain management
– PVC, DEHP free, extruded tubes sourcing
– Silicon tubing sourcing
4. Assembly with gluing
5. 100% quality inspection and testing
6. Packing and ETO sterilization
PRODUCT EXAMPLE
Disposable device (Class III MD) intended for the insufflation of CO2 into the open cardiothoracic wound cavity to reduce the risk of air embolism during open heart and cranial surgery.
SCOPE:
1. Injection moulding of diffuse plate
2. Extruded, PVC, DEHP free, tubes sourcing
3. Filters and plate assembly
4. Blister packing & sterilization
PRODUCT EXAMPLE
Diffuser to be use for distribution of humidified and headed CO2 during open surgery in order to avoid dehydration and cooling of the operative wound.
SCOPE:
1. Design & Development of diffuse plate
2. Injection molding of diffuser plate
3. Gluing Jig Development
4. Tubes sourcing
5. Assembly with gluing
6. Packing and sterilization
PRODUCT EXAMPLE
Protective Hoops/Dispensers for Cardiovascular Catheters.
SCOPE:
1. Development of coiling equipment
2. Building injection moulding tools
3. Injection molding of clips
4. Coiling and assembly with clips
OTHER EXPERTISE
• Pad printing on tubes
• Plasma treatment and coating of tubes
• Bending of tubes
• Wiping and disinfecting of tubes
• Quality control under microscope
GLOBAL ENOUGH to team up with Customers with
an international footprint
BIG ENOUGH to handle requirements of BIG MDEV
and BIG PHARMA
SMALL ENOUGH to stay
entrepreneurial
Capabilities Summary
Contract Engineeringo Concept Development
o Materials Research & Selection
o Design and Product Development
o Design Assessment for Manufacturing
o Design Optimization for Manufacturing
o Re-engineering and cost reduction improvements
Process Integration, Validations and Testingo Development of Validation Plans
o FAI Measurements and Testing
o Process Development & Validation (DoE, IQ, OQ, PQ)
o Gauge R&R
o Test Method Validation
o Microbiological Testing
Supply Chain Managemento Vendor Management (qualification,
audits, monitoring, re-assessment)
o Components and Raw Materials Sourcing
o Incoming Inspection
o Supply Chain Optimization
o Serialisation
Contract Regulatory Adviseo Regulatory Advise
o CE Marking/Device Registration
o 510K submission
o Sterilization Consulting
o Test Methods Consulting
Contract Manufacturingo Injection Molding
o Product Cleaning & Disinfecting
o Plasma Treatment & Coating
o Powder & Liquid Filling
o Gel mixing & Filling
o Overprint on Devices
o Heat & US Welding
o Coiling & Bonding
o Thermoforming & Shaping
Assembly and Packagingo Automated and Manual Product
Assembly & Kitting
o Blister Filling & Sealing
o Pouch Filling & Sealing
o Form Fill Seal Packaging
o Labelling
o Secondary & Tertiary Packaging
o (Pharma specific) Tablets Blister Packaging
o (Pharma specific) Drug-Delivery Devices Assembly
SterilizationManagemento Sterilization Validation
Management
o Sterilization Management (EO, Gamma, E-beam, Steam)
Microbiological Labo ISO 17025
o Sterility
o Bioburden
o LAL
Appendix Slides
SAFETY NEEDLES
CHALLENGEDesigning functional blister, leveraging medical standard quality of the needle to pharma requirements within extremely short timelines.
SOLUTIONRibs enabling easy opening. 100% incoming inspection of the components prior to packaging. Prototypes delivered within 1 week.
SCOPEo FFS blistering with 2D matrix readability for further processing.
o CE mark and 510K submission.
o Developing the process from small to big scale manufacturing with automated inspection and packaging.
Case Study
PHARMA ACCESSORY KIT
CHALLENGEMatching pharma quality expectations with quality of medical grade components within expected short lead time.
SOLUTIONPro-active approach to vendor management.
SCOPEo Sourcing of primary packed needle + syringe.
o Sourcing of packaging components.
o Pouching (secondary packing) and labelling.
o Printing variable data on single pouch and unit box.
o Packing single pouch + IFU into the unit box.
o Packing unit boxes into the shipper box.
Case Study
PAIN RELIEF INHALER
CHALLENGETransfer of injection moulding and manual assembly from Australia to Asiawith expectations of cost reduction. Final packing, localisation and distribiution to be performed in Poland.
SOLUTIONPro-active approach to vendor management, utilising synergy between SteriPack production sites in Asia and Europe.
SCOPEo Vendor Management
o Injection Molding
o Assembly
o Packaging
o Serialization
ORTHOPEDIC BONE CEMENT
CHALLENGEDesign Developement and Review, siliconizaiton of the barrel
SOLUTIONPatented design soluitons and custom made siliconization
SCOPEo Vendor Management
o Injection Molding and Overmolding
o Hot stamp printing
o Siliconization
ADVANCED WOUND CARE KIT WITH PHARMA COMPONENTS
CHALLENGEDifferent interpretation of product classification by local EMA representatives in Poland and other EU countries.
SOLUTIONEscalating the topic and situation to the EMA Committee and consulting a 3rd EU member of the EMA to resolve the dispute, resulting in common agreement between local EMAs. Product final classification fell under ISO 13485.
SCOPEo Automatic syringe assembly.
o FFS packaging to inner blister (with pharma component closed in a vial).
o FFS Packaging to outer blister.
o Vision system implemented for 100% inspection.
o Automatic labelling system.
o Sterilisation: ETO.
Case Study
ORTHO SCREW
CLEANING & PACKING
CHALLENGEVery small annual part volume and lot size requirements of 1000+ SKUs project handling.
SOLUTIONUtilising the 4 eye-principle with vision system controls combined with variable data retrieved directly from ERP system.
SCOPEo Implants rinsing & drying.
o Blister packaging, labelling and boxing.
o Gamma irradiation.
Case Study
ORTHO PLATECLEANING & PACKING
CHALLENGEVery small annual part volume and lot size requirements of 1000+ SKUs project handling.
SOLUTIONUtilising the 4 eye-principle with vision system controls combined with variable data retrieved directly from ERP system.
SCOPEo Implants rinsing & drying.o Blister packaging, labelling and boxing.o Gamma irradiation.
Case Study
ARTHROSCOPIC SURGERY PUMP SET
CHALLENGEMove production from Europe to Asia and offer minimum 40% cost reduction.
SOLUTIONReverse engineering. Cost reduction by 50%, local suppliers and DEHP free materials.
SCOPEo Supply chain.
o Moulding.
o Gluing.
o Assembly.
o Packing.
o Sterilisation.
Case Study
WOUND GEL CLASS IIA TECHNICAL TRANSFER FROM USA TO IRELAND
CHALLENGEMedical Customer looking to Expand into Europe.
SOLUTION
o Conducted Pilot run.
o Carried out Process Validations.
o Developed Manufacturing Process.
o Sourced all Raw materials & Components.
o Audited raw material and component suppliers.
o Invested in an Autoclave to support customers business.
SCOPEo Development .
o Manufacture.
o Fill.
o Sterilise.
o Pack.
Case Study
FEMALE HEALTH GEL CLASS IIA & III TECHNICAL TRANSFER
CHALLENGEProduct was manufactured in UK & Filled in Ireland.
SOLUTIONTransfer all products.
SCOPEo Technical Transfer of 8 Products.
o Conducted Pilot runs.
o Carried out Process Validations.
o Developed Manufacturing Process.
o Sourced & Designed all Components.
o Upgraded Clean room to Class 8.
o Invested in new Filling lines, HPLC & Carton Machine.
o Offered a Full Service Contract Solution.
Case Study
CLASS III MEDICAL DEVICE BURN DRESSING
CHALLENGETransfer 20 year old class 3 medical burn product from USA to Malaysia.
SOLUTIONCompletely re worked SOP’s and production procedures to correctly reflect the actual procedures used historically, to manufacture the product and validated same.
SCOPEThe scope of the project involved taking a 20 year old class 2 product and moving production to Malaysia, the re-certifying it as a Class 3 device. The process itself involves 12 chemical process along with curing, stitching, packing and steam sterilization. All this takes place in our class 8 cleanroom.
Case Study
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