1. Sterilization and Irradiation – Operator Perspective “Why Gamma remains important”
Dipl.-Ing. (FH) Reiner Eidenberger MBA
Synergy Health Allershausen GmbH
A STERIS Company

2. STERIS Business Units PATIENT CARE
Healthcare Product 48% of total revenue *
Serves patient care facilities.
Sterilizers and accessories,
Washers, Lights and tables,
Connecting software OR
Healthcare Services 21% of total revenue *
Serves patient care facilities.
On/off-site decontamination services, Surgical instrument management,
Equipment service and parts
PATIENT
CARE
Applied Sterilization Technologies (AST) 18% of total revenue *
Serves mainly medical product manufacturers.
59 global locations
Radiation processing, ethylene oxide, steam
Microbiological laboratories
Our Mission: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Life Sciences 13% of total revenue *
Serves research/pharmaceutical facilities
GMP sterilizers
Washers
VHP
Chemical cleaners
* FY17 Data

3. Global Strength – Local Focus
$2.6 BILLION
revenue in FY17
56% Service
22% Consumables
22% Capital Equipment
12,000 employees worldwide
Over 3,000 Customer
Notes:
STERIS AST locations in blue and manufacturing locations in orange
not listed are close to 50 outsourced reprocessing centers in the UK, US, Italy, China and the Netherlands.

4. STERIS AST – Technology neutral service provider

5. Industrial Sterilisation Methods – basic Overview
Moist Heat
no residues  to dry
not suitable for thermoplastics
limited suitable for bigger volumes
Ionizing Radiation
„Cold Sterilisation“
no residues
impact on materials
Chemical Methods – EO
critical for hollow spaces, tight cavities and porous material
„Quarantine“  degassing
EO - residues
THE sterilization methode not existing
Not all material/product compatible with every sterilization method – finding the right compromize

6. STERIS AST – two main sterilization Methods
Volume split at STERIS AST
40% EO
60% ionizing radiation
50% gamma
10% e-beam/X-Ray
Global volume split could be slightly different:
50% EO
40% Gamma
10% E-Beam
We provide terminal sterilization services, primarily for single-use medical devices, using two main modalities of sterilization – Radiation and Gas.

7. Ionizing Radiation – three Technologies
Gamma Rays (g) from Cobalt 60 (60Co)
Photon Radiation
suitable for palletized goods
no induced radioactivity
Accelerated Electrons (E-Beam)
Particle Radiation
suitable for single boxes
X-Ray
accelerated electrons being transformed into Photon Radiation (Bremsstrahlung, hard X-Ray)

8. Ionizing Radiation – Dose Distribution

9. Cobalt 60 used for terminal sterilization
Description of a Source Pencil
Half life time 5.26 years
In a modern gamma plant with 6MCi installed the annual decay is approx. 740kCi (12.3%) = need for replacement
20 years warranty (< 4 HLT) – after the work life of 20 years: back to manufacturer

10. ≈ 80 MCi p.a. needed for decay compensation + market growth
Global need for Cobalt 60
Worldwide ≈ 250 Gamma Plants
≈ 475 MCi installed
≈ 59 MCi for decay compensation p.a. (12.3%)
global market growth ≈ 3% to 5% p.a.
≈ 14 MCi to 24 MCi p.a.
≈ 80 MCi p.a. needed for decay compensation + market growth

11. Challenges operating a Gamma Plant
Cobalt availability
Capacity constraints at the Cobalt manufacturers
Regulatory issues regarding
Transportation Licenses
Disposal & Disposal Routes
Delays in getting sufficient amount of Cobalt
Increasing costs
Regarding increasing costs:
Sterilization of a medical disposable is not added value to justify higher price of the product (surgical gloves, blood lancets, implants, …)
„The product has to be steril“ fullstop!

12. ≈ 20% more Cobalt needed in 5 years…
Summary
Customers need Gamma
very reliable service
well known and well established technology
many Customers reluctant to change technology
X-Ray as an alternative technology already available
up to date not sufficient capacity
very complex technology
high energy costs
Gamma Radiation Industry will be there for the next 50 years
≈ 20% more Cobalt needed in 5 years…

13. Thank you very much for your kind attention!
STERIS Business Units
Thank you very much for your kind attention!
Dipl.-Ing. (FH) Reiner Eidenberger MBA
Synergy Health Allershausen GmbH
A STERIS Company