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

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

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.

STERIS AST – Technology neutral service provider

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

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.

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)

Ionizing Radiation – Dose Distribution

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

≈ 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

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!

≈ 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…

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