Optimized Solution For Prefilled Syringe Product Provided by Hutem, Korea

Hutem Co., Ltd. #302, Daeryung Technotown 3rd, Gasan Digital 2nd Road, Geuncheon-Gu, Seoul, Korea Tel : +82-2-855-2277 / Fax : +82-2-855-2276 www.hutem.co.kr | Company Profile |

2016 Agent Agreement with Allpharm Technology from India The Best Agent Agreement with Pharmcontract from Russia 2015 Agent Agreement with Shinva Pharmatech from China Technology Launching HFS-4000 model Finger Grip & Rod Insertion (Full-automation ) HAS-4000 launched Harmony of Human and Technique, 2014 Agent Agreement with PSR Co. from Iran Hutem Creates the better life! Injection filling with Vaccum controlled sealing patent (no. 10-2011-0080325) 2013 Air Bubble Free filling using vacuum pad / High-accuracy filling patent (no. 10-2011-0050193)

Inno-Biz sellected by Korean Government 2012 Injector filling device and method patent (no. 10-0917916)

Quality Management System ISO9001 certified 2011 High-tech material company Awarded by Korean Goverment

High-viscosity product (-Facial beauty) applied in success 2010 Prefilled Syringe Filling Patent (No. 2009-0026971)

Launching Pharmaceutical Business Human Technology Moment 2009 Transparent-facial Heater and manufacturing patent (제10-0861787)

Built R&D Center Hutem has continuing to develop Prefilled Syringe Filling & Stoppering 2008 Venture Biz Award by Korea Technology Financial Association more than 10years with number of patents and provide total solution for prefilled syringe product from R&D to Mass-productivity and Filling to End-. 2007 Company founded

HUTEM is named based on Human, Technology and Moment and it signify Hutem’s Company Vision and further more our properties are People, Technologies and Speed. “Starting Point of Acrossing Worldwide” Human-oriented Technology-oriented Moment proceed to the successful Those are company philosophy all our employees and partners are persuing Based on strong reference in local market Hutem has aggressively promoting overseas market. Currently numbers of active and valuable distributors and agents are already working for us together in worldwide as Hutem’s qualified partner network and we are trying to serve up to customer satisfaction.

CEO

Managing Director Outside Director

Business Admin. Production R&D Sales Dept.

Account Design Overseas Head Quarter Purchasing/Logistics Engineering Domestic

Customer Service

HQ #302, Daeryung Technotown 3rd, Gasan Digital 2nd Road, R&D Center Geuncheon-Gu, Seoul, Korea Factory #302, Daeryung Technotown 3rd, Gasan Digital 2nd Road, Geuncheon-Gu, Seoul, Korea Pre-filled Syringe manufacturing process Pre-filled Syringe Filling & Sealing machine

Hutem provide Lab-size Filling & Sealing machine

Prefilled Syringe Filling & Stoppering De-nesting & Particle Inspection - Liquid Filling into syringe - Transfering indivisual syringes from to Linear feeding - Rubber Stoppering for sealing into Inspection system Inspection system - Inspection particles inside of syringe - Semi-automatic / visual inspection

Basic Shape Covered with ORABS Blistering Assembling injector’s accessories - Blister packaging - Labeling - Finger Grip assemble - Plunger Rod Insertion

• Optimizing for small production with variable kinds of product Technical Specification And Laboratories…. Model HFS-200 • Variable applications for any kinds of System Operation HMI - - Syringe Liquid Type Low to High Viscosity Cartoning End Product - Cartridge Filling Process Individual Filling with Vacuum with fast change-over format parts - Leaflet insertion Individual Syringe / Vial • Useable for non-nested and sterilized bulk syringes - packaging Loading / Unloading Manual • Applicable for ORABS / Isolator for toxic product Types & Plastic Syringes Filling Individual Syringe / Vial Types Individual Stoppers Filling Manual Dosing Volume 0.5 ml ~ 20 ml Filling Nozzle 1 Throughput 300 syringes / Vial per hour Pre-filled Syringe Filling & Sealing machine

Mass-production Filling & Sealing machine Process

Automatic Removal De-liner Filling, Stoppering Stage

Filling Picking up NEST Piston Pump

Covered with ORABS Basic Shape

Placing NEST in Filling stage Rubber Stopper Feeding Rubber Stopper inspection Technical Specification Model HFS-4000 System Operation HMI Liquid Type Low to High Viscosity Filling Process Individual Filling with Vacuum Nested Syringe Loading / Unloading Tub after removing vinyl Types Glass & Plastic Syringes Filling Nested Syringes • Up to 10 Nozzle for mass-production capacity Rubber Stoppering Types Bulker Stopper • Optimized solution for nested Syringe / Vial / Cartridge Stoppers Filling Bowl Feeder • Applicable for ORABS / Isolator for toxic product Application All kinds of nested syringe, vial, cartridge are available for filling and sealing in Hutem’s technologies. Dosing Volume 0.5 ml ~ 10 ml ( Available other size as option ) Filling Nozzle 2 ~ 10 nozzles Throughput 600~900 syringes / hour per nozzle Tyvek Removal Function RABS Function Options Manual / Auto Nest Transfering System Isolator Semi / Auto Debagging System CIP Function Sterilized Nested Cartridge Sterilized Nested Prefillable Syringe Sterilized Nested Vial Syringes, , Cartridge Pre-filled Syringe assembling with injector’s accessories primary packaging

Labeling – Finger Grip assemble – Plunger Rod insertion - Process

Assembled syringe discharging Finger Grip Assembling Finger Grip Feeding

Labeling module Finger Grip, Plunger Rod inspecting Labeling Inspection

Plunger Rod Insertion Plunger Rod Feeding Syringe Feedling

• One pass for Plunger rod insertion – Labeling – Finger Grip Technical Specification Assembling in one body machine Model HFS-5000 • Full modular process for Syringe firstly packaging - De-nester Finger grip assembly plunger rod inserting Machine description Application Any shape, any color, any weight even customized shape of finger grip and plunger can be available for our assembling machine labelling machine - Visual Inspection - Labeling Mode of operation Intermittent - Finger Grip assemble Syringe systems All common syringes - Plunger Rod assemble Syringe size 0.5 ml – 20 ml - Connected to secondary packaging • High Speed and reliable operation Output (syringes/h) 3,000 (Max. 3,600) • Easy connection to down-stream and up-stream in one-line Product infeed Inclined infeed track • Up-stream : De-nester and Inspection stage Finger grip infeed Linear feeder track • Down-stream : Blister packaging and Cartoning Plunger rod infeed Linear feeder track Syringe discharge Inclined discharge track

Space requirements 5~7 ㎡ Any type of plunger rod Any type of syringe with variable shape Name of assemble Easier injection (depends on the shape of material) of finger grip Pre-filled Syringe secondary packaging Pre-filled Syringe packaging

Blister Packing machine Cartoning machine

• One pass for Blister thermo-forming – Technical Specification product placement – backing sealing – die-cutting • Easy set up and Adjustment Capacity 600ppm • High Speed and reliable operation 1~20ml • Easy connection to down-stream and up-stream Application Vial, 7~20ml Syringe • Fully servo controlled Technical Specification • Comfortable User-Interface Dimension 6570(L) * 1010(W) * 1980(H) • Easy set up and Adjustment (mm) Capacity (ppm) <100 • High Speed and reliable operation Weight (kg) 1700 • Automatic folding and insertion of leaflet Product Application Ampoule / Vial / small / Syringe / Bag / Stack • Easy connection to down-stream and up-stream • Special designed loading platform Functions • Robotic product placement arm Carton Size (L) 20~110mm* (W) 20~100mm* (H) 50~200mm • Finished product discharge conveyor Dimension • Connection to upstream and downstream 1600(L) * 840(W) * 1900(H) (mm)