IN CAP BENCH TOP AUTOMATIC CAPSULE FILLER & WIP IN CAP ISOLATION SYSTEM

1. IN CAP BENCH TOP AUTOMATIC CAPSULE FILLER & WIP IN CAP ISOLATION SYSTEM

2. CONTENTS Dosage Forms In Cap Isolation System Change Parts Maintenance & Service Warranty Validation Ancillary Equipment Contacts

4. DOSAGE FORMS • Powders • Powders + Powders • Beads + Beads • Single or Multiple mini tabs or caps (up to two API) • Mini Tabs or Caps + Powder • Liquids • Liquids + Powder • Beads + Powder +(Beads) • Beads + Liquids

5. Intermittent Tamping Technology Minimum excess powder after batch run = 40g Low volume dosing to 10mg utilizing custom disks and smaller tamping pins 1,500 to 3,000 cph Dosing Combinations: Liquids, Mini Tabs and Tablets, Pellets, Powder dosing system included in base machine price Power Filling

7. Volumetric Filling Can dose 2 different bead profiles Variable Volume control from 100mg Standard Variable Volumes from 10mg to 100mg with low volume sleeve 1,500 to 3,000 cph Dosing Combinations: Beads, Powders, Mini Tabs, Tablets Pellet Bead Filler

9. Separate electric jackets for hopper and pump to 100c (212 f) Positive displacement pump with variable dosing volumes from .15ml Viscosities from 75cps to 1000cps Nozzle ID’s .5 to 1.5 mm to accommodate different viscosities 1,200 to 2,200 cph Dosing combinations: Powder, Pellet Liquid Filling

11. Up to 2 different API Dosing from 1 dose - to total volume of cap body Dual count verification Change kit for different size doses Powder Back Fill for blinded studies Speed is count dependent Mini Tab Feeder

12. Fills (1) or multiple tablets or capsules 5mm minimum size Dual Sensor Verification Presence no presence prox sensor Count controlled by e-prompt Tablet/Capsule Feeder

14. In Cap Isolation System (ICIS) Features • Designed for integration into STI Isolation Systems for processing potent compounds • Isolator constructed of 316SS and Poly Carbonate Panels • On Casters for Mobility (dimesions) • 8 Inch Hydralic Lift to accommodate small to tall operators • Wet In Place (WIP) Spray Wand for Wetting • All through wall components have tri clover fittings, IE discharge. • System utilizes recalculated air • Sealed to prevent moisture and powder from ingress to sensitive operational areas • Breach System with 3 light alarm that activates when chamber negative/positive pressure changes • Interlock Safety Switches over glove ports and on doors • Isolator Utilizes Turbulent Flow • HEPA Filters to .3 microns at 99.99% efficient in Main chamber, Dynamic Airlock and Vacuum Filter (ULPA Filters to .12 micron at 99.999% efficient) • 2 Piece Nitril Gloves for greater tactility: System has 7 glove ports all with safety interlocks • Utility Manifold for outside utilities such as vacuum, water, compressed air, etc. • Capsule discharge to Continuous Bagging System • Installation of .3 micron particle counter per request • Docks to Separate Compounding, Mixing, Weighing Isolator

15. Filter Membranes Keeps HEPA Filters Free of Moisture During Wetting Dual HEPA Filtration Isolated Mechanical Box Utility Manifold External Control Panel Casters for Mobility

16. Glove Ports With Safety Interlocks 2 Piece Gloves

17. Independent HEPA Filtered Dynamic Air Lock

18. Recessed Table

19. Drain Port Located In Recessed Table

20. HEPA Filtered Vacuum Cartridge Discharge to Exterior Continuous Capture & Bag System

21. Tie Tie Tie

22. Filter Cartridge & External Vacuum PumpConnection

23. All Areas of possible ingress to mechanical systems are double sealed

25. Compounding Isolator

26. Process Review Compounding Isolator • Weigh formula components • Blend components • Fill transfer vessel with formula • With compounding isolator docked to ICIS transfer vessel into ICIS air lock ICIS • Place capsules into ICIS air lock • Transfer powder vessel and capsules into ICIS next to In Cap

27. Process Review (cont) • Charge Powder and Capsule hoppers • Run batch • Continue to cycle air through HEPA filters • When filtration is complete (utilize particle counter inside ICIS) use ULPA vacuum system (disconnect hose from external vacuum fitting on In Cap) to eliminate gross particulate that has settled on the machine and isolator interior surfaces • Use the WIP wand to mist all surfaces inside the isolator to settle any remaining airborne particulate

28. Process Review (cont) • Wipe all surfaces and powder contact parts with approved cleaning agent • Direct moisture and excess into the drain port • Excess is captured in a containment vessel attached to the end of the drain chute located outside the isolator • Place powder contact parts into bag, wipe down and remove • Process may have to be repeated to assure interior stability • Once ICIS is stable remove filled capsule, powder and unused capsule vessels • Similar procedures should be utilized to stabilize the compounding isolator

29. CHANGE PARTS • Simple tool less change over • All Standard Capsule Sizes #000 - #4 • All DB and Elongated sizes available

31. GENERAL MAINTENANCE • External vacuum should be utilized to eliminate air borne powder • Make certain compressed air is moisture free and moisture separators checked • Maintenance schedule should be altered based on dosage form and machine use • A dedicated qualified maintenance person should perform or oversee maintenance

32. SERVICE & WARRANTY • 10 years of In Cap technical experience • 2 Dedicated Technicians available for phone and on site assistance • STI maintains an on site inventory of consumables and wear parts • Dosing disks and other non standard parts machined in STI factory • One year warranty on workmanship and all non wear parts

33. Validation • Cleaning Procedures • SOP’s • Maintenance Procedures • IQ/OQ Protocols • FAT / SAT Protocols • PQ Protocols • Documents in Blank or Executed

34. ANCILLARY EQUIPMENT • Lab Top Capsule Bander • R/D Blister Packaging - - In Pack • Capsule Check Weigher - - CW 30 • Instrumented R/D Automatic Tablet Press - - CPR6 • R/D Scale V Blender - - MP6

35. CONTACTS Tom Nelson 801-50-4220 thomasgnelson@msn.com Doug Lawrence: Master Technician 800-435-7174 6:00am – 2:30pm est dlawrence@schaefertech.us Brian Dexheimer: Senior Technician 602-684-0316 10:00am to 7:00pm est brylodex@cox.net