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

2. In Cap Isolation System
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. Power Filling 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

7. Pellet Bead Filler 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

9. Liquid Filling
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

11. Mini Tab Feeder 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

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

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 % 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
Features

15. Filter Membranes Keeps HEPA Filters Free of Moisture During Wetting
Dual HEPA Filtration
Isolated Mechanical Box
Utility Manifold
Easy to Operate Externally Mounted Control Panel.
Bottom left, manifold plate for water, electrical, air pressure and vacuum fixtures.
Completely contained dual hepa filtration with turbulent flow
Three Access doors that are interlocked
Filters protected with permiable membrane to protect from moisture yet allows particulate to flow thru.
External Control Panel
Casters for Mobility

16. Glove Ports With Safety Interlocks 2 Piece Gloves
Two Piece nitril gloves for better feel
Interlocked ports for safety.
2 Piece Gloves

17. Independent HEPA Filtered Dynamic Air Lock
Dynamic Air Lock with separate HEPA filtration system.
Independent HEPA Filtered
Dynamic Air Lock

18. Discharge Chute----Lexan Seals----Recessed table to capture moisture and excess during cleaning.

19. Drain Port Located In Recessed Table
Drain Port in recessed table
Drain Port Located In Recessed Table

20. HEPA Filtered Vacuum Cartridge
Discharge to continuous bag on isolator exterior for safe and easy containment. Filters are accessable inside isolator for containment.
Discharge to Exterior
Continuous Capture &
Bag System

21. Tie
Tie
Tie

22. Filter Cartridge & External Vacuum Pump Connection
Easy access to filter cartridge of changing
A hose will pass from the external vacuum port fitting to the manifold and out to an external ULPA vacuum.

23. All Areas of possible ingress to mechanical systems are double sealed
All areas sensitive to moisture and powder exposure have been double sealed.
All Areas of possible ingress to mechanical systems are double sealed

25. Compounding Isolator for Weighing, Sampling, Mixing, Compounding.
Compounding Air Lock docks to ICIS air lock by tongue and groove connection to prevent egress.
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. Doug Lawrence: Master Technician Brian Dexheimer: Senior Technician
CONTACTS
Tom Nelson
Doug Lawrence: Master Technician
:00am – 2:30pm est
Brian Dexheimer: Senior Technician
:00am to 7:00pm est