IN CAP BENCH TOP AUTOMATIC

CAPSULE FILLER&

WIP IN CAP ISOLATION SYSTEM

CONTENTS

Dosage FormsIn Cap Isolation System

Change PartsMaintenance & Service

WarrantyValidation

Ancillary EquipmentContacts

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

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

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

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

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

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

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

External Control Panel

Utility Manifold

Dual HEPA Filtration

Isolated Mechanical Box

Casters for Mobility

Filter Membranes Keeps HEPA Filters Free of Moisture DuringWetting

2 Piece Gloves

Glove PortsWith SafetyInterlocks

Independent HEPA FilteredDynamic Air Lock

Recessed Table

Drain Port Located In Recessed Table

Discharge to ExteriorContinuous Capture & Bag System

HEPA Filtered Vacuum Cartridge

Tie

Tie

Tie

Filter Cartridge & External Vacuum Pump Connection

All Areas of possible ingress to mechanical systems are double sealed

Compounding Isolator

Process ReviewCompounding 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

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

• 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

Process Review (cont)

CHANGE PARTS

• Simple tool less change over

• All Standard Capsule Sizes #000 - #4

• All DB and Elongated sizes available

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

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

Validation

• Cleaning Procedures

• SOP’s

• Maintenance Procedures

• IQ/OQ Protocols

• FAT / SAT Protocols

• PQ Protocols

• Documents in Blank or Executed

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

CONTACTSTom Nelson801-50-4220

thomasgnelson@msn.com

Doug Lawrence: Master Technician 800-435-7174 6:00am – 2:30pm est

dlawrence@schaefertech.us

Brian Dexheimer: Senior Technician602-684-0316 10:00am to 7:00pm est

brylodex@cox.net