IN CAP BENCH TOP
AUTOMATIC
CAPSULE FILLER
&
WIP IN CAP
ISOLATION SYSTEM
CONTENTS
Dosage Forms
In Cap Isolation System
Change Parts
Maintenance & Service
Warranty
Validation
Ancillary Equipment
Contacts
DOSAGE FORMS
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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
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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
Filter Membranes Keeps HEPA
Filters Free of Moisture During
Wetting
Dual HEPA Filtration
Utility Manifold
Isolated Mechanical Box
External Control Panel
Casters for Mobility
Glove Ports
With Safety
Interlocks
2 Piece Gloves
Independent
HEPA Filtered
Dynamic Air Lock
Recessed Table
Drain Port Located In Recessed Table
HEPA Filtered
Vacuum Cartridge
Discharge to Exterior
Continuous Capture &
Bag System
Tie
Tie
Tie
Filter Cartridge & External Vacuum Pump Connection
All Areas of possible ingress to mechanical systems are double sealed
Compounding Isolator
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
Process Review (cont)
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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
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
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
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Cleaning Procedures
SOP’s
Maintenance Procedures
IQ/OQ Protocols
FAT / SAT Protocols
PQ Protocols
Documents in Blank or Executed
ANCILLARY EQUIPMENT
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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
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