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IN CAP BENCH TOP AUTOMATIC CAPSULE FILLER

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IN CAP BENCH TOP AUTOMATIC CAPSULE FILLER & WIP IN CAP ISOLATION SYSTEM CONTENTS Dosage Forms In Cap Isolation System Change Parts Maintenance & Service Warranty ... – PowerPoint PPT presentation

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Title: IN CAP BENCH TOP AUTOMATIC CAPSULE FILLER


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

3
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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

6
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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

8
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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 IDs .5 to 1.5 mm to accommodate different
    viscosities
  • 1,200 to 2,200 cph
  • Dosing combinations Powder, Pellet

10
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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

13
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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 Pump Connection
23
All Areas of possible ingress to mechanical
systems are double sealed
24
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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

30
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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
  • SOPs
  • 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_at_msn.com
  • Doug Lawrence Master Technician
  • 800-435-7174 600am 230pm est
  • dlawrence_at_schaefertech.us
  • Brian Dexheimer Senior Technician
  • 602-684-0316 1000am to 700pm est
  • brylodex_at_cox.net
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