4 DOSAGE FORMS Powders Powders + Powders Beads + Beads Single or Multiple mini tabs or caps (up to two API)Mini Tabs or Caps + PowderLiquidsLiquids + PowderBeads + Powder +(Beads)Beads + Liquids
5 Power Filling Intermittent Tamping Technology Minimum excess powder after batch run = 40gLow volume dosing to 10mg utilizing custom disks and smaller tamping pins1,500 to 3,000 cphDosing 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 profilesVariable Volume control from 100mg StandardVariable Volumes from 10mg to 100mg with low volume sleeve1,500 to 3,000 cphDosing Combinations: Beads, Powders, Mini Tabs, Tablets
9 Liquid FillingSeparate electric jackets for hopper and pump to 100c (212 f)Positive displacement pump with variable dosing volumes from .15mlViscosities from 75cps to 1000cpsNozzle ID’s .5 to 1.5 mm to accommodate different viscosities1,200 to 2,200 cphDosing combinations: Powder, Pellet
11 Mini Tab Feeder Up to 2 different API Dosing from 1 dose - to total volume of cap bodyDual count verificationChange kit for different size dosesPowder Back Fill for blinded studiesSpeed is count dependent
12 Tablet/Capsule Feeder Fills (1) or multiple tablets or capsules5mm minimum sizeDual Sensor VerificationPresence no presence prox sensorCount controlled by e-prompt
14 In Cap Isolation System (ICIS) Features Designed for integration into STI Isolation Systems for processing potent compoundsIsolator constructed of 316SS and Poly Carbonate PanelsOn Casters for Mobility (dimesions)8 Inch Hydralic Lift to accommodate small to tall operatorsWet In Place (WIP) Spray Wand for WettingAll through wall components have tri clover fittings, IE discharge.System utilizes recalculated airSealed to prevent moisture and powder from ingress to sensitive operational areasBreach System with 3 light alarm that activates when chamber negative/positive pressure changesInterlock Safety Switches over glove ports and on doorsIsolator Utilizes Turbulent FlowHEPA 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 interlocksUtility Manifold for outside utilities such as vacuum, water, compressed air, etc.Capsule discharge to Continuous Bagging SystemInstallation of .3 micron particle counter per requestDocks to Separate Compounding, Mixing, Weighing IsolatorFeatures
15 Filter Membranes Keeps HEPA Filters Free of Moisture During Wetting Dual HEPA FiltrationIsolated Mechanical BoxUtility ManifoldEasy 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 flowThree Access doors that are interlockedFilters protected with permiable membrane to protect from moisture yet allows particulate to flow thru.External Control PanelCasters for Mobility
16 Glove Ports With Safety Interlocks 2 Piece Gloves Two Piece nitril gloves for better feelInterlocked ports for safety.2 Piece Gloves
17 Independent HEPA Filtered Dynamic Air Lock Dynamic Air Lock with separate HEPA filtration system.Independent HEPA FilteredDynamic 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 tableDrain 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 ExteriorContinuous Capture &Bag System
22 Filter Cartridge & External Vacuum Pump Connection Easy access to filter cartridge of changingA 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 componentsFill transfer vessel with formulaWith compounding isolator docked to ICIS transfer vessel into ICIS air lockICISPlace capsules into ICIS air lockTransfer 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 filtersWhen 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 surfacesUse 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 agentDirect moisture and excess into the drain portExcess is captured in a containment vessel attached to the end of the drain chute located outside the isolatorPlace powder contact parts into bag, wipe down and removeProcess may have to be repeated to assure interior stabilityOnce ICIS is stable remove filled capsule, powder and unused capsule vesselsSimilar procedures should be utilized to stabilize the compounding isolator
29 CHANGE PARTS Simple tool less change over All Standard Capsule Sizes #000 - #4All DB and Elongated sizes available
31 GENERAL MAINTENANCEExternal vacuum should be utilized to eliminate air borne powderMake certain compressed air is moisture free and moisture separators checkedMaintenance schedule should be altered based on dosage form and machine useA 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 assistanceSTI maintains an on site inventory of consumables and wear partsDosing disks and other non standard parts machined in STI factoryOne year warranty on workmanship and all non wear parts
33 Validation Cleaning Procedures SOP’s Maintenance Procedures IQ/OQ ProtocolsFAT / SAT ProtocolsPQ ProtocolsDocuments in Blank or Executed
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