GMP & HAPI CONTAINMENT

SYSTEMS

SOLUTIONS TAILORED TO YOUR NEEDS

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CSV CONTAINMENT DESIGN· TAYLOR MADE · CO DESIGNED WITH THE USER· IMPROVED OPERATOR ERGONOMICS· QUICK IMPLEMENTATION· EASY TO MODIFY AND TO IMPROVE· SUITABLE FOR HIGH CONTAINMENT· SUITABLE FOR NEW OR EXISTING EQUIPMENT

CSV CONTAINMENT MATERIALS· EU & US GMP COMPLIANCE· ANTISTATIC/CONDUCTIVE · SOLVENTS COMPATIBLE· USDMF AVAILABLE

CSV CONTAINMENT PROJECT· REDUCED INVESTMENT COSTS · FAST TRACK DELIVERY · NOT INVASIVE INSTALLATION· SMEPAC TESTED AND VALIDATED

CSV CONTAINMENT SERVICES· FEASIBILITY STUDIES· TRAINING· FAT & MOCK-UP· SMEPAC MONITORING· VALIDATION

DISPENSING FLEXIBLE ISOLATORKILOLAB APPS _GLASS REACTOR CHARGING

KILOLAB APPS _BUCKNER FILTER DISCHARGE

KILOLAB APPS _GLASS REACTOR CONTAINMENT

BENCH ISOLATORSSMALL SCALE CHARGING SYSTEM MILL CONTAINMENTDRUMS/BAGS CHARGING STATIONMANWAY REACTOR CHARGING SYSTEMREACTOR CHARGING CHAMBEREQUIPMENT CHARGING_ DOUBLE CHAMBERCONTINUOUS LINER _IN LINE POWDER SAMPLER

FILTER DRYER CAKE RECOVERYMOBILE DISCHARGING CLEAN ROOMCENTRIFUGE SCOOPING OUTLID OPENING ENCLOSUREBASKET CENTRIFUGE OFFLOADINGFLUID BED DRYERWET GRANULATORTRAY DRYERTABLETTING/CAPSULE FILLINGCOATING MACHINEMILL CONTAINMENTCLEAN MOBILE INTERFACEIBC SAMPLINGGLOVE BOX _DISCHARGE/SAMPLING VIA LINER

POWDER TRANSFER CONTAINMENT SYSTEMVENTURI EQUIPMENT_ CHARGING/DISSOLUTIONLUMP BREAKER AND DOCKING STATIONBAG/BIN TO BIN DISPENSINGPRIMARY PACKAGING CONTAINMENTMOCK-UP AND SMEPAC TESTIHP® CLEAN ROOM & GLOVEBOX STERILIZATION

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INDEX

KILOLAB APPS _GLASS REACTOR CHARGING

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· Man-way charging containment· Conductive materials (ATEX)· Plug and play installation· Solvent free operations· Vacuum and pressure tested valves (liquid and gases)

DISPENSING FLEXIBLE ISOLATOR

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· Compact and movable· Plug and play utilities· Collapsible frame for storage· Designed for any discharging interfaces/containers· Option with ventilation available· No SW automation required for pressure control· Suitable for high containment

· Plug and Play installation· Self sustained by lid

KILOLAB APPS _BUCKNER FILTER DISCHARGE

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· Fully Contained Charging & Sampling· N2 Inertization decontamination· Cleaning/deconamination Spray Gun available

KILOLAB APPS _GLASS REACTOR CONTAINMENT

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BENCH ISOLATORS

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· Powder residual recovery by solvent ushing · N2, compressed air or solvent injection· Fluids Quick connection· Suitable for any interface (split valves...) · Suitable for Aseptic charging

SMALL SCALE CHARGING SYSTEM

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· Compact and movable· Plug and play utilities· Designed for any interfaces/containers· Option with ventilation available· No SW automation required for pressure control· Suitable for high containment

· Applicable to:- Manway- Dedicated ange

· Designed for contained charging of:- Drums- Bags- Tins

· Movable con guration available· Telescopic con guration available· No utilities required· N2 inertization of the system available

DRUMS/BAGS CHARGING STATION

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· Contained loading and of oading operation· Sampling & weighing on line option available· Main & Pre Chambers (pass box)· N2 inertization of the system available · Improved operator ergonomics

MILL CONTAINMENT

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· Applicable to:- Manway- Dedicated ange

· Designed for contained charging of:- Drums- Bags- Tins

· Movable con guration available· Telescopic con guration available· No utilities required· N2 inertization of the system available

REACTOR CHARGING CHAMBER

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MANWAY REACTOR CHARGING SYSTEM

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· Just softgoods· No utilities required· N2 inertization available· No gloves

· Contained of oading & sampling into continuous liners· N2 inertization available· On line weighing & dosing options available· Drum liner contained separation by crimping· Cip & Sip option available

CONTINUOUS LINER _IN LINE POWDER SAMPLER

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EQUIPMENT CHARGING_ DOUBLE CHAMBER

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· Applicable to:- Manway- Dedicated ange

· Designed for contained charging of:- Drums- Bags- Tins

· Movable con guration available· Main & Pre Chambers (pass box)· No utilities required· N2 inertization of the system available

· Compact and movable · Flexible clean room · Fast recovery time · Compressed air or N2 quick connection available· EPA lters on board· Designed for any discharging interfaces/containers· Easy to install and remove

MOBILE DISCHARGING CLEAN ROOM

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· Contained and safe body valve opening· Contained residual product recovery· Contained gasket & seals cleaning· Plug and play installation· N2 inertization of the system available· Solvent free operations

FILTER DRYER CAKE RECOVERY

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· GMP & safe enclosed exposed operation· Contained and safe product recovery· Plug and play installation· N2 inertization of the system available· Solvent free operations· Internal gas monitoring

LID OPENING ENCLOSURE

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· Flexible clean room environment· Fast recovery time· Compressed air or N2 quick connection available · EPA lters on board

CENTRIFUGE SCOOPING OUT

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· Contained loading and of oading operation· Contained residual product recovery· Safe & contained lters change· Improved operator ergonomics

FLUID BED DRYER

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· GMP & safe centrifuge of oading· Flexible clean room environment· Fast recovery time· Compressed air or N2 quick connection available · EPA lters on board· Easy to install

BASKET CENTRIFUGE OFFLOADING

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· Contained loading and of oading operations· In line dispensing· In line sampling· In line milling· N2 inertization of the system available

TRAY DRYER

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· Safe of oading· Contained residual product recovery· Contained gasket & seals cleaning· Plug and play installation· N2 inertization of the system available· Solvent free operations· Improved operator ergonomics

WET GRANULATOR

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· Contained loading and of oading· Contained sampling· Improved operator ergonomics

COATING MACHINE

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· Contained loading and of oading· Contained sampling and rejection· Improved operator ergonomics

TABLETTING/CAPSULE FILLING

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· Clean room interface for local GMP grade & humidity control· N2 or Filtered Air Injection available· Dosing by Iris valve · Collapsible structure

CLEAN MOBILE INTERFACE

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· Contained loading and of oading· Sampling on line option available· In line weighing and weight correction· N2 inertization of the system available · Improved operator ergonomics

MILL CONTAINMENT

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· Applicable to reactor manway, valve & ange· For contained, gmp & humidity controlled applications· Removable to be used as temporary bubble barrier· Easy to install and remove· Collapsible· N2 inertization of the system available· Does not require sampling devices

IBC SAMPLING

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· Contained of oading & sampling into continuous liners· N2 inertization available· On line weighing & dosing options available· Drum liner contained separation by crimping

GLOVE BOX _DISCHARGE/SAMPLING VIA LINER

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· Preparation tank, Reactor and equipment charging· Real time dissolution· Light & Movable · No Process mechanical heating· Dedusting integrated in the skid hopper · Suitable for viscous uids

VENTURI EQUIPMENT_ CHARGING/DISSOLUTION

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POWDER TRANSFER CONTAINMENT SYSTEM

· GMP & contained drum transfer by vacuum· Light & easy to use· Compact and movable · Improved operator ergonomics · No utilities required· Available option with ventilation· N2 inertization of the system available · Suitable for different pneumatic conveyors

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· Movable dosing station integrated on board of a special IBC· Integrated IBC TO IBC DISPENSING for direct mixing, excipient adding· No needs of dispensing room · Minimize the IBC transfers increasing ef cency (material and personnel ows) · No needs to lift up materials to be dispensed · Dispensing/dosing IBC is charged on the same operator level and lifted up at user point

BAG/BIN TO BIN DISPENSING

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· Movable Integrated Big Bags and Bags charging station· Delumper· Suitable to be connected to any powder transfer system (gravity & pneumatic)· Contained drums charging con guration available

LUMP BREAKER AND DOCKING STATION

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· Each system is tested and operated using demo skid· Mock-up for owner testing and design improvements· Containment level monitoring and certi cation

MOCK-UP AND SMEPAC TEST

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· Contained loading· Contained packaging· Sampling on line option available· Improved operator ergonomics

PRIMARY PACKAGING CONTAINMENT

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· No needs of humidity control· No needs HVAC· No surface wetting· Minimize corrosion & degradation · Short sterilization cicle· Integration with EMS available

IHP® CLEAN ROOM & GLOVEBOX STERILIZATION

Features

Works independently of temperature & humidity

Has short cycle & aeration times

Excellent materialscompatibility

Outstanding distribution properties

Easy to contain & control

Superior biological ef cacy

Non-carcinogenic

Easy cleanup with no precipitate

Considered environmentally friendly

iHP® VHP® Formaldehyde ChlorineDioxide

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