a prosys laboratory analytical isolators-us-rev1reactors and crystallizers, etc. dispensing and...

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www.prosysus.com Custom and standard isolators for analytical and QA laboratories Contained handling of samples for dispensing and analysis Integration of a wide range of different weigh scale systems and other instrumentation Provision of special atmospheres, such as inert, dry and gassed atmospheres Integration of work spaces, data hook up points and monitoring and recording instrumentation Integration with existing and new laboratory equipment ProSys Laboratory Analytical Isolators ProSys Containment and Sampling Technology y [email protected] y Þ www.prosysus.com y 732-364-1810

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www.prosysus.com

Custom and standard isolators for

analytical and QA laboratories

Contained handling of samples for dispensing and analysis

Integration of a wide range of different weigh scale systems and other instrumentation

Provision of special atmospheres, such as inert, dry and gassed atmospheres

Integration of work spaces, data hook up points and monitoring and recording instrumentation

Integration with existing and new laboratory equipment

ProSys Laboratory Analytical Isolators

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Custom gloveboxes to allow for

contained small scale processing of HAPI compounds

Gloveboxes may be linked directly to existing or new fume hoods via material transfer airlocks to segregate liquid processing within the fume hoods and solids handling within the glovebox

Gloveboxes may contain a variety of different processing equipment, such as tray dryers, Nutsche filters, rotary evaporators, small scale reactors and crystallizers, etc.

Dispensing and packaging of final solids compound may be carried out within the Glovebox

ProSys Laboratory Small Scale Isolators

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Dry chamber glovebox for

analytical QA facility

Achieves less than 1% RH by continuous Dew Point analysis

Fully integrated recirculation desiccator system

Nitrogen purge facility for airlock chamber and working chamber

Air purge system to remove all nitrogen from either chamber before windows are unlocked for opening

Full touch screen HMI that allows for monitoring the running and maintenance status of the isolator as well as fault diagnostics

'Traffic Light' type indicator to allow quick status check of isolator

Integrated power sockets, service hook up points and data transfer points

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High Containment

Isolator retrofits to existing processing equipment (e.g. Encapsulators, Tablet Presses, etc.)

Fully contained powder infeed and final dosage form output

Complete Project Management from Start to Finish, inclusive of any work being required from the OEM of the machine

Integration and supply of ancillary equipment, like dust collectors, tablet samplers, de-dusters, metal checkers, solids feed systems, etc.

BEFORE

AFTER

ProSys Encapsulator & Tablet Press Isolators

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Multi-functional Glovebox system is integrated with the ProSys Recirculation Top Reactor Sampling System (RTRS)

Multi-function glovebox that can be mounted either for liquids/solids charging directly into the sight-glass assembly of the RTRS or for the contained removal of samples from the RTRS

Transfer in/out of the glovebox via Rapid Transfer Port

Working chamber is nitrogen purged

Internal safe change HEPA filters (removal via Rapid Transfer Port)

Complete system can also be trolley mounted, when space on top of the reactor is limited

ProSys Samp

ling & Slurry C

harging Gloveboxes

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Isolator for sterility testing: greatly reduces the risk of false positives

Can be customised to fit customer application

Can be fully bio-decontaminated using vaporised Hydrogen Peroxide. Integration with Steris or Bioquell gas generators

Validated fast gassing cycle on airlock ports (single or multiple transfer ports possible)

H2O2 Cycle development and validation services offered

Integrated pump for sterility testing, particle monitoring (viable and non viable), etc.

ProSys Ste

rility Testing

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Large scale vessel charging glovebox from drums and other types of containers

Drum interface with glovebox is via a host container to permit handling of differently sized drums without the need for changeover parts

Material entry via Rapid Transfer Port, drum docking hoist or through opened front window

Nitrogen purged working chambers with cascading pressure

Twin Chamber design to protect the drum docking point from powder contamination

Internal safe change inlet and outlet HEPA filters (changed via Rapid Transfer Port)

Single, double or triple chamber systems

ProSys Large Scale Reactor Charging G

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Mobile slurry charging system

for use with multiple process vessels

400mm height adjustability to provide optimum ergonomics for different height operators

Solids enter the working

chamber via Rapid Transfer Port

Integrated

pneumatic/magnetic stirrer for slurrying up of solids within the glovebox

Pressure/vacuum transfer of

slurry via disposable transfer lines

Vacuum source, nitrogen

purge for working chamber and slurrying bottle, low micron filtration of liquids and gasses are all integrated into the glovebox envelope

Integrated flush/cleaning cycle

for slurrying bottle and transfer lines

Inlet and outlet HEPA filters are

internal safe change (removal from glovebox via Rapid Transfer Port)

ProSys M

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Pharmaceutical active ingredients dispensing stations

Designed to achieve an OEL of less than 1microgr/m3

Fully automated nitrogen purge system and pressure control circuit

Designed to dispense either into ILC Dover continuous liner or into Split Butterfly Valve (integrated into the base of the glovebox)

Drum docking to the base of the glovebox for either the removal or addition of small quantities

Integrated weighscales

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tors

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Small scale vessel charging glovebox, e.g. Seed Charging, small liquid editions, etc.

Material entry via Rapid Transfer Port, Airlock (Passbox) or through opened front window

Nitrogen purged working chamber

Material transfer via funnel allows for cleandown of the glovebox without draining into the process vessel

Internal safe change inlet and outlet HEPA filters (change via Rapid Transfer Port, Continuous Liner Port or Airlock)

Large radius corners and edges for ease of cleaning

ProSys Reactor Charging/Seed

ing Gloveboxes

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ProSys V

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Sam

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Fully contained top vessel sampling station (solids and liquid sampling from reactors, dryers, etc.)

Automated sample lance with removable and interchangeable sample cup arrangement

Option for taking a fixed sample volume at a fixed level within the vessel

Nitrogen purged glovebox chamber Sample transfer either via continuous liner system or

via Rapid Transfer Port The top sampler principle has also been combined

with pressure and vacuum rated cabinets and simple (non-glovebox) cabinets for non-toxic applications

www.prosysus.com

Isolators for sampling, solids discharge and heel removal from

Nutsche filters, dryers and filter dryers or a combination of all these functions into one system

Isolators are purpose built to suit existing and new filtration & drying equipment

Existing filter dryer discharge valves are replaced with integrated solids discharge doors to allow for contained access to the filter dryer interior via the glovebox system

Assessment of existing filtration & drying equipment for suitability for containment carried out by ProSys experts

Drum filling may be via continuous liner system, split butterfly valve, ILC Dover type bags or inflatable seal head interface

Integration of special atmospheres, solids metering, weighing, particle size reduction (screening, milling, etc.) and more into the containment system is possible

ProSys Filte

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Unloading of solids vessel to

very low OEL's and high weighing accuracy

Multiple filling heads for off-loading into either single liners via inflatable sealhead, continuous liner or RTP

Managed airflow throughout the system to prevent cross contamination between chambers or fully segregated chambers

Options for manual or fully integraded solids dosing system to achieve very high filling accuracies

Solids chute nitrogen purge and filtered extract options

Integrated weigh system and roller track

Optional pneumatic drum pusher to assist in removal of filled product drums

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Liquid drum unloading and sampling of

toxic compounds Single chamber or multi chamber

systems Small liquids additions or charges from

large IBC’s Simple manual dip pipes or fully

automated, fully sealed dip pipes with integrated nitrogen blanketing and WIP, blow down and drying cycles

Drum weigh systems and automated dosing of the liquid transfer

Hastelloy product contact surfaces for highly corrosive liquids (e.g. Bromine)

Dock

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Purge

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Contained systems for the safe removal of in-line

cartridge filter elements

Disposal of used filter cartridges via continuous linger system

Nitrogen purge of working chamber

Lift up windows for easy maintenance access to the filter housings

Introduction of clean filter cartridges via airlock access

Internal safe change HEPA filters (removal via continuous liner system)

Optional integrated storage racks

ProSys In-Line

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