POWDER SYSTEMS LIMITED

Containment

NaNo CoNTaINMENT aNd STErIlE FULL PROCESS SOLUTIONS

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SYNTHESIS

CoNTaINEd CHARGING Pg7

TOTAL SYNTHESIS SOLUTIONS Pg9

dISCHarGE AND Pg8

CONTAINED OFFLOADING

MIllING AND MICRONIZING Pg10

drUM FIllING SOLUTIONS Pg12

TOTAL ForMUlaTIoN SOLUTIONS Pg13

FORMULATION

www.powdersystems.com

SIEVING / TABLETS AND FILLING Pg11

dISPENSING ANDSAMPLING Pg6

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All PSl high containment solutions benefit from:

• Nitrogen purge system

• VHP capability

• Clean-In-Place (CIP) and Wash-In-Place (WIP) systems

• fixed or lift-up windows

• Safe change HEPA filters (“push-push”)

• front and rear operator working positions

• from laboratory to production size

• Gaged 4mm SS construction

• World recognised components and solvent resistant materials

• Designed according to required

universal regulations

• HmI / PLC control

PrECISIoN BUILT SYSTEmSEnginEErEd for high ConTAinMEnT To nAnogrAM lEvEls

Full proceSS integration ergonomically deSigned

containment perFormance teSting

PSL is an award winning international manufacturer providing quality innovative technology with process development expertise to the pharmaceutical, biopharmaceutical, chemical and laboratory industries since 1989.

Our experienced engineering teams work closely with our in-house chemists to accelerate process development and create the most suitable and ergonomic solutions.

OUR GLOBAL OFFICE BASEPSL continues to increase its number of global offices, agents and distributors to aid the smooth distribution of its equipment to any part of the world. www.powdersystems.com

PSL’s established supply chain management ensures all components, sourced from across the globe, are of the highest quality and value. This enables market savings to be passed directly onto our customers.

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In conjunction with our clients, we define Containment Performance Testing to achieve OEL parameters for each containment system. Our containment solutions can then be tested and validated to achieve guaranteed containment to nanograms level.

PSL generate performance test protocol, following industry best practice guidelines, such as ISPE guidelines. We use a third party industrial hygienist to monitor testing and generate a final performance report. Micronized lactose is typically used as the surrogate powder and an independent analytical testing laboratory is used to generate the final result.

PSl provide 3D models and full-scale product mock-ups of your chosen containment equipment.

This allows ergonomic aspects to be addressed and the placement of process equipment to be reviewed and modified prior to production. We guarantee reliable manufacture quality through precision built systems designed for performance longevity, up to commissioning and installation (including IQ/OQ service).

erGoNoMy AND PErformANCE

3D Simulation, full Scale Product mock-ups, full Equipment and Service Set Up

FULL SCALE MOCK-UPS

InStALLEd On SItE

dEtAILEd 3d MOdELS

FACtOry tEStEd

Containment Performance Testing and Installation

www.powdersystems.com

INTErNAL cGmP WEIGH SCALE

CoNTINUoUS LINEr BAGoUT PorT CoNTAINED SAmPLING

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DISPeNSING AND SAmPLING

SYNTHESIS

PSl’s Dispensing & Sampling Isolator

• Auto control valves

• Integrated multi drum hoists with double inflatable seal

• Continuous liner bagout port

• rTPs / Split valve / Integrated airlock

• Internal cGmP weigh scale

• rH measurement and control available

• Internal vacuum cleaner

Sampling from drums

• Warehouse drum sampling

• Liquid & powder sampling

PSL Weigh Scale

rAPID TrANSfEr PorTS (rTPs)

INTErNAL cGmP WEIGH SCALE

CoNTINUoUS LINEr BAGoUT PorT CoNTAINED SAmPLING

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CHArGING

SYNTHESIS

PSl contained charging

Contained process equipment: SlurryBox

• API reactor charging

• Slurry vessel charging

• IBC’s

PSl pressure rated plug

Reactor charging under pressure after charging has taken place. Eliminating the need for an isolation valve.

SPLIT VALVE rTP ACCESS

CoNTINUoUS LINEr SYSTEmS

DISCHArGe AND CoNTAINeD offLoADING

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Contained Discharging offloading

• filter dryer

• fIBC

SYNTHESIS

KILO LABOrAtOry PILOt PLAnt COMMErCIAL PrOdUCtIOn 0.03m2 to 0.125m2 0.3m2 to 0.6m2 1m2 to 2.5m2

Contained Sampling and Heel recovery System

• Sampling port

• Plug valves

• raking tools

• Warehouse drum sampling

• Liquid & powder sampling from drums

SPLIT VALVE rTP ACCESS

CoNTINUoUS LINEr SYSTEmS

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ToTAL SyNTHeSIS SoLUTIoNS

PSl can combine all these processes into high containment synthesis facilities.

PSL Contained CakeStand Tray DryerGlass Vessel Reactor Continuous Liner Bag Out Port

SYNTHESIS

CLInICAL trIAL ISOLAtOr

SWING-OUT DOORS WITH SAFETY INTERLOCKS

SPECIAL GLOVEPORT RETAINERS

INTEGRATED FEEDER

INERT M

ILLING FOR PRODUCT AND OPERATOR PROTECTION

VARIE

TY OF CONTAINER SIZE INPUTS & OUTPUTS

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Milling Glovebox

PSL integration with other suppliers provides a real time in-line milling suite.

• Universal Milling Glovebox can accommodate different mills in a single glovebox

• PSL qualified UL panel builder

• Specially designed purged airlock for multiple entries

• Into the glovebox

• Full milling facility

Contained Mills

• Micronizing

• Ball mills

• Quadro mills

• Jet mills

• Fitz mills

MILLING AND MICRONIZING

FORMULATION

Front and back view of Interchangeable Milling System

Integrated in-line Feeder, Micronizing Jet Mill and Particle Size Analyzer

SWING-oUT DoorS WITH SAfETY INTErLoCkS

SPECIAL GLoVEPorT rETAINErS

INTErNAL VACUUm CLEANING SYSTEm

INTEGrATED fEEDEr

INErT m

ILLING for ProDUCT AND oPErATor ProTECTIoN

VArIE

TY of CoNTAINEr SIZE INPUTS & oUTPUTS

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SIeVING / TABLETS AND fILLING

Tablets and filling

PSL provide high containment retrofit systems to existing capsule filling machines and tablet presses.

Sieving and Blending

• Integrated processes available: milling, sieving, blending, granulator, weighing

• operator lifting aids

• Interlocked glove guards

formULATIoN

XceloprotectTM: High Containment Xcelodose® Micro-Dosing system

WEIGHT ACCUrACY

ErGoNomIC DESIGN

C

oNTINUoUS LINEr SYSTEmS

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DrUM FIllING SoLUTIoNS

formULATIoN

PSl Drum Filling and Continuous Liner systems

Extraction booths and gloveboxes: FlowBox

• roller track

• In-flight Sampler

• Continuous liner loading table

• metering systems

• Integrated Weighing systems

• Automation

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ToTAL ForMUlATIoN SoLUTIoNS

formULATIoN

Purged airlock and Rear Access Multi Drum Hoist

PSl can combine all these processes into high containment formulation facilities.

Full Formulation: Sieving, Blending and Milling integration

PSL USAIDAHO

PSL EUROPE

LYON

PSL INDIA

MUMBAI

PSL APACPERTH

PSL APAC

SINGAPORE

PSL CZECHLIBEREC

PSL UKLIVERPOOL

C.O.P.E.PA, USA

PSL Serve is our dedicated after sales customer care, on-site service and spares team. They are technical specialists, here to aid the smooth installation of new equipment, along with the servicing and repairs of existing PSL equipment and any spare parts required.

PSL Serve offers full installation, commissioning, training and preventative maintenance contracts. Information on our IQ/OQ packages is available upon request.

SPARES, SERVICE AND CUSTOMER CARE FROM PSL

E: info@powdersystems.comW: www.powdersystems.com Serving our customers since 1989

High Containment Glovebox and Sterile Isolator

GFD® range Tray DryersMicrosphere Formulation

Nutsche Agitated Filter Dryers

PSL products range from R&D and lab scale development up to large scale commercial production.