ultra high specification PRO & PCM WASHING SYSTEMS

Process validation

ultra high specification

PRO & PCM WASHING SYSTEMSfor PHARMACEUTICAL MANUFACTURING

Clinical trialsResearch

in QC labs

Food processing

ms for Parenteral

Biopharma

Cosmetics formulatContamination con

GMP compliant

Validation docum

OQ

IQ/OQ

FDA

MCAualityto GMP

Drugs manufactu

Asceptic processin

LANCERprofessionals

servingPROFESSIONALS

The leading pharmaceuticalcompanies as well as the cosmetics

and food industry have chosenLANCER washing systems, such as:

Abbott Laboratories • Amersham • Amgen •Astra Pharmaceuticals • Bayer • Bodyshop •Boots • British Biotechnology • British Sugar• Cadbury Schweppes • CAMR • CantabPharmaceuticals • Celltech • Chiroscience •Coty Manufacturing • Courage • Dairy Crest •Genentech • GlaxoWellcome • Golden Wonder• Guinness • Heinz • Hoechst Marion Roussel •Huntingdon Life Sciences • Imutran • InvereskResearch • Johnson & Johnson • Lilly Industries• L’Oreal • Medical Research Council • Merck• Merck Sharp & Dohme • Nestle Rowntree •Novartis • Ortho-Clinical Diagnostics • PeptideTherapeutics • Pfizer • Procter & Gamble •Reckitt & Colman • Revlon • Rhone-PoulencRorer • Roche Products • SB Pharmaceuticals• Shield Diagnostics • Unilever Research •United Biscuits • United Distillers • Van DenBergh Foods • Walker Snack Foods • WyethAyerst • Xenova • Zeneca Pharmaceuticals

For further information or foradvice on your particular

cleaning needs please contact:

Lancer UK Ltd1 Pembroke Avenue WaterbeachCambridge CB5 9QR UKTel: 01223 861665Fax: 01223 861990

Lancer UK Ltd (Northern)1 Lancer Court AstmoorRuncorn WA7 1PN UKTel: 01928 580783Fax: 01928 580784

E-mail: [email protected]: www.lancer.co.uk

Sales Information Tel: 01223 861665

QualityPerformance

Service

PRO & PCMproduction range

High-spec PRO and PCM models from Lancer havebeen specially developed to meet the requirementsof the pharmaceutical industry for high performancewashing and drying systems with validation whichsatisfy cGMP and latest MCA and FDA require-ments.

The following pages introduce the Lancer rangeand demonstrate why it provides effective cleaningsolutions in critical environments.

Always at the forefront of progress, Lancer’sphilosophy is one of continual improvement anddevelopment, embracing new technology and thechanging needs of the customer.

The full list of users is a testament to the quality ofLancer washing systems.

Dimensions and outline technical detailsof standard PRO and PCM models

are shown on page 10

Critical cleaning -its our business!

2

QUALITYcGMP features

A full specification PCM washing machine willinclude these outstanding features alongside abuild-quality second to none.

Dual Super-drying to both chamber and com-plete hydraulic system through HEPA filtersdownstream of all particulate generatingsources

Magnehelic gauge options provide constantmonitoring of drying efficiency

User-friendly controls and flexible program-ming with PIN code security and one-touchcycle start

DOP ports and differential pressure transmit-ters provided as standard for an unmatchedcapability for filter validation

Self-diagnosis, cycle status and error report-ing (with audible alarms) on LCD display

Powerful jet washing at temperatures up to95°C via standard and customised racks andbaskets

Built-in conductivity meter options for check ofwater quality in final rinse cycle

Validation monitor option - a completely sepa-rate system which independently verifies (withhard-copy printouts) that programmed param-eters of the cleaning cycle have beenachieved as well as recording all incidents

Zero dead-leg valves with PTFE diaphragmsfor perfect drainability

Complete IQ/OQ documentation packages forvalidation

Sloping design and smooth crevice-free con-struction of all components, racks, chamberand pipework. Threads prohibited.

Certified orbital welding in pipework which ispolished inside and out

Robust stainless steel construction in 316L

Sales Information E-mail: [email protected]

“...the most comprehensiveGMP build specification

available today”

DEDICATEDsystems

Lancer has not merely adapted or upgraded stan-dard machines to satisfy the needs of GMP wash-ing in pharmaceutical manufacturing. Just asLancer has product ranges specifically for the labo-ratory and hospital markets, the PCM and PROrange for production environments has been sepa-rately developed in co-operation with users and withan understanding of the special demands and strin-gent regulations in the industry. The PCM and PROrange of washing systems from Lancer provide themost comprehensive build specification availabletoday.

Parenteral or non-parenteral.....to meet FDA andMCA requirements.....with full IQ/OQ and documen-tation procedures.....performance process valida-tion options? Whatever your requirement, thediversity of critical cleaning problems needs differ-ent specifications and solutions.

Lancer understand and strive to provide everythingyou should expect from a market-leading profes-sional in these key aspects:

DESIGN & CONSTRUCTION

PERFORMANCE & RELIABILITY

CONTROL PACKAGES

TRACEABILITY & MONITORING

VALIDATION (IQ/OQ) PACKAGES

TECHNICAL SUPPORT


Details of someof the high quality

GMP featuresincluded in the

build specificationof Lancer PRO

and PCMsystems

are shown onpage 3

4


custom-built racks &baskets are a LANCER

speciality

Design and manufacture basedon a full appreciation

of cGMP requirements

PROJECTsupport

When a cleaning application has been identified,from the point of initial contact Lancer have thetechnical experience and dedication to work closelywith customers through all the stages of a typicalGMP installation.

From quotation to order, from design to commis-sioning, the Lancer team ‘hand-hold’ throughout theproject - working to the User’s RequirementSpecification, reviewing where necessary and pro-viding full documentation packages for IQ/OQ (andassisted DQ and PQ) for validation purposes. Aswell as washing trials in Lancer’s demonstrationfacilities, visits to Lancer’s manufacturing plant maybe required for FAT or other tests.

Close-up of compression tooling on specially designedwashing rack

Wide-chambered 4800PROSS washing kegs & s/s vessels

4500PRO washing pharmapallets

1400DP double doorpassthrough modelcleaning small s/s parts

Special PCM rack/basket for cleaning silicone and metaltubing and tri-clamps

4800PCM showing wide chamber with dedicated rack forcleaning large stainless steel pharma vessels

change parts, vessels, kegs,compression tooling, vials,

hoppers, glassware, etc

1600PCMSS with racks to wash 316L stainless steelvessels and glassware

Hybrid PRO with custom-built change parts rack on lowerlevel and jet rack for glassware above

5

dual DRYING through bothCHAMBER and hydrauliccircuit including PUMPS

There are built-in conductivity meter options tocheck and validate water quality of final rinse cycle,with hard-copy evidence of each batch processed.

Lancer’s exclusive Super-drying system has HEPAfilters downstream of the heating elements therebypreventing any possible risk of particulate contami-nation. Powerful turbines blow hot air into both thechamber and through the complete hydraulicsystem including pumps.

key aspects of

PRO & PCMmodel range

Lancer’s PRO and PCM washing systems are notjust about ultra high-specification...or validation....orGMP.....or effective cleaning. Evolved throughexperience and working closely with professionalsin pharmaceutical manufacturing, the model rangeis successful because Lancer realises the impor-tance of the combination of several key factors.

DESIGN & CONSTRUCTIONAll Lancer models are robustly built with care to pro-vide the high standard of performance and resultsdemanded from professionals, with user-friendli-ness, reliability and quality being fundamentalaspects of their design and production. CE markedand manufactured under ISO9002 and EN46002accreditation, Lancer offer the most comprehensiverange of over thirty PRO and PCM models togetherwith custom-build options.

With features such as radius-cornered chambers,PTFE and 316L stainless steel, the PRO range issuitable for the critical cleaning of vessels, glass-ware, parts and equipment in pharmaceutical pro-duction and also the chemicals, food and beverageindustry.

Where an even higher specification is required -such as for clinical trials, pilot plants or sterile pro-duction - the PCM models completely embrace thesanitary concept throughout their construction. Forexample: the hydraulic system is completely self-draining, no crevices or entrapment areas, orbitalwelding is certified, pipework is polished inside andout. Non-shedding materials, zero dead-leg valvesand tri-clamp connections are exclusively used.


embracing the SANITARYconcept throughouttheir construction

Clean room (exit) side of built-in 1400PCMDPSS

1600PCMSS for washing large vessels

Glass vials loaded on input side of built-in 1400PCMDPSSdouble door passthrough model

DOP ports and differential pressure transmittersare supplied as standard for filter validation.Magnehelic gauge options provide constantperformance integrity during drying.

PERFORMANCE & RELIABILITYLancer’s reputation ultimately relies on the perform-ance and quality of results of its washing systems.

For PRO and PCM washing to GMP it is vital thatthe choice of model and racks matches the cleaningrequirement. Items to be washed are loaded intothe chamber on a suitable support carrier, injectorrack or basket. Lancer technical staff’s vast experi-ence of many varied cleaning applications: changeparts, kegs, compression tooling, slat counters,vials, hoppers, vessels, etc. (examples - page 5)enables them to give informed advice on themost suitable and cost-effective design and solution.

6

generally the model rule isPRO for non-parenteral

PCM for parenteral

VALIDATION (IQ/OQ) PACKAGESLancer provides a full range of documentationpackages and protocol for qual i f icat ion andval idat ion - see page 8. Experience in this areais one of Lancer’s particular strengths.

TECHNICAL SUPPORTLancer is proud of its technical support - from initialapplication discussions with product specialists tothe full extent of after sales support services from itsnationwide team of Lancer-employed engineers.

User training, call-out repairs, service contracts forpreventative maintenance, comprehensive adviceon (or organisation of) installation and commission-ing and much more.

CONTROL PACKAGESLancer offers two control packages for the operationof the PRO/PCM range. The standard package isthe Lancer microprocessor with up to 40 programswhich can be preset to suit a variety of washingapplications and required cycles. With touchpadcontrols, digital readout display and self-diagnosticsthis control package is ideal for most uses andcan be combined with validated traceability andmonitoring options - see page 7 below.

Alternatively, for those facilities that have standard-ised on the Allen Bradley ‘PLC’ control systems,Lancer has three options. PACK I, II and III offer anincreasing level of operation and control parametersand standard features. Each version is built on thesame source code and logic but provides a pro-gressively detailed package of data points andprinting capabilities. Lancer’s programming for thePLC has been completely audited and provides thelevel of integration required to address processoperations, SCADA, HVAC and process control.

TRACEABILITY & MONITORINGAt first level is Lancer’s standard auto-diagnosticchecking system which constantly monitors and dis-plays current cycle status. This will alarm audiblyand visibly should a problem occur, automaticallyvoiding the cycle and displaying the fault.

Higher and more sophisticated levels of monitoringare normally required in the critical pharmaceuticalenvironment in order to validate the cleaningprocess to the satisfaction of GMP and legislation.Suitably interfaced, Programmable Logic Control(PLC) systems such as Allen Bradley are one solu-tion but Lancer can provide the necessary level ofhard-copy traceability and monitoring with a varietyof process validation options - see page 9.

4500PCM


4500 washing out product traces from freeze dry trays

1600PROSS hybrid washing nalgene polypropylene vessels

7

VALIDATION(IQ/OQ)

DOCUMENTATIONpackages

As part of GMP it is normal for pharmaceutical andother companies to require suppliers to have inplace a fully documented set of procedures to beused to check and validate each stage in the pur-chase of major items of equipment. Often referredto as IQ/OQ (Installation Qualification/OperationQualification) the documentation can also includequalification of design drawings, electrical wiring,calibration certificates and Factory AcceptanceTests (FAT).

A typical customer order for a PRO or PCM wash-ing system might involve many or all of theprocesses including IQ/OQ documentation packageas shown on this page.

Lancer provides this Qualification protocol with var-ious Documentation Packages to FDA complianceand which can be adapted to suit customers ownvalidation documentation systems.

The objective should be to work together to ensurethere is an effective way of checking that the speci-fication of a washing system agrees with the clientrequirements and that the equipment meets thatspecification prior to being used for cleaning (eitherdirectly or indirectly) in the manufacturing process.


from URS to PQLANCER knows the drill

not just the jargon!IQ

DQ

PQ

OQ

Factory acceptance test

Operation on siteCommissioning

FillingTemperature probes calibration

Transmitters & flowmetersHeating

Drain & OverflowRecirculation pump

DryingAlarms & Diagnostics tests

Washing efficiency

Performance & application tests(by customer)

User Requirement SpecificationQuotation

TrialsDiscussions

Contract awardContract review

Project planningDrawings

Construction

FAT

InstallationConnection to services

Pre-requisitesSpecifications

Wiring & PID checkLoading & Unloading

Water retentionMaterials & Surface status

Typical GMP order protocol for critical environments

8

Whichever degree of validation is required, Lancercan provide the most suitable option.

Also available is a software program speciallydeveloped by Lancer to read, process and storeinformation (in a Windows environment) from thewashing system. It can be connected to up to fourmachines simultaneously. The software reads thecommunication ports and displays all informationreceived from the washing machine: cycles, time,temperature and details of any faults or incidents,all of which are held on the database; user’s com-ments can be added. Usual search, print andimporting/exporting functions are available on thedatabase. Machine view displays general informa-tion of the particular machine and its current func-tion; Program view displays full details of every pro-gram record.

PROCESSVALIDATION

optionsValidation of the washing and drying process itselfis necessary for GMP - often in QA and certainly insterile production and clinical trials. Lancer offersseveral choices from chart recorders and thermo-couple entry ports, extended PLC packages,Lancer’s VALIDATION MONITOR and integralprinter to a computer-link output.

The Validation monitor is a built-in but separate con-trol system which permanently checks the cleaningcycle via completely independent sensors situatedthroughout the washing machine in order to verifythat all programmed parameters have truly beenachieved.

With a PLC system option such as Allen Bradleyinstalled, the PACK II and III versions providevalidation software and monitoring to various levels.

Program view screen (example)

Built-in chart recorder for program validation

Dimensions and outline technical details ofstandard PRO and PCM models

are shown on page 10

Machine front panel with standard microprocessor control,conductivity meter and validation monitor printer

Machine front panel with PLC and conductivity meter forprocess validation

Built-in validation printer showing details of cycle parameters

discuss with LANCER themost suitable choices for

process validation


Details of some of the high qualityGMP features included in the buildspecification are shown on page 3

9

Technical Specifications Overall ChamberDimensions Dimensions

Model h x w x d (mm) h x w x d (mm)

1400PCM washer 1655x1150x1420 640x625x625

1400PCMSS with super drying 2080x1150x1420 640x625x625

1400PCMDP double door washer 1655x2010x840 640x625x625

1400PCMDPSS double door with super drying 2080x2010x840 640x625x625

1600PCM washer 1880x1210x1555 855x705x705




4500PCM washer 1995x1400x1705 1030x850x850




4800PCM washer 1820x2600x1005 850x1300x850




TECHNICALspecifications

Dimensions, power ratings and the most commonlyrequired technical specifications of standard PCMmodels are shown below. PRO models are thesame in their basic dimensions/specifications.

Because Lancer recognises the variety of cleaningapplications, the specification changes oftenrequired and that each contract is more akin to amini-engineering project, these dimensions shouldonly be considered as initial guidelines. Furtherdetails can be obtained from Lancer on request.

Full design drawings are provided as necessary.Lancer’s in-house Pro-Engineer (CAD equivalent)facilities can also assist customers in deciding themost suitable configuration for siting the washingmachines or services in the customer’s availablespace.

Basic specification of all PRO and PCM models: 316L stainless steel construction throughout.Radius-cornered chamber. Full sanitary sloping pipework on PCM only. Electrical power 230V or 400V3-phase. Water inlets for hot, cold and purified water. Heating by switchable immersion heaters or, onrequest, by steam. Input and dosing of detergent and additives controlled automatically by 2 meteringpumps (additional pump optional). Microprocessor memory holds up to 40 adjustable programs whichare PIN code protected. Water consumption per normal cycle: 40 litres (1400 series), 70 litres (1600series) and 100 litres (4500/4800 series). Recirculating pump flow rate 600-1100 litres per minutedepending on model.

QualityPerformance

Service

Details of some of the high qualityGMP features included in the buildspecification are shown on page 3


FS 51748


Critical cleaning - its our business!

CLEANINGchemicals

Where cGMP compliance is required, if a cleaningadditive is used it is always considered a contami-nant. Lancer routinely provide both identificationmethods and product recipes to enable clients tovalidate that such additives are eliminated as part ofthe PQ process.

Lancer supplies its own range of cleaning concen-trates specially formulated to give the best possibleresults from Lancer washing systems. As well asthe popular LANCERCLEAN detergent andLANCERINSE neutraliser, the product rangeincludes other detergents, decontaminants, emulsi-fiers and other products commonly used in auto-mated washing.

For high performance washingof laboratory glassware and

equipment in research orQC labs ask for ourlaboratory catalogue

PURE WATERsystems

Purified water is an essential requirement for finalrinses in any process wash cycle. In the pharma-ceutical environment often the whole of the cleaningoperation is done with purified water. As this supplyneeds to be linked directly to the washing machinewhile maintaining the integrity of the client’s distri-bution system, Lancer have developed severaloptions for this critical interface - all in accordancewith Good Practice.

Lancer supply pure water systems of the leadingmanufacturers as part of a package (if appropriate).Fully conversant with a wide range of systems fromvarious suppliers, Lancer can advise on the mostsuitable for a particular washing application.

Refer to Lancer for further details of pure wateroptions available.

LABORATORYwashers

For use in QC, research, testing and general labo-ratories, Lancer supplies laboratory washingmachines for automated cleaning of all types oflaboratory glassware and equipment.

Its market-leading range provides the most compre-hensive choice - from underbench to vast doubledoor passthrough there is a model to suit almostany application or available laboratory space. Anunrivalled choice of injector racks and basketsallows great flexibility without compromising thepowerful washing action.

Universities, government tesing and researchorganisations, hospitals, QA and research laborato-ries in all the leading pharmaceutical, food andchemical companies have chosen Lancer for theircritical cleaning requirements

For details of Lancer’s high performance wash-ing systems for laboratories, ask for separatecatalogue.

11

Critical cleaning - its our business!

Lancer Industrie SA30 Bd de l’Industrie, Z I Pahin

31170 TournefeuilleFRANCE

Tel: +33 (0)5 61 15 1111Fax: +33 (0)5 61 15 1616

E-mail: [email protected]

Lancer USA Inc140 State Road 419

Winter Springs, Florida 32708USA

Tel: +1 407 327 8488Fax: +1 407 327 1229


Lancer Holland BVpostbus 33

6659 ZG WamelNETHERLANDS

Tel: +31 487 51 8088Fax: +31 487 51 7978


Lancer UK Ltd 1 Pembroke Avenue, Waterbeach, Cambridge CB5 9QR UKTel: +44 (0)1223 861665 Fax: +44 (0)1223 861990

Lancer UK Ltd (Northern) 1 Lancer Court, Astmoor, Runcorn WA7 1PN UKTel: +44 (0)1928 580783 Fax: +44 (0)1928 580784

E-mail: [email protected] Web: www.lancer.co.uk

Documents

ultra high specification PRO & PCM WASHING SYSTEMS