PCM & PRO Range Washers - EquipNet · PDF file2 peristaltic pumps ... Characteristics MATERIALS AND FINISHES ... PCM range) meet the most rigorous demands of cutting edge industries

MATERIALS AND FINISHES

AISI 316L stainless steel chamber ✓ ✓

Rounded edges and internal welds on the inside of the chamber ✓ ✓

Walls and bottom of chamber polished Ra 0.6 £gm ✓ ✓

Welds inside the chamber polished Ra 0.6 £gm ✓

AISI 316L stainless steel drop down door ✓ ✓

AISI 304 stainless steel frame ✓ ✓

316L stainless steel external panels ✓ ✓

Chamber and panels insulated with “particle – free”, non – chloride insulation ✓ ✓

Hinged or removable maintenance access doors ✓ ✓

316L stainless steel washing pump ✓ ✓

316L stainless steel pipes, 1% slope minimum ✓ ✓

Orbital welded piping, internal fi nish 0.6 £gm Ra (excluding weld) ✓ ✓

Weld mapping and weld certifi cates ✓

Connections via 316L stainless steel Tri-clamps ✓ ✓

316 LS stainless steel, pneumatically activated piston valves ✓

Pneumatically actuated Sanitary Diaphragm valves ✓

DRYING SYSTEM

Injection of hot fi ltered air into the tank (for the outside of the items to be dried) ✓ ✓

Injection of hot fi ltered air into the hydraulic circuit (for the inside of the items to be dried) ✓ ✓

Pre-fi lter located upstream of the drying componets ✓ ✓

Ceramic heating resistances ✓ ✓

HEPA H13 fi lters located downstream of all drying components ✓ ✓

Drying temperature, adjustable up to 110°C ✓ ✓

HEPA fi lter loading alarm via a differential pressure switch ✓ ✓

Magnehelic gauge for viewing HEPA loading ❍ ❍

DOP ports for HEPA fi lter integrity testing ✓ ✓

SAFETY FEATURES

Pneumatic door locking during the cycle cool down phase ✓ ✓

Interlocking doors (DP double-door models) ✓ ✓

CLEANING CHEMICALS

2 peristaltic pumps (standard) ✓ ✓

Additional peristaltic pumps ❍ ❍

Liquid level detection ✓ ✓

Verifi cation of chemical addition via fl owmeters or pressure transmitters ❍ ❍

CONTROL SYSTEMS

Programmable microprocessor, 2-line display interface ✓ ✓

40-column built-in printer ✓ ✓

RS-232 output port (if controlled by the microprocessor) ✓ ✓

Characteristics PCMSS

PROSS

✓ : STANDARD ❍ : OPTIONAL NA : NOT APPLICABLE

19

PCM & PRO Range Washers and Washer/DryersA high level of cleanliness engineered

to the pharmaceutical industry’s cGMP demands

LANCER USA INC.3543 State Rd 419Winter Springs, Fl 32708 USATél. +1 407 327 8488Fax : +1 407 327 [email protected] - www.lancer.com

LANCER HOLLAND BVPostbus 336659 ZG Wamel - NETHERLANDSTél. +31 487 51 80 88Fax : +31 487 51 79 [email protected]

LANCER INDUSTRIE30 bd. de l’Industrie - Z.I. Pahin31170 Tournefeuille - FRANCETél. +33 (0)5 61 15 11 11Fax : +33 (0)5 61 15 16 [email protected] - www.lancer.fr

LANCER UK LTD.1 Pembroke Avenue WaterbeachCambridge CB5 9QR - UKTél. +44 1 223 861 665Fax : +44 1 223 861 [email protected] - www.lancer.co.uk

Non

co

Characteristics

MATERIALS AND FINISHESAISI 316L stainless steel chamberRounded edges and internal welds on the inside of the chamberWalls and bottom of chamberpolished Ra 0.6 £gmWelds inside the chamberpolished Ra 0.6 £gmAISI 316L stainless steel drop down doorAISI 304 stainless steel frame316L stainless steel external panelsChamber and panels insulated with “particle – free”, non – chloride insulationHinged or removable maintenance access doors316L stainless steel washing pump316L stainless steel pipes, 1% slope minimum Orbital welded piping, internal fi nish 0.6 £gm Ra (excluding weld) Weld mappingand weld certifi catesConnections via 316L stainless steel Tri-clamps 316 LS stainless steel, pneumatically activated piston valves Pneumatically actuated Sanitary Diaphragm valves

DRYING SYSTEMInjection of hot fi ltered air into the tank (for the outside of the items to be dried)Injection of hot fi ltered air into the hydraulic circuit (for the inside of the items to be dried)Pre-fi lter located upstream of the drying componetsCeramic heating resistancesHEPA H13 fi lters located downstream of all drying components

Drying temperature, adjustable up to 110°CHEPA fi lter loading alarm via a differential pressure switchMagnehelic gauge for viewing HEPA loading DOP ports for HEPA fi lter integrity testing

SAFETY FEATURESPneumatic door locking during the cycle cool down phaseInterlocking doors (DP double-door models)

CLEANING CHEMICALS2 peristaltic pumps (standard)Additional peristaltic pumps Liquid level detection Verifi cation of chemical addition via fl owmeters or pressure transmitters

CONTROL SYSTEMSProgrammable microprocessor, 2 line of characters interface24-column printer in the frontRS-232 output port (if controlled by the microprocessor) Validation Monitor• Separate temperature probes• Hydraulic circuit pressure sensor• 2 pressure sensors for controlling washing products take-upAllen Bradley SLC 5/04 industrial programmable logic controller(PLC), PV600 colour touch screen, DH+ communicationSiemens S7 industrial programmable automatic system (PLC), TP 170 B colour touch screen, Profi bus communicationAllen Bradley SLC 5/05 industrial programmable automatic system (PLC), with Ethernet communication, PV600 colour touch screenSiemens S7 industrial programmable automatic system (PLC), with Ethernet communication, TP170B colour touch screen“Pack +” for Allen Bradley PLC:• Hydraulic circuit pressure sensor• 2 pressure sensors for monitoring of chemical addition“Pack +” for Siemens PLC:• Hydraulic circuit pressure sensor• 2 pressure sensors for monitoring of chemical additions Monitoring of fi nal rinse conductivity Monitoring of wash solution conductivity Sampling programe and sample valve CYCLE CONFIGURATION User-programmable, password protected cycle parameters (temperatures,

NA

NA

PCM & Pro WashersMeeting all your requirements

Experience with cGMP/FDA requirements p.4/5

Flexibility starting from the design stage p.6/7

Technological innovations p.8/9

Certified quality of manufactureing process p.10/11

FAT: Repeatability p.12/13

Traceability and validation p.14/15

Ease of use and maintenance p.16/17

Meeting all your requirements p.18/19

Lancer’s success within the pharmaceutical, biotechnology and cosmetics industries is due not only to the high qualityof our washer/dryers but also to our wide experience with cGMP cleaning applications.

• Sanitary design from the conceptual stage. HEPA filtration upstream for the drying air (for models with drying capability), tubs with rounded edges, orbital welds, Tri-clamp connections and sanitary valves (on the PCM range) meet the most rigorous demands of cutting edge industries.

• Monitoring of Quality procedures during manufacture.The machines are manufactured under ISO 9001:2000 certification. Programmable industrial automatic systems (PLCs) have been developed in accordance with GAMP (Good Automated Manufacturing Practices).

• Washers perfectly adapted to each of our customers’ specific constraints.The tub, the baskets and the accessories are designed according to the specific nature of the items to be washed.

• Validation and constant control of the washing process. Microprocessor or PLC (Programmable In-dustrial Automatic System) control, built-in printer and control of the rinsing water’s conductivity (available as an option), etc. ensure and provide proof of efficient, re-producible washing cycles.

• Total traceability and full documentation for validation.Every component in the washer/driers bears identifica-tion labels, the welds are identified and supplied with a certificate (on the PCM range), the QI/QO protocols (FAT/SAT) verify the machine’s suitability for the customer’s specifications (URS)… in fact, everything has been done to make the validation teams’ and auditors’ work easier.

5

Our références

Akzo Nobel • Alcon Amersham • Amgen • Allergan

Astra Zeneca • Aventis • Baxter Bayer • BCG • Biogen • Biomerieux

Boehringer Ingelheim • Boots • BMSCamr • Cancer Research CEA • Centocor CEVA • City of Hope • Cryolife • Dabur DCB • DSM Biologicals • ELANFedera • Fujisawa • GaldermaGenentech • Genprobe • GSK Biologicals

GSK • Immunogen • Ipsen Biopharm Johnson&Johnson • Janssen • Leciva Praha

Lederle • Lemery • Leo-Lovens • LFB • Lilly L’Oreal • Medimmune • Medipolis • Merck Merial • MSD • Nestle • Novartis • Novo Nordisk Nycomed Amersham • Octoplus • Organon Pateur Merieux • Pfizer • Rotavirus • Royal Victorian Infirmary • Sanofi Synthelabo

Schering • Searle • Serbio • Solvay • Shell Tayside • Techno Servier • Transgene

UCB • Weston • Wyeth Lederle

cGMP/FDA experience:Pharmaceutical, Biotechnology,Cosmetics.

From customer specifications (URS), through validation to everyday use, Lancer accompanies you in your project every step of the way.

Our Design department designs washers, baskets and accessories for different applications. Several tub sizes are available accordingto the size and the geometry of thetems to be washed. On request, Lancer will study and manufac-ture tubs to special dimensionsand appropriate baskets.

• Washing glassware.Injectors welded onto the manifolds enabling access to the interior of the glassware, from the simplest to the most complex, for perfect washing and drying.

• Washing pipes.The helical supports on these pipe baskets enable very long pipes to be washed.

• Washing valves, Tri-clamps, filters.A secure connection for the valves is ensured by distri-bution manifolds with clamps of various sizes.

• Washing batches of specific items.Special baskets can be developed for washing as quickly as possible and sometimes simultaneously for washing items with very complex geometries. They can also take into account a particular layout for the items. Ergonomic design and time savings necessarily result in better production flow.

Analysing your specificneeds and providingappropriate solutions.

Lancer offers solutions for cGMP cleaning:

• In the following sectors:- Research & Development - Production lines (scale-up, pilot, large-scale production)- Areas associated with production (weighing, filtration)- Quality Control / Quality Assurance laboratories

• For the widest variety of items and equipment:- Production machinery components: filling lines, mixers, hoppers, filter casings, valves, pipes, Tri-clamps, etc.- Production tools: funnels, shovels, sampling sticks, etc.- ransfer tanks, containers, cans, Nalgene bottles, etc.- Miscellaneous glassware: Bellco and Erlenmeyer flasks, pipettes, test tubes, bottles, etc.- Clean glassware before sterilisation/ depyrogenisation: bottles, phials, etc.

• Other production area items and components.

7

32

1

01 – Customer specification (URS)

• A water circuit for innovative hygiene standards.The washers’ hygienic design enables all the components in the tank and the water circuit to be totally drained (in particular, the valves and the recirculation pump on the PCM range): internally welded tubs, careful polishing, rounded edges at the bottom of the tubs, and gradients on the pipes prevent any water retention and eliminate any risks of contamination.

Designing increasingly innovative hygiene standards.

• A Lancer innovation: an exclusive, high-performance drying system.Our research teams are constantly making innovations. They have perfected an exclusive drying process using HEPA-filtered hot air. The high-temperature HEPA filters are protected by pre-filters: the system traps every particle. Every component in the drying system is installed upstream of the HEPA filter: the tub cannot be contaminated after the washing process.

98

02 – Study of the specification03 – List of deviations / quotation

The Pharmaceuticals industry, whose demands are becoming higher and higher, finds in Lancer a partner who never leaves anything to chance. Quality improvements are much more than just a state of mind: they are proved in action.

• Weld quality.Wherever possible, orbital techniques are sued for welding the pipes. Certified welders perform the welding work. The water circuit’s welds are marked with a number enabling them to be found in the documentation supplied with the weld certificate (PCM range).

• Qualité des matériaux.The water circuit is manufactured from very high quality materials and meets the manufacturing requirements of the cGMP regulations. The materials used must be capable of resisting corrosion from purified water, such as PPI water or aggressive washing products. The tubs, the casings and the pipes are exclusively manufactured from 316L stainless steel.

Certifying everymanufacturing stageand ensuring quality.

11

04 - Order05 - Design Qualification (DQ)06 - Manufacture

For such a high level of demands and perfection, the washers must undergo many tests and checks and assure the operator, at all times, that the washing cycle will be run perfectly.

• Checking the washers with FAT-SAT.Lancer has established a rigorous system for checking that the manufactured machine conforms highly to the specifications laid down on the order. The FAT (“Factory Acceptance test”) and SAT (“Site Acceptance test”) protocols enable the installation and its operation to be qualified (QI/QO). The first is conducted in the factory, with the customer; the second is conducted after the machine has been delivered and installed. They guarantee high quality compliance with the machine’s specifications.

Validating and checkingto ensure reliability.

13

• Checking the cycle with microprocessors or PLCs.A control system records and prints the cycle’s data and parameters. This provides a check that the cycle conforms to the initial validation. This check is conducted by a Lancer microprocessor or an industrial programmable automatic system (PLC) from Allen Bradley or Siemens, which conform to the GAMP system of reference and satisfactorily meet the requirements of 21 CFR Part 11. Checking by PLC also enables interfacing to SCADA type external monitoring systems.

07 - FAT (Pre QI/QO)08 - Delivery

In addition to the control and qualification systems and protocols, full documentation is provided with the washer. This is an inexhaustible source for anyone wishing to find out information about the machine. It is supplied in two stages: after ordering, the “design dossier” provides all the elements for qualifying the design (DQ); on delivery, the TQC (“as manufactured”) documentation comprises the full dossier enabling the system to be validated in accordance with the FDA’s strict guidelines.

• The design dossier.This covers all the stages prior to initiation and production of the washer:- Quality plan, project planning.- Description and general operating specifications and hardware (FS, HDS).- Software design specifications (SDS, SMDS) only for the PLC.- Installation drawings.

• The TQC (“as manufactured”) documentation.This contains the following information, in addition to the documents already sent with the design dossier:- Technical, preventive maintenance and operating manuals.- Exploded drawings and spare parts lists.- The supplier’s technical sheets for the machine’s components.- Materials certificates.- Welding procedures and weld certificates, passivation, roughness test (certificates only supplied on the PCM range).- Completed FAT documentation and SAT protocol.- Complete control system manual.- Diskette or EPROM with the software source codes.

Providing traceability and maximum safety.

15

09 - Documentation10 - SAT (QI/QO)11 – QP Performance Qualification12 - Validation

16

Ease of useand maintenance.Ergonomic handles and shock-absorbing gas cylinders make opening the doors easy. The door can therefore be used in the open position as a loading and unloading area. A pneumatic lock prevents the door from being opened during acycle. For models with double doors, interlocking the doors ensures the equi-pment progresses.

The washing products are dispensed automatically by peristaltic pumps. On the 1400 and 1600 models, housings are provided inside the casing for cans of washing products. The integral level detection system alerts the operator when the cans need to be replaced.

Everything has been designed to ensure that maintenance work can be performed rapidly: standard branded components available throughout the world, very easy component placement, interior of the machine fully accessible via the key-operated door panels … reducing production equipment downtime.

17

13 - Training14 - Use15 - Maintenance16 - Revalidation

Technical specifications:meeting your needs.

AUTOMATIC SYSTEMS AND CONTROLS (SUITE)

Validation Monitor• Separate temperature probes• Hydraulic circuit pressure sensor• 2 pressure sensors for controlling washing products take-up

❍ ❍

Allen Bradley SLC 5/04 industrial programmable logic controller(PLC), PV600 colour touch screen, DH+ communication ❍ ❍

Siemens S7 industrial programmable automatic system (PLC), TP 170 B colour touch screen, Profibus communication ❍ ❍

Allen Bradley SLC 5/05 industrial programmable automatic system (PLC), with Ethernet communication, PV600 colour touch screen

❍ ❍

Siemens S7 industrial programmable automatic system (PLC), with Ethernet communication, TP170B colour touch screen ❍ ❍

“Pack +” for Allen Bradley PLC:• Hydraulic circuit pressure sensor• 2 pressure sensors for monitoring of chemical addition

❍ ❍

“Pack +” for Siemens PLC:• Hydraulic circuit pressure sensor• 2 pressure sensors for monitoring of chemical additions

❍ ❍

Monitoring of final rinse conductivity ❍ ❍

Monitoring of wash solution conductivity ❍ ❍

Sampling programe and sample valve ❍ ❍

CYCLE CONFIGURATION

User-programmable, password protected cycle parameters (temperatures, times, cycle phases) ✓ ✓

Final rinse with non-recycled WFI water, using the recirculation pump ✓ ✓

Number of rinses programmable ✓ ✓

Single pass final rinse ❍ ❍

DOCUMENTATION

Complete validation documentation including IQ/OQ protocols (FAT, SAT) ✓

Complete validation documentation including IQ/OQ protocols (FAT, SAT), roughness and weld certificates ✓

Material certificates ✓ ✓

Fully traceable material certificates ❍

CONNECTIONS TO THE SERVICES

Cold water supply ✓ ✓

Hot water supply ✓ ❍

water supply, Purified/USP/WFI ✓ ✓

Loop actuation ❍ ❍

Steam heating ✓ ✓

Electric heating ❍ ❍

Compressed air ✓ ✓

Gravity drain ✓ ✓

Steam chimney ✓ ✓

Butterfly valve on steam chimney ❍ ❍

INSPECTIONS

Electrical inspection by an independent Agency ❍ ❍

Hydraulic test on the steam coil by an independent agency ❍ ❍

Characteristics PCMSS

PROSS

18 19

Room

’s

dim

ensi

ons

Mac

hine

’s

dim

ensi

ons

Refe

renc

esM

odel

’s a

ppea

ranc

eh : 2405 mml : 1400 mmp : 1705 mm

h : 2405 mml : 2250 mmp : 1190 mm

h : 2230 mml : 2600 mmp : 1009 mm

h : 2230 mml : 2600 mmp : 1230 mm

h : 1030 mml : 850 mmp : 850 mm

h : 1030 mml : 850 mmp : 850 mm

h : 850 mml : 1300 mmp : 850 mm

h : 850 mml : 1300 mmp : 850 mm

PRO and PCM washers and driers have been specially designed to meet pharmaceutical industry requirements. Both ranges are based on 4 basic models with 4 different tub sizes.

PRO SS and PCM SS washer/driers are also available in single or double-door versions with very high-performance drying systems. PRO washers are also available without a drying system.

Room

’s

dim

ensi

ons

Mac

hine

’s

dim

ensi

ons

Réfé

renc

es 1400 PROSS1400 PCMSS

h : 2065 mml : 1150 mmp : 1415 mm

h : 2065 mml : 2010 mmp : 855 mm

h : 2290 mml : 1210 mmp : 1555 mm

h : 2090 mml : 2020 mmp : 935 mm

h : 640 mml : 625 mmp : 625 mm

h : 640 mml : 625 mmp : 625 mm

h : 855 mml : 705 mmp : 705 mm

h : 855 mml : 705 mmp : 705 mm

1400 PRODPSS1400 PCMDPSS

1600 PROSS1600 PCMSS

1600 PRODPSS1600 PCMDPSS

4500 PROSS4500 PCMSS

4500 PRODPSS4500 PCMDPSS

4800 PROSS4800 PCMSS

4800 PRODPSS4800 PCMDPSS

✓ : STANDARD ❍ : OPTIONAL NA : NOT APPLICABLE

Mod

el’s

app

eara

nce

Validation Monitor• Separate temperature probes• Hydraulic circuit pressure sensor• 2 pressure sensors for controlling washing products take-upAllen Bradley SLC 5/04 industrial programmable logic controller(PLC), PV600 colour touch screen, DH+ communicationSiemens S7 industrial programmable automatic system (PLC), TP 170 B colour touch screen, Profibus communicationAllen Bradley SLC 5/05 industrial programmable automatic system (PLC), with Ethernet communication, PV600 colour touch screenSiemens S7 industrial programmable automatic system (PLC), with Ethernet communication, TP170B colour touch screen“Pack +” for Allen Bradley PLC:• Hydraulic circuit pressure sensor• 2 pressure sensors for monitoring of chemical addition“Pack +” for Siemens PLC:• Hydraulic circuit pressure sensor• 2 pressure sensors for monitoring of chemical additions Monitoring of final rinse conductivity Monitoring of wash solution conductivity Sampling programe and sample valve

CYCLE CONFIGURATION User-programmable, password protected cycle parameters (temperatures, times, cycle phases)WHAT ARE WE SAYING ??? Single pass final rinse

DOCUMENTATIONComplete validation documentation including IQ/OQ protocols (FAT, SAT) ADDRESSED EARLIERMaterial certificates REMOVE

UTILITIESCold water supply Hot water supply water supply, Purfied/USP/WFI Loop actuationSteam heatingElectric heatingCompressed air Gravity drainSteam chimneyButterfly valve on steam chimney

INSPECTIONSElectrical inspection by an independent AgencyHydraulic test on the steam coil by an independent agency

•: STANDARD •: OPTIONAL NA: Not Applicable

GENERAL NOTES FOR CHANGES:CHANGE ALL “PROGRAMMABLE AUTOMATIC SYSTEMS” TO “PROGRAMABLE LOGIC CONTROLLER” IN ALL LOCATIONS

Model’s appearanceReferencesMachine’s dimensionsRoom’s dimensions

There is also a range for laboratories…The LANCER range of washer-dryers includes also washers for the washing of glassware in research laboratories, analysis, quality control… - Labexia LX range : washer-dryers under bench.- UP range : washer-dryers for 2, 3 or 4 glassware levels.- Labexia LXA range : washer-dryers for centralized facilities (double door version, automatic loading…)

NA

NA

NA