GetinGe GeW Washer/Dryers securinG critical cleaninG in
Contents
1. parametrically controlled cleaning for the Bio Pharma ceutical industry in the early 19905 Formerly known as the Lancer PCM range the features of these washer dryers have been honed by a process of technological development coupled with the experience of working with a very wide variety of ap plications on behalf of our clients in the pharmaceutical biotechnology and cosmetics industries globally Today the Lancer factory is equipped with the latest technology and fabrication equipment for design and as sembly of these washer dryers The equipment is distrib uted and supported through the Getinge organization which comprises more than 25 Getinge sales companies serving all major markets and more than 70 authorized distributors We can provide a truly global service to support you wherever you choose to manufacture Hinged and sliding glass door s e Designed to optimize installation footprint e Heat and noise insulating glass allows visual monitoring of cleaning process Single or double door models Cross contamination barrier to prevent clean area contamination and excessive air loss Completely drainable sanitary design e Maximized use of orbital welding e L D Ratio of lt 4 e Chamber and piping slopes gt 2 Powerful sanitary main pump BPE compliant design and components P version HEPA filtered dual path drying system e Independent channels for chamber and load Low power and utilities consumption Selec2. ISO9000 21CFR PART 11 FDA EMEA All of our washer dryers are manufactured in accor dance with the guidelines or standards relating to the intended applications and the country of installation Protecting the environment All processes are optimized to minimize the use of energy and chemicals 6 Getinge GEW cGMP Series A COMPREHENSIVE RANGE GEW 666 The range begins with the GEW 666 which is intended for use in the QA laboratory and for small scale pro duction operations including pilot plants and hospital pharmacies he base specification includes a com prehensive variety of core features designed to provide repeatable validatable cleaning reliability and longevity A range of optional features facilitates customization according to the client s specific application needs These fully automatic compact washer dryers are available with a single vertical sliding door or two sliding doors for pass through operation The loading height is 800 mm 32 A selection of standard loading racks is available for common applica tions Alternatively Getinge provides a parts modelling E xl service to design customised racks The racks are trans GEW 666 ported to and from the washer dryer on a trolley GEW 131313 The medium sized GEW 131313 is designed primarily for the manufacturing area and has a high specification base platform with a wide variety of optional features to make it adaptable to a variety of applications The
3. chamber is equipped with one or two vertical hinged doors for single ended use or pass through oper ation The use of a hinged door on this model optimizes space and minimizes the footprint of the basic unit The loading height is 710 mm 28 for ergonomic operation and a variety of standard racks together with a convenient transport trolley are available for common GEW 131313 applications Custom racks may also be designed and provided GEW 131820 The largest washer in the series the GEW 131820 is designed for pit mounting in a 300 mm 12 deep pit allowing direct floor loading of large heavy or bulky items Where pit mounting is not possible the machine may be floor mounted with just 300 mm 12 loading height This unit is intended for Bio Pharmaceutical manufac turing operations including cleaning of bulk chemical con tainers vessels and machine parts Racks are designed according to the application based on our extensive experience GEW 131820 Getinge GEW cGMP Series 7 FEATURES THAT SATISFY YOUR PROCESSING NEEDS SUPPORT THAT SATISFIES YOUR GLOBAL PLANS The Getinge GEW Series pedigree The GEW cGMP washer dryers have been developed using the knowledge and experience gained over many years These industry leading washers are manufactured in Getinge s Center of Excellence for Life Science wash ers the Lancer factory in Toulouse France which has been a part of the Getinge Group since the inception of
4. eliminates water retention and sites for biofilm or corrosion Dead legs are limited to a maximum of 4 x pipe diameter L D lt 4 Type 316L stainless steel is used throughout with EPDM PTFE or other FDA approved gaskets 21CFR part 177 Globally available components e g GEMU process valves are standard Orbital welding is used wherever possible and extensive documentation is provided 5 Washing configurations Multi level washing optimizes load configuration and mini mizes processing time Water is heated using a steam water heat exchanger in the sump of the chamber electrical heating optional SINGLE DOOR CHAMBER SIZE OVERALL SIZE MODELS Nominal internal WxHxD WxHxD GEW 666 1 LU 660 x 660 x 660 1800 x 1993 x 965 inch 26 x 26 x 26 71X 78x38 mm 1300 x 1300 x 1300 2470 x 2560 x 1485 mm BGs 97 x 101 x 58 1300 x 1800 x 2000 3250 x 2850 x 2300 GEW 131820 1 cH 51x71x79 128 x 112 x 90 i LJ TE PEEETETTEETETE WRRFERAGSE hee ES DOUBLE DOOR MODELS mm GEW 666 2 z inch mm GEW 131313 2 E inch mm GEW 131820 2 rel ia Feo ew ELLITLIIEI m PPE NTT DLP rations 21k BEGETY ae s LE Z MM T tcc TEFIE HEH r P p UN IL Gu T eee 4 F E E _ E 3 i 1 Nr CHAMBER SIZE Nominal internal WxHxD 660 x 660 x 660 26 x 26x 26 1300 x 1300 x 1300 5155151 1300 x 1800 x 2000 51x71x79 camo OVERALL SIZE
5. system design steam generation and water distillation equioment extensive ranges of washer dryers and sterilizers closure processing systems barrier isolation technology instal lation validation Support and maintenance Dealing with just one competent company saves you time effort and money Getinge can satisfy virtually all your sterile proces sing needs from concept to compliance Optimal lifecycle economy Our systems are based on compatible modular units that can quickly be integrated and installed to form complete customized solutions based solely on your needs The high quality and performance that have made Getinge the world leader in cleaning and sterilization systems ensure optimal lifecycle economy Because Getinge is a worldwide company we have the resources to meet your service maintenance and other support needs wherever you are And our Getinge Academy offers thorough training to assure the proper and efficient handling of equipment for sterile processing You re in safe hands with Getinge nw Getinge GEW cGMP Series 5 SAFEGUARDING YOUR INVESTMENT A production system represents a major capital investment That s why Getinge works hard to ensure that our GEW washer dryers provide true value In terms of design performance and lifecycle economy State of the art production Getinge continually invests in state of the art factories production equipment and process development for o
6. 71x 78X38 97 x 101 x 58 128 x 112 x 102 Getinge GEW cGMP Series 9 6 Installation All models are provided with brush finish stainless steel fascia panels for recessed installation with additional side panels to form a cabinet as an option Single or dual cross contamination barriers to maintain clean area clas sification and facilitate room air balancing Available on larger models 7 Chemical addition The washer is fitted with 1 to 5 peristaltic dosing pumps according to application for cleaning and neutralization agents to aid the mechanical cleaning process Additional pumps are available Sanitary dosing valves are uniquely welded directly to the chamber wall to ensure proper rinsing Pump pressure is monitored and a conductivity sensor is available to confirm proper additive dosing 8 Final rinse with WFI The sump is filled with WFI and recirculated throughout the hydraulic circuit to provide a single fluid path design en suring complete rinsing of the entire system The process continues for a time interval determined by conductivity and or TOC during process development studies Optio nal conductivity and or TOC monitors are available to con firm that all cleaning agents and soil have been removed This process minimizes WFI consumption and provides a validatable repeatable result A drain cooler system is available to limit the drain outlet temperature typically to typically to 60 C 140 F 9 Custom
7. GETINGE GETINGE GEW WASHER DRYERS SECURING CRITICAL CLEANING IN THE MANUFACTURING ENVIRONMENT 2 Getinge GEW cGMP Series COMPLETE STERILE PROCESSING SYSTEMS Getinge develops manufactures and supplies completely integrated cleaning and sterilization systems for use within the Bio Pharmaceutical Industry Two typical installation examples for applications in Bio Pharmaceutical production and quality assurance laboratories are shown below PHARMACEUTICAL PRODUCTION QA QC LABORATORY A Formulation suite A Reception area B Aseptic suite Filling area B Preparation area C Equioment component preparation C QA test area clean area D Utility area CPS System WSSD MPV CGMP Sterilizer Isolator transfer technologies Component sterilizers cGMP Washer dryer Steam generators WFI generation storage CGMP Washer dryer Water pretreatment Sterility test isolators not shown Isolators for API subdivision handling amp formulation Barrier Clean Zone Barrier Distribution Utilities Getinge GEW cGMP Series 3 PURPOSE DESIGNED FOR THE APPLICATION Getinge GEW washer dryers have been designed from the ground up to meet the needs of the Bio Pharmaceutical Industry Working in cooperation with users and engineers our equioment has been developed to satisfy the unique demands and stringent regulations of the industry The GEW Series of CGMP washer dryers constitutes the most
8. VALVES Fully drainable hydraulic circuit Orbitally welded deadleg ratio L D lt 4 chamber and piping slope gt 2 BPE 2002 Compliance Forged sanitary diaphragm valves Hygienic Angle Seat valves PUMP Sanitary recirculation pump Recirculation pump pressure monitoring WATER INLETS Quantity of water inlets Additional water inlets up to 3 total 00S Water distribution loop piloting CHEMICAL DOSING SYSTEM Quantity of dosing pumps Additional dosing pumps up to 5 Chemical pump pressure monitoring Conductivity monitoring Final rinse phase Conductivity monitoring Final rinse and wash phases AUTOMATION SYSTEM Getinge PACS Allen Bradley Siemens PLC O Printer INSTALLATION Full frontal GEW 666 or side GEW 131313 and 131820 access for easy maintenance Single or dual cross contamination barrier seal GEW 131313 and 131820 Flush brush finish stainless steel front panels easy cleaning washdown capable DOCUMENTATION selected items from a comprehensive list of docurment options GAMP compliant validation support documentation package and comprehensive manuals Weld numbering weld map and weld boroscope report Full material traceability 31B Certificates TESTING AND QUALIFICATION Prequalification in factory ACCESSORIES Range of standard racks basic rack jet rack Custom made racks e g glassware filling line hoses IBC s carboys OOO O Transfer trolle
9. and prove that the product is designed built and tested according to the customer specifications and performance requirements Our objective is to demonstrate and document that we adhere to a cohesive quality control program in ac cordance with Good Engineering Practice Comprehensive validation support documentation During the manufacturing process in process checking is performed to ensure compliance with specifications and documentation is maintained as confirmation After manufacturing every unit undergoes comprehensi ve and rigorous Factory Acceptance Testing FAT again accompanied by detailed documentation A complete package comprising these together with installation user and technical manuals is provided with the equip Every GEW washer dryer undergoes rigorous factory acceptance testing in a dedicated test bay with facilities to support our clients during the ment These documents are intended to support your subsequent qualification procedures thus saving conside rable time effort and expense on site We can also provide a Pre Qualification of the system upon request carrying out the same test procedures as de fined in the IQ OQ protocols which will later be performed on site as part of the validation exercise This exhaustive procedure identifies any minor issues with equipment and documentation and ensures a trouble free start up and site acceptance testing later on Deliverable documentation packages inc
10. comprehensive range on the market today The versatility of GEW cGMP washer dryers The GEW Series washer dryers are suitable for many common applications within Bio Pharmaceutical produc tion and are equipped with appropriate features options and processes for demanding applications within produc tion and the QA QC Laboratory environments For cleaning of glassware equipment parts in the Bio Pharmaceutical manufac turing area and Quality assurance Quality control laboratory Single or double door models Vertical sliding door for ergonomic operation Chamber capacity 0 3 m 10 ft Internal dimensions 660 x 660 x 660mm 26 x 26 x 26 For cleaning of IBC s carboys equipment parts in the Bio Pharmaceutical manufactur ing area and bulk chemical API production Single or double door models Vertical hinged for ergonomic operation Chamber capacity 2 2 m 78 ft Internal dimensions 1300 x 1300 x 1300mm 51 x 51 x 51 For cleaning of IBC s vessels carboys machine parts in the Bio Pharmaceutical manufacturing area and bulk chemical API production Single or double door models Sliding door for ergonomic operation Chamber capacity 4 7 m 165 ft Internal dimensions 1300 x 1800 x 2000mm 51 x 71 x 79 Four configurations are available for specified applications with a range of configurable options PHARMACEUTICAL GEW P Series Configured to meet the deman
11. designed inventory systems Hacks and frames are designed to solve specific clea ning and drying challenges based on extensive expe rience gained over many years and hundreds of projects 3D CAD modelling software is used to assure that cleaning is effective internally and externally 10 Door configurations Each model is available in single door or double door configuration Doors on the pass through models inter lock to prevent simultaneous opening and doors remain locked while the chamber is above a preset temperature 10 Getinge GEW cGMP Series Sanitary spray systems rotating spray arms and or balls in the chamber in combination with injection points on racks ensure complete uniform coverage of both internal and external surfaces of the items to be cleaned Optional rotation sensors on spray arms confirm correct operation Chambers are 316L stainless steel and fully welded no crevices All welds are polished and passivated All models feature rounded corners gt 12mm radius and a sloping base min 2 to ensure complete drain age Chamber fixtures are sanitary and all non stainless steel materials are FDA approved e g PTFE A sanitary steam heating coil in the sump rapidly heats circulating water and accurately controls the temperature If steam is not available electrical heaters may be provided in the same location Exclusive twin channel drying system Each channel comprises a high capacity blower
12. ding requirements for pharmaceutical manufacturing This model together with purpose designed inventory systems is designed for criti cal cleaning of equipment parts and components BIOTECH GEW B Series Biotech industry requirements differ from pharmaceutical applications in terms of types of cleaning requirements and technical specifications The GEW B is based on the same platform as the GEW P but is configured to meet the process and budgetary needs of Biotech users LABORATORY GEW L Series In the laboratory sector the focus is on efficient clean ing of glassware and utensils For QA work this must be repeatable and validatable to an extremely high level while considering budgetary requirements COSMETICS GEW C Series Applications in the cosmetics industry increasingly requir ing CGMP cleaning for their process equipment A robust machine with flexible chemical control is required to remove these hard to clean soils 4 Getinge GEW cGMP Series EXPERIENCE TO RELY ON Getinge is uniquely capable of offering you complete sterile process systems The earlier we are involved in the planning process for your new or replacement system the more cost effective the solution we can offer you Our knowledge and application expertise are drawn from over 100 years of dedication to cleaning and sterilization equioment within Healthcare and Life Sciences From concept to compliance We can support you with initial advice
13. ge GEW cGMP Series 13 Y A CELIU T CHEHRE E HPA WEN ti DIA TT TTT ere CE j LEE Ee FAAA EH EZ N i Titi iti tt TT 43 jaa 123 JA Jaxa Rus Du 155 1 Lo s AT iu LL wwe i e Ch z r s Injection rack designed and fabricated using Machine parts are frequently sent to Getinge 3D CAD modeling is used to design tailor made a wealth of experience for modelling rack design racks for different applications usually in coop eration with the user or equipment supplier LE Fi i ZW e i i m SE Injection nozzles designed for effective cleaning Loading trollies can be provided to efficiently Special rack basket for cleaning and drying and drying may themselves be disassembled for move materials to and from the washer silicon and metal tubing together with their cleaning and maintenance dryers tri clamp fittings 14 Getinge GEW cGMP Series INSPECTION TESTING AND DOCUMENTATION As a general principle Getinge follow ISPE s GAMP guidelines in respect of project execution and provision of documentation to support our clients qualification of sterile process equipment inspection and test of their equipment Quality is an intrinsic feature of every Getinge product From the design specification through component selection fabrication assembly and factory testing every aspect of the manufacturing process is examined and documented to ensure
14. harmaceutical industry and processing presentation and storage are FDA 21 CFR part 11 capable Every system is sup ported with comprehensive documentation Local HMI Panels Ask your representative for machine operation for more detailed infor GETINGE mation concerning the range of automation systems available from Getinge P1 Textiles Remaining Getinge IT solutions T DOC asset management and traceability solutions data storage systems local network or remote over internet z PACS supervisor Ethernet amp USB GI 3 j Printing and storage solutions Network and Internet Client scope or Getinge IT solutions T DOC Network communications module I Independent IO e g pressure and I I temperature sensors NEN DN 389 33 Ses 3 Se Sag XR Printer Digital inputs Digital outputs Analog inputs Analog outputs Service tool Factory settings for batch reports Switches buttons On off control valves e g temperature and Analog control valves Technician laptop for local Programming and setup pumps motors pressure sensors variable speed drives parameter setup and validation CS 100 settings setup studies CS 100 Software CS1000 programming U Note Illustration shows all possible connections though not all can be made simultaneously Getinge provides complete solut
15. ions for effective and efficient cleaning disinfection and sterilization in the healthcare and life science sectors Our know how comprises everything from architectural planning production and handling equipment to systems for full traceability of sterile goods Our commitment covers expert advice training and long term technical support GETINGE Getinge Infection Control PO Box 69 SE 310 44 Getinge Sweden Phone 46 35 15 55 00 Fax 46 3518 14 50 infoQgetinge com www getinge com GETINGE GETINGE GROUP is a leading global provider of equipment and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences Equipment service and technologies are supplied under the brands ArjoHuntleigh for patient handling and hygiene disinfection DVT prevention medical beds therapeutic surfaces and diagnostics GETINGE for infection control and prevention within healthcare and life science and MAQUET for surgical work places cardiopulmonary and critical care 1929 ENG 08 06 G teborgstryckeriet We reserve the right to make technical and construction changes
16. lude e Submittals design documentation e Construction Automation mal e esting amp Qualification i B e Installation Manual e User Manual e Technical Manual Getinge GEW cGMP Series 15 CONTROL SYSTEMS Reproducibility and reliability of process control is crucial in life science applications To achieve this and minimize human error Getinge supp Versatile features lies PLC based automation systems designed for the The features included in our challenging environments typically found in life science automation systems are applications and programmed using a wealth of expe e User friendly interface rience gained since Getinge introduced the first PACS e Extensive documentation computer controlled sterilizers in the mid 19805 e Remaining cycle time indicator Getinge offers a choice of hardware platforms each e Automatic sensor calibration Alternate Local HMI Panel with the same fundamental equipment functionality and e Comprehensive alarms alerts programming methodology e Process and alarm logging m Rockwell Allen Bradley Logix Platform Multi level password protection E Siemens Simatic S7 Based platform Regulatory compliance E Getinge PACS 3500 Getinge s automation systems are developed according to stringent GAMP Good Automated Manufacturing All systems accurately handle tasks such as parameter setting recipe handling sequence control and data Practice guidelines of the p
17. ne reason to ensure that we can continue to provide our clients with the best equipment available We believe we offer true value for money This is reflected in our impres sive client base the world s leading Bio pharmaceutical companies rely on Getinge Satisfying your needs GEW Series washer dryers the products of many years of practical experience are designed to handle the toug hest applications We recognize that most applications are unique so we offer made to order racks and handling systems as well as an extensive choice of standard accessories for common applications Single door and double door models are available to suit your building layout and workflow Ergonomic design Our load handling systems are developed for user friendliness Hinged and sliding doors provide easy and safe access during loading and unloading while a range of trolleys and other accessories enable easy transport of racks and articles to and from the work area Wide selection of chamber configurations The Getinge GEW Series comprises a range of chamber sizes that offer optimal handling of common loads Three standard models meet the requirements of most applications Regulatory issues Getinge closely follows industry trends practices gui delines and regulatory requirements We also actively participate in groups and committees that work to refine these requirements GAMP cGMP ASME BPE MHRA ISPE BASELINE GUIDES
18. powered by a brushless fan a heating system electri cally heated ceramic element as standard steam heating as option and a HEPA filter in that sequence One channel is used to dry the chamber and load exterior whilst the other assures rapid drying of the hydraulic circuit rack and load interior CAD is used extensively in the design phase Our customization and 3D modeling service for example is normally used to help design inventory systems for specialized components to be processed eo Me Doors slide or are hinged to provide convenient and ergonomic loading while optimising space usage overall footprint and ergonomics All doors comprise of two sheets of toughened tempered glass with an air gap providing heat and noise insulation The glass door allows visual monitoring of the cleaning action e g spray arm rotation facilitating qualification Optional chamber illumination Getinge GEW cGMP Series I 11 PHARMACEUTICAL BIOTECH LAB e COSMETIC Q CHAMBER 316L stainless steel construction FDA approved elastomeric seals 0 6 micron 24 Ra surface finish or better Radius corner chamber gt 12mm 1 2 and fully draining hydraulic circuit Chamber welds ground flush Chamber welds polished Chambe light for load viewing verification of water distribution DOOR Glass door for load viewing double pane insulated safety glass for verification of water distribution PROCESS PIPING AND
19. tion of automation systems e Rockwell Allen Bradley Compact Logix as standard e Siemens Simatic S7 platform e Getinge PACS 3500 platform GAMP compliant documentation and programming Highest level of parametrically controlled cleaning to meet the demands of the industry 8 Getinge GEW cGMP Series INTELLIGENT FUNCTION AND DESIGN 1 Efficient drying Two separate drying systems one for the chamber and one for the process path and racks Ceramic heating elements steam heating is an option allow variable drying temperature control for different materials All components are upstream of the final HEPA filters Air is exhausted to a vent connection 2 Filter monitoring DOP ports and differential pressure transmitters are stan dard features providing essential routine monitoring capa bility Magnehelic differential pressure gauges are available option for visual verification of filter loading 3 Fully automated The Getinge GEW Washer Dryer is equipped with a GAMP compliant 21CFR Part 11 capable state of the art modu lar PLC system Getinge offers a choice of our own PACS 3500 system or a selection of Allen Bradley or Siemens JOUITIO platforms all with equal functionality and documentation 4 Robust and sanitary construction Sanitary main circulation pump with vertical outlet Sloping min 2 design and smooth Ra lt 0 6um 25L crevice free construction of chamber piping and racks
20. ys for racks Standard O Option Not available 12 Getinge GEW cGMP Series INVENTORY SYSTEMS EFFICIENCY ERGONOMY AND EFFICACY Smooth uninterrupted production requlres that the right tools and equioment are available and ready for use when you need them Equally important is the ability to move heavy or awkward articles to where they re needed safely and efficiently Getinge s inventory management and handling acces sories are specifically designed to meet these needs Working in cooperation with our customers and where necessary manufacturers of production equipment we optimize washer dryer accessories to assure a Safe ergo nomic system that keeps you up and running Equally important to production efficiency is cleanliness elimination of the possibility of cross contamination with residues or dirt from previous use Getinge uses CAD systems with 3D modeling to ensure that every corner and cavity of the article being processed is thoroughly washed After washing the same injection porting is used to convey hot sterile filtered air inside for drying The pictures on this page show examples of the many customized systems Getinge has supplied A wide variety of standard racks are available for the more common applications Valve bodies mounted on a customized manifold fitted to an otherwise standard rack ensure 100 coverage of all product contact parts as well as the exterior surfaces Getin
Download Pdf Manuals
Related Search