LC590.700.VE100
Contents
1. Frame is made of SS304 with an external finish at Grit 220 about 1 6 um Ra 62 u inches Ra External frame s welds are grinded The LC590 700 VE100 is rated to be operated in ATEX Zone 2 IIB T4 hazardous area refer to section 2 1 3 DYNAMIC AXIAL COMPRESSION The Column Skid is a self packing column It is based on the Dynamic Axial Compression DAC technology lis main feature is the presence of a piston attached to a hydraulic jack The piston travels the entire length of the column tube The hydraulic jack is operated by the Hydraulic Unit The piston has three functions in the DAC column Column Packing A slurry of packing material in an appropriate solvent is first transferred into the column tube through 1 side fill nozzle The piston is then moved downward thus eliminating firstly the air through the frit of the column piston secondly the slurry solvent through the frit of the column flange When the packing process is complete the piston stops moving The column is then ready for use The whole packing process typically takes less than 20 minutes including the slurry preparation Maintaining Bed Stability During the column operation the particles of packing material reorganize over the time and the whole bed tends to settle usually forming a void at the fixed bed column inlet with a concomitant decrease in column performance The dynamic action of the piston provides continuous compression to the bed and preven2. FAT FAT report SAT Protocol SAT test procedures Test reports of each individual test performed during the SAT SAT report This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement www novasep com Page 13 of 15 5 SPARE PARTS LIST NVS20429 LC590 700 VE100 NVS CODE Qty DESCRIPTION ITEM Note This spare parts list is not included in the deliverables of a column Indicated quantities are to be seen as a recommendation CUSTOMER SERVICE EUROPE NOVASEP Process Customer Service Site Eiffel 81 boulevard de la Moselle BP 50 54340 Pompey FRANCE NOVASEP Inc Customer Service 23 Creek Circle Boothwyn PA 19061 USA Phone 33 0 3 83 49 71 00 Hot line Phone 1 610 494 0447 ext 30 NOVASEP Asia NOVASEP Japan K K Customer Service Customer Service Build No 1 306 308 Bunshokudan Bldg 7F Lane 898 Halei Road Kudanminami 1 4 5 Zhangjiang Hi Tech Park Chiyoda ku Shanghai 201203 CHINA Tokyo 102 0074 Phone 86 0 21 3895 0252 Phone 81 03 3221 1960 Bilan orca pra Fax 86 0 21 5407 0206 Fax 81 03 3221 1970 J l pharma novasep com china novasep com japan novasep com NOVASEP Partner Nishotech Customer Service W199 E MIDC Khairane Thane Belapur Road Navi Mumbai 400 705 INDIA This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior
3. clean change the frit or the seals The reversed procedure is used to install the piston or the flange Manual forklift Piston Rotation Unit Piston Flange tables LC590 700 VE100 HANDLING TOOLS DESCRIPTION This manual forklift has 2 main functions e Install and remove the piston onto from the column e Install and remove the flange onto from the column The manual forklift mainly is made of SS304 The forklift and all its components including wheels are compliant with ATEX no aluminum used in the construction This accessory is used to remove the piston from the Piston table and rotate it for maintenance operations cleaning changing piston frit and seals The rotating section is designed in such a way that minimum effort is required to rotate the piston This accessory is mainly made of SS304 These tables are used to accommodate the piston and flange once they are removed from the column These accessories are mainly made of SS304 This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement 1 5 WEIGHT amp DIMENSIONS 1394 54 9 1292 50 9 47 2 1200 WEIGHT approximated Column 3500 kg Hydraulic unit 470 kg Manipulating tools 170 kg www novasep com Page 8 of 15 3808 150 ee 1300 This confidential document is Novasep s property It must not be used duplicated or trans
4. written agreement 6 HOW TO ORDER To place an order please recall in your order the following NOVASEP s code DESCRIPTION NOVASEP CODE LC590 700 VE100 CODAP NVS22701 SPARE PARTS NVS20429 OPTIONAL PRESSURE TRANSMITTER panes HANDLING TOOLS NVS22857 This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement Contacts Www novasep com EUROPE Novasep Process Site Eiffel 81 boulevard de la Moselle BP 50 54340 Pompey FRANCE Phone 33 0 3 83 49 70 00 Fax 33 0 3 83 49 70 02 pharma novasep com USA Novasep Inc 23 Creek Circle Boothwyn PA 19061 USA Phone 1 610 494 0447 Fax 1610 494 1988 pharma usa novasep com ASIA Novasep Asia Build No 1 306 308 Lane 898 Halei Road Zhangjiang Hi Tech Park Shanghai 201203 CHINA Phone 86 0 21 5407 0208 Fax 86 0 21 5407 0206 china novasep com JAPAN Novasep Japan K K Bunshokudan Bldg 7F Kudanminami 1 4 5 Chiyoda ku Tokyo 102 0074 Phone 81 03 3221 1960 Fax 81 03 3221 1970 japan novasep com INDIA NOVASEP Partner Nishotech Customer Service W199 E MIDC Khairane Thane Belapur Road Navi Mumbai 400 705 INDIA Phone 91 22 27781481 82 83 Fax 491 022 2778 1484 0865 pharma novasep com Pompey FRANCE Headquarters Le Mans FRANCE Leverkusen GERMANY Chasse Rh ne FRANCE Saint Maurice d
5. Novasep acess NVS22701 TECHNICAL amp PROCESS DESCRIPTION Dec 2010 Ovase Pai process m LC590 700 VE100 Pure Performance for the Life Sciences 1 oe i gt Is i TECHNICAL DESCRIPTION FLOW CHART TECHNICAL SUMMARY DYNAMIC AXIAL COMPRESSION HANDLING TOOLS WEIGHT amp DIMENSIONS CUSTOMER INTERFACES REQUIRED UTILITIES h h h h b b Y NDURUYNH STANDARDS amp NORMS SCOPE OF TESTING DELIVERED DOCUMENTATION 4 1 ENGINEERING DOCUMENTATION 4 2 TECHNICAL DOCUMENTATION 4 3 TESTING DOCUMENTATION SPARE PARTS LIST HOW TO ORDER CONTENT www novasep com Page 3 of 15 _h OOON OO A _h ol 11 11 12 13 14 This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement www novasep com Page 4 of 15 1 TECHNICAL DESCRIPTION 1 1 FLOW CHART N dp D pD N 4 3 Dox Th ic a 36 _ 2 7S we Ge Bre aE E a ae valis wv EWN 08 seq 9 11y pessaiduioD This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement www novasep com Page 5 of 15 1 2 TECHNICAL SUMMARY The LC590 700 VE100 preparative High Performance Liquid Chromatography HPLC column is designed for cGMP operation Any type of packing material can be used to fill the column provided
6. designed following the CODAP calculation code It complies with the following EC directives e EC Machine Directive 2006 42 EC May 17 1998 e EC Pressure Vessel Directive 97 23 EC 23 of May 1997 e EC Directive for apparatus in explosive atmospheres 94 9 EC 23 of March 1994 e With the following ATEX marking Ex II3G IIB T4 IEC CENELEC Optional pressure transmitter NVS20924 e EC Low Voltage Directive 2006 95 EC December 15 2004 including amendments e EC Electro Magnetic Compatibility Directive 2004 108 EC December 12 2006 including amendments LC590 700 VE100 US Version As a pressure vessel the LC590 is designed following the ASME calculation code It conforms to widely accepted industry standards and good manufacturing practices and is provided with U stamp Optional pressure transmitter NVS20924 e Rated for Class 1 Div 2 Group C amp D NEC500 This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement www novasep com Page 11 of 15 3 SCOPE OF TESTING The LC590 is fully tested during the Factory Acceptance Test FAT and the Site Acceptance Test SAT in order to gather evidence that e The equipment has been manufactured following NOVASEP Process design documentation e The manufactured equipment is operating within the specified tolerances LE Only tests due to dismounting for transportation purposes or tests wh
7. e Beynost FRANCE Mourenx FRANCE Pure Performance for the Life Sciences Se Shanghai CHINA
8. ere the customer environment has an impact on the equipment setting are reproduced during SAT The applicable tests are mainly but not limited to the following e Check of the equipment against the engineering documents P amp ID Mechanical Drawing etc e Check of the instrumentation test or verify against calibration certificate if still valid e Check of the safety devices emergency stops relief valve etc e Check of the critical functions To get a fully detailed list of applicable tests please refer to the FAT amp SAT protocols of the LC590 which are available upon request 4 DELIVERED DOCUMENTATION 4 1 ENGINEERING DOCUMENTATION The following documentation is provided as an electronic copy CD Rom DISCIPLINE ENGINEERING DOCUMENTATION Piping amp Instrument Diagram P amp ID Process Detail Engineering Process Parts List PPL Interfaces Design Specifications IDS Process Mechanical Mechanical Detail General Drawing including detail drawings nomenclature Engineering General tubing drawings including item nomenclature This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement Wwww novasep com Page 12 of 15 4 2 TECHNICAL DOCUMENTATION The following documentation is provided as an electronic copy CD Rom DISCIPLINE ENGINEERING DOCUMENTATION e User Manual Sta Spare Parts List Piping amp Instrume
9. hich allows the user to pack beds of variable lengths The hydraulic jack exterior is painted steel Novasep standard paint An electrical driven pump is used to motion the piston up and downwards An air driven amplification pump is Hydraulic pumps 2 used to pressurize the oil and to maintain the dynamic axial compression onto the packing material The oil pressure is proportional to the air supply pressure in static conditions piston not moving Emergency Stop Emergency stop to shut down the hydraulic pump in case of emergency Pneumatic push button to reset the Reset button 3 hydraulic unit after the emergency button has been disengaged Air supply Valve 4 Pneumatic 2 way valve used to supply the hydraulic pump with compressed air Motion Selector Oil E i distributor 5 Pneumatic switch to control the oil distributor in order to select the piston s motion up down stop Air pressure regulator to set the air pressure supply to the pneumatic amplification pump N2 The air 6 pressure is linear with the oil pressure Oil pressure relief valve to protect the column in case of an accidental over pressure This relief valve can be CODAP certified for EU version ASME Certifed for US version Pressure gauge 11 Pressure gauge indicating the oil pressure This indication is used to determine the bed compression Pneumatic 3 way ball valve to isolate the column from the pumping skid for the packi
10. mitted without Novasep s prior written agreement www novasep com Page 9 of 15 1 6 CUSTOMER INTERFACES Connections to hydraulic unit Slurry inlets Packing purge Compressed air 2 From pumping skid 2 To pumping skid LC590 700 VE100 DESCRIPTION Compressed Air 3 4 compression fitting from Swagelok From pumping skid HIPERSEP To pumping skid HIPERSEP 3 4 compression fitting from Swagelok Packing Purge Slurry Ports 1 Triclamp The LC590 column is provided with the following e Two 3 4 OD flexible hoses for connection of the Piston and Flange to the Column packing valves e One 1 set of column tools wrenches for assembly packing unpacking operations and maintenance operations This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement www novasep com Page 10 of 15 1 7 REQUIRED UTILITIES LC590 700 VE100 TYPE QUALITY CAPACITY PRESSURE TEMPERATURE Compressed Air 40 um filtered oil free dry 5 Nm3 min Process 2 um Filtered 2500 I h max 100 barg max 5 C to 60 C Thermostation N A N A N A N A 2 During Packing operation otherwise negligible The hydraulic oil used is MOBIL DTE FM46 which is a clear oil suitable for pharmaceutical and food applications 2 STANDARDS amp NORMS LC590 700 VE100 EU Version As a pressure vessel the LC590 is
11. ng and unpacking Packing valves 12 ater n l n 13 14 operations and to select solvent direction toward the flange s or piston s side during packing operation in Relief valve 10 order to bleed the air and or remove the slurry solvent Column state Pneumatic switch to change the column state from elution mode to packing mode by actuating packing Selector 15 valves Purge state Selector Pneumatic switch to change the purge state during packing operation from piston to flange by actuating the 16 packing valve This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement www novasep com Page 6 of 15 ITEM DESCRIPTION Jack roe ae Manual 2 way ball valve to isolate the jack for maintenance purposes Sight glass 19 Sigth glass installed on the purge line to identify liquid or air presence during packing operation Pressure transmitter Optional pressure transmitter and its isolation valve The pressure transmitter can be connected to the 49 HIPERSEP unit in order to manage record amp alarm the hydraulic oil pressure LC590 700 VE100 The design of the Column is made in such a way to reduce as much dead volume as possible All wetted parts of the column module are made of SS316L stainless steel FEP and PTFE Packing valves are high pressure valves with an internal surface finish not better than 2 4 um 94 u inches
12. nt Diagram P amp ID Process Parts List PPL Interface Design Specifications IDS Process Mechanical Process Manufacturer technical documentation for process components Material conformity certificates and FDA certificates of the components in contact with the process Calibration certificates for process components General Drawing including detail drawings nomenclature General tubing drawings including item nomenclature Mechanical Material conformity certificates and FDA certificates of the components in contact with the process Column manufacturer book Safety instruction Incorporation declaration EC 97 23 if applicable Incorporation declaration covering o EC Machine Directive 2006 42 EC May 17 1998 o EC Pressure Vessel Directive 97 23 EC 23rd of May 1997 o EC Directive for apparatus in explosive atmospheres 94 9 EC 23rd of March 1994 EC Low Voltage Directive 2006 95 EC December 15 2004 including amendments EC Electro Magnetic Compatibility Directive 2004 108 EC December 12 including amendments Normative If this equipment is associated with another NOVASEP equipment like a pumping module additional certificates will be provided 4 3 TESTING DOCUMENTATION The following documentation is provided as two binders e 1 binder copy of the FAT e 1 binder copy of the SAT DISCIPLINE ENGINEERING DOCUMENTATION FAT Protocol FAT test procedures Test reports of each individual test performed during the
13. the proper packing pressure is chosen to avoid destruction of the particles It can be operated with the most common solvents used in chromatography The column module is composed of the column itself and its compression system mounted on a stainless steel frame It can be connected to any pumping system MAIN CHARACTERISTICS Internal Diameter Operating Temperature 5 to 60T Maximum Bed Length Compression feature Dynamic Axial Compression DAC Operating pressure ooo Slurry intets LC590 700 VE100 DESCRIPTION Column Tube The internal diameter of the column tube is 590 mm The standard surface roughness of the column tube ID is 0 4 um 15 7 u inches The external finish is approximately 1 6 um 63 u inches Piston and Flange The piston and flange of the column contain a woven mesh frit 2um nominal porosity and a flow distributor to provide even distribution of the liquid plug flow over the cross section of the packed bed The finish of the wetted surface roughness of the piston and flange is approximately 0 8um 30 u inches Column 1 The flange is sealed to the column tube with a FEP encapsulated O ring and held in place by the use of screws The piston is sealed to the column tube with a dynamic spring loaded seal The piston seals are PTFE FEP encapsulated and SS316L Hydraulic Jack The hydraulic jack is mounted above the column tube The hydraulic jack has a stroke length of 700 mm w
14. ts void formations thus providing a stable column performance over the time Good packing bed arrangement Column Unpacking In order to unpack the column the pressure is released from the hydraulic system and the column flange is removed An appropriate sized container is placed under the column tube The hydraulic pressure is then increased and the piston is directed downward to push the packing material out of the column and into the container The unpacking time is less than 30 minutes This confidential document is Novasep s property It must not be used duplicated or transmitted without Novasep s prior written agreement 1 4 HANDLING TOOLS www novasep com Page 7 of 15 These accessories mainly made of SS304L stainless steel are used to simplify the piston and flange removal installation procedure They include a manual forklift a piston rotation unit a piston table and a flange table The table frame is placed under the column using the manual forklift The table is lifted up until it comes in contact with the piston which has been previously set to its lowest position or the flange For the piston the special quick release chain attaching the piston to the jack is then opened and the piston sits free on the table Finally the table is lowered with the piston or the flange on top of it and can be pulled away If desired the piston can then be attached to the piston rotation unit where it can easily be rotated to
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LC590.700.VE100