IQ-OQ Docu Vacuum Filtration Manifold BS100 e.jet
Contents
1. HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification ll Start Up and Functional Test II A COMBISART TAP POSITIONS AND THEIR FUNCTIONS Purpose To ensure that the Combisart tap is used correctly So the vacuum below the membrane filter is released sterilely Tap Position Open Vent Close Finish Autoclave 6 o clock 9 o clock 3 o clock Function For Filtration After Filtration After the Filtration Run The full vacuum The vacuum The residual draws the sample between the tap vacuum between through the and membrane filter the pump and valve membrane filter is released under is released via the The venting filter sterile conditions sterilizing grade is off line Secondary filter contamination of the bottom of the filter is ruled out entirely Operator Signature Date COMPANY Witness Signature Date COMPANY 12 o clock For Autoclaving For reliable sterilization the steam flows freely through all openings Page 20 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OQ Protocol Operational Qualification Il Start Up and Functional Test Il B START UP THE SYSTEM Purpose To ensure that the Combisart System is working correctly B 1 Start Up the system Turning each of the Combisart taps to position Vent Close 9 o clo2. HE sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors IQ OO DOCUMENTATION Vacuum Filtration Equipment 1 3 branch Combisart Manifold Type of vacuum filtration system Biosart 100 Monitor Type of funnel Fluid Vacuum Pump Type of vacuum pump Page 1 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors INSTALLATION amp OPERATIONAL QUALIFICATION DOCUMENTS Vacuum Filtration Equipment 1 3 branch Combisart Manifold amp Type of vacuum filtration system Biosart 100 Monitor Type of funnel Fluid Vacuum Pump Type of vacuum pump Page 2 of 27 HE sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors INSTALLATION QUALIFICATION DOCUMENT Vacuum Filtration Equipment 1 3 branch Combisart Manifold amp Type of vacuum filtration system Biosart 100 Monitor Type of funnel Fluid Vacuum Pump Type of vacuum pump Page 3 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification Content CLIENT INFORMATION Client name Type of vacuum filtration system Manifold Combisart System No of filter stations 1 or 3 Type of funnel Biosart 100 Monitor 1x Biosart 100 Monitors Model no and Lot no 1
3. A 4 Combisart Manifold A 5 Minisart SRP Venting Filter 1 Packing carton Yes O No O 2 Foam inserts Yes O No O 3 Carton stickers Yes O No O 4 User manual Yes O No O 5 Combisart Individual Base Yes O No O 6 Minisart SRP venting filter Yes O No O A 6 Vacuum Hose 1 Vacuum hose tubing Yes O No O A 7 Vacuum Pump 1 Packing carton Yes O No O 2 Foam inserts Yes O No O 3 Carton stickers Yes O No O 4 CE conformity statement Yes O No O 5 User manual Yes O No O 6 Vacuum pump Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 9 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification 2 Physical Inspection 2 B PHYSICAL ASPECTS Purpose To ensure that the equipment is supplied integer and undamaged A General appearance no visible damage Yes O No O B Type plate Serial numbers attached Yes O No O C CE approval plate attached Yes O No O D Line cord installed Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 10 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification 2 Physical Inspection 2 C VERIFICATION OF POWER MANAGEMENT Purpose To ensure that all electrical devices are suitable for the locally pro
4. tested Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 22 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification ll Start Up and Functional Test Il C VERIFICATION OF THE COMBISART TAP Purpose To ensure that the Combisart tap is working and used correctly So the vacuum below the membrane filter is released sterilely C 2 Functionality Combisart Tap Position Vent Close Turn the Combisart tap to position Vent Close 9 o clock Refill the Biosart 100 Monitor with tap water 1 Vacuum occurs on the venting filter Minisart SRP Yes O No 2 No water is drawn through the Biosart 100 Monitor Yes O No O 3 All Combisart taps were tested Yes O No O C 3 Functionality Combisart Tap Position Finish The Biosart 100 Monitor is filled with tap water Turn the Combisart tap to position Finish 3 o clock 1 Vacuum occurs on the venting filter Minisart SRP Yes O No O 2 No water is drawn through the Biosart 100 Monitor Yes O No O 3 The vacuum of the system is released Yes O No O 4 All Combisart taps were tested Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 23 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OQ Protocol Operational Qualification I
5. 0 Monitor Lot no Combisart Manifold Serial no Vacuum Pump Serial no CONTENT OF OPERATIONAL QUALIFICATION Assembly of the System Il Start Up and Functional Tests A Combisart tap positions and their functions B Start up the system C Verification of the Combisart taps Ill Test Filtration Operator Signature Date COMPANY Witness Signature Date COMPANY Page 14 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification I Assembly I ASSEMBLYOF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly Set Up of a manifold filtration system with a Fluid Vacuum Pump Operator Signature Date COMPANY Witness Signature Date COMPANY Page 15 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification I Assembly I ASSEMBLYOF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly Remark n the following section the assembly of the Combisart System is described in detail If your Combisart System has more than one filter station please make sure that you follow the instructions for every filter station 1 Changing the positions of the hose nipple and the cap of the Combisart manifold 4 by using a 24 mm open end wrench
6. SEMBLY OF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly 4 Place the Biosart 100 adapter 2 onto the Combisart single base 3 All Biosart 100 adapters are placed Yes O No Firm fit of all components Yes O No 5 Insert the air filter 5 into the venting hole Venting hole closed with Minisart SRP Yes O No All venting holes closed with Minisart SRP Yes O No 6 Cutting the vacuum hose 6 in half Vacuum hose cut Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 18 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OQ Protocol Operational Qualification I Assembly I ASSEMBLY OF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly 7 Mounting one end of one half of the vacuum hose 6 on the hose nipple providing vacuum of the vacuum pump 7 Microsart e jet Right side and the other end on the hose nipple of the Combisart manifold 4 Hose seated tight at both ends Yes O No O 8 Mounting the remaining vacuum hose 6 with one end on the outlet hose nipple of the vacuum pump 7 and direct the other end to the drain All hose connections tight Yes O No O 9 Connecting the line cord Firm connection of the cable Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 19 of 27
7. ck and switching the vacuum pump on If a Woulff s bottle is used making sure the tap is closed Place Biosart 100 Monitor s 1 on top of the Biosart 100 Adapter s 2 1 Pump running audible noise Yes O No 2 Vacuum is build up in the system Yes O No 3 Biosart 100 Monitor s are installed Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 21 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OQ Protocol Operational Qualification Il Start Up and Functional Test Il C VERIFICATION OF THE COMBISART TAP Purpose To ensure that the Combisart tap is working and used correctly So the vacuum below the membrane filter is released sterilely Remark n the following section the test of the functionality of the Combisart 3 way taps is described If your Combisart System has more than one filter station please make sure that you follow the instructions for every Combisart tap separately while the other taps are closed 9 o clock position C 1 Functionality Combisart Tap Position Open Place a Biosart 100 Monitor 1 on top of the Biosart 100 Adapter 2 and fill the Monitor with 100 ml tap water Turn the Combisart tap to position Open 6 o clock 1 Water is drawn through the Biosart 100 Monitor Yes O No O 2 No vacuum occurs on the venting filter Minisart SRP Yes O No 3 All Combisart taps were
8. ction 2 A DELIVERY CONTROL Purpose To ensure that all standard components have been supplied Set Up of a manifold filtration system with a Fluid Vacuum Pump Operator Signature Date COMPANY Witness Signature Date COMPANY Page 7 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification 2 Physical Inspection 2 A DELIVERY CONTROL Purpose To ensure that all standard components have been supplied A 1 Biosart 100 Monitors 1 Packing carton Yes O No O 2 Packaging foil Yes O No O 3 Carton stickers Yes O No O 4 User manual Yes O No O 5 Certificate Yes O No O 6 Biosart Monitors Yes O No O 7 Plugs Yes O No O 8 PE adapter Yes O No O A 21 Adapter s for Biosart 100 units Biosart 100 Adapter Yes O No O PE bag Yes O No O 3 Sticker on PE bag Yes O No O A 3 Combisart Single Base s units 1 Packing carton Yes O No O 2 Packaging paper Yes O No O 3 Carton stickers Yes O No O 4 Combisart Single Base Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 8 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification 2 Physical Inspection 2 A DELIVERY CONTROL Purpose To ensure that all standard components have been supplied
9. g procedure functioning Yes No 3 All Combisart taps were tested Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 25 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification Ill Test Filtration lll VERIFICATION OF THE FUNCTION TEST FILTRATION Purpose To ensure that the Combisart System is working correctly 3 After the filtration turning the Combisart tap to position Vent Close 9 o clock The vacuum between the tap and Biosart 100 Monitor is released under sterile conditions by the Minisart SRP 1 Vacuum occurs on the venting filter Minisart SRP for a short moment Yes O No 2 Noiseless removing of the Biosart 100 Monitor Yes O No 3 All Combisart taps were tested Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 26 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OQ Protocol Operational Qualification Summary PROTOCOL OF OPERATIONAL QUALIFICATION The following operational qualification protocols had been completed satisfactorily O Assembly O Start Up and Functional Tests L1 Test Filtration Operator Signature Date COMPANY Witness Signature Date COMPANY Page 27 of 27
10. l Start Up and Functional Test 2 C VERIFICATION OF THE COMBISART TAP Purpose To ensure that the Combisart tap is working and used correctly So the vacuum below the membrane filter is released sterilely C 4 Functionality Combisart Tap Position Autoclave The Biosart 100 Monitor is filled with tap water Turn the Combisart tap to position Autoclave 12 o clock 1 Water is drawn through the Biosart 100 Monitor Yes O No 2 Vacuum occurs on the venting filter Minisart SRP Yes O No 3 All Combisart taps were tested Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 24 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OQ Protocol Operational Qualification Ill Test Filtration Ill VERIFICATION OF THE FUNCTION TEST FILTRATION Purpose To ensure that the Combisart System is working correctly 1 Placing Biosart 100 Monitor s 1 on top of each of the Biosart 100 Adapters 2 and turning the Combisart tap s to position Vent Close 9 o clock Switching on the vacuum pump 9 the tap of the Woulff s bottle must be closed 1 Pump running audible noise Yes O No O 2 Vacuum is build up in the system Yes O No O 2 Filling the Biosart 100 Monitor with 100 ml of tap water and turning the Combisart tap to position Open 6 o clock 1 Filling procedure functioning Yes O No 2 Emptyin
11. spanner The hose nipple is on the left side of the Combisart manifold 4 when tap s are in front Yes O No O The cap is on the right side of the Combisart manifold 4 when tap s are in front Yes O No Firm fit of all parts Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 16 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification I Assembly I ASSEMBLYOF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly 2 Screw the Combisart single base 3 into the thread of the Combisart manifold 4 turning the Combisart single base 8 until the two pins are positioned either right left or front back Tighten the threaded nut using a 24 mm open end wrench spanner Firm fit of the Combisart single base Yes O No All Combisart single bases fit Yes O No 3 Insert the flat silicone gasket into the Combisart single base 3 and place the stainless steel filter support frit onto the silicone gasket Gasket and frit are positioned Yes O No All gaskets and frits are positioned Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 17 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification I Assembly I AS
12. vided power supply C 1 Voltage Supply Voltage locally V Suitability to local Voltage Yes O No O C 2 Frequency Supply Frequency locally Hz Suitability to local Frequency Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 11 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors IQ Protocol Installation Qualification Summary PROTOCOL OF INSTALLATION QUALIFICATION The following installation qualification protocols hade been completed satisfactorily O Document Inspection O Physical Inspection Operator Signature Date COMPANY Witness Signature Date COMPANY Page 12 of 27 HE sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OPERATIONAL QUALIFICATION DOCUMENT Vacuum Filtration Equipment 1 3 branch Combisart Manifold amp Type of vacuum filtration system Biosart 100 Monitor Type of funnel Fluid Vacuum Pump Type of vacuum pump Page 13 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification Content CLIENT INFORMATION Client name Type of vacuum filtration system Manifold Combisart System No of filter stations 1 or 3 Type of funnel Biosart 100 Monitor Serial Lot numbers of the equipment Biosart 10
13. x Combisart Manifold Model no and Serial no __ x Combisart Single Base Model no 1x Vacuum Pump Model no and Serial no 1x Vacuum Hose Model no x Biosart Adapter Model no for each filter station one single base and one adapter should be available Operator Signature Date COMPANY Witness Signature Date COMPANY Page 4 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors IQ Protocol Installation Qualification Content CONTENT OF INSTALLATION QUALIFICATION 1 Document Inspection 2 Physical Inspection 2 A Delivery Control 2 B Physical Aspects 2 C Power Management Operator Signature Date COMPANY Witness Signature Date COMPANY Page 5 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification 1 Document Inspection 1 DOCUMENTS PROVIDED WITH THE VACUUM FILTRATION EQUIPMENT Purpose To ensure that all standard documentation has been supplied A User manual for Combisart system including adapters and accessories Yes O No B User manual for vacuum pump Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 6 of 27 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification 2 Physical Inspe
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