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1. HE sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors IQ OG DOCUMENTATION Vacuum Filtration Equipment 1 3 6 branch Combisart Manifold Type of vacuum filtration system Biosart 100 Monitor Type of funnel Suction Flask 1 2 Liters Type of suction flask Electrical Membrane Pump Type of vacuum pump Page 1 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors INSTALLATION amp OPERATIONAL QUALIFICATION DOCUMENTS Vacuum Filtration Equipment 1 3 6 branch Combisart Manifold Type of vacuum filtration system Biosart 100 Monitor Type of funnel Suction Flask 1 2 Liters Type of suction flask Electrical Membrane Pump Type of vacuum pump Page 2 of 30 HE sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors INSTALLATION QUALIFICATION DOCUMENT Vacuum Filtration Equipment 1 3 6 branch Combisart Manifold Type of vacuum filtration system Biosart 100 Monitor Type of funnel Suction Flask 1 2 Liters Type of suction flask Electrical Membrane Pump Type of vacuum pump Page 3 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors IQ Protocol Installation Qualification Content CLIENT INFORMATION Client name2. 2 Physical Inspection 2 A DELIVERY CONTROL Purpose To ensure that all standard components have been supplied A 11 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 12 of 30 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 13 of 30 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 provided 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 O
3. Documentation Biosart 100 Monitors OQ Protocol Operational Qualification I Assembly I ASSEMBLY OF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly 6 Screwing the hose nipple on the outlet of the suction flask 9 not necessary for 1 Liter flask Firm fit of the hose nipple Yes O No O 7 Cutting the vacuum hose 6 in half Vacuum hose cut Yes O No O 8 Mounting one end of one half of the vacuum hose 6 on the tube connector 7 and the other end on the hose nipple of the Combisart manifold 4 Hose seated tight at both ends Yes O No O 9 Cutting the remaining vacuum hose 6 in half Hose cut Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 21 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification I Assembly I ASSEMBLY OF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly 10 Mounting one end of one half of the vacuum 11 hose 6 on the hose nipple of the suction flask 9 and the other end on the inlet hose nipple of the water trap 10 The inlet of the Woulff s bottle is the long glass tube Hose seated tight at both ends Yes O No O Mounting the remaining vacuum hose 6 with one end on the outlet hose nipple of the water trap 10 short glass tube of the Woulff s
4. 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 Emptying procedure functioning Yes No 3 All Combisart taps were tested Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 28 of 30 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 29 of 30 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 ope
5. No O 4 All Combisart taps were tested Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 26 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OQ Protocol Operational Qualification Il 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 27 of 30 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
6. ONTENT 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 17 of 30 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 1 2 liter suction flask ZR i5 A Operator Signature Date COMPANY Witness Signature Date COMPANY Page 18 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 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 Screw the Combisart single base 3 into the thread of the Combisart manifold 4 turning the Combisart single base 3 until the two pins are positioned either ri
7. Type of vacuum filtration system Manifold Combisart System No of filter stations 1 3 or 6 Type of funnel Biosart 100 Monitor 1x Biosart 100 Monitors Model no and Lot no 1x 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 1x Suction Flask Model no 1x Silicone Stopper Model no 1x Tube Connector Model no for each filter station one single base and one adapter should be available Choice one out of two water traps please delete where inapplicable O 1x Vacusart Model no and Lot no L 1x Woulff s bottle Model no Operator Signature Date COMPANY Witness Signature Date COMPANY Page 4 of 30 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 30 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 stan
8. bottle and with the other end on the hose nipple providing vacuum of the vacuum pump 11 All hose connections tight Yes O No O 12 Connecting the line cord Firm connection of the cable Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 22 of 30 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 23 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation B
9. dard 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 30 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 Set Up of a manifold filtration system with a 1 2 liter suction flask ti A Operator Signature Date COMPANY Witness Signature Date COMPANY Page 7 of 30 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 pap
10. er 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 30 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 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 Tube Connector 1 Tube connector Yes O No O 2 PE bag Yes O No O 3 Sticker on PE bag Yes O No O A 7 Vacuum Hose 1 Vacuum hose tubing Yes O No O A 8 Silicone Stopper 1 Silicone stopper Yes O No O 2 PE bag Yes O No O 3 Sticker on PE bag Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 9 of 30 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 9 Choice one out of two Suction Flasks please delete where inapplicable O 2 Liters Suction Flask Vacuum B
11. ght 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 2 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 19 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors OQ Protocol Operational Qualification I Assembly I ASSEMBLY OF ALL SYSTEM COMPONENTS Purpose To ensure that all supplied components are connected correctly 3 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 4 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 5 Insert the tube connector 7 into the silicone stopper 8 and insert the stopper into the opening of the suction flask 9 Firm fit of the stopper and the tube connector Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 20 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ
12. iosart 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 clock 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 24 of 30 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 to
13. ottle 1 Packing carton Yes O No O 2 Foam inserts Yes O No O 3 Carton stickers Yes O No O 4 Suction Flask Vacuum Bottle Yes O No O 5 Hose nipple Yes O No O L 1 Liter Suction Flask Vacuum Bottle 4 Packing carton Yes O No O 5 Foam inserts Yes O No O 6 Carton stickers Yes O No O 7 Suction Flask Vacuum Bottle Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 10 of 30 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 10 Choice one out of two Water Traps please delete where inapplicable O Vacusart 1 Packaging carton Yes O No O 2 Carton stickers Yes O No O 3 PE bag Yes O No O 4 Sticker on PE bag Yes O No O 5 Vacusart Filter Unit Yes O No O O Woulff s Bottle 1 Packing carton Yes O No O 2 Foam inserts Yes O No O 3 Carton stickers Yes O No O 4 Woulff s Bottle Yes O No O 5 Glass tube long Yes O No O 6 Glass tube short Yes O No O 7 Glass tube with tap Yes O No O 8 Caps Yes O No O Operator Signature Date COMPANY Witness Signature Date COMPANY Page 11 of 30 HE Sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart 100 Monitors IQ Protocol Installation Qualification
14. p 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 tested Yes O No Operator Signature Date COMPANY Witness Signature Date COMPANY Page 25 of 30 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
15. perator Signature Date COMPANY Witness Signature Date COMPANY Page 14 of 30 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 15 of 30 HE sartorius biotech Manifold Vacuum Filtration System IQ OQ Documentation Biosart amp 100 Monitors OPERATIONAL QUALIFICATION DOCUMENT Vacuum Filtration Equipment 1 3 6 branch Combisart Manifold Type of vacuum filtration system Biosart 100 Monitor Type of funnel Suction Flask 1 2 Liters Type of suction flask Electrical Membrane Pump Type of vacuum pump Page 16 of 30 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 3 or 6 Type of funnel Biosart 100 Monitor Serial Lot numbers of the equipment Biosart 100 Monitor Lot no Combisart Manifold Serial no Vacuum Pump Serial no Vacusart Lot no please delete where inapplicable C
16. rational 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 30 of 30
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