Sartorius Maxicaps MR Virosart HF Instructions For Use Manual
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Sartorius Maxicaps MR Virosart HF Instructions For Use Manual

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Instructions for Use
Maxicaps
MR Virosart
HF,
®
®
Max and Media
1000063447

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Summary of Contents for Sartorius Maxicaps MR Virosart HF

  • Page 1 Instructions for Use Maxicaps MR Virosart ® ® Max and Media 1000063447...

  • Page 3: Table Of Contents

    Contents Contents 1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Intended Use .
  • Page 4 Contents 7 Filtration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29 Part I: Connection and Filtration.

  • Page 5: General Information

    General Information General Information Following additional parts are needed (Sartorius order number) and were send in a separate box: − 3 manual SU valve drives (3 x BPR0202): re-usable − 1 pressure safety device (1 x 26787---PS): re-usable − Pre-filter: single-use...

  • Page 6: Language

    MR Virosart HF, Max and ® ® Media can be found on our website www.sartorius.com. Labeling The filter type, pore size or retention rate are lasered on the filter housing. The remaining information lasered on the individual filter housings only refer to the individual filter capsules themselves and not to the complete...

  • Page 7: Maximum Allowable Differential Pressure

    It is highly recommended to use a pressure indicator on Maxicaps ® Virosart Inlet side (e.g. a Sartorius Sensor Transfer Set – Data Sheet: ® S--2209-e) for pressure control throughout all process steps. Further it is highly recommended to have a flow rate indicator at the inlet side.

  • Page 8: Integrity Tests And Integrity Test Data

    General Information Integrity Tests and Integrity Test Data After wetting, Maxicaps MR Virosart can be integrity tested. It is highly ® ® recommended that testing is performed by an automatic integrity testing device like Sartocheck ® For the Maxicaps MR Virosart HF and Media the test conditons are: ®...

  • Page 9: Use In A Suitably Protected Environment

    General Information Alarm values for the corresponding product: 54A7358N3--MR3 ≤ 16.0 mL/min 54A7358N3--MR6 ≤ 31.0 mL/min 54A7358N3--MR9 ≤ 46.0 mL/min For more information about single device integrity testing and product specific integrity test data, please refer to the respective validation guides of the single filter elements. External mechanical impacts (e.g.

  • Page 10: Application Support

    1.12 Liability Sartorius Stedim Biotech does not assume liability if the filter devices are handled improperly. In the interest of further developing Sartorius Stedim Biotech products, we reserve the right to make changes to the product.

  • Page 11: General Product Description

    General Product Description General Product Description Maxicaps MR Virosart is a single-use device for large scale virus filtration. ® ® Gamma-irradiatable filters can be delivered pre-sterilized but cannot be gamma irradiated multiple times. The device includes either 2, 3, 4, 5 or 6 filters of 2.4 m of process modules Virosart HF filter elements, 3 or 6 of process modules 1.0 m...
  • Page 12 General Product Description The tubing sets of the Maxicaps MR Virosart allow either sterile connection ® ® via AseptiQuik * connectors or alternatively connection via Tri-Clamp con- ® nectors. For the use of the Tri-Clamp connector the sterile connector needs to be removed manually.

  • Page 13: Parts Overview

    Parts Overview Parts Overview Pos . Description Air Filter (Sartopore Air) ® Air Filter Holder Inlet (AseptiQuik above Tri-Clamp) ® The IT wetting kit is implemented for Virosart HF only. When used ® for wetting, the kit ensures a defined back pressure needed for a successful IT testing.

  • Page 14: Inlet Tube

    Parts Overview Inlet Tube Pos . Description Inlet (AseptiQuik above Tri-Clamp) ® Inlet Valve Reinforced Silicon Tube ¾” x ⁹⁄₈” (ID x OD) Instructions for Use Maxicaps MR Virosart HF, Max and Media ® ®...

  • Page 15: Outlet Tube For Virosart

    Parts Overview Outlet Tube for Virosart HF Filter ® Pos . Description The IT wetting kit is implemented for Virosart HF only. When used ® for wetting, the kit ensures a defined back pressure needed for a successful IT testing. Outlet (AseptiQuik above Tri-Clamp) ®...

  • Page 16: Outlet Tube For Virosart Max And Media Filter

    Parts Overview Outlet Tube for Virosart Max and Media Filter ® Pos . Description Outlet (AseptiQuik above Tri-Clamp) ® Reinforced Silicon Tube ¾” x ⁹⁄₈” (ID x OD) Outlet Valve Instructions for Use Maxicaps MR Virosart HF, Max and Media ® ®...

  • Page 17: General Process Description

    General Process Description General Process Description The virus filtration is typically performed in the following steps: 1. Installation Venting Venting 2. Wetting for Pre- 3. Wetting for Use-Integrity-Test operations Waste Waste Venting 2.1 Pre-Use- 4. Equilibration Integrity-Test Buffer Waste Venting 5.

  • Page 18: Installation

    Installation Installation IMPORTANT Pallet hats are used to improve careful shipment and handling. Maxicaps MR Virosart packaging ® ® is qualified (ASTM D4169-09, DC 2, Assurance Level 2) to withstand a plane top load of at least 700 kg | 1543 lbs. An undamaged cardboard box is the main indicator for correct shipment. Unpacking and Transfer to Clean Room 1.
  • Page 19 Installation 3. Inside the air lock carefully remove the outer plastic bag (one of the two). If using a cutter take extra care not to damage the underlying bag and the tubing of the device. 4. Pull the plastic bag down to floor. Lift one end of the Maxicaps MR Virosart , roll the bag...

  • Page 20: Installation Manual Actuators

    Installation 7. Be sure that the Maxicaps MR Virosart ® ® upright: the air filter should be on top side and the wheels should stand on the ground. Re- move all pink foam from the Maxicaps ® Virosart ® Fig. 1: Before Fig.

  • Page 21: Installation Air Filter Venting Line

    Installation Installation Air Filter Venting Line 1. Remove the transportation screw located at the bottom of the Maxicaps MR Virosart ® ® 2. Remove the air filter line holder (2) and screw it in the thread on the top of the device. Please refer to the picture of the Maxicaps ®...
  • Page 22 Installation 4. Fix the air filter line at the tube inlet in holder and secure with a cable tie if needed. 5. Remove the blind cap of the air filter Tri-Clamp (1). (This might be done at a later stage just before wetting). Installation Inlet: Unpack inlet (3) and their tube sets, remove orange cable ties and packaging bag.
  • Page 23 Installation Installation Outlet: Unpack outlets (5) and their tube sets, remove orange cable ties and packaging bag. CAUTION Position the tube in the middle of the clamp (do not follow the instructions of the Pure-Fit ® clamp, which recommends tube positioning at the hinge side of the clamp).
  • Page 24 Installation CAUTION Inlets (3) and Outlets (5) are sterile AseptiQuik ® connections. Venting (1) is a Tri-Clamp connec- tion. Opening the clamp and removing the blind cap at the venting will not lead to the loss of sterility as a sterile air filter will ensure sterility. Removing the AseptiQuik connectors from ®...

  • Page 25: Wetting & Equilibration

    Wetting & Equilibration Wetting & Equilibration Filling and Venting 1. Connect the supply of the filling medium to the Inlet (3) and put a tube clamp onto the other inlet line not in use. Make sure the supply is free of air. 2. Remove the Tri-Clamp blind cap from the sterile air filter (1). 3. Connect the receiving line to the outlet (5) for product and outlet (5) for waste (for Virosart HF use the line with the wetting kit (4) as waste line).

  • Page 26: Wetting & Equilibration For Maxicaps Mr Virosart Hf

    Wetting & Equilibration 7. Fill up the device at a very low flow rate, e.g. 1 – 2 L/min or 0.1 – 0.2 bar | 1.45 – 2.9 psi inlet pressure in order to evacuate all air inside the dry Maxicaps MR Virosart . When the wetting media did pass the gauge ® ® glass close the venting line valve (10) immediately . Otherwise the fluid will immediately fill up the Venting Line, blocking the air evacuation. In case the Venting Line is filled up with fluid and no air is passing through: close supply;...

  • Page 27: Mr Virosart ® Max

    Wetting & Equilibration Wetting & Equilibration for Maxicaps ® Virosart ® When the venting line valve (10) is closed increase to an inlet pressure of 2 bar | 29 psi. Flush for 10 min via the outlet (5) of the waste line. Alternative the Virosart Max can be flushed at 1 bar | 14.5 psi inlet pressure for 20 min. ® Observe the pressure at inlet: do not exceed 2.5 bar | 36 psi when filling through the Inlet (3). After following this procedure the Maxicaps ®...
  • Page 28 Wetting & Equilibration After following this procedure the Maxicaps MR Virosart Media is wetted ® ® completely. CAUTION Observe the venting line carefully: when the liquid level goes up, close the Venting Line Valve (10). The liquid entering the venting line can be observed at the Tri-Clamp | Hose barb connector at beginning of the venting line tubing.

  • Page 29: Filtration

    Filtration Filtration Part I: Connection and Filtration 1. Perform filling and venting as described in the previous chapter. If no pre- use IT is needed the chapter “6 Wetting & Equilibration”, page 25 can be skipped. 2. Make sure the venting line valve (10) is closed. 3.

  • Page 30: Part Ii (Optional): Emptying With Pressure After Filtration

    Filtration Part II (optional): Emptying with Pressure After Filtration If not needed proceed to Part III – Disconnection. Option A: Emptying using inlet line 1. Close the inlet valve (8) and venting line valve (10). Possibly not needed if other equipment (e.g. Maxicaps MR Virosart Max) is connected to the ®...

  • Page 31: Part Iii Disconnection

    Filtration Part III Disconnection 1. Make sure the device is not under pressure anymore. 2. Close inlet valve (8), venting line valve (10) and outlet valve (7). 3. Disconnect the supply lines from inlet (3). 4. Disconnect the receiving line from Outlet (5). Instructions for Use Maxicaps MR Virosart HF, Max and Media...

  • Page 32: Pre- & Post-Use Integrity Test

    MR inlet side ® (e.g. Sartorius Sensor Transfer Set) for pressure control throughout all pro- cess steps. Further it is highly recommended to have a flow rate indicator at the inlet side. Prior to integrity testing close the inlet valve (8), outlet valve (7) and venting line valve (10).

  • Page 33: Integrity Testing

    Pre- & Post-Use Integrity Test 5. Perform an integrity test only with an installed pressure safety device (see chapter “8.2 Pressure Safety Device”, page 34). It is important to take the air filter off the air filter holder during the integrity test with Pressure Safety Device MR for safety reasons.

  • Page 34: Pressure Safety Device

    The pressure safety device has to be installed at the Sanitary connector of the air filter (1) of the Maxicaps MR Virosart ® ® Sartorius Order Code: 26787---PS Instructions for Use Maxicaps MR Virosart HF, Max and Media ® ®...

  • Page 35: Disassembling

    Disassembling Disassembling For post-use decontamination it might be appropriate to disassemble the Maxicaps MR Virosart stand. By taking of the stand, the filter system will still ® ® be closed, but the size of the filter assembly is significantly reduced. Thereby it fits better to common autoclaves.
  • Page 36 Disassembling Please find the dimensions of the Maxicaps MR versions without stand ® below. Maxicaps Maxicaps Maxicaps ® ® ® Width Length Diameter 1,000 Height 1,050 1,050 1,050 Step by step disassembling (images below are representative for Maxicaps  MR Virosart ®...

  • Page 37: 10 Technical Data

    Technical Data 10 Technical Data Please find the technical data of the Maxicaps MR Virosart HF and Media ® ® versions below. Maxicaps Maxicaps ® ® MR2 & MR3 MR4 & MR5 & MR6 Width Depth 1041 Height 1,050 1,050 Height with installed vent 1,375 1,375 filter and holder...
  • Page 38 Technical Data Maxicaps Maxicaps ® ® MR2 & MR3 MR4 & MR5 & MR6 Sterilization, gamma gamma irradiation, compatible filter delivered pre-sterilized, no re-sterilization Decontamination for Limited compatibility (valves & filters) disposal after use for autoclave sterilization, sterilization acc. to evaluation & responsibility of user possible, no inline steaming Please find the technical data of the Maxicaps MR Virosart...
  • Page 39 Technical Data Maxicaps Maxicaps Maxicaps ® ® ® Recommended max. pressure for pressure safety protection for any use of pressurized gas (for use of gas, i.e. air or nitrogen) Autoclave sterilization, Limited compatibility (valves) for autoclav. filter autoclave sterilization, delivered non- sterile, sterilization acc.

  • Page 40: Pressure Safety Device Mr

    ® ® i.e. for integrity testing, the use of a protective measure to prevent excess pressure is needed. In accordance to Pressure Equipment Directive 2014/68, Sartorius provides a pressure safety device. This device consists of a 1½” Sanitary T-union assembled with a burst disc protecting the Maxicaps MR Virosart from pressure exceeding ®...
  • Page 41 Technical Data The pressure safety device has to be installed at the sanitary connector of the Air Filter (1) of the Maxicaps MR Virosart ® ® Sartorius Order Code: 26787---PS Sartocheck ® Air | N max. 2.5 bar Pressure Safety Device with Burst...

  • Page 42: Appendix

    Appendix Appendix 11.1 Applications Support If required, please contact your Sartorius Stedim Biotech representative to obtain further infor- mation about technical data, product integrity testing or general information concerning specific applications. Moreover our Validation Service and Technical Support units are always available to assist in...

  • Page 43: 12 Conformity

    Conformity 12 Conformity 12.1 EU Declaration of Conformity The attached Declaration of Conformity hereby confirms compliance of the device with the directives cited. Instructions for Use Maxicaps MR Virosart HF, Max and Media ® ®...
  • Page 44 Conformity Instructions for Use Maxicaps MR Virosart HF, Max and Media ® ®...
  • Page 45 Conformity Instructions for Use Maxicaps MR Virosart HF, Max and Media ® ®...
  • Page 46 Conformity Instructions for Use Maxicaps MR Virosart HF, Max and Media ® ®...
  • Page 47 The information and figures contained in these instructions correspond to the version date specified below. Sartorius reserves the right to make changes to the technology, features, specifications and design of the equipment without notice. Masculine or feminine forms are used to facilitate legibility in these instructions and always simultaneously denote all genders.
  • Page 48 List of Sartorius material numbers applying to EPA-FIFRA 3V2--28-IVG-MR3 3V2--28-IVG-MR6 3VI--28-MCG-MR2 3VI--28-MCG-MR3 3VI--28-MCG-MR4 3VI--28-MCG-MR5 3VI--28-MCG-MR6 54A7358N3--MR3 54A7358N3--MR6 54A7358N3--MR9...

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