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Summary of Contents for cytiva Minimate TFF Capsule
- Page 1 Minimate™ TFF Capsule and Minimate EVO TFF system Operating Instructions Original instructions cytiva.com...
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Page 2: Table Of Contents
Flushing the system with water ........................ 52 Adding and circulating cleaning agent ....................53 Flushing the cleaning agent from capsule ................... 54 Determining the membrane recovery for the cleaned Minimate TFF Capsule ...... 55 Determining the water permeability after cleaning ................. 56 Reference information ..................57 Specifications .............................. - Page 3 General regulatory statements ......................65 Ordering information ........................... 66 Appendix A: Pump calibration .................. 67 Appendix B: Measurement temperature ..............68 Appendix C: TFF process datasheet ................. 69 Index ........................... 74 Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 4: Introduction
This chapter contains information about this manual and associated user documenta- tion, important user information, and intended use of the product. In this chapter Section See page Important user information About this manual Associated documentation Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 5: Important User Information
The Minimate™ TFF Capsule is intended for buffer exchange or concentration of samples up to 1 liter. For laboratory use only. Not for use in a manner other than indi- cated. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 6: About This Manual
This manual provides information needed to install, operate, and perform maintenance in a safe way. Scope of this manual This manual is valid for the Minimate TFF Capsule and Minimate EVO TFF system. Notes and tips Note: A note is used to indicate information that is important for trouble-free and optimal use of the product. -
Page 7: Associated Documentation
1 Introduction 1.3 Associated documentation Associated documentation Access user documentation online Scan the QR code or visit cytiva.com/instructions. Enter the title or the document number to access the file. Additional documentation Refer to the following documentation: • Minimate TFF Capsule Quick Start Guide •... -
Page 8: Safety Instructions
All users must read and understand the entire contents of this general safety chapter, and the specific safety precau- tions information in each subsequent chapter of this manual to become aware of the hazards involved. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 9: Safety Precautions
It is important not to proceed until all stated conditions are met and clearly understood. NOTICE NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 10: Labels And Symbols
2 Safety instructions 2.2 Labels and symbols Labels and symbols Nameplate The nameplate provides information about the model, manufacturer, and technical data. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 11: System Description
3 System description System description About this chapter This chapter gives an overview of Minimate TFF Capsule and Minimate EVO TFF system and a brief description of their functions. In this chapter Section See page System overview Minimate EVO TFF fittings kit... -
Page 12: System Overview
System overview Introduction The Minimate TFF Capsule is the central part of a system for performing concentration or diafiltration on solutions of biomolecules. It is available with low protein binding Omega™ ultrafiltration membranes in several different molecular weight cutoffs. The... -
Page 13: Minimate Evo Tff Fittings Kit
3.2 Minimate EVO TFF fittings kit Minimate EVO TFF fittings kit Introduction The Minimate TFF Capsule comes with threaded luer plugs in each of the 4 ports. A fitting package with the following components is included. Kit components The Minimate EVO TFF fittings kit (part number 97014) includes: •... -
Page 14: Storage
Sterile water or saline solution <6 months 0.05 to 0.1N NaOH >6 months 15% glycerin + 0.05% sodium azide Recommended storage temperatures: 4°C to 15°C (optimal), 25°C (maximum). Do not freeze. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 15: Typical Minimate Tff Capsule Setup
The pump is connected with tubing between the process sample reservoir and the feed port on the Minimate TFF Capsule. Tubing connected to the retentate port is returned to the reservoir. This allows flow of product across (tangential to) the membrane surface to create a sweeping action that helps prevent membrane fouling by reducing buildup of particles and product on the surface. - Page 16 Tubing connected to one of the filtrate ports serves to carry the filtrate (permeate) away from the device. The other filtrate port can be used as a vent for draining all liquid in the tubing after the process is finished. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 17: Installation
4 Installation Installation In this chapter Section See page Required equipment Recommended equipment Installing the Minimate EVO TFF system Installing the Minimate TFF Capsule system Calibrate feed pump Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 18: Required Equipment
• Minimate EVO TFF system: The Minimate EVO TFF system (Part no. OAPMPUNV) is optimized for use with Minimate TFF Capsule. The system includes a pump, pump head, 2 pressure gauges, 500 ml reservoir, stir plate and magnetic stir bar, valves, fittings, and a compact drip tray. -
Page 19: Recommended Equipment
(crossflow and filtrate flux rate). Pipettes and sample tubes Collect samples for analysis. Beakers and reservoirs To hold and collect sample and waste. Graduated cylinders For accurately determining collected volumes. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 20: Installing The Minimate Evo Tff System
Installing the Minimate EVO TFF system Follow the steps below to install the Minimate EVO TFF system. Step Action Cut PharMed tubing (yellow) to lengths as specified in the table below. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... - Page 21 Lay drip tray on work counter. Note: If there is any rocking of tray, the bottom feet can be adjusted by rotating as necessary as shown in te image below. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
- Page 22 (3)and 3 way valve inlet (2). Attach male luer plugs (1,4) onto female luer connectors on 3-way valves. Place the reservoir onto a stir plate with outlet toward rear of the plate. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
- Page 23 Connect the long tube (1) to the 3-way valve at the reservoir outlet (2) and to the fitting on the rear gauge mount. Attach the pump head (1) onto the pump (3) with the supplied mounting screws (2). Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
- Page 24 Attach the male luer coupler to the fitting on the front of the gauge mount. Attach the Minimate TFF Capsule feed port to the coupler, rotate capsule to the left into the capsule stand and onto the capsule bracket for support.
- Page 25 Remove the clamp when not in use, tubing can deform over time without fluid passing through the tubing. Cut a length of tubing from the Minimate TFF Capsule packaging long enough to reach the filtrate collection vessel from the filtrate port on the filter capsule.
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Page 26: Installing The Minimate Tff Capsule System
4 Installation 4.4 Installing the Minimate TFF Capsule system Installing the Minimate TFF Capsule system Follow the below steps to install the Minimate TFF Capsule system when not using the Minimate EVO TFF system. Step Action Remove the caps from the feed and retentate ports of the Minimate TFF Capsule system. - Page 27 The use of pressure gauges allows accurate adjustment of feed pressures, which provide for better reproduci- bility between process runs. They can also help in the diagnosis of system problems. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 28: Calibrate Feed Pump
Take measurements at 5 or more settings. Record setting and flow rate. This will allow you to easily adjust flow rates for the following procedures. Table 4.2: Pump calibration Pump setting Flow rate Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 29: Operation
5 Operation Operation About this chapter This chapter gives instructions on how to operate the Minimate TFF Capsule system in a safe way. In this chapter Section See page Procedures Concentration and diafiltration Normalized water permeability System hold-up volume Minimate TFF Capsule integrity test... -
Page 30: Procedures
Do not exceed the pressure rating of any component in the system. In this section Section See page 5.1.1 Flushing 5.1.2 Sanitization (recommended for critical applications) 5.1.3 Buffer-conditioning (optional) Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 31: Flushing
(>500 mL total). Note: If the Minimate TFF Capsule is not be sanitized prior to use, it is recom- mended that this step is repeated to further remove the glycerin and preser- vative. - Page 32 The valve can then be turned to drain the liquid into the beaker or close off the port. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 33: Sanitization (Recommended For Critical Applications)
Sanitization (recommended for critical applications) Introduction If required, the Minimate TFF Capsule can be sanitized prior to use. The following solutions can be used to sanitize and depyrogenate the capsule. • 0.1 to 0.5 N NaOH at 35°C to 45°C •... -
Page 34: Buffer-Conditioning (Optional)
Buffer-conditioning (optional) Introduction The buffer-conditioning step is used to precondition the Minimate TFF Capsule into the sample buffer (equilibrating solution) before the sample is added. This adjusts the pH and prevents the sample from being diluted with water, which may lower the ionic strength and possibly cause precipitation of product or other sample components. -
Page 35: Concentration And Diafiltration
Diafiltration: A Fast, Efficient Method for Desalting or Buffer Exchange of Biological Samples. A TFF process datasheet is included for use in recording experimental conditions (see Appendix C TFF process datasheet, on page 69). Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 36: Normalized Water Permeability
The original NWP of the Minimate TFF Capsule is essential to calculate as it is used as the basis to determine membrane recovery, i.e., how effectively the membrane was cleaned. - Page 37 The following tables may be used as an example for recording data and calculations. Below table is for recording data and calculating NWP. This table is available to print at the rear of the document. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
- Page 38 NWP (LMH/TMP @ 20°C) = Filtrate flux rate (mL/min/cm ) × 600 Filtrate flux rate (LMH) = Filtrate flux rate (LMH) × Temperature correction factor (TCF) at operating temperature Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
- Page 39 Example determination of NWP on a Minimate TFF Capsule Water filtrate flux rates were measured for a Minimate TFF Capsule at TMP of 5, 10, and 15 psi. The temperature of the water was 16°C. Determine the original normalized water permeability (NWP).
- Page 40 (correcting water permeability for temperature; from 16°C to 20°C) Temperature correction factor from Table 5.2, on page 39 for 16°C = 11.0°C LMH/psi x Normalized Water Permeability = 11.0°C × 1.109 = 12.2 LMH/psi Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 41: System Hold-Up Volume
Carefully transfer the retentate line into a 25 mL graduated cylinder. Turn on the pump and allow remaining liquid to be pumped out. Record the volume. This volume is the system hold-up volume. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... - Page 42 Stop the pump. If any liquid remains in the reservoir, add it to the cylinder. Record the volume in the cylinder. This is the minimum working volume for the system. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 43: Minimate Tff Capsule Integrity Test
Capsules are 100% integrity tested. Therefore it is not necessary to perform an integ- rity test on a new Minimate TFF Capsule. However, for critical applications or if the capsule will be reused, it is recommended that a forward flow air integrity test be performed to confirm integrity before and after use. - Page 44 This protocol describes performing the procedure using a peristaltic pump to generate airflow. For more accurate testing, a regulated, compressed air or nitrogen supply must be used. The below image shows a setup for air integrity testing of the Minimate TFF Capsule. Part Description...
- Page 45 Forward flow air integrity test procedure Follow the below steps for a Forward flow air integrity test procedure. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
- Page 46 If you see a lot of air bubbling through the filtrate line, there could be an integrity failure. In this case a quantitative integrity test must be performed. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 47: Product Recovery
Make sure the end of the filtrate tubing is placed in the vessel. Open the vent port and allow any remaining filtrate in the capsule and tubing to be drained. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 48: Maintenance
Flushing the system with water Adding and circulating cleaning agent Flushing the cleaning agent from capsule Determining the membrane recovery for the cleaned Minimate TFF Capsule Determining the water permeability after cleaning Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 49: Flushing And Cleaning After Use
6.1 Flushing and cleaning after use Flushing and cleaning after use If the Minimate TFF Capsule is to be reused, it must be cleaned after use and properly stored. Recommended cleaning solutions and protocols are given below. The recommended cleaning agents for Omega membranes in the Minimate TFF Capsule are as follows. -
Page 50: Post Treatment Of Minimate Tff Capsule
It is also important to develop a positive pressure profile along the entire membrane path length (feed to retentate). The procedure below will accomplish both requirements. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 51: Flushing The Retentate Stream Of Excess Matter
Start the pump and increase speed until retentate flow rate is 50 to 80 mL/min. Flush about 200 mL to drain to assure that a thorough flushing is accom- plished. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 52: Flushing The System With Water
Do not exceed a feed pressure of 2 bar (30 psi). Pump at least 250 mL of the water through the retentate tubing and 250 mL through the filtrate tubing to the drain (>500 mL total). Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 53: Adding And Circulating Cleaning Agent
Do not continue to circulate dirty cleaning solution as it will reduce the effectiveness of the cleaning process. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 54: Flushing The Cleaning Agent From Capsule
Start pump and increase flow until the feed pressure is about 2 bar (30 psi). Run until a minimum of 250 mL is flushed through the filtrate to drain. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 55: Determining The Membrane Recovery For The Cleaned Minimate Tff Capsule
0.2 μm filtered deionized water. All water permeability rates are normalized to a temperature of 20°C by using a temperature correction factor (TCF 20°C) in Table 5.2, on page Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 56: Determining The Water Permeability After Cleaning
Therefore, it is not unusual to find membrane recoveries increase after storage versus values obtained immediately after cleaning. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 57: Reference Information
7 Reference information Reference information About this chapter This chapter lists the technical specifications of the Minimate TFF Capsule. The chapter also includes recycling information, regulatory information and ordering infor- mation. In this chapter Section See page Specifications Recycling information... -
Page 58: Specifications
Operating temperature range 5°C (41ºF) to 50°C (122ºF) Maximum operating pressure 4 bar (400 kPa, 60 psi) at 20°C (68ºF) Recommended crossflow 30 to 80 mL/min (0.6 to 1.6 L/min/ft Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... - Page 59 7 Reference information 7.1 Specifications Connections Parameter Specification Feed Female luer with external thread Retentate Female luer with external thread Filtrate Male luer with threaded lock ring Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 60: Recycling Information
Capsule in the bag, and do not open after autoclaving. Do not seal the inlet and outlet connectors of the Minimate TFF Capsule prior to auto- claving as this will cause a build up of pressure, which may rupture the device. -
Page 61: Regulatory Information
Local language translations are only provided according to regulatory requirements. In this section Section See page 7.3.1 Contact information 7.3.2 European Union and European Economic Area 7.3.3 South Korea 7.3.4 General regulatory statements Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 62: Contact Information
Manufacturing information The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Cytiva Puerto Rico Pall Boulevard Road 194 KM 0.4 Fajardo, PR 00738 Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 63: European Union And European Economic Area
• used according to the Operating Instructions or user manuals, and • used in the same state as it was delivered, except for alterations described in the Operating Instructions or user manuals. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 64: South Korea
Korea. The registration number of the product will appear beside the symbol. 이 기호는 한국에서 호환성에 대한 RRA 등록을 나 타냅니다. 제품의 등록 번호는 기호 옆에 나타납니 다. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 65: General Regulatory Statements
Intended use for supplied power cord NOTICE Power cord. Do not use the supplied power cords for any other equipment. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 66: Ordering Information
- 1/8” hose barb elbow (4), female luer lock - 1/8” hose barb (1), tubing clamps (8), PharMed tubing (2 ft.), screw clamp for tubing (1), male luer plug (4) Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 67: Appendix A Pump Calibration
A. Pump calibration Appendix A Pump calibration Pump setting Flow rate Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 68: Appendix B Measurement Temperature
LMH/T sure pres- pres- rate rate flux bility MP @ psi/bar sure sure mL/min mL/min rate LMH/TMP 20°C psi/bar psi/bar Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... -
Page 69: Appendix Ctff Process Datasheet
C. TFF process datasheet Appendix C TFF process datasheet • Sample identification: • Application: • TFF system: • Membrane/cassettes • Membrane area • Date: • Operator: Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... - Page 70 Feed temp. (ºC) Con. factor (x) Diafiltrate Comments (hr:mm) volumes (DV) Initial water data Filtrate flux rate Delta P Process data Final data water Filtrate flux rate Delta P Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 71: Pressure Readings
Filtrate (psi/ TMP (psi/bar) Delta P (psi/ (psi/bar) bar) bar) Optimization yes or no Flow/Flux rate Retent. (L/min) CFF (L/min/ft Filtrate (mL/min) Filtrate (LMH) Volume Feed (mL) Filtrate (ML) Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... - Page 72 Retentate flow rate ÷ membrane area (liters/ (CFF) minute/ft Filtrate flow rate mL/min Measured filtrate flow rate Filtrate flux rate Filtrate flow rate ÷ membrane area (liters/meter hour. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
- Page 73 Indicate any observations or information consid- ered important to fully describe process or events To convert milliliters/minute to liters/hour, multiply by 0.06. To convert square feet to square meters, multiply by 0.093. Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA...
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Page 74: Index
Sanitization, 33 Specifications, 58 Important user information, 5 Typographical conventions, 6 Installation, 20, 26 Minimate EVO TFF, 20 Minimate TFF Capsule, 26 Water displacement, 43 Manufacturing information, 62 Minimate TFF Capsule and Minimate EVO TFF System Operating Instructions 29870317 AA... - Page 75 Page intentionally left blank...
- Page 76 QR code. cytiva.com Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corporation or an affiliate doing business as Cytiva. Centramate, Minimate, and Omega are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.
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