CultiBag STR. Disposable CultiBags

Transcription

1 CultiBag STR Disposable CultiBags Description The CultiBag STR is a cultivation chamber optimized for cell cultivation. Bags are available in various configurations depending on customer requirements. The CultiBag STR is available in working volumes of 12.5 L 200 L. Other volume ranges will become available shortly. The CultiBag STR utilizes stirred motion mixing technology and can be combined with the expert control capabilities of the Sartorius Stedim Biotech Controller. Applications Single-use bag technology results in improvements in validation costs, removes the need for cleaning and sterilization and reduces contamination risk. Easy to use, it is hassle-free and applicable to a large variety of cell types, such as insect cells and mammalian cells. Single-Use Cultivation Chamber The CultiBag STR has a working range of 12.5 to 200 L depending on the bag type. Its vertically positioned stirrer is pre-installed inside the bag and contains two impellers. Both 3-blade pitched as well as 6-blade disk impellers are available. Traditional ring spargers and micro spargers are also available for integration inside the CultiBag STR. A dip tube allows gentle feeding without shear stress. Furthermore, various ports are available for feed, inoculation, harvest and sampling. Single-use optical chemical sensors for ph and DO are pre-installed in every CultiBag STR.

2 Sensors Single-use sensors for ph and DO come pre-installed and pre-sterilized with the bag. This avoids risky insertion of traditional sensors. An optical fibre connects to the sensor patch through a sterile barrier at the end of a sleeve in the bag. Sterility is maintained at all times. The optical fibre transmits light of specific wavelength to the sensor patch and returns the luminescence response from the sensor back to the measuring amplifier. Calibration is fast and easy. A PT100 reusable sensor for temperature is installed inside a special silicon sleeve. Easy Implementation, Flexible Combinations CultiBag STR bags are supplied sterilized and ready to use. This allows easy process implementation and setup times are kept to a minimum. The cylindrical bag holder is designed as two hemispherical doors which can be opened for easy installation of the CultiBag STR. Sterile connection and disconnection devices like the BioWelder or the BioSealer, also provided by Sartorius Stedim Biotech, can be used for safe transfer of your medium to the next process step. Needle-free sampling ports allow easy and convenient sampling without the risk of cross contamination. Bag material The CultiBag STR has a multilayer film structure to provide a robust structure with low gas permeability and high chemical resistance. Polyethylene terephtalate (PET) acts as a light, strong and clear protective layer. PET provides robustness and contributes to the reduction of gas transition through the film. Polyamide (PA) increases durability and strengthens the bag as well as reducing gas transition through the film. Ethyl Vinyl Alcohol (EVOH) acts as the main gas barrier minimizing transmission of gases such as O 2 and CO 2 across the film. The contact layer is made of ultra-low density polyethylene (ULDPE). ULDPE is in compliance with respective pharmacopoeias and provides a clean, inert and highly chemical resistant contact layer. The different layers are linked together by a thermoset polymer in compliance with the FDA Regulation 21CFR (c)(2)(vi). Total film thickness is 200 ± 25μm. The bag material is certified BSE TSE free and is in compliance with the EMEA s guidance (EMEA ) and the European Pharmacopoeia # on minimizing the risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Product. Furthermore, it meets or exceeds the requirements of the USP Class VI 70 C Plastic tests and is considered as non- cytotoxic and non-haemolytic. Quality Assurance For quality assurance, all materials are selected carefully in accordance with current regulations, such as FDA CFRs, cgmp s inhouse guidelines and the specifications of our Research and Development Department. This includes the terms of delivery and acceptance of our Purchasing Department. Finished CultiBag STR bags undergo final product quality control. Quality Management Systems Sartorius Stedim Biotech implemented Quality Management Systems to assure consistent high quality of products for Biotechnology. Exemplary Quality Systems Certificates: Quality Management System SQS ISO 9001:2000 Quality Management System TÜV Nord Certificate DIN EN ISO 9001:2000 Quality Management System Intertek Certificate ISO 9001:2000 The complete Quality Systems Certificates are continuously updated and can be downloaded on our website: Ordering information For more info on ordering a single use CultiBag STR please contact your Sartorius Stedim Biotech representative.

3 Standard CultiBag STR Design CultiBag STR 50L, article number FRB Pos. Function Description Total length* Distal connection A Overlay Aeration Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) + OPTA SFT-I 300 mm 0,2 sterile grade air filter aseptic connector 1/2" + Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) B Feed Si(Pt) tube 3/8 ID + 5/8 OD (2500 mm) connects 3000 mm Quick Coupling Female 3/8 + plug C Feed Si(Pt) tube 3/8 ID + 5/8 OD (2500 mm) connects 3000 mm Quick Coupling Female 3/8 + plug D Sparging Aeration Internal ring sparger connects to Si(Pt) tube 3/8 ID + 5/8 OD 950 mm 0,2 sterile grade air filter (650 mm) tube connects outside the bag to Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) + OPTA SFT-I aseptic connector 1/2" + Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) E Feed Internal Si(Pt) tube 3/8 ID + 5/8 OD (500 mm) connects 2750 mm E1: outside the bag to Si(Pt) tube 3/8 ID + 5/8 OD (1000 mm) Quick Coupling Female 1/4" + Plug splits to: E2: E1: Si(Pt) tube 1/4 ID x 3/8 OD (750 mm) connects to Quick Coupling Female 3/8 + plug C-Flex tube 1/4 ID x 7/16 OD (500 mm) E2: Si(Pt) tube 3/8 ID x 5/8 OD (750 mm) connects to C-Flex tube 3/8 ID x 5/8 OD (500 mm) F Addition base Si(Pt) tube 1/4 ID + 3/8 OD (150 mm) connects to Si(Pt) 1150 mm Clave connector Female Luer 1/8 tube 1/8 ID + 1/4 OD (500 mm) connects to C-Flex 1/8 ID + 1/4 OD (500 mm)

4 Pos. Function Description Total length Distal connection G Feed Si(Pt) tube 1/4 ID + 3/8 OD (2500 mm) connects to 3000 mm Quick Coupling Female 1/4 + plug C-Flex tube 1/4 ID + 3/8 OD (500 mm) H Gas Out Si(Pt) tube 1/2" x 3/4" OD (100 mm) splits to: H1: 400 mm H1: 0,2 sterile grade air filter H1: Si(Pt) tube 1/2" x 3/4" OD (150 mm) + OPTA SFT-I aseptic H2: 250 mm H2: OPTA SFT-I aseptic connector connector 1/2" + Si(Pt) tube 1/2" x 3/4" OD (150 mm) 1/2", Male* H2: Si(Pt) tube 1/2" x 3/4" OD (150 mm) I T sensor Thermowell sensor port for pt100 sensor 74 mm / (Inside length 135 mm) J DO sensor Thermowell sensor port for glass fibre cable DO sensor 50 mm / K ph sensor Thermowell sensor port for glass fibre cable ph sensor 50 mm / L Small volume Si(Pt) tube 1/4 ID + 3/8 OD (150 mm) reduced to 650 mm Clave connector Female Luer 1/8 sampling C-Flex tube 1/8 ID + 1/4 OD (500 mm) M Bottom Drain Si(Pt) tube 1/2 ID + 3/4 OD (2500 mm) 3000 mm Quick Coupling Male 3/8 + plug Harvest connects N Sparger Ring sparger / / O Stirrer O1=3-blade pitched top bottom impellers + O2=3-blade pitched top bottom impellers / / * A second exhaust filter line, article n DS200L-SBFLO, can be ordered separately as an option for connection to line H2. This back-up filter line can than easily be installed during cell cultivation to line H2 in case a problem occurs on filter line H1. CultiBag STR 200L, article number FRB Pos. Function Description Total length* Distal connection A Overlay Aeration Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) + OPTA SFT-I 300 mm 0,2 sterile grade air filter aseptic connector 1/2" + Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) B Feed Si(Pt) tube 3/8 ID + 5/8 OD (2500 mm) connects 3000 mm Quick Coupling Female 3/8 + plug C Feed Si(Pt) tube 3/8 ID + 5/8 OD (2500 mm) connects 3000 mm Quick Coupling Female 3/8 + plug D Sparging Aeration Internal ring sparger connects to Si(Pt) tube 3/8 ID + 5/8 OD 1550 mm 0,2 sterile grade air filter (1250 mm) tube connects outside the bag to Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) + OPTA SFT-I aseptic connector 1/2" + Si(Pt) tube 1/2 ID + 3/4 OD (150 mm) E Feed Internal Si(Pt) tube 3/8 ID + 5/8 OD (1000 mm) connects 3250 mm E1: outside the bag to Si(Pt) tube 3/8 ID + 5/8 OD (1000 mm) Quick Coupling Female 1/4" + Plug splits to: E2: E1: Si(Pt) tube 1/4 ID x 3/8 OD (750 mm) connects to Quick Coupling Female 3/8 + plug C-Flex tube 1/4 ID x 7/16 OD (500 mm) E2: Si(Pt) tube 3/8 ID x 5/8 OD (750 mm) connects to C-Flex tube 3/8 ID x 5/8 OD (500 mm) F Addition base Si(Pt) tube 1/4 ID + 3/8 OD (150 mm) connects to Si(Pt) 1150 mm Clave connector Female Luer 1/8 tube 1/8 ID + 1/4 OD (500 mm) connects to C-Flex 1/8 ID + 1/4 OD (500 mm)

5 Pos. Function Description Total length Distal connection G Feed Si(Pt) tube 1/4 ID + 3/8 OD (2500 mm) connects to 3000 mm Quick Coupling Female 1/4 + plug C-Flex tube 1/4 ID + 3/8 OD (500 mm) H Gas Out Si(Pt) tube 1/2" x 3/4" OD (100 mm) splits to: H1: 400 mm H1: 0,2 sterile grade air filter H1: Si(Pt) tube 1/2" x 3/4" OD (150 mm) + OPTA SFT-I aseptic H2: 250 mm H2: OPTA SFT-I aseptic connector connector 1/2" + Si(Pt) tube 1/2" x 3/4" OD (150 mm) 1/2", Male* H2: Si(Pt) tube 1/2" x 3/4" OD (150 mm) I T sensor Thermowell sensor port for pt100 sensor 135 mm / (Inside length 135 mm) J DO sensor Thermowell sensor port for glass fibre cable DO sensor 75 mm / K ph sensor Thermowell sensor port for glass fibre cable ph sensor 75 mm / L Small volume Si(Pt) tube 1/4 ID + 3/8 OD (150 mm) reduced to 650 mm Clave connector Female Luer 1/8 sampling C-Flex tube 1/8 ID + 1/4 OD (500 mm) M Bottom Drain Si(Pt) tube 1/2 ID + 3/4 OD (2500 mm) 3000 mm Quick Coupling Male 1/2 + plug Harvest connects to C-Flex tube 1/2 ID + 3/4 OD (500 mm) N Sparger Ring sparger / / O Stirrer O1=3-blade pitched top bottom impellers + O2=3-blade pitched top bottom impellers / / * A second exhaust filter line, article n DS200L-SBFLO, can be ordered separately as an option for connection to line H2. This back-up filter line can than easily be installed during cell cultivation to line H2 in case a problem occurs on filter line H1. CultiBag STR Design variations Tubing Size Specific tubing sizes are available on request Tubing Length Specific tubing lengths are available on request Sparger Type Choice between ring or microsparger Impeller Type Choice between blade pitched impeller, blade disk impeller or combination of both Connectors Specific connectors are available on request Please note: not all variations are possible for all ports

6 Sartorius Stedim Systems GmbH Schwarzenberger Weg Melsungen Phone Fax Sartorius Stedim North America Inc. 5 Orville Drive Bohemia, NY Toll-Free Fax Sartorius Stedim Systems Inc. 201 South Ingram Mill Road Springfield, MO Phone Fax UK France Italy Spain Japan Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH W/sart-000 G Publication No.: SBI2022-e09093 Order No.: Ver