Allegro 3D Biocontainers and Standard Systems

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1 Allegro 3D Biocontainers and Standard Systems Contact Us: Description Pall Allegro 3D biocontainers have been specially designed for large scale applications where 3D systems need to be both reliable and flexible while providing extreme ease of use during their installation in the appropriate tote. They are made from high quality film that meets the critical performance requirements expected for biotechnology and pharmaceutical manufacturing. As an extension to the Allegro 2D biocontainers product line, the Allegro 3D biocontainers incorporate state-of-the-art design features that not only improve the design and robustness of single-use systems, but bring considerable advantages in terms of ease of use and product recovery when dealing with large fluid volumes. The materials of construction for all of the Allegro biocontainer product range are kept the same, thus allowing for very easy scale-up. Unique Design for Ease of Use Allegro 3D biocontainers are currently available in 50 L, 100 L, 200 L, 500 L, 1000 L, 1500 L, 2000 L and 3000 L sizes. A sampling port is available for all options. The 50 L, 100 L, 200 L, 500 L, 1000 L and 1500 L biocontainers have two inlet top ports for inclusion of sensors, allowing process monitoring or for use as an additional inlet port.the 2000 L and 3000 L biocontainers have three 1.5 in. sanitary fitting bottom port connections consisting of a sample line and two additional lines that can be dedicated to filling and draining process operations. MORE SINGLE USE SYSTEMS Film Properties and Benefits Coextruded film, comprising inert polyethylene in the inner and outer layers and a gas barrier film interlayer Inert ultra low density polyethylene (ULDPE) fluid contact layer Excellent gas barrier properties High clarity and flexibility Compatible with a wide range of chemicals Very low level of leachables No animal derived ingredients Superior Design of the Allegro 3D Biocontainer New design to ensure fast and robust installation No operator involvement during biocontainer filling, reducing the risk of mishandling No tools or accessories needed during biocontainer filling Fill from top or bottom (50 L, 100 L, 200 L, 500 L, 1000 L, and 1500 L sizes) See our full range of single-use 2D and 3D biocontainers and standard systems Learn More HARDWARE SOLUTIONS See our full range of collapsible, stackable maneuverable totes; transportation and thermal control totes, and mobile workstations Learn More Combination of the biocontainer and tote allows for efficient drainage of the product (hold-up volume approximately 100 ml for all sizes of biocontainer) Choice of inlet and outlet connections: 3 8 in. to 1 in. to accommodate a wide range of flow rates Option to insert probes through a ½ in. port Ports designed to allow tubing attachments with cable ties or BarbLock* fittings Improved labeling for optimum traceability Biocontainer part number and batch number visible on the top of the biocontainer User area to input product batch information Quality Standards The Allegro biocontainers are 100% leak tested The biocontainers are manufactured under a Quality Management System Certified to ISO 9001 Biocontainers are manufactured in a controlled environment (Class 10,000)

2 The materials of construction of the Allegro biocontainers meet: Biological reactivity in vivo for Class VI 50 C USP 87 (cytotoxicity) ISO (biological compatibility) USP 661 Physicochemical tests for plastics European Pharmacopeia (Section 3.1.5) Japanese Pharmacopeia (Section 61 Part 1) European directive 85/572/EEC for food contact plastic materials An Extensive Validation Program has been Conducted to Include Testing for: Oxygen permeability Carbon dioxide permeability Water vapour transmission rate Gamma stability and shelf life Endotoxin and particulate testing Extractables Allegro 3D Standard Systems The Allegro 3D systems are state-of-the art single-use systems designed and built by Pall Life Sciences in order to speed up the current biopharmaceutical production process. These best-in-class systems are available in standard configurations in order to facilitate faster qualification following customer evaluation. In addition, Pall Life Sciences also provides the supporting hardware for these systems in the form of totes and trolleys, which are essential best-fit solutions for transport, storage and handling. Pall Life Sciences tests and delivers customized Allegro single-use system solutions to our customers to meet specific application requirements. These systems are employed throughout the Active Pharmaceutical Ingredient (API) production process to hold and process bulk product as well as to manage and supply peripheral fluids around unit operations, such as cell culture media, buffer and cleaning solutions.the systems are supplied as a single part number as a fully integrated and validated solution. Stringent quality control procedures are followed throughout the manufacturing and supply process including component selection and qualification, system validation, and manufacturing.where appropriate, these systems can be used immediately for holding various solutions during processing. All standard systems are gamma irradiated. Typical activities these systems can be used for include: Long term stability studies/shelf life Compatibility studies Adsorption studies Freezing studies Holding process intermediates when no filtration is required Leachable studies The Allegro systems are available with either platinum-cured silicone or C-Flex* tubing depending on the application requirements. Application Allegro 3D Systems Applications Cell culture media preparation and storage Buffer preparation and storage Product and cell harvesting Intermediate product storage Bulk product storage prior to filling Specifications Allegro 3D Biocontainers Typical Film Data: Characteristics Methods Typical Values Thickness 325 µm Haze ASTM D % Water Vapor Transmission Rate ASTM F g/m².day Oxygen Permeability ASTM D-3985 (23 C, 0 % RH) 0.1 cm³/m².day.bar

3 Carbon Dioxide Permeability Mocon Permatran C-IV (23 C, 0 % RH) 0.2 cm³/m².day.bar Materials of Construction Film: Inner layer Ultra Low Density Polyethylene Gas barrier layer Outer layer EVOH Ultra Low Density Polyethylene Ports Polyethylene Operating Parameters Temperature 4 C to 40 C Sterilization Method Gamma irradiation Max dose: 50 KGy Allegro 3D Biocontainer Nominal Dimensions * Biocontainer Volume Length (L) Maximum Width (W) Maximum Height (H) Inlet Port Outlet Port Sample Port 50 L 440 mm (17.3 in.) 420 mm (16.5 in.) 300 mm (11.8 in.), ½, ¾ and 1 in., ½, ¾ and 1 in. 2 x ¼ in. 100 L 725 mm (28.5 in.) 525 mm (20.7 in.) 290 mm (11.4 in.), ½, ¾ and 1 in., ½, ¾ and 1 in. ¼ in. 200 L 725 mm (28.5 in.) 525 mm (20.7 in.) 570 mm (22.4 in.), ½, ¾ and 1 in., ½, ¾ and 1 in. ¼ in. 500 L 1056 mm (41.6 in.) 725 mm (28.5 in.) 660 mm (26.0 in.), ½, ¾ and 1 in., ½, ¾ and 1 in. ¼ in L 1290 mm (50.8 in.) 980 mm (38.6 in.) 830 mm (32.7 in.), ½, ¾ and 1 in., ½, ¾ and 1 in. ¼ in L 1465 mm (57.7 in.) 1110 mm (43.7 in.) 960 mm (37.8 in.), ½, ¾ and 1 in., ½, ¾ and 1 in. ¼ in L 1100 mm (43.3 in.) 910 mm (35.8 in.) 2040 mm (80.3 in.) 1.5 in. 1.5 in. ¼ in L 1100 mm (43.3 in.) 910 mm (35.8 in.) 2940 mm (115.7 in.) 1.5 in. 1.5 in. ¼ in. * Retrofit biocontainer systems also available, please contact allegro@pall.com for further details.

4 Ordering Information Allegro BiocontainersAllegro biocontainers will not be sold as a stand-alone item, but rather integrated into Allegro single-use systems. Standard Irradiated Allegro System Part Numbers Part Number Quantity Biocontainer Volume Tubing System Configuration/Figure Ref. No D L Platinum-cured E L Platinum-cured Figure 2 (below) F L Platinum-cured L Platinum-cured L Platinum-cured Figure 1 (below) L Platinum-cured Packaging Each unit placed is double bagged and heat sealed Gamma irradiated Documentation System certificate supplied Allegro 3D Standard Systems NOTES: Not drawn to scale. Actual systems may differ slightly in clamp positioning and tubing lengths. The fluid path of the irradiated Allegro 3D biocontainer systems is sterile and has been validated per ISO and AAMI TIR 33. Figure 1 Standard Sterile 100, 200 and 500 L Systems Part Numbers: , ,

5 Port 1: 90 cm (3 ft) platinum-cured silicone tubing with male Kleenpak sterile connector Port 2: 180 cm (6 ft) C-flex tubing with male Kleenpak sterile connector Port 3: 20 cm (7.9 in.) platinum-cured silicone tubing with male quick connect and cap Outlet: 2 m (6.5 ft) platinum-cured silicone tubing to female Kleenpak sterile connector and t-off to 40 cm (1.3 ft) C-flex to 500 ml sample bag Figure 2 Standard Sterile 100, 200 and 500 L Systems Part Numbers: D, E, F

6 Port 1: 90 cm (3 ft) platinum-cured silicone tubing with male Kleenpak sterile connector Port 2: 180 cm (6 ft) C-flex tubing with male Kleenpak sterile connector Port 3: 20 cm (7.9 in.) platinum-cured silicone tubing with male quick connect and cap Outlet: 2 m (6.5 ft) platinum-cured silicone tubing to female Kleenpak sterile connector and t-off to 40 cm (1.3 ft) C-flex to 500 ml sample bag Contact Information 2014, Pall Corporation, Pall, and other names are trademarks of Pall Corporation. indicates a registered trademark in the USA.

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