pall,颇尔,Allegro TK8 2D Biocontainers and Standard Systems,705744, 705742, 705737, 1100064, 1100065, 1100066, 1100067, 1100068

产品名称:
Allegro TK8 2D Biocontainers and Standard Systems
产品型号:
705744, 705742, 705737, 1100064, 1100065, 1100066, 1100067, 1100068
产品描述:

产品介绍

pall,颇尔,Allegro TK8 2D Biocontainers and Standard Systems,705744, 705742, 705737, 1100064, 1100065, 1100066, 1100067, 1100068
pall,颇尔,Allegro TK8 2D Biocontainers and Standard Systems

Allegro™ TK8 2D Biocontainers and Standard Systems

Cleanliness and simplicity

Highlights

  • State-of-the-art designs and materials
  • Manufactured on automated equipment under ISO Class 5 (class 100) cleanroom conditions
  • Suitable for virtually any storage application
  • Standard and custom configurations available
  • Integrity tested using advanced whole-bag testing technology
    MORE SINGLE USE SYSTEMS
    See our full range of single-use 2D and 3D biocontainers and standard systems
    HARDWARE SOLUTIONS
    See our full range of collapsible, stackable maneuverable totes; transportation and thermal control totes, and mobile workstations
  • "Universal" Allegro TK8 biocontainer film

概述

Efficient movement and storage of liquids is critical to modern biotechnology processes.The deployment of single-use containers for this task has become ubiquitous in recent years because they reduce risk while also driving down costs in comparison with traditional stainless steel equipment.

Allegro TK8 2D biocontainers have been developed to meet the demand for cost-effective, scalable single-use liquid storage containers that are compatible with 颇尔’s market-leading range of single-use mixing and bioreactor technologies.

At the heart of Allegro TK8 systems and products is Allegro TK8 film, a state-of-the art multi-layer gas-barrier polymer laminate.The product-contacting layer of the Allegro TK8 film is blowextruded in-house under cleanroom conditions using medicalgrade ultralow-density polyethylene resin, then laminated to create a gas barrier film of exceptional cleanliness, strength and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements.

The Allegro TK8 film is constructed from laminated layers of PA (polyamide), EVOH (ethylene vinyl alcohol polymer) and ULDPE (ultralow density polyethylene).外层的PA层提供卓越的防刺穿、高强度以及优异的热稳定性。EVOH层实现最低的气体扩散过膜性能,同时实现良好的防挠裂性能。ULDPE是一种灵活的、完整的超洁净、超纯、低溶出的产品接触层。上述多层组合形成具有良好透光性的膜,便于使用,在多个生物工艺应用中性能表现良好。The inner ULDPE layer used in the Allegro TK8 film is blow-extruded in-house by 颇尔 under cleanroom conditions (0.2 μm filtered air), ensuring the cleanest possible product-contacting surface.多层挤压也是在受控的、超洁净条件下完成。Lastly, the Allegro TK8 film is converted into 颇尔 biocontainer products in our ISO Class 5 cleanroom.
 
 

可追朔性与合规

All of the layers in the Allegro TK8 film are made from "medical grade" materials, meaning that they comply with industry standards and are subject to strict change controls.The entire structure of the Allegro TK8 film is totally free of any animal derived components (ADCF).颇尔 has also created the Allegro TK8 film with dual sourcing and contingency planning in mind, to ensure security of supply.
  • Allegro TK8 film complies with USP Class VI (USP<87>, USP<88>, and USP<661>)
  • ULDPE resin complies with European Pharmacopoeia (EP) 3.1.3
  • Shelf life is supported by validation studies on aging
  • ADCF认证
  • 生物负荷可用(ISO11737)
  • 颗粒计数数据可用 (EP2.9.19 or USP<788>)
  • 利用室内吹挤成型工艺, 颇尔 实现了对膜接触层组份的全面控制与追朔性,从颗粒到最终完成的容器。

Scalable and Configurable

Standard 2D Biocontainer sizes range from 50 mL to 50 L, and are consistent with industry dimensional norms.By incorporating Allegro TK8 film, users can easily scale up to the Allegro TK8 3D biocontainer range as process scale dictates.Tubing connections are made via a molded boat fitment sealed into the end of each 2D biocontainer.Broad connectivity options exist, with tubing sizes from 18 in. to 38in.as standard.Specialty components such as sterile connectors and filters are available upon request.To discuss your specific needs, contact your 颇尔 single-use specialist.

技术参数

 
Metric 技术参数
Standard Nominal Capacity 50 mL, 150 mL, 250 mL, 1 L, 5 L, 10 L, 20 L, 50 L
Capacity Overage 10%
Port Locations End ported, boat fitment.
管道 C-Flex TPE standard.Platinum cured silicone optional.
连接器 Luer connectors and CPC MPC connectors as standard, others available upon request.
过滤器 Most brands available upon request.
% Liquid Recovery (WFI) > 99.9%
TK8 – Specification available upon request.
Compliances All materials and final assemblies to meet USP Class VI requirements (USP<87>, USP<88>, USP<661>), USP<788> (particulates), EP 2.9.19 (particulates), ISO 11737 (bioburden).Full extractables/leachables data package available upon request.All contact materials certified Animal Derived Component Free (ADCF).
Supplied Documentation Certificate of Conformity delivered with every order.Certificate of Analysis available upon request.
Sterilization Method Gamma irradiation, 25-40 KGy.
Shelf Life 24 months after gamma irradiation
生产 Under cGMP protocols in ISO Class 5 cleanroom conditions.Full traceability of all components.
Packaging Clean and double-bagged.Labels on packaging with gamma indicator, article code, description, expiration date and batch code.
 

System Specifications

 
能力 Part Number Biocontainer
Body Dimensions
管道 连接器 Handle
Configurations
50 毫升 705744 88 mm (W) x 115 mm (H) 100 mm x 14 in., 14 in., 18 in.ID C-Flex TPE Luer M, Luer M, Luer F Hanging Cutout
150 毫升 705742 88 mm (W) x 175 mm (H) 100 mm x 14 in., 14 in., 18 in.ID C-Flex TPE Luer M, Luer M, Luer F Hanging Cutout
250 毫升 705737 88 mm (W) x 215 mm (H) 100 mm x 14 in., 14 in., 18 in.ID C-Flex TPE Luer M, Luer M, Luer F Hanging Cutout
1 L 1100064 178 mm (W) x 312 mm (H) 508 mm x 14 in., 14 in., 18 in.ID C-Flex TPE Luer F, Luer M, Luer F Hanging Cutout
5 L 1100065 292 mm (W) x 457 mm (H) 508 mm x 38 in., 38 in., 14 in.ID C-Flex TPE CPC MPC F, CPC MPC M, Luer F Hanging Cutout and
Rigid PETP Rod
10 L 1100066 292 mm (W) x 688 mm (H) 508 mm x 38 in., 38 in., 14 in.ID C-Flex TPE CPC MPC F, CPC MPC M, Luer F Hanging Cutout and
Rigid PETP Rod
20 L 1100067 445 mm (W) x 670 mm (H) 508 mm x 38 in., 38 in., 14 in.ID C-Flex TPE CPC MPC F, CPC MPC M, Luer F Hanging Cutout and
Rigid PETP Rod
50 L 1100068 597 mm (W) x 898 mm (H) 508 mm x 38 in., 38 in., 14 in.ID C-Flex TPE CPC MPC F, CPC MPC M, Luer F Hanging Cutout and
Rigid PETP Rod
 

 


pall,颇尔,Allegro TK8 2D Biocontainers and Standard Systems
上一条pall,颇尔,Allegro STR 200 一次性搅拌式生物反应器,
下一条pall,颇尔,Allegro TK8 3D Biocontainers and Standard Systems,1100076, 1100078, 1100079, 1100081, 1100082, 730212

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