pall,颇尔,Allegro TK8 3D Biocontainers and Standard Systems,1100076, 1100078, 1100079, 1100081, 1100082, 730212

产品名称:
Allegro TK8 3D Biocontainers and Standard Systems
产品型号:
1100076, 1100078, 1100079, 1100081, 1100082, 730212
产品描述:

产品介绍

pall,颇尔,Allegro TK8 3D Biocontainers and Standard Systems,1100076, 1100078, 1100079, 1100081, 1100082, 730212
pall,颇尔,Allegro TK8 3D Biocontainers and Standard Systems

Allegro™ TK8 3D Biocontainers and Standard Systems

Cleanliness, integrity 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 颇尔 Life Sciences 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.

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

At the heart of Allegro TK8 systems and products is the Allegro TK8 film, a state-of-the-art multi-layer gas-barrier polymer laminate.The product-contacting layer of the Allegro TK8 film is blow-extruded in-house by 颇尔 Life Sciences under cleanroom conditions using medical-grade 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 TK8 is blow-extruded in-house by 颇尔 under cleanroom conditions (0.2 μm filtered air), ensuring the cleanest possible productcontacting 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 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 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 3D biocontainer system sizes range from 100 L to 1,000 L, and are consistent with industry dimensional norms.By incorporating Allegro TK8 film, users can easily scale down to Allegro TK8 2D biocontainers and systems as process scale or application dictates.Tubing connections are made via a molded fitment sealed into the biocontainer.Broad connectivity options exist, with tubing sizes from 1⁄8 in. to 1 in. as standard.Specialty components such as sterile connectors and filters are available upon request.To discuss your specific needs, contact your 颇尔 Life Sciences single-use specialist.

技术参数

 
Metric 技术参数
Standard Nominal Capacity 100 L, 200 L, 500 L, 1,000 L
Capacity Overage 5%
Port Locations Face ported.Top mounted single- or multipleport fitments for fill lines.Bottom mounted single-port fitment for drain.Dip tubes or Easy Drain available upon request.
管道 C-Flex TPE standard.Platinum cured silicone optional.
连接器 Luer connectors and CPC MPX connectors as standard, others available upon request.
过滤器 Most brands available upon request.
TK8 – Specification available upon request.
Compliances All materials and final assemblies 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 - 50 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 Individual bags, clean double-bagged.Labels on packaging with gamma indicator, article code, description, expiration date and batch code.
 

System Specifications

 
能力 Part Number Bag Body Dimensions Top-Mounted Fill Tubing Bottom-Mounted Drain Tubing 连接器 Container
100 L 1100076 720 mm (W) x 307 mm (H) x 520 mm (D) 500 mm x 12 in.ID C-Flex TPE 500 mm x 12 in.ID
C-Flex TPE
CPC MPX M 100 L Cubical "Q-Mix"
200 L 1100078 720 mm (W) x 614 mm (H) x 520 mm (D) 500 mm x 12 in.ID C-Flex TPE 500 mm x 12 in.ID
C-Flex TPE
CPC MPX M 200 L Cubical "Q-Mix"
500 L 1100079 1107 mm (W) x 725 mm (H) x 720 mm (D) 500 mm x 12 in.ID C-Flex TPE 500 mm x 12 in.ID
C-Flex TPE
CPC MPX M 500 L Cubical "Q-Mix"
1000 L 1100081 1095 mm (W) x 1098 mm (H) x 910 mm (D) 1,000 mm x 12 in.ID C-Flex TPE 1,000 mm x 12 in.ID
C-Flex TPE
CPC MPX M 1,000 L Cubical "Q-Mix"
100 L 1100082 392 mm (W) x 726 mm (H) x 332 mm (D) 500 mm x 12 in.ID C-Flex TPE 500 mm x 12 in.ID
C-Flex TPE
CPC MPX M 100 L Cylindrical "W-Mix"
200 L 730212 462 mm (W) x 924 mm (H) x 402 mm (D) 500 mm x 12 in.ID C-Flex TPE 500 mm x 12 in.ID
C-Flex TPE
CPC MPX M 200 L Cylindrical "W-Mix"
 

 


pall,颇尔,Allegro TK8 3D Biocontainers and Standard Systems
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