Allegro™ TK8 2D Biocontainers and Standard Systems product photo Primary L

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 7 cleanroom conditions
  • Suitable for virtually any storage application
  • Standard and custom configurations available
  • 100% biocontainer integrity testing
     
  • “Universal” Allegro TK8 biocontainer film

Overview

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 Pall’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). The outer PA layer provides robust puncture resistance, strength, and excellent thermal stability. The EVOH layer minimizes gas diffusion across the film while maintaining a very good flex crack resistance. The ULDPE layers provide flexibility, integrity and an ultra-clean, ultra-pure, low-extractables product contacting layer. The combination of these layers results in a film that has outstanding optical clarity, is easy to handle, and performs well in a broad range of bioprocess applications. The inner ULDPE layer used in the Allegro TK8 film is blow-extruded in-house by Pall under cleanroom conditions (0.2 μm filtered air), ensuring the cleanest possible product-contacting surface. Lamination is also performed under controlled, ultra-clean conditions. Lastly, the Allegro TK8 film is converted into Pall biocontainer products in our ISO Class 5 cleanroom.


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Description

Cleanliness and simplicity

Highlights

  • State-of-the-art designs and materials
  • Manufactured on automated equipment under ISO Class 7 cleanroom conditions
  • Suitable for virtually any storage application
  • Standard and custom configurations available
  • 100% biocontainer integrity testing
     
  • “Universal” Allegro TK8 biocontainer film

Overview

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 Pall’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). The outer PA layer provides robust puncture resistance, strength, and excellent thermal stability. The EVOH layer minimizes gas diffusion across the film while maintaining a very good flex crack resistance. The ULDPE layers provide flexibility, integrity and an ultra-clean, ultra-pure, low-extractables product contacting layer. The combination of these layers results in a film that has outstanding optical clarity, is easy to handle, and performs well in a broad range of bioprocess applications. The inner ULDPE layer used in the Allegro TK8 film is blow-extruded in-house by Pall under cleanroom conditions (0.2 μm filtered air), ensuring the cleanest possible product-contacting surface. Lamination is also performed under controlled, ultra-clean conditions. Lastly, the Allegro TK8 film is converted into Pall biocontainer products in our ISO Class 5 cleanroom.
Specifications

Traceability and Compliance

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). Pall 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
  • Certified ADCF
  • Bioburden evaluation available (ISO 11737)
  • Particle count data available (EP 2.9.19 or USP<788>)
  • By performing blow extrusion in-house, Pall maintains full control and traceability of the contact film composition, from resin through to finished bag product.

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 Pall single-use specialist.

Specifications

 
Metric Specifications
Standard Nominal Capacity 50 mL, 100 mL, 250 mL, 1 L, 5 L, 10 L, 20 L, 50 L
Capacity Overage 10%
Port Locations End ported, boat fitment.
Tubing Advantaflex♦ TPE standard. Platinum cured silicone optional.
Connectors Luer connectors and CPC MPC connectors as standard, others available upon request.
Filters Most brands available upon request.
% Liquid Recovery (WFI) > 99.9%
Film TK8 – Specification available upon request.
Compliances Manufactured in a controlled environment (Class 10,000)
Manufactured under a quality management system certified to ISO 9001
The materials of construction meet:
  • Biological reactivity in vivo for class VI - 50 ºC plastics
  • USP 87
  • ISO 10993
  • USP Physiocochemical test for plastics
An extensive validation program has been conducted to include testing for:
  • Oxygen permeability
  • Carbon dioxide permeability
  • Water vapor transmission rate
  • Extractable and leachable data
Contact materials are 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
Manufacturing 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.
 
Ordering Information

System Specifications

 
Part Number Volume Description Biocontainer Assembly Design
6190-0390P 50 mL Standard system 50 mL 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID ¼ in. OD 7⁄16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
6190-0390Q 100 mL Standard system 100 mL 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID ¼ in. OD 7⁄16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
6190-0390R 250 mL Standard system 250 mL 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID ¼ in. OD 7⁄16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
6190-0390S 1 L Standard system 1 L 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID ¼ in. OD 7⁄16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
6190-0390T 2 L Standard system 2 L 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID ¼ in. OD 7⁄16 in. with pinch clamp, male MPC connector closed with mPC cap
Line 3: Sealed-off port
6190-0390U 5 L Standard system 5 L 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
6190-0390V 10 L Standard system 10 L 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
6190-0390Z 20 L Standard system 20 L 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
6190-0390W 50 L Standard system 50 L 2D Allegro TK8 biocontainer Line 1: 10 cm Advantaflex ID ¼ in. OD 7⁄16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm Advantaflex ID 3⁄8 in. OD 5⁄8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
 
Application
Biocontainers