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DPTE-BetaBag®

DPTE-BetaBag® Tyvek and PE filled with components
DPTE-BetaBag® 105 Tyvek filled with components
DPTE-BetaBag® 190 pe-evoh-pe filled with components
DPTE-BetaBag® 190 Tyvek filled with components

DPTE-BetaBag®

The single-use DPTE-BetaBag® is a solution for safe, fast and contamination-free transfer of components to maintain high speed production.

The DPTE® system is based on the interaction of an Alpha part with a Beta part – each fitted with a door, a lock and a sealing function.

Getinge DPTE® Solutions

Getinge develops, manufactures and supports complete DPTE® transfer systems for aseptic production processes.

Overview

The DPTE-BetaBag® provides bidirectional containment without intermediate bio-decontamination. Safe leak-tight transfer is assured by these RTU (Ready To Use) or RTS (Ready To Sterilize) products.

Getinge DPTE® Solutions

Getinge DPTE® Solutions

DPTE® Alpha port with DPTE-BetaBag® for liquid transfer application

DPTE-BetaBag® for liquid transfer

  • Available as part of a sterile, single-use filling assembly from our partners – the efficient way to increase manufacturing flexibility and scalability.
  • Enables machine vendors to accommodate multiple products or multiple fill formats and makes it easier to switch between batches.
  • Enables faster transfer with fewer cleaning and sterilization steps and reduced setup times.
  • Ensures the highest safety levels and protects both operators and patients by eliminating the risk of contamination to filling needles or tubing.

How to speed up aseptic liquid transfer while maintaining sterility? Read full article

We partner with multiple liquid transfer experts to supply the industry standard in single-use aseptic liquid transfer solutions using the single-use DPTE-BetaBag® technology. Read more about two of our partners.

Merck Mobius Final Fill Display

Partner profile: Merck

The Millipore® portfolio’s Mobius® single-use (SU) final fill assemblies allow you to rapidly respond to manufacturing demands by eliminating cleaning, reducing setup time and minimizing the risk of cross-contamination. These assemblies contain SU components, including sterile connectors, 2D header bags, overmolded 1.5” TC multi-tube manifolds, peristaltic pump tubing, filling needles and the DPTE-BetaBag®. The DPTE-BetaBag® and Alpha port connection enable Mobius® SU components to be safely installed into the filling machine for sterile transfer and filling of the liquid drug product.

Learn more

Saint Gobain Final Fill Display

Partner profile: Saint-Gobain Life Sciences

Saint-Gobain Life Sciences’ patented overmolding technology in single-use assemblies enables customers to increase productivity, reduce contamination risk, and ensure product integrity. Their vertically integrated components such as Pure- Fit® SIB connectors, BarbLock® retainers, and bioprocess bags, coupled with industry-proven silicone tubing, SPT-60L, can help achieve your critical filling process requirements. Saint-Gobain Life Sciences partners with Getinge for their customizable DPTE-BetaBag® solution: sterile, single-use liquid transfer from source bag to filling needles for demanding aseptic processing environments.

Learn more

Component Insertion

Components such as stoppers, plungers, plastic bottles can be inserted into a sterile zone.

With pre-filled single-use DPTE-BetaBag® the complete sterility is guaranteed, there is no maintenance, no cleaning, no washing and no prior decontamination. It is a process time reduction.

Environmental Monitoring (EM)

To control sterility inside isolators, petri dishes can be inserted through DPTE®-BetaBag. 

Validated system

The validation of our DPTE-BetaBag® complies with international regulations:

  • Mechanical validation: leak testing of DPTE® Beta unit; leak testing if bag welded onto DPTE®, seal strength of the bag
  • Sterility validation : gamma irradiation cycle between 25 and 50 kGy
  • Microbiological validation: Bioburden, Endotoxin level
  • Particulate validation

Technical data

Standard diameter are available: 105 mm, 190 mm, 270 (PU)

Bag materials: Tyvek™, PE/EVOH/PE or PU

Bag volumes adapted to applications: from 10L to 150L

Shelf-life: from 18 to 24 months, depending on material (contact us for more information)

Direct delivery or via component manufacturer: Ready To Sterilize (RTS) and Ready To Use (RTU)

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