DPTE-BetaBag®

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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

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.

Liquid Transfer

DPTE-BetaBag® for single-use liquid transfer are directly connected to a liquid drug vessel.

They are available from our partners to fill vials or bottles inside a clean environment.

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)