DPTE-BetaBag®
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)
Related products
DPTE® Alpha
The core of the DPTE® transfer system is the Alpha port with its secure interlock enabling totally safe connections and disconnections. The DPTE® system enables material to be moved from one sterile zone to another through a non-sterile zone, with leak-tight, risk-free reconnection.
Getinge Closure Processing System (CPS)
The Getinge Closure Processing System (CPS) provides an unbroken chain of sterility for efficient processing of all types of closures in conjunction with filling lines in pharmaceutical production.
DPTE® Beta Containers
Stainless steel or plastic DPTE® Beta Containers allow for safe transfer into and out of a barrier system in various life science applications. The Getinge 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.
Transfer Leak Testers (TLT)
Meet current and future regulations with the wireless and pipeless Transfer Leak Tester for DPTE® Alpha ports and rigid Beta parts. Leak test performed with a pressure decay method.