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
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.
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.
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.
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)
Downloads
Related products
DPTE®-XS Alpha Port
The core of the DPTE® transfer system is the Alpha Port, the original Rapid Transfer Port, designed to ensure flexible, optimized and cost-effective production with the highest level of process and patient safety. The DPTE® Alpha Port’s safety interlock and lip seal are rigorously tested to ensure reliable and 100% leak-tight transfer.
DPTE® Beta Containers
Available in polyethylene or stainless steel, the reusable DPTE® Beta Containers are designed for efficient loading and unloading of components and equipment into a sterile zone. The optional racks stabilize items inside the canisters while they are transferred and sterilized.
DPTE® Transfer Trolley
The smart, mobile transfer platform for use with all DPTE® Beta solutions. Using the DPTE® Transfer Trolley safeguards optimum production efficiency and filling line uptime, guaranteeing the complete integrity of the product inside the DPTE® aseptic transfer system.
DPTE® Transfer Leak Testers (TLT)
Wireless integrity testers for DPTE® Alpha ports and Beta containers ensuring safe production and process control. Meet current and future regulations with reliable, repeatable, traceable leak detection for rapid transfer port systems.
GSS P Steam Sterilizer for pharmaceutical production
GSS P is a steam sterilizer from Getinge for component sterilization in pharmaceutical production. GSS P ensure a reproducible process, product quality and a safe environment. This makes it easier to achieve high performance, productivity and a streamlined process.
DPTE®-EXO Alpha Port
The DPTE-EXO is an automated and externally operated rapid transfer port and provides a secure, reliable, and automated transfer solution. Its external opening function was designed to significantly reduce the risk of contamination with gloveless rapid transfers.