The pharmaceutical industry has new challenges to face in terms of ergonomics, productivity and ever more stringent safety concerns. One area of concern is the safe (ie contaminant-free) insertion of pre-sterilised products eg components and cleaning materials into the production line. Removal of toxic substances is another instance where maintaining containment is essential. Technology is evolving to respond to these concerns, bringing major improvements in transfer security.
Getinge – La Calhène is an expert in the science of containment technologies. After the launch of the DPTE-S in 1993 and the DPTE-XS in 2012, the new DPTE-XO ultra-clean transfer system from Getinge La Calhène is a new step in this technological revolution.
Greater safety
The DPTE-XO, like all classic transfer systems whose purpose is to maintain containment, is based on the interaction of two separate units, each comprising a door and a flange:
- The Alpha part fixed on an isolator wall
- The Beta part : a DPTE container or DPTE BetaBag
In order to preserve the containment between the two sterile volumes (isolator and container) after docking, both their doors are fixed together to form a single unit. To date this has been achieved by rotation which causes issues frequently encountered in the industry when heavy or bulky Beta parts have to be manually rotated and when fragile components are being transferred1.
The functioning principle of the DPTE-XO Alpha port ensures that there is no rotation, either of the Alpha flange or the Beta part, when the two doors are linked together as one. The absence of rotation also reduces the risk of creating particles by rubbing when the two units are connected and/or disconnected. Contamination-free transfers can be done.
The activating mechanism of the new DPTE-XO port is located outside the isolator on the edge of the Alpha part. There is no longer a requirement for a glove system to be positioned next to the port in order to activate it, so risk is further reduced because this contributes to minimizing operator intervention, probably the biggest potential source of contamination in the industry2. Depending on the application, the activating mechanism may be remote and/or motorised.
This single activating mechanism drives the entire sequence of actions involved in the transfer operation: locking the Beta flange, unlocking the Beta port, connecting both doors, unlocking and opening the Alpha door with the Beta door fixed onto it. With its single command, the system reduces risks of faulty manipulation on the part of the operator.
Functional security is further improved by integration of a lock which prevents the double door unit from separating when the transfer is under way. When the doors are connected together the interlock is automatically activated, without any operator intervention, ruling out any risks of omission or manipulation errors.
Productivity gains
With its modular, upgradable design, the DPTE-XO is available in a variety of models so end-users can define the solution best suited to their requirements in terms of layout and applications. The motorised version, for example, is particularly useful for high throughput production lines. The model that is motorised and remote is highly suited to layouts where it is difficult to manually actuate a transfer from outside the isolator, near the transfer system, eg in facilities with RTP systems positioned at a very high level.
From the start of the design process, all the relevant industrial rules and regulations were integrated making the DPTE-XO compatible with validation and qualification requirements. Particular attention was paid to cleanability and reliability, taking a GMP approach. Simplified shapes have been used to make the new port easy to clean and the DPTE-XO was designed to minimise surfaces not directly accessible for cleaning with wipes. In terms of durability the DPTE-XO was developed to be extra long-lasting and has undergone rigorous mechanical testing.
Conclusion
The DPTE-XO joins the DPTE-XS among the range of solutions provided by Getinge La Calhène for leak-tight safe transfers. It provides an extra degree of security while being backwards compatible with the entire DPTE range of products already installed on production lines. Together with the various accessories and control systems available for Beta parts, the DPTE-XO is the foundation stone of the DPTE transfer system, paving the way to carry out ultra-clean transfers with better efficiency and productivity.