Reducing risk in pharmaceutical production with sterile transfer ports

In this article, Anneke Evers, senior director Sales & Market Support DPTE Sterile Transfer, Getinge, discusses sterile transfer systems, industry standards and what the next steps to evolve these systems need to be.

Transferring materials from one confined space to another in a sterile and safe way has been an important consideration for the pharmaceutical industry now for many years. In fact, in some aspects of pharmaceutical production, manufacturers are legally obliged to ensure almost completely particle- and germ-free environments, as defined by the standards of Good Manufacturing Practice (GMP).

A solution to this type of material transfer is in the form of the rapid transfer port (RTP). These systems are installed on enclosures such as an isolator or production line and enable the transference of material between two chambers of similar cleanliness or can connect two chambers of similar cleanliness without alteration of the environmental and containment properties.This means that clean material can be moved from one sterile zone to another through a non-sterile zone, using the DPTE container or single use bag which can be reconnected without risk because the inside of the container is still sterile.

The first system of its type

In the 1960s La Calhène (which was acquired by Getinge, a global medtech company, in 2005) built the first system of this type, initially in the nuclear industry sector, so that highly dangerous radioactive substances could be transferred safely. This system was called the Double Porte pour Transfert Étanche — double door for leaktight transfer — (DPTE).

The DPTE system comprises two distinct parts: An Alpha port, which is installed on an isolator or filling line, and a Beta part, which is a rigid container or flexible DPTE-BetaBag, that docks onto the Alpha port.

Once connected, these two components form a safe and leaktight barrier so that transfer, introduction or extraction of sterile and/or highly potent material is possible without the risk of sterility of the material being compromised or contamination to the outside when using toxic materials. Therefore, overcoming the challenge of not contaminating the operators and the working environment around the isolator or filling line making potent drugs.

Reliable solution

The benefits of this system being able to safely transfer radioactive material and providing high security in containment configurations has led to other industries, separate from nuclear, finding it advantageous. Nowadays, the system is used for many applications within the pharmaceutical industry and with more than 40,000 Alpha units sold to global locations is recognised as a successfully validated and guaranteed system.

As a result of its success many other transfer systems have become available on the market. In a comparative study of the DPTE and five standard RTP systems manufactured for both the nuclear and pharmaceutical industries, multiple parameters were evaluated, including leaktightness, locking toque, security, ergonomics and multiple connections.¹ From this study, the position of the DPTE as a reliable solution for leaktight transfers with guaranteed safety was affirmed.

Continual evolution

In this age of increasing demand for drugs and a new era of biologics becoming more prevalent, reliable transference systems are also in higher demand. Single-use technology is of particular interest in the biopharmaceutical sector as it has the potential to reduce the cross-contamination risk. Here, the DPTE-BetaBag can provide bidirectional containment without intermediate bio-decontamination.

Continuing the evolution of these systems to meet the ever more stringent regulatory requirements set out by the relevant authorities worldwide will mean an increased level of cleanliness and the lowest rates of particulates. As a company at the forefront of sterile transfer technology, Getinge will look to reply to these requirements.

Reference:

1. Mounier, C. and Guilmet, C., Rapid transfer port systems – a comparative study, Clean air and Containment Review, Issue 20, October 2014, pp 26–29.