Reinraum
Summary
The presented overview gives a picture of the actual technology in terms of continuous or batch wise transfer in and out of a containment isolator or RABS disregarding the purpose of the containment.
During the past years, containment technology for aseptic production in the pharmaceutical industry has developed in several ways to separate the product from the operator and environmental influences. With the increasing importance of isolator technology, there was a need for the development of aseptic transfer systems. Some of the transfer systems are dedicated to a certain application like the transfer of plastic containers with nested syringes with an E-beam tunnel, or glass objects with a hot air tunnel. Both are used for the safe sterile transfer of large amounts of packaging material in a short time into a filling line isolator.
The engineers have designed many different approaches for the aseptic transfer, but only some of them came to market. There were developments with UV light, with pulsed light and other, but in the end the E-beam technology was chosen to transfer nested syringes into the filling line isolator by the manufacturers of sterile drugs. The hot air tunnel was not specifically developed for the use with containment technology, but was adapted to filling line isolators and became the transfer system of choice to bring in glass objects in a sterile manner.
Some of the transfer systems are more commonly used like RTP systems, which can also be applied bi-directional that means the transfer can be done in both directions in and out of an isolator.
Furthermore transfer systems for the aseptic transfer of liquids in and out of a containment using the alpha/beta technology are available.
Korrespondenz:
Frank Lehmann, SKAN AG, Binningerstr. 116, 4123 Allschwil (Schweiz); e-mail: frank.lehmann@skan.ch
Key Words
Aseptic transfer; E-beam tunnel; hot air tunnel
RTP systems; decontamination air lock; aseptic liquid transfer systems
Summary
The presented overview gives a picture of the actual technology in terms of continuous or batch wise transfer in and out of a containment isolator or RABS disregarding the purpose of the containment.
During the past years, containment technology for aseptic production in the pharmaceutical industry has developed in several ways to separate the product from the