The discussion in this part of the history of isolator and containment technology reviews the development and use of various devices that permit the aseptic transfer of components such as sterile vials, syringes, bottles and other types of container as well as the actual product itself into and out of the aseptic filling area of an isolator or RABS (restricted access barrier system).
Some of the systems that permit aseptic transfers, such as pass-through hatches or devices, autoclaves and dry heat tunnels, used in current cleanroom technology, have been adapted by isolator and RABS manufacturers and users. With the advent of isolators and RABS, other devices have been developed as well as new techniques for aseptic transfers. Some of the devices are shown in Figure 1.
Note: RTP is rapid transfer port.
The discussion of the various devices will be divided into three sections:
1. The use of systems during the performance of sterility testing.
2. The use of systems for the compounding and transfer of
a pharmaceutical product into and out the aseptic area of an isolator or a RABS. Non-sterile compounding of hazardous product is also included as an illustration of the containment aspect of the technology.
3. The use of systems for the entry and exit of sterile containers, components and testing equipment into and out of the aseptic area of an isolator or RABS.
Early pass-through technology
In aseptic manufacture using the classic cleanroom approach the problem of getting sterile materials and components into the cleanroom was to use a doubledoor autoclave or a dry heat sterilising tunnel. This enabled the transfer of items of filling equipment (autoclave) and sterile containers (dry heat tunnel). For other items, usually to replenish stocks of sterile gloves, garments, etc., as well as items forgotten in the preparation for the filling process, simple double door pass-throughs were used, see Figure 2.[…]
A courtesy of ‘Clean Air & Containment Review’ – www.cleanairandcontainment.com
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- author: Thorogood Doug