Working with aseptic procedures is the most challenging activity within the pharmaceutical industry and in pharmaceutical compounding units today.
Aseptic production is, furthermore, the production principle that puts the end-user, the patient, at the highest risk, due to the lack of terminal sterilisation after filling and sealing the product in its vial.
This article discusses the future of Grade B cleanrooms and garment systems used during aseptic production.
Not all aseptic production can be performed using barrier technology
Annex 1 recognises that traditional aseptic production is a high-risk operation by stating that barrier technology should be considered to increase the protection of the product.
However, not all aseptic production can be performed using barrier technology, and, furthermore, the use of RABS, Restricted Access Barrier System, still requires the use of Grade B cleanrooms as background to the aseptic core.
Personnel in cleanrooms
During the introduction of cleanrooms in the air and space industry, it was discovered quite early that operators are one of the largest sources of contaminants in the form of particles.
This was due to the process of human skin renewal that generates and disperses an enormous number of particles, including microorganisms.
This is the reason why humans are considered not only the greatest source of contaminants but also the source of the most critical contaminants, especially when working with biocontamination control.
The overall demands stated in Annex 1 is that everything must be in accordance with QRM
The problem with operators in cleanrooms was partly solved by gowning the personnel in specially designed cleanroom garments to act as a barrier or a filter to minimise the possibility for skin particles, including microorganisms, from operators to be suspended into, and thus contaminating, the surrounding air of a cleanroom.
The cleanroom garment is an important barrier: Alvin Leiberman wrote in one of the first books on cleanroom technology that “The cleanroom garment and gloves are the primary barrier between the operator and the surrounding air of a cleanroom …”. It must be noted that the garment is not only the primary barrier but also the only barrier.
Annex 1 and aseptic production
One of the most striking aspects of Annex 1 is the requirement of using barrier technology. This means that, during critical handling and manufacturing of pharmaceutical products, the operators should be physically separated from the product handled using various barrier concepts. A barrier system can comprise of using isolators, closed process systems and (or) RABS - Restricted Access Barrier System.
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