What have been the key innovations that have shaped current aseptic practices and techniques?
Jerold Martin
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Henderson: The number one consideration for aseptic practices and technique is risk minimization. Since the mid-1990s, the development
of isolators and restricted access barrier systems (RABS) has substantially changed how operators interact with sterile drug
product and their associated technique. A physical barrier between the operator and the critical zone of the isolator controlled
at positive pressure with HEPAfiltered air creates a high level of contamination control. Most interactions through isolators
and RABS are done through glove ports, which again limits the risk to the associated product. In addition, the ability to
biodecontaminate the critical zone and clean-in-place/steam-in-place (CIP/SIP) contact parts has led to less operator involvement
and further reduces risk. Magriotis: Isolation technology is replacing conventional clean room aseptic technology within the most developed areas of the pharmaceutical
industry. The technology's major benefit is the higher aseptic conditions that can be achieved and maintained during manufacturing.
Isolators provide a complete barrier between product and operators, who are the highest source of contamination in aseptic
processing. Isolators also guarantee a higher sterility assurance level after decontamination compared with conventional clean
room technology (usually 6 Log contaminants reduction versus 3 Log reduction). This is achieved by means of vaporized hydrogen
peroxide.
(George Doyle/Getty Images)
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Furthermore, in 2008, the European Commission issued a GMP document for sterile drugs preparation stating that the sealing
of sterile vials with aluminium caps must happen under Grade A laminar air flow. Consequently, the most innovative machinery
manufacturers have reviewed the design of their aluminium capping machines; the latest models incorporate features that make
them suitable to work under laminar air flow and that minimize particle generation to maintain the required level of air cleanliness.
Martin: Key innovations have been singleuse systems (processscale filter capsules, tubing, biocontainers, etc.), which are presterilized
(by gamma irradiation) and preassembled to eliminate aseptic connections and cleaning. These systems have been further enabled
by the introduction of sterile connectors. Use of singleuse systems and sterile connectors reduces risk of both microbial
contamination and chemical contamination from lottolot or producttoproduct carryover or from cleaning agent residues. Because
they are closed systems, they can even enable sterile processing to be done outside of isolators or Class A environments.
David Henderson Jr
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Another key innovation is the development of new high capacity 0.1µm-rated filters with high mycoplasma removal capability.
These are used for sterilizing filtration of soy peptonebased bacterial culture media used in aseptic filling line validation
to ensure the absence of mycoplasma, such as Acholeplasma laidlawii, in the sterile media fill validation of the aseptic filling line.
