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Dear Readers, Welcome to the latest issue of The Magazine
There is a wide range of processing technologies Aseptic connections, they can be supplied as either discrete components or more often as pre-validated, pre-sterilized single-use systems – ready to open and use. They are used to connect single-use fluid paths – these falls into two basic categories based on how the connection is achieved: those that connect by welding or fusing together two fluid paths and those that mechanically couple two components installed in the fluid pathway.
The advantages of aseptic connectors are not only that they provide more robust sterility assurance, the connectors also permit the operation to be conducted within a lower classification for the surrounding cleanroom (for example, where a traditional connector would require ISO class 5 / EU GMP Grade A, and ISO class 7 / EU GMP Grade B area could be used).
Sterile connectors for aseptic processing (commonly referred to as ‘aseptic connectors’) enable two lines of tubing to be joined while maintaining a sterile fluid pathway. Each line of tubing is pre- connected to one connector end. At the end of the connector is a removable membrane which facilitates the two pieces of tubing to connect (mechanical coupling). Once the two connectors ‘connect’ the membrane is removed. Through the act of connection, the process line is maintained as closed and sterility ideally assured.
Furthermore, whereas the risk with traditional connectors includes the operator and hence finger plates are typically taken, the aseptic connector does not require finger plates to be taken as the impact of the operator and the level of bioburden carried on gloved hands will not affect the assurance of sterility as the connection is made.
Traditional biologics like vaccines and mAbs as they have been early adopters of aseptic connectors and single-use technologies (SUT) overall.
To create an aseptic connection between the two lengths of complementary thermoplastic tubing, sterile tubing welders were built. Two ends of tubing from the same module are firmly inserted into the tube clamp mechanism as part of the welding process configuration. Sterile tubing welders make connections quickly and safely while maintaining a functionally closed system, whether dry tubing or wet tubing is being attached. Cross-contamination is limited because each wafer is thrown after a single-use. A functionally closed system is maintained by the ideal sterile welder.
A general question that can arise is how to determine if you should use a tube welder or an Aseptic connector. Tube welders are commonly used when a small number of connections are to be made per day and when only one dimension of tubing is used. As the number of connections increase use of aseptic connectors is preferred as they provide more flexibility of using multiple tube sizes and take less time as tube welding takes more time. Aseptic connectors are available in both gendered and genderless versions. Gendered connectors are composed of two different connectors (typically male and female component) connected together to create a fluid pathway. In Genderless connectors two components brought together to make a connection are identical. Genderless connector offers various significant advantages over gendered connector leading to time saving, reduced inventory, increased operational and design flexibility.
A single-use assembly provider should be flexible when working on a client’s design that includes sterile connectors. Tubing types, methods of securing tubing onto connectors (i.e., cable ties, barb locks), and willingness to use customer-specified components (i.e., those of their competitors) are aspects that should be considered when customers are selecting suppliers. Other factors to consider are sterilization options, gender-specific assemblies, and pricing.
Typically, two options are available for sterile connectors. The manufacturer may provide the connector on an assembly that has been pre-sterilized by gamma irradiation. Alternately, connectors may be autoclaved along with assemblies made in-house.
Various tests should be performed on Aseptic connectors to ensure connector has been challenged using worst case condition for proper selection and to mitigate risk.
The bacterial challenge test typically is done by exposing the connector mating surfaces to a bacterial solution (by direct soiling or by aerosol) with a minimum colony forming unit (CFU) concentration, assembling the connection, passing sterile media through the connection, and collecting it. After incubation of the collected sample, absence of microbial growth confirms prevention of ingress of a contaminant. Proper controls must be demonstrated.
Pressure and temperature tests are other important tools in validating components for use within specific applications. Bubble leak testing is performed to verify the integrity of these components in a variety of temperature and pressure conditions potentially found in certain bioprocessing applications.
Another key assessment for components utilized for bioprocessing are bioburden and endotoxin particulate tests, which are designed to validate that components are free of a range of living organisms (bioburden) and gram-negative bacteria (endotoxins) that could compromise a system.
End users are responsible for evaluating the functionality and performance characteristics of a connector or component before integrating it into a bioprocessing application.
Training in the use of these consumables is highly recommended to ensure they provide an integral connection. Implementing these products involves a number of steps and some require careful attention to avoid such mishaps as over- or under-actuation, misalignment, displacement of o-rings, and interference with membranes (i.e., peeling them off inappropriately).
Sterile connectors make operation easier and faster than other methods of connections in an aseptic environment, such as open manipulations, while completing the path of a sterile closed system. Nonetheless, due diligence is required to ensure that an appropriate connector type is selected and tested to satisfy the user, product requirements, system integrity, and safety.
prabhat.b@amipolymer.com
