Click image to see animation
|One of the most basic applications for sterilized disposable bioprocess assemblies is mixing/filling/storage. In the above illustration, biologics are blended, then pulled from the mixer through sterile tubing using a peristaltic pump. After passing through a 0.2 µ sterilizing filter, the material is collected in sterile bio-bags, which are eventually separated off from the system by heat sealing the filling lines. The remainder of the assembly is discarded after use.|
Why have disposable bioprocess consumables become so popular? Because they reduce risk of cross-contamination, lower capital expenditure, offer flexibility, and save time while typically improving quality.
Previously, when a company went into biologic production they had to purchase components like filters, tubing, valves, and storage containers from multiple vendors. Then cleanroom support teams would have to spend time assembling, sterilizing, and validating the components before even beginning production.
Purchasing custom-ordered, sterilized, and preassembled bio-production assemblies such as those available through our Masterflex Single-Use, allows companies to limit downtime in their plants, reduce the amount of facility space needed for bioprocess, and eliminate a substantial portion of their cleaning and validation requirements. In other words, it allows them to avoid what is often the most costly and complex, validation-intensive portion of the process.
What applications can these integrated disposable solutions be applied to? Media filtration, cell culture supplements, clarification, separation, ultrafiltration, and final fill just to name a few. They are ideal for pharmaceutical and biologic drug production, and for the storage and shipping of any sterile-filtered fluids. They also have many potential uses in the food & beverage market.
At their most basic, these are simple, closed systems which create a Class Zero environment, meaning cleanrooms are not required to maintain sterile operation. No environmental or clean air controls are necessary.
The assemblies are available either sterile or non-sterile. Sterilization is most often accomplished through gamma irradiation, as is the case with Masterflex Single-Use assemblies. All custom-designed and custom-assembled units produced by Masterflex Single-Use are irradiated with a minimum of 25kGy to assure a sterility assurance level (SAL) of 10-6 , which represents a critically acceptable one-per-million chance of microbial contamination. Sterilized units are then shipped to the end user, where they are installed and can be put immediately into operation.
Masterflex, is the first company to validate the sterility of the entire assembly. While competitors validate the sterility of bags and filters separately before assembly, with Masterflex Single-Use the entire system—from tubing to filters to individual connections—is assembled then validated for sterility to the 10-6SAL. Our selection of fluid handling products, filling systems, filtration equipment, and process containers is second to none. All assemblies have full lot traceability and are manufactured in a IS0 class 7 cleanroom. Our facility is ISO-13485-certified, cGMP-compliant, and FDA-registered.