Today’s bioprocessing and pharmaceutical manufacturers are facing some of the most challenging market conditions ever. They are under constant pressure to shorten development cycles, reduce time to market, improve production yields, and deliver high-quality products at competitive prices. At the same time, the U.S. Food and Drug Administration and other regulatory agencies expect manufacturers to develop robust processes and incorporate strong risk-management programs.

In response to these challenges, the industry has seen a substantial growth in the use of single-use bioprocessing systems. Many types of expensive, stainless steel bioprocessing equipment, such as hold tanks and transfer lines, are being replaced with bioprocessing bags and tubing sets.

SINGLE-USE ADVANTAGE
The increased volume and diversity of pharmaceutical products is causing manufacturers to design their facilities based on shorter production runs with more changeovers.Meeting these demands requires operational flexibility. Plants must be able to easily add new products to the mix, rapidly convert processes, and quickly make operational adjustments as needed. In addition, they must execute these changeovers while meeting required safety, time-to-market, and efficiencygoals.

This is where single-use systems can deliver significant value. These systems offer many benefits, including rapid implementation and cost savings. In bioprocessing applications, for instance, single-use systems can help minimize the risk of cross-contamination, which is especially critical as companies continue to increase multi-product manufacturing. And, unlike fixed piping systems, disposable systems enable quick modification of the media transfer between existing processing equipment.

Another critically important benefit is that single-use systems can help boost productivity and accelerate time-to-market by reducing the downtime associated with cleaning and validation. This, in turn, helps reduce operational expenses by minimizing labor, chemical, water, and energy demands.

Moreover, by incorporating a single-use strategy, manufacturers can reduce their equipment and floor space requirements, lowering their capital investment costs, and improving profitability. For instance, the implementation of single-use technologies can increase production capacity at an existing facility where traditional fixed systems would require costly facility expansion.

INTEGRATION WITH STAINLESS STEEL
Considering the industry’s large installed base of stainless systems, an important question is how to integrate single-use technologies with traditional stainless steel equipment. To solve this problem, a connection technology, which creates a sterile link between pre-sterilized bag systems or tube sets and stainless process equipment, was developed, featuring an innovative three-port design that eliminates “dead legs” and allows steam to pass directlythrough the connection to “steam on” to stainless equipment.

Functionality is further expanded with the introduction of a “steam on” and “steam off” capability, allowing both a sterile connection and sterile disconnection without the need for a laminar flow hood. This reduces the potential of microbialcontamination of media, as well as environmental contamination within facilities.

PERFORMANCE CAPABILITIES
Viable connection technologies require reliability, flexibility, and compatibility, including several valve and termination options that provide the flexibilityneeded to meet today’s mounting and flow requirements. The connection isattached to single-use bag systems or tubing, then pre-sterilized by gamma irradiationup to 50-kGy or autoclaved up to 128 °C for 30 minutes, depending on theproduct configuration.

For mounting to the processing equipment, manufacturers can specify the connection with either a ¾" or 1 ½" sanitary termination on the middle port. Tri-clover clamps are used to secure the middle sanitary to the equipment and the lower sanitary to the steam trap.