Single-use Technology: Balancing the Risks and Rewards

Developing a quality agreement template for single-use systems.

Single-use systems are being used more and more in manufacturing. The time savings, reduced incidence of cross-contamination, reduced need for cleaning, and increased overall efficiency, to name a few advantages, make these technologies a very attractive proposition for manufacturers. There are, however, several obstacles to implementing the single-use systems; a key obstacle being manufacturers' unwillingness to replace fully installed and validated technologies, while the lack of clarity in understanding the regulatory requirements for single-use technology presents another barrier.

Notwithstanding the …