Single-use technologies (SUTs) have received increasing acceptance for biopharmaceutical manufacturing as companies have begun to realize their numerous benefits and equipment manufacturers have addressed key concerns, such as the potential for extractables and leachables from plastic components and interconnectivity of equipment from different suppliers.

Implementation of single-use technologies for biopharmaceutical drug production helps to reduce the risk of contamination, reduces scheduling times, increases operational efficiencies, and reduces capital expenditures, including both fixed and consumables costs. Single-use systems come pre-sterilized; thus, eliminating the need for cleaning and sterilization and significantly reducing setup and switch-over times. As a result, they also provide flexibility and enable manufacturers to quickly change their portfolios in response to market needs. When implementing SUTs, no clean-in place and steam-in-place (CIP/SIP) operations are required because disposable technologies generally are sterilized with gamma radiation. Thus, SUT piping and instrumentation are significantly simpler than those for traditional stainless-steel equipment.

SUTs have reduced dependency on utilities for sterilizing product-contact parts of bioreactors between batches. Thus, processing times have been shortened, operational costs have been lowered, and cleaning validation and training have decreased.

In particular, single use technologies are ideal for scaling down biologic manufacturing processes and is a key trend in the biopharmaceutical industry. Single-use technologies are also well-suited for use in modular facilities, which are designed to enable high-quality production of biologic APIs and formulated products around the world, including in places where traditional facilities cannot be constructed.

As a result of these benefits, single-use bioreactors are widely used in upstream biopharmaceutical manufacturing processes. It is quite clear that disposable production technologies are now common place for many biopharmaceutical operations and their use can only be expected to expand further as additional innovative solutions are introduced by single-use equipment suppliers.

Ami Polymer Pvt Lrd is specialised in the production of custom assemblies for bioprocesses. The company understands that time is important to the clients. For this reason, it fully adapts to client requirements. Plug-and-play solutions are now also available for fluid management. With Ami Polymer’s assemblies, the user can easily connect multiple containers, vessels, and process lines in one controllable system.

A solution toward single use assemblies
Ami polymer offers wide range of gamma irradiated single use assemblies for various critical applications in biopharmaceuticals. These are range from simple tubing with connector to complex manifold with several joint/connection. All the assemblies are manufactured and packed in Class 7 certified clean room. Few applications of upstream production in Biopharmaceutical industries where Ami polymer supplying assemblies listed below:

About the author:
Chandan Kumar Sah is the Senior Manager - Quality/Technical Biotechnologist at Ami Polymer Pvt Ltd. For details, contact on email: chandan.s@amipolymer.com, or visit: www.amipolymer.com