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.
We Ami polymer private limited are specialized in the production of custom assemblies for bioprocesses.
We understand that time is important to our clients. For this reason, we fully adapt to client requirements. Plug-and-play solutions are now also available for fluid management. With our assemblies, you 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:
- Buffer and media transfer (feeds, the addition of base/acid, antifoam, growth medium, and other liquids),
- Collecting samples with zero risk of contamination,
- Media filtration,
- Removal of liquids from bioprocess,
- Carboy/bottle assemblies, and
- Peristaltic pump tube assemblies.
Mr. Chandan Kumar Sah
Senior Manager- Quality/Technical