The platform is designed for bioprocess applications from clinical batch to industrial scale, with fills ranging from 0.2 milliliters to 100 liters.
ATMI and Disposable-Lab, a clinical filling services and contract manufacturing organization (CMO), will jointly commercialize the technology.
The fill/finish platform will be exhibited at the INTERPHEX trade show in New York from 23-25 April.
The disposable platform is modeled after conventional manufacturing fill/finish processes, though on a smaller scale.
All of the process equipment used in conjunction with the fill/finish platform is disposable, including the connectors, vials, baskets and caps.
As a result, the platform reduces maintenance costs and provides a smaller footprint compared with traditional systems.
The easier to use format also helps in saving time during setup and operation.
ATMI LifeSciences senior vice president and general manager Mario Philips said, "When combined with the mixing system, bioreactor and vessel offers we already have in place, this new addition allows us to provide customers with a truly comprehensive range of single-use technology solutions."
Decontaminating the non-disposable box in/flushing isolator with hydrogen peroxide, the vial baskets are manually placed in the preparation isolator before the vials are filled using disposable dispensing needles in the transfer area.
Weighing and capping operations are performed in a sterile finishing isolator, where the vials are closed in one step prior to weighing.
The operation of the platform includes decontamination of the non-disposable box in/flushing isolator with hydrogen peroxide.
The next step is to manually place the vial baskets in the preparation isolator before they are filled using disposable dispensing needles in the transfer area.
The weighing and capping operations are performed in a sterile finishing isolator where the vials are closed in one step before weighing.
Disposable-Lab president Jean-Pascal Zambaux said, "Working with ATMI has allowed us to optimize our complete single-use platform for fill/finish operations and bring it to market with a secure supply chain."
ATMI has initially engaged with Disposable-Lab as a minority investor in 2008 and later acquired the full rights to their fill/finish platform.
The fill/finish platform is available in two formats.
One, in which customers can choose installation through the technology transfer format, or they can outsource the clinical batches using the Disposable-Lab CMO service capability.