ATMI, the US-based provider of ultra-clean film products and single-use systems and packaging for the life science and semiconductor industries, has extended its Integrity product line for the biopharmaceutical and biotechnology industries with the introduction of a new range of single-use bioprocess vessels (BPVs).
The new vessels are available from ATMI LifeSciences in both 2-D and 3-D bag formats, and are manufactured using the company’s exclusive Integrity TK8 polymer film. The BPVs have been designed for use in the storage and transfer of clean or sterile liquids that are critical to biotechnology processes.
Integrity BPVs have been developed to meet the demand for cost-effective, scalable single-use storage containers that are compatible with ATMI’s single-use mixing and bioreactor technologies. Designed for deployment across a wide variety of applications, the 2-D and 3-D BPVs range in size up to 3,000 litres and are configurable to a broad range of end user processes.
‘We have developed Integrity Bioprocess Vessels in response to dialogue with our customers. By incorporating the best features of established liquid storage bags, and augmenting them with some key ATMI innovations, we believe these new BPVs deliver significant process efficiency gains to the biotech end user, said Richard Bhella, global product manager, single-use storage and delivery for ATMI LifeSciences.
‘In particular, our customers appreciate the reduction of risk afforded by our ISO Class 5 cGMP manufacturing environment and our advanced integrity testing capabilities.’
Integrity TK8, ATMI’s ‘universal’ bioprocess polymer film, is used across the entire Integrity line of single-use storage and transfer vessels, mixing vessels and bioreactor vessels. This standardisation allows customers to implement TK8-based products throughout their facility with greatly reduced validation burden, and to scale up seamlessly as production demand dictates.
The TK8 film used in production of the vessels is compatible with bioprocess materials and significantly reduces risk to product integrity. Key attributes of this multi-layer gas-barrier polymer laminate include cleanroom extrusion using only medical grade polymers, USP Class VI certification and 100% Animal Derived Component Free (ADCF) materials. This high standard of cleanliness and purity makes ATMI BPVs suitable for any storage application, from buffers and media to intermediate bulk hold and final product fill.
