Market requirements for filling sterile liquid media and reagents in flexible bulk packaging are driven by specific processes and applications. At Irvine Scientific, we offer versatile solutions for bulk liquid packaging for basic or intricate custom requirements to meet pre-determined customer specifications.
Currently, we offer single lot sizes of up to 10,000L and the capability to fill liquid into vials, bottles, or bioprocess containers (BPC) within our multiple aseptic filling suites. Ready-to-use standard bulk packaging configurations ensure short lead times and no delays for your next production batch. In addition to our standard packaging, we also offer complete custom bulk liquid packaging options. Please Contact us for more information.
Water For Injection
The quality and effectiveness of biopharmaceutical products depend on the quality of the components used to manufacture them. We have a state-of-the-art WFI system to ensure that the highest quality water is available to our customers.
Quality Systems - Bioprocess Containers
Fluid integrity is paramount and therefore designed in for every single-use bulk packaging system to risk mitigate potential product loss during shipping and deployment of culture media and process liquids at the point of use.
Superior welding technology of bulk packaging biocontainers combined with extensive ISTA testing of the bulk packaging systems ensures a high level of system robustness and packaging integrity.
Comprehensive certification is achieved by strict adherence to our GMP compliant quality systems, but also through comprehensive prequalification of standard components.
Full lot-to-lot traceability of every raw material and serialization of every bulk packaging biocontainer assembly provides an unprecedented level of quality assurance.
Bulk packaging single-use systems offer operator convenience as they can readily be deployed in various operational settings from R&D to Process Development to full GMP production scale.
Film
We selected the industry's leading pharmaceutical-grade polyethylene-based film as the premier solution for bulk packaging systems. Advantages include:
o Animal derived component free
o Devoid of slip agents
o Film extruded in ISO Class 7 cleanroom
o Very low leachables and extractables profile
o Highest combined oxygen and water vapor gas barrier
This premier film truly innovates in a critical area of inherent purity because it does not use slip agents such as oleamide and erucamide which are often used as internal lubricants.
Lubricants that purposely migrate to the surface of the film's solution contact area have been recognized for their potential interference with media constituents and certain biological assays. They may also hamper the long term stability of the bulk media solution further limiting its shelf life and may otherwise affect cell culture performance in critical applications. Removing all internal and external lubricants respectively from the film and the film's manufacturing process not only results in an exceptionally clear bulk packaging system, but also provides it with a very low leachables and extractables profile.
This specialized film provides the highest combined oxygen and water vapor gas barrier available in the industry today, which quells undesirable degradation effects on media components, and promotes product stability and furthers shelf life. Equally the manufacturing of the bulk packaging biocontainer and all assembly operations are conducted in ISO Class 7 cleanrooms. The emphasis on Quality-by-Design and the implementation of risk mitigation strategies ensure a high quality bulk packaging biocontainer assembly within a GMP compliant quality system.
For more information on our Bulk Standard and Custom Liquid Packaging Contact Us.
