Single Use Systems
mdi works closely with the process owners in biopharmaceutical manufacturing to understand their application requirements in order to establish the technical feasibility of a single use system (SUS) in terms of size, pressure, temperature, complexity of the system as well as compatibility, and to design customized systems by integrating AseptiBag Gold with a wide range of pre-qualified components such as membrane capsule filters, connectors, tubing and fittings.
All the system components are deeply characterized and validated for microbial retention, bio-burden, bacterial endotoxins, biosafety and extractables etc to minimize ‘product risk’ and maximize regulatory compliance.
These customized systems are realized from user approved drawings with detailed definitions of materials of constructions, pore size and dimensions.
Sterilizing grade membrane capsule filters mdi capsule filters with PES and hydrophilic PVDF membranes are available in different pore sizes, sizes and end connections for sterile filtration of cell culture media, buffers, drug substance and drug formulations. To know more, visit the link: Click here
Single use disposable pre-sterilized storage and transfer systems help overcome all the above functional challenges and help achieve greater regulatory compliance. These systems however, need to address user concerns with respect to integrity and strength, sterility, endotoxins, biosafety, extractables, particle/fiber release that may impact the identity, strength, quality and purity of the process fluids
mdi AseptiBag Gold systems provide validated and reliable single use disposable solutions for biopharmaceutical process requirements such as storage and transfer of sterile media, process intermediates, sterile buffers with wide ranging pH, sterile drug substances and formulations. These are well characterized for various physical, chemical and microbiological properties to alleviate all the above mentioned concerns.
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Genderless Sterile Connectors
Genderless sterile connectors allow quick and easy sterile connections during biopharmaceutical manufacturing such as connecting sterile media storage bags to mammalian cell bioreactors.
These are available in different end connections such as ¼” Hose Barb, 3/8” Hose Barb, ½” Hose Barb, ¾” Hose Barb and ¾” Sanitary Flange.
mdi offers multiple tubing options of thermoplastic elastomers as well as platinum cured silicon. These are available in a wide range of inner and outer diameters to meet the process requirements with respect to fitment into peristaltic pump and to different size hose connections.
TPE tubing offers chemical compatibility with a wide range of organic solvents and buffers. These are heat weldable to allow leak free sterile connections for sampling and storage applications.
Platinum cured silicone tubing offers enhanced flexibility for easy integration into single use systems and for use in peristaltic pumps.
A wide range of MDI gamma stable fittings such as cross connections, T connections, Y connections and reducers are available to support various plumbing requirements within these customized single use systems.