Single Use Systems
The biopharmaceutical industry is increasingly moving towards use of single use disposable systems for development as well as manufacture of a wide range of vaccines, therapeutic proteins and Mab’s. Biopharmaceutical processes involve multiple steps with a multitude of process intermediates with different process conditions and objectives at each step. Single Use Systems (SUS) offer multiple advantages of reduced capital expenditure, reduced change over time and increased process flexibility while doing away with expensive and time consuming CIP/ SIP procedures and validation requirements associated with reusable stainless steel systems.
SUS have not only facilitated continuous processing but also enabled research scientists as well as process owners to work with different molecules such as antibodies, proteins, vaccines etc in the same facility. All this has resulted in faster lab to market movement of the new bio pharmaceutical drugs contributing to overall growth of the industry.
However, SUS involve a wide variety of polymeric components such as membrane filtration devices; bags; connectors; tubing; and fittings; and range from simple transfer systems to complex disposable filling lines. This along with the criticality of the applications that they serve raises multiple concerns at the user’s end ranging from regulatory such as microbial retention; sterility; bacterial endotoxins; and biosafety as well as functional such as flow rates; burst strength; temperature; and pressure resistance.
One key concern area is extractables/leachables as it has impact on the impurity profile of the drug substance. Since SUS include a wide range of polymeric components, the incidence of different compounds and their degradants leaching into the drug product is very high. The user needs to quantify these and their subsequent impact on drug purity. Detailed information on extractables from the SUS supplier is thus an important requirement as a precursor to leachable studies.
mdi offers a wide range of gamma irradiated SUS for various critical applications in biopharmaceuticals and pharmaceuticals. These range from simple storage and transfer systems for media, buffers and drug substances; and sampling manifolds for bioreactors and process intermediate reservoirs; to more complex disposable filling lines complete with separate tubing connections for integrity testing and drain bags for collection of wetting fluids. mdi Single Use Systems are custom designed, in close interaction with the user, to maximize regulatory compliance and process efficiency. All the key components used in these SUS are produced in house which are deeply characterized and validated for integrity, microbial retention/ingress, sterility, bacterial endotoxins, biosafety and extractables.
MDI SUS are deeply characterized and validated with detailed documentation for microbial retention, bioburden, bacterial endotoxins, biosafety and extractables etc.
Most of these components such as sterilizing filters, bags, sterile connectors, quick connectors, fittings and tubing are produced in house through validated processes under stringent quality management systems. However, to facilitate extensive customization MDI outsources and incorporates user specified components as well.