Cost-effective single use single-use technology for the highest demands
More and more, disposable process reactors (also known as Disposable Reactor or Single Use Reactor) are replacing traditional glass or stainless steel reactors. In contrast to conventional systems, disposable process reactors use pre-sterilized disposable bags that replace the traditional process vessel made of glass or stainless steel.
New to the patented MRC “LidLining” system is the combination of commercially available and cost-effective drums and an LD-PE inliner with a fixed barrel lid attachment, in which the parts that come into contact with the medium are made of disposable material of the so-called “LidLiner”. By means of a clamping ring closure, a barrel can mutate into a fully functional bio reactor in seconds. High-tear-resistant polyethlen films are used for process applications.
The materials used for the disposable products are BORMED® or SABIC PCG and comply with FDA regulations, European Pharmacopeia and the United States Pharmacopeia.
Up to five-layer composite films could be used for diffusion values. These consist of support layers (e.g. LDPE) and gas-impermeable barrier layers (e.g. polyamide). Our “Lid Lining Systems” can be used to manufacture biopharmaceutical products. This enables complete solutions from disposable systems to be used for an entire process line. This may include, for example, media and buffer manufacturing, bioreactors, cell harvesting, deep filtration, tangential flow filtration, chromatography and virus inactivation.
There are basically two different construction methods of disposable process reactors, which differ in the technology of mixing. The “LidLiner” is available without agitators or as a stirred disposable process reactor, which are modelled on conventional propeller agitators or magnetic agitators. The stirring organs are also designed as disposable products and are already integrated in the disposable bag and pre-sterilized. When using the bag, these are mechanically or magnetically coupled to a special stirring motor.
The “LidLiner” are available for stainless steel barrels made of material 1.4404/316 L from nominal volume 20 L to 200 L and fit on any standard lid drum with standard diameter 343/550 mm. Smaller volume and diameter on request. Optionally, the drums can be heated or cooled in a heating jacket.
Sterile connection technologies, usually hose connections, can be connected to the pre-configured disposable systems for connection to the on-site process technology. Commercially available mechanical disposable couplings, such as screw, clamping or TC connections, can also be attached.
Measurement and control
The plastic bag is a closed, pre-sterilized system during operation. Connections for thermostat sensors, pH and conductivity measuring electrodes, glucose and oxygen electrodes, pressure sensors, etc. can be assembled as required and the sensors can be inserted into the bag without contact.
As standard, the “LidLiner” with installations by electron radiation with 25 kGy are made germ-free in the eBeam process and delivered in a double barrier bag.
The disposable technology avoids complex cleaning and sterilization processes, which leads to less complex qualification and validation procedures, especially in pharmaceutical production, and thus to considerable cost savings. As with other disposable technologies, the use of disposable process reactors reduces the risk of cross-contamination and thus increases process reliability.
Compared to traditional process reactors, disposable process reactors consist of very few parts. As a result, the acquisition costs are significantly lower and maintenance costs are greatly reduced. The stability of the inliners with increasing volume and internal pressure is guaranteed despite the relatively thin materials, as the barrel is designed as a carrier container up to +0.1 bar pressure-resistant. This not only relieves the bags, but also increases operational safety in the case of leaks that are collected in the barrel as a dense vessel.
Disposable bioreactors are not necessarily more polluting than conventional process reactors because of the disposable aspect of the bags used. In comparison with disposable process reactors with conventional bioreactors made of stainless steel or glass, there is also a strong case for the use of disposable process reactors from an ecological point of view. Similar to reusable bottles and PET bottles, it is necessary to consider not only the production of the products, but also the entire life cycle, especially when using and reusing them. The plastic bag with connections as well as installation of stirring organs, if necessary, consist almost exclusively of petroleum-based plastics. Current recycling concepts assume after use of incineration. The energy stored in the product, which comes from the oil, is recovered in the form of electricity or heat. Since most of the oil is burned in power plants or vehicle engines anyway, the additional environmental impact of the combustion of disposable systems from bioprocess technology, which only make a detour in their life until combustion, is negligible. Finally, energy for production and transport remains to be taken into account. The production of conventional process reactor vessels made of steel or glass is undoubtedly more energy-intensive than the production of a plastic bag.
When using the conventional process reactor, the process vessel must be cleaned after each use, for which large quantities of water are required, but also acids, bases or cleaning agents and disinfectants. Finally, the reactors are sterilized with hot steam at 121 °C under pressure of 1 bar, which in turn devours large amounts of water and energy. The water used, especially in pharmaceutical applications where the purity of the products is important, is distilled water, which in turn has to be produced by a high energy expenditure. On closer inspection, disposable process reactors are therefore much better off than might have been expected. According to a study, the use of disposable bioreactors compared to conventional bioreactors can save 30% of electrical energy for operation, 62% of the energy used for manufacturing, 87% of water and 95% of detergents. [*]
* From Sinclaire A., Leveen L. : The Environmental Impact of Disposable Technologies