Author: Blog Admin

The growing trend towards incorporation of single use technologies into bioprocesses as an alternative to reusable systems have paved the way for many single use components and systems as these provide increased manufacturing flexibility.

Bioprocess operations such as cell-culture and mixing involve disposable systems which require real time monitoring to determine whether various critical process parameters (CPPs) such as pH, conductivity, dissolved oxygen, etc are maintained within specifications.

To measure CPPs, different types of on-line sensors are used. On-line sensors interface directly with Bioreactor/Mixer and are in contact with contents in it. Such systems are also available with pre installed single use sensors. However, these disposable sensors have multiple challenges in terms of accuracy, reliability, on site calibration, etc.

These disposable sensors also reduce the overall residual shelf life of high value Single Use Mixers/ Bioreactors, making reusable sensors the preferred choice. The reusable sensors can be calibrated and autoclaved before use.

MDI AseptiProbe Bellow Assembly is designed to address the need to aseptically connect reusable sensors to single use bioreactors or mixers. These assemblies enable real-time monitoring while eliminating laborious cleaning validation requirements, reducing the risk of cross-contamination, and improving sterility assurance. These Bellow Assemblies are validated to prevent microbial ingress and are 100 % integrity tested.

Aseptiprobe Bellow assemblies are manufactured in GMP facilities with ISO clean room areas and comply with various international standards and guidelines such as USP, ISO and CFR for biosafety, bioburden, bacterial endotoxins, and particulate matter.

Click here to more information

Mixing is a critical process requirement at multiple steps in Biomanufacturing. Various processes that involves mixing operation range from liquid-liquid mixing and solid-liquid mixing of different fluids such as media, growth regulators, harvests, post centrifuge supernatants, buffers, process intermediates and formulations for a biopharmaceutical process. Conventionally, fixed stainless steel systems were used for these processes consisting of glass bottles, large carboys or stainless steel vessels. These traditional systems faced multiple challenges in terms of extraneous contamination, cleaning & validation requirements and flexibility. Several life cycle assessment reports on use of single use systems and conventional fixed systems demonstrated the high environmental impact of fixed systems which are driven by huge water and energy consumption required for cleaning and sterilization processes during the use phase of product life cycles compared to gamma sterilized single use systems which eliminate the need for cleaning and validation and provide process flexibility.

The above considerations and challenges have led biopharmaceutical manufacturing process owners to adopt disposable single use systems and make a shift from stainless steel systems as it allows quick , economical and scalable production and can be adapted to nearly any process.

MDI AseptiMix MI 3D mixer bags provide validated and reliable mixing platform for biopharmaceutical process such as mixing of media, process intermediates, sterile buffers with wide ranging pH, and formulations. mdi AseptiMix MI mixer bags come with a magnetic impeller and are available for volumes up to 1000 liters. These are also available with 4” and 8” sanitary flange powder port for powder-to-liquid mixing.

Mixing operation of AseptiMix MI single use mixer bags is carried with magnetic impeller which is coupled with pre-fitted magnetic motor drive unit on mdi BioMixer MI mixer systems through magnetic forces. There are no dynamic seals or shaft penetration inside the mixer bag. By switching ON the motor through BioMixer MI control panel, rotation of the impeller is induced inside the AseptiMix MI mixer bag with the magnetic motor drive, offering uniform and fast mixing with very low extractable profile for low ‘Product risk’.

Continue reading “MDI Aseptimix MI: Single Use Mixer Systems”