Features And Benefits Of A Disposable Bioreactor

Disposable bioreactor is designed to utilize disposable stirred bag bioreactor alternatively of using culture vessel, it is distinct than Stain- steel vessels in the main principle of mixing, culture war and the temperature control, and it is well- established technology by many of biopharma manufacturing industry. Currently, biopharmaceutical improvements adjust into disposable bioreactor that lead to raise the advantages from using it for the production processes and the environment. One of the features that Disposable bioreactor contained is having high level of flexibility during production processes, there are short procedures and short downtime to change the equipment - such as bags- during successive production processes. for instance, it is spent approximately 1-2 hours for product changeover procedure. (re).

Also, the process workflow for disposable bioreactor is more flexible and less complexity. in contrast, the process workflow for the stain steel vessel, is considered as more fixed (re). In addition, the single -use bioreactor is utilized of portable and transparency equipment which are easy to replace them and allow to check production conditions - such as the volume of the fluids - during the consecutive manufacturing process. The efficient cleaning and validation are very essential for any process to avoid the cross of contamination, and it is considered that single – use bioreactor has lower chance to have validation issues because there are approved and qualified cleaning-in-place (CIP) and steam-in-place (SIP) procedures to prevent the cross air-contamination. Also, the equipment for disposable bioreactor are efficiently sterilised to remove any biological agent that will cause contamination. In addition, the disposable system is less complex. Consequently, there are eliminated of using cleaning-in-place (CIP) and steam-in-place (SIP) specially when changing the equipment between various products process as they are already being neatly sterilised.

Consequently, this is impacting the environment by reducing the consumption of water for injection (WFI) - which usually utilized during (CIP) and (SIP)- and a purified water (PW). according to the study done by biopharma, and part of this study shows comparison for utilizing (WFI) and (PW) between disposable bioreactor facility and stain- steel vessel facility, and the result was “disposables-based facility consumes 87% less water than the stainless steel– equipped facility” (re). Consequently, reducing the consumption of (WFI) - by not using extinctive validation and cleaning -, is influenced in the emission of CO2, it is found that the disposable- based facility has reduced the emission of CO2 by approximately 25. 5% related to the traditional stain-steel plant and this might be decreased the effect to climate change. (re)Furthermore, there is very favourable feature on the disposable bioreactor where it has small size as closed system which it is very suitable efficiently to use of laboratory space and biopharmaceutical facility (re).

Also, this feature has several positive impacts such as easier for transporting product and replacing the equipment, workflow – like easy for manual handling – and waste flow. Moreover, it is also decreasing the cross- contamination, saving time increasing of producing various products simultaneously. in addition, decreasing the uses spaces in the laboratory is an influenced reducing of square footage of the facility which mean has positive impact for the environment as utilising less lands. furthermore, the less space facility might be effected the consumption of the electricity to be less,and according to the summery of the study done by biopharma, single-use facility is saved approximately 30% of electricity, which it consider as “energy- efficient” facility. (re),

In addition, other impact for environment the less amount of using steel for building disposable – based facility, it is needed of steel around 62% less than required for stain-steel engineered facility. Another advantage of using a single- use bioreactor is reducing of the cost as resulting of eliminating the validation and cleaning mechanism and decreasing of capital investment. (re)In another side, there are negative impact regarding of using single-use bioreactor. for instance, the plastic equipment - which used in the disposable system – had sided effect related to temperature sensitivity, pressure and potential for puncture. Also, the disposable bioreactor has limited scale, and cannot use high volume of liquids as it will raise the risk of bag bursting and inability to store hot liquids. However, it might be done additional testing under real process conditions. Moreover, it has expensive cost relative to consumable materials (such as bags, filters and tubes). (Re)