Three Innovations Setting New Benchmark in Sterile Manufacturing

Abhrasnata Das

The pandemic has put the sterile manufacturing sector through unprecedented and escalating obstacles, which have been made worse by the demand for quick development of sterile vaccines. Finding innovative ways to be flexible and efficient while maintaining sterility across the whole production process is necessary to meet these difficulties. This, in turn, has pushed several trending ideas and considerations to the forefront of pharma manufacturers’ minds.

Although the fundamental function of sterilizing-grade filters is to control bio-burden and provide sterility assurance, there are many more filtration product offerings today that can improve efficiency and expand flexibility in process design. Innovative technologies SUT, Split Butterfly Valve, and more are now aggressively hitting the market, helping the industry to raise its bar in terms of the sterile transfer of products.

Here are three strike manufacturing trends that are expected to dominate the pharma industry in the near future.

Single-Use Technology

The recent technological advances are now actively enabling the manufacturers to move away from the equipment that needs to be sterilized, towards the adoption of the disposable and single- use sterile products. Starting with syringes, tubing, capsule filters, bioreactors, sampling receptacles, and more, a new wave of SUT’s are coming into live.

These SUT’s not only eliminates the requirement for sterilizing and cleaning processes but also creates room for more efficiency, while decreasing the operational and manufacturing costs. This in turn helps the pharma industry to improve the control, and helps to assure sterility and reduce the chance of product batch rejection.

Indian based OmniBRx for example, are now offering single-use assembling and other bioprocessing solutions. The start-up offers disposable bioreactors that may be operated in a matter of minutes by one person. Due to the increased operational flexibility, time to market is shortened, and profit margins are raised.

Rise of Split Butterfly Valve

Personal protective equipment has been historically used for risk protection. However, despite their undeniable role in protecting workers, containment suits carry the potential of cross contamination in the workspace due to product transfer from them, in addition to unpleasant working circumstances.

Challenges can also arise when trying to find containment solutions for existing equipment and facilities. In this circumstance SBV can prove to be a cost-effective solution, particularly where space and existing equipment constraints limit the options available. These valves have demonstrated the ability to meet the containment targets required for handling APIs.

Charge Point Technologies manufactures a SBV that offers numerous benefits including the reduced risk of contamination, meeting GMP and product quality requirements, maximizing yield by transferring poorly flowing and high value products and removing costly secondary barrier containment and cumbersome PPE.

Advanced Aseptic Processing

The phrase "advanced aseptic processing" (AAP) refers to a variety of isolator and restricted access barrier systems. AAP approaches are often physical barriers that are intended to restrict and protect products during industrial activities while separating (mainly) personnel from the process.

To guarantee that the product is not exposed to living organisms and particle contamination, these techniques are most frequently utilized during open procedures or other crucial process phases. There are different options, but there is no denying that AAP approaches are frequently employed.

Vetter’s V-crt is one example of the AAP. V-crt combines the advantages of isolator and RABS technology. This approach allows companies to achieve safety and quality standards that are competitive with isolator performance, yet take advantage of the flexibility of restricted access barrier systems. The innovative concept is based on the central idea of fully automated decontamination in the entire cleanroom, including the RABS, using H2O2. V-CRT® is a novel two-barrier concept that minimizes risk of contamination.

Adapting to the Pressure

Regardless of the drug product involved, the basic objective remains the same: to produce safe medicine for patients as efficiently and effectively as possible. Any issues during the sterilization processing steps could lead to risks in patient safety and can result in product recalls, logistical delays, operational disruption, and increased costs.

The demand for vaccine manufacture, as a result of the COVID-19 pandemic, proved to be a test for the industry, not least of which was determining how quickly vaccine production could be sped up. The pandemic shone a spotlight on the capacity available of a particular type of facility due to the spike in demand.

Producing sterile vaccines is far from simple, and a complex task such as this questions whether or not the industry is set up to meet the challenge of producing a product at the speeds needed. The demand highlighted the requirement for manufacturing facilities that are flexible and able to turn around a quicker response to immediate need.