Aseptic processing: reducing the risk of contamination using SBV technology

Published: 1-Dec-2020

The pharmaceutical market has seen a growing need for innovation as drugs requiring sterile manufacturing conditions continue to be developed, reports Ben Wylie, Senior Product Manager, ChargePoint Technology

Demand has grown for improved operational efficiency as well as greater quality control and reduced costs relating to manufacturing processes.

A key challenge facing an increasing number of drug and ingredient suppliers is the need to eliminate the risk of contamination. The use of effective containment strategies and the close monitoring of critical processes have become critical.

Industry needs

Amid the COVID-19 crisis, the global market for aseptic processing was valued at $62. 2 billion during 2020 and is projected to reach a revised size of $73. 6 billion by 2027.1

Owing to the growing demand for safe, sterile products, technologies used in aseptic processing have seen considerable innovations in recent years.

However, an ever-greater emphasis is being placed on the further cost reductions, process efficiencies and quality improvements that these solutions can offer.

Contract partners meeting sterile production needs

The rapid growth of the sterile market is, in turn, fuelling the thriving contract services space.

Contract development and manufacturing organisations (CDMOs) can often offer equipment and capabilities that drug developers do not possess in-house, meaning that many projects involving sterile drug development, manufacturing and packaging are completely outsourced to contract partners.

The outsourcing of production can bring added complexity to the manufacturing journey, as drug substances and products often need to be transferred between different facilities and geographic locations while maintaining sterility.

As a result, technologies that ensure the integrity of sensitive ingredients while in transit are now increasingly being investigated by manufacturers.

Current solutions for the transportation of pharmaceutical ingredients include fibre or plastic drums with flexible liners. These can pose challenges in terms of the filling, sealing, handling and emptying of packages while maintaining sterility.

The processes associated with transporting drug substances using plastic or fibre drums can also require considerable time and resources to ensure sterility is maintained. This is in direct opposition to market demand for quicker procedures and reduced costs.

In response, manufacturers are now looking to implement hybrid, single-use technologies as part of their procedures.

Single-use technologies are generally easy to use, can boost efficiency and ensure the integrity of products while in transit as well as within the manufacturing facilities, allowing firms to ensure product quality while enabling cost and process efficiencies.

Split butterfly valve technology

Split butterfly valve (SBV) technology offers a solution for the transfer of powders (including drug substance and drug product) during pharmaceutical manufacturing.

The technology consists of an active and passive half: the active half is connected to the manufacturing process, whereas the passive half is connected to a filling container.

Ben Wylie

Ben Wylie

When the two halves of the disc are brought together, a single plate is created that allows product to flow into the process via the interior surface of each half.

A disposable version of the passive half of the valve now exists, which can be connected to a single-use flexible bag to enable the contained and sterile transfer of pharmaceutical powders between manufacturing process steps and facilities.

And, as they are manufactured within an ISO Class 6 cleanroom environment and gamma sterilised before use, they are suitable for use in aseptic processing.

Such hybrid solutions provide a flexible means of powder transfer while also removing the time and cost associated with cleaning, maintenance and validation.

The need for cleaning and sterilising the passive half of the system is eliminated by using disposable products, which also increases productivity.

Continuing to innovate

As discussed, the industry is moving forward with new technological advancements such as single-use solutions.

In addition, the adoption of smart monitoring technology will make it possible to receive key equipment performance data and generate an audit trail much more quickly.

This can allow maintenance, health and safety and compliance teams to proactively manage the maintenance and validation programmes for their SBV technology.

Smart monitoring offers the potential to revolutionise traditional containment strategies by giving manufacturers an automatic and reliable way to understand the health status of their valves and, when required, take preventive action. Users can access data from their mobile device or an online dashboard to access data remotely.

Smart monitoring can improve both operational performance and productivity and help to manage risk. It may also be possible to take an automated approach to real-time, “real-world” validation and equipment performance monitoring.

Final thought

The sterile market continues to thrive and it is expected that new innovations will focus on the challenge of product sterility without compromising manufacturing efficiency.

In addition, many novel therapies with strict sterility requirements are currently being developed, which will undoubtedly result in the evolution of extant regulations.

As industry requirements continue to develop in line with new therapies and innovations, prevalidated, ready-to-use single-use solutions, which can be effortlessly integrated into current processes, offer significant convenience, productivity and control benefits to the industry.



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