By Malcolm Cunningham
There is no doubt that the growth in drug manufacturing using high potency active pharmaceutical ingredients (APIs) and the demand for aseptic processing has led to the development of exciting new transfer methods. But which methods are most prominent in the industry today? And what are the key challenges facing pharmaceutical businesses?
The market today
It is expected that the global contract pharma manufacturing market will reach an impressive $79.24bn next year, and this figure is only expected to rise over the next decade.
The sterile contract manufacturing sector in particular has seen significant development over recent years, and there are multiple reasons for this quick progression. The contract manufacturing of injectables, for example, has sparked impressive growth in the sector. The cancer treatment market is also expected to reach approximately $100bn in value by 2024, making it one of the most rapidly expanding areas in the industry. In addition to this, the antibiotics market is expected to reach a compound annual growth rate (CAGR) of 4% over the next seven years. Moreover, the advancements in API manufacturing, the increase in chronic disease, the growing significance of generics and improving mortality rates have also molded the industry.
With so much rapid expansion occurring in the market, pharmaceutical companies need to ensure the efficient transfer of their APIs now more than ever. In doing this, businesses will make sure that their products are safe, secure and sterile. In addition, containment is of the upmost importance when it comes to managing risks to operators and ensuring that stringent safety requirements are adhered to. But there are many challenges involved in making sure that all pharmaceutical products and their manufacturing environments are safe.
As human intervention is always needed during the manufacturing process, there are many challenges when it comes to ensuring that environments are fully secure and sterile.
Regulations and cleanroom environments have helped to alleviate some risks. From grade A to D, there are multiple approaches within each grade that assist with the handling of sterile products.
A wide range of new technologies have also helped companies to keep on top of their containment and sterility assurance requirements. Isolators, restricted access barrier systems (RABS) and split butterfly valves (SBVs) can now be used to safeguard medicines and people throughout the manufacturing process.
By creating an enclosed space using physical barriers, isolators ensure a safe, sterile environment where operators can still carry out their work using glove ports and half-suits, allowing manipulation to occur from outside of the enclosure.
Although there are many advantages to using isolators, there can be some limitations. It can be difficult, for example, to transfer materials from the cabinet. This means that a docking isolator may have to be connected and the interior may need to be sanitized before materials can be moved.
RABS also put a physical barrier between operators and production spaces. This method is especially popular because it allows operators to maintain a distance from the production area, whilst allowing the enclosure to be opened if intervention is needed. RABS also have quicker start-up times, allow for swift changeovers and bring increased operational flexibility.
Many businesses are choosing to use a mix of methods to help them operate effectively and safely. Most companies will, for example, use SBVs and integrate them into their isolator or RABS, to ensure that they achieve the highest levels of sterility. SBVs are split valves which allow for decontamination to take place in closed environments by creating a gap between the discs, and flushing hydrogen peroxide through the enclosure so that it decontaminates the area. Validation is also achieved by using chemical indicators to ensure full coverage of the enclosure and the necessary sterility assurance level (SAL).
Not only do SBVs achieve the required SAL and reduce the need for manual handling, they also increase yield from product transfers and flow.
Many companies also use SBVs because they allow for rapid processing times of around 30 minutes. Compared to conventional airlock techniques which can take up to six hours, this is clearly much quicker and more efficient.
In addition to this, because SBVs ensure sterile, sealed transfers, external cleanroom environments can often be downgraded as SBVs create internal grade A environments of their own. By allowing for the downgrading of areas, SBVs have transformed the ways in which drug products are developed.
The use of containment methods is ever-increasing, driven by the growing demand for sterile and potent pharmaceutical products and the inherent need to ensure that they are developed in safe environments. Many pharmaceutical companies recognize the significance of containment techniques today, whether they use isolators, SBVs, the RABS approach or a mixture of the three, the containment market will only continue to grow going forward.