By 2028, the global market for injectable drugs is set to reach $69.13 billion, growing at a CAGR of 8.9%. There are many reasons for this boom in demand, from the drive to develop innovative treatments for rare diseases to heightened demand for faster vaccine rollouts.
However, as these drug products are injected directly into the body and therefore bypass the body’s natural defences, parenteral such as injectables and topicals used in ophthalmics require aseptic processing to ensure total sterility.
Aseptic processing is a fast-growing market, expected to reach 12.5 billion USD by 2027. Recent spikes in growth for this market are driven by the latest innovations in vaccine development for the COVID-19 pandemic, as well as the rise of biopharma treatments to manage serious chronic conditions.
As a result of this growth, there have been a number of innovations and techniques adopted to enhance efficiencies across aseptic processes.
The Aseptic Processing Technology Landscape in 2022
The legal requirements for aseptic product manufacturing have undergone many changes in recent years. As a result, containment technology experts have had to explore further innovations to ensure these regulations are met, resulting in the rising growth of the aseptic technology market. Aseptic procedures must follow long-established strict guidelines to ensure the safety of all drug products. Most prominently, all cleanroom environments must adhere to Good Manufacturing Practice (GMP) guidelines for the manufacture of sterile products – meaning that all cleanroom spaces must be classified according to the required characteristics of the environment.
These environments must meet rigorous classifications to remain compliant with ISO14644, which stipulates that cleanroom spaces must be categorised as Grade A, B, C or D. As a result, pharmaceutical technologies have been developed alongside these regulations to ensure safe and compliant aseptic processing techniques are followed across cleanrooms.
Alongside these well-established guidelines, however, manufacturers must also ensure that their aseptic processes are aligned with any new updates that come into force.
In 2018, amendments to Annex 1 of the GMP were drafted, and are set to come into effect imminently. These revisions offer significant changes to the aseptic requirements across cleanroom spaces.
These amendments place a stronger emphasis on pharmaceutical companies to minimise the number of manual interventions across aseptic cleanroom processes as much as possible, while still maintaining optimal sterility.
As a result, this has further motivated technology manufacturers to ramp up their development of innovative new technologies to not only help boost efficiencies and productivity but to also help their customers remain compliant.
These technologies have been designed to minimise manual interventions by allowing manufacturers to sidestep lengthy cleaning and validation procedures, resulting in less production downtime.
In previous versions of Annex 1, all connections for aseptic processes were required to be performed under highly classified Grade A environments.
However, some of the latest technological amendments take into account recent technological advancements being implemented across cleanrooms, making it possible in some cases to declassify cleanroom environments while still performing compliant aseptic manufacturing processes.
Limitations of Existing Aseptic Processing Technologies
Across sterile manufacturing environments, there are many potential sources of contamination that can pose serious risks when it comes to drug manufacturing. From the microbes and potential pathogens carried by human operators to the particles of other APIs, there are many potential contaminants that must be contained. If any were to make their way into the drug manufacturing areas and processes, they can pose a serious risk to the health and safety of patients taking these drug products.
To maintain high levels of sterility across cleanrooms and production lines, drug manufacturers are required to implement highly specialised equipment and infrastructures, as well as follow stringent operating processes.
Achieving sterility across critical cleanroom areas and operations (e.g. fill/finish processes) has traditionally been done through the use of equipment such as restricted access barrier systems (RABS).
Manufacturers using RABS must ensure they have the right airflow measures in place, provide a physical barrier for operator interventions across critical zones, and have automated processes and procedures in place to minimise manual interventions as much as possible.
Isolator systems are also used across pharmaceutical cleanrooms to separate operators from the drug product during manual handling. These isolators help prevent any ingress of contaminants, as enclosures are accessed by operators via attached gloves to perform manual interventions while remaining totally separate from the drug product material.