Why is the Aseptic Processing Challenging?

 

Why is the Aseptic Processing Challenging?

We may not realize it, but every person in the universe could be affected by the usage of sterile products. This can include the use of lifesaving prescription drugs like Epinephrine or Insulin, needles to inject vaccines, the insertion of ventilator tubes to help patients breathe, as seen in 2020 during the COVID-19. In general, aseptic fill-finish can affect every single person in the world.

At AbbVie, we have successfully advanced and distributed drug products for over 130 years, delivering products to more than 175 countries globally. There is no basis for the question as to whether or not we are excellent at what we do. 

Our article has highlighted some of the challenges in Aseptic Processing. Continue reading to learn more about them.

 

1. The first opposition in aseptic processing is the facility where the fill-finish manufacturing occurs or where the products are generally being produced. The facility needs to be constructed in a way so as to reduce occluded surfaces, easily decontaminated, maintained, cleaned, and well ventilated with the use of HEPA (High-Efficiency Particulate Air filters)

2. The next challenge in aseptic processing is that the tools and equipment used to produce both the final or intermediate component products must be easy to maintain and clean. It must also be non-shedding. In standard companies, during innovations, there will be cost-benefit balances as to whether or not you should stick with other technologies that are efficient or buy the latest equipment. Equipment is prone to breakdowns, damages, shearing of parts, or leaks of lubricant as they age. And these could potentially lead to the contamination of the facility. This is why it is essential to have a constant requalification and maintenance regime. These challenges could be contained and minimized more readily if the equipment is maintained and installed accurately. 

3. Further challenges occur via the introduction of certain equipment like tools for the extraction or maintenance of materials and the component materials required for the production of finished products. These items must be transferred into the aseptic manufacture environment from an uncontrolled environment, for instance, the storage warehouse, the delivery car, or the pre-production facility. For this to occur, the aforementioned decontamination procedure must be observed on the materials like the pharmaceutical fill-finish before packaging them for entry into the aseptic processing portion and once more upon the outer layer of the packaging just before entry. 

4. The last and most significant challenge is that the process of aseptic processing will at some stage involve human interaction. This can be minimized, however, through barrier usages like mechanization or glove ports. But even if there is full isolation of the process, any fault or error will need human interaction. 

Conclusively, and as far as practicability is concerned, numerous possible actions can be put in place to decrease the risk of contamination entering the fill-finish processes. These methods could range from maintaining the facilities, tracking and controlling the environment, establishing specific instructions for the flow of the process, maintaining machinery, to sanitizing materials. 

Regardless of the practical method put in place, constant monitoring will always be needed alongside constant control reviews to ensure that ill patients continually gain access to a regulated and safe supply chain of medicine fill-finish or aseptically produced products. 

At AbbVie, we handle your product as our own. The nature of your biologic drug notwithstanding, you can count on us when it comes to aseptic fill-finish manufacturing. We will provide reliable and safe products that patients are ready to use. To learn more about how we can assist you with aseptic fill-finish, feel free to contact us.