The Fundamentals of Aseptic Fill Finish

 

Aseptic processing is a production method that can manufacture products that do not have bacteria or other contamination without subjecting the product to terminal sterilization processes. Several products degrade and lose their effect when subjected to the tough conditions of terminal sterilization.

Aseptic process manufacturing permits these products to be manufactured in a sterile environment, letting them maintain their usefulness while being safe to use on humans.

This article talks about the fundamentals of aseptic processing. Continue reading to learn more.

At AbbVie, we are number one when it comes to fill finish manufacturing. We deal on all kinds of pharmaceutical fill finish.

The Importance of Establishing Environment Controls for the Aseptic Process

All drug manufacturing, including terminal sterilization and solid oral dose manufacturing, must have environmental controls. This condition is addressed in cGMPs (Global Current Good Manufacturing Practices.)

The aim of these controls is to prevent product contamination that is caused by unsanitary conditions. The environmental controls to be scrutinized include, but are not limited to, microbial contamination and air pressure. These control limits are stricter for aseptic processing producers due to the nature of their business.

The Difference Between Terminal Sterilization and Aseptic Processing

The major difference between terminal sterilization and aseptic processing is when the step of sterilization happens in the process. In aseptic processing, the manufacturing process requires the product and any excipients, the stoppers, and the container to be separately decontaminated before being added to the sterile or cleanroom producing core, where the final product is produced in a highly controlled environment always monitored for potential microbial ingress and air quality.

In terminal sterilization, on the other hand, the manufacturing process is carried out after the stoppers, containers, excipients, and API have been assembled. The amassed product is thereafter exposed to radiation and/or high heat that causes the final product to become sterile.

The processes in terminal sterilization are harsh and can negatively affect the product's usefulness. Manufacturers opt for aseptic manufacturing for drug products that cannot withstand terminal sterilization.

 

Why is PUPSIT Required

Pre-use Post-sterilization Integrity Testing (PUPSIT) is a term used in aseptic processing operations. This testing is carried out on the sterilizing filter after it is installed before the product is manufactured and again after the product manufacturing is completed.

PUPSIT aims to ensure that the sterilization and installation process has not destroyed your filter before your product is filtered. It is also meant to show that the filter stayed intact and undestroyed during the real filtration of the drug product.

 

Why is Aseptic Drug Manufacturing Challenging?

Aseptic production requires experienced and highly trained experts to carry out the operations, constant environmental monitoring, cleaning procedures, and special equipment even when the production area is not in use. The risk to the patients and the product is great if the aseptic process is compromised.

At AbbVie contract manufacturing, we understand the importance of adhering to strict FDA standards. This understanding is one of the many reasons we are certified and FDA-registered. With this, our clients can be certain that they are working with an establishment that listens to their requirements and needs.

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