Critical Considerations for Fill Finish Manufacturing

 

Critical Considerations for Fill Finish Manufacturing

The biopharmaceutical industry continues to expand rapidly, and biopharmaceutical manufacturers are investing significantly in new technologies, facilities, and pipelines for the production of drug products.

At the same time, the need to prevent contamination places strict packaging and handling requirements on manufacturers. The sterilization of equipment usually requires dry heat and autoclaves. Read more to learn about the critical considerations for fill-finish manufacturing.

At Abbvie, we process over a million vials annually with an automated filling line. Your drug product’s fill and finish procedures can be suited with customized packaging and labeling. 

1. Sterilizing Techniques Must Be Suitable for Equipment and Formulation

Before packaging or equipment can enter a cleanroom, it must pass through the process of sterilization. There must be a careful selection of systems used to sterilize equipment. This is because every approach will have dissimilar packaging materials and formulations on different types of contamination that may exist on tools and equipment used in the fill-finish process.

2. Considerations to Safeguard Aseptic Conditions

In designing a fill-finish process, the first thought is to develop a facility in which the fill-finish process will be performed. An aseptic fill-finish system entails a cleanroom, and its maintenance goes beyond simply sterilizing equipment. For example, the air in a cleanroom must be circulated through a HEPA (High-efficiency Particulate Air) filtration system.

Here, equipment or packaging materials using aluminum seals must not come in contact with equipment that can get contaminated by contacting aluminum.

3. Prefilled Syringes

Prefilled syringes can be included in a manufacturing pipeline regardless of their scale. This is useful for producers that need to feed multiple syringes through a sterilization instrument such as an electron beam sterilizer. A significant result is that prefilled syringes of drug products can be sent to any endpoint quickly and at a lower cost compared to traditional syringes.

Prefilled syringes can help to decrease human error by controlling the need for manual contact with syringes.

4. Manufacturing Must Be Done Aseptically

Before bottling, many biologics are lyophilized. A sterile fill-finish step worsens the already many challenges and risks of lyophilization. And this causes a need for a design of a packaging pipeline that reduces the transfer time between a bottle or vial filling and a lyophilizer.

Manufacturers these days address this challenge with semi automated or automated loading procedures. This type of filling procedure necessitates an astonishing precise setup: Here, vials are prepared in batches, with their stoppers on vial edges. After that, vials are meticulously loaded into a lyophilizer, where they go through freezing alongside drug formulation.

To learn more about our pharmaceutical fill-finish, how we can assist you with aseptic fill-finish, or steps to kickstart your drug product, feel free to reach out to us; we shall be more than pleased to support you.