Understanding the Fill Finish Process
The value of the fill-finish manufacturing market is estimated to reach $5.15 billion by 2024, according to a report published by Zion Market Research. Pharmaceutical and biotechnological companies dominated the fill-finish market in 2017.
Drug products that are delivered to individuals via the parenteral, ophthalmic, or inhaled routes typically bypass the body’s immune system. The US Food and Drug Administration (FDA) requires that Pharma companies package these types of drug products using a sterile method for the safety of consumers. However, the fill-finish step has proven to be a major rate-limiting step in the process of delivering vaccines, according to a report to the president on reengineering the influenza vaccine.
The fill-finish process is a significant step in the drug manufacturing process. When manufacturing injectable vaccines, there is no method for sterilizing the vaccine when it has been packaged in its final container. This is why the vaccine needs to be filled in an sterile environment, also known as an aseptic fill-finish. During this step, the sterile drug is transferred from a filling needle to a sterile container such as a vial or syringe. Any marginal error in this process can lead to quality failure and can cause harm to recipients of the vaccine. Aseptic processing is challenging due to the need for specialized equipment and skilled personnel. The FDA only recommends this step for formulations where terminal sterilization is not possible.
In 2013, the United States Biomedical Advanced Research and Development Authority (BARDA) recognized the need for Pharma companies to expand their manufacturing facilities, including their fill-finish capacity. BARDA awarded contracts to four companies to make up its “fill and finish manufacturing network.
In 2020, BARDA is yet again funding several pharma companies to help expand their fill-finish capacity for the speedy manufacturing and delivery of COVID-19 vaccines globally.
Re-Evaluating Fill Finish Manufacturing Lines and Processes for SiO2 Hybrid Vials
Although we have designed SiO2 vials and syringes to meet the International Organization for Standardization (ISO) standards, we still needed to re-evaluate their compatibility with fill-finish manufacturing lines since the conventional fill-finish equipment was initially designed with glass in mind.
To ensure smooth fill-finish operations with a new primary vial and syringe, the properties of the packaging material need to be cross-examined, including the weight, surface finish, defect inspection, propensity for static charge, and particle loads.
SiO2 has conducted extensive trials with machine-filling manufacturers to ensure the compatibility of our SiO2 hybrid vials. Although the weight of an SiO2 vial is approximately two-thirds of a similar-sized glass vial, we shifted the center of mass of the SiO2 vial down to reduce the risk of tipping over.
According to the results from our fill-finish trials, the cyclic olefin polymer surface finish of SiO2 vials does not impede them from running smoothly on the fill-finish line.
We observed that the inspection systems for defects on SiO2 vials require some recalibration since what may be perceived as a serious defect in glass is only cosmetic in SiO2 vials.
Static Change and Particle Loads
The SiO2 cleanroom environment is controlled for contamination and other environmental factors such as temperature, humidity, and pressure. We manufacture SiO2 vials in this environment with automated controls and inspection systems that eliminate static charge, visible particles, and subvisible particles to well below USP 789 requirements (Figure 4). In-line deionizer systems ensure that vials nested in tub and tray configurations are free of static charge. Particles are not statically attracted to the vials during the final secondary packaging before shipment for sterilization.
SiO2 Vials are optimized for Fill-Finish Lines
Not only do SiO2 vials and syringes meet ISO standards, but they also do not affect the critical fill-finish step in packaging vaccines. We have re-evaluated factors that can affect fill-finish operations, including weight, surface finish, defect inspection, static change, and particle loads. Our findings show that our hybrid vials will be useful to companies expanding their fill-finish capacity and, ultimately, will be a contributor to the delivery of the COVID-19 vaccine to millions of people globally.