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Solutions such as vial trays and vaccine trays are crucial to successful pharmaceutical manufacturing, but how are these containers filled and prepared for distribution? This is where fill/finish comes into play — a process that bridges the gap between pharma production and deployment in the field.
Understanding Fill/Finish
Fill/finish refers to the filling and finishing that comes at the end of the manufacturing process. In the pharmaceuticals industry, finishing refers to the sterilization and standardization of medical materials and containers, while filling means simply adding medicines to containers and sealing them.
This is a critical phase of pharma manufacturing. Failing to complete fill/finish to a satisfactory level can result in medicine batches becoming damaged or otherwise unfit for consumption. In turn, this means increased costs for manufacturers who would need to re-do these defective batches.
How Fill/Finish Works in Pharma Manufacturing
Let’s take a closer look at how the fill/finish phase works during pharma manufacturing.
The Pharma Fill/Finish Process
Different pharma manufacturing facilities may adopt their own practices during the pharma fill process. However, a typical process will follow this general workflow:
- Container Preparation
The medicine containers are assembled and arranged, ready to be filled. These containers will be washed before the process can begin.
- Initial Sterilization
Following the washing procedure, medicine containers are fed into a sterilization unit where further contaminants are removed and pathogens are killed.
- Stopper Preparation
The container stoppers are washed and sterilized before the product is filled. These stoppers are then fed into the filling machine and ready to be added to the filled containers.
- Product Sterilization and Filtration
The medicine product also needs to be filtered and sterilized. After this phase is complete, it is fed into the filling machine for packagaging within the containers.
- Product Filling
With the medicine material, containers and stoppers all prepared and fed into the filling machine, the machine can handle the actual filling procedure. This filling procedure is handled via automated processes with a container or vial filling machine to ensure standardization of doses and to eliminate wastage and loss within the facility. The containers are filled with the medicine product during this stage, and the stoppers are placed on the containers to form a preliminary seal.
- Further Processing
Further processing may also occur following this stage. Processing will vary according to the industry best practices and the specific type of medicine being handled. Some facilities utilize a process of lyophilization — or freeze drying — at this stage.
- Capping
When all processing and filling are complete, the containers can be capped. The caps will be prepared and arranged externally to the filling machine and will only be fed into the machine at this late stage in the process. The containers will be closed and sealed according to industry guidelines and regulations.
- Storage
The bulk of the fill/finish process is now complete. From here, the products need to be stored in medication and vaccine trays ahead of distribution and delivery to healthcare providers or retailers. Quality control practices may also be applied at this stage to ensure all products meet the high standards required of medicines and healthcare items in the United States.
Fill/Finish Provided by Third Party Entities
The filling and finishing process of pharma manufacturing has traditionally been a point of friction in the process. Many pharma producers have found that their time to market is severely inhibited by inefficiencies in the final phases of filling and finishing — something that has a significant impact on the company’s bottom line.
In an effort to streamline their operations and bring much-needed products to market with greater speed, pharma manufacturers may turn to third-party operators who can handle the fill/finish process. Once the vaccine or other medication is developed, it is passed to these third-party enterprises who complete the finishing and filling of the products ready for distribution.
Approved Filling and Finishing Networks
The use of third parties in the fill/finish phase of development certainly makes life easier for pharma producers, but it can also be problematic in some senses. Back in 2013, the United States Department of Health and Human Services identified how the use of unregulated third parties could put public health at risk, and so they implemented a network of approved fill/finish service providers.
With this network in place, end-to-end regulation of the pharma production process becomes easier to achieve. Producers also have a direct reference point where they can connect with fill/finish service providers. Meanwhile, the overall quality of the healthcare product is assured, providing peace of mind for consumers in the market.
Fill/Finish for Vaccines in the Covid-19 Landscape
The fill/finish process has been pushed into the spotlight in recent years as the Covid-19 pandemic has placed increased strain on healthcare structures. As of January 11, 2022, almost 304.3 million Pfizer-BioNTech vaccines have been administered, followed by Moderna with almost 198.5 million. In addition to this, more than 17.8 million Janssen vaccines have been administered during the pandemic and over half a million vaccines from other sources. All of this is part of an unprecedented drive to get the American public vaccinated in the face of the coronavirus crisis.
Modern automated technology is helping to ease the strain on pharma providers. When procedures are automated, there is less wastage and loss during manufacturing, and overheads are kept low. This means a stable and efficient supply of vaccines and medications to the market is achievable, even at scale.
Fill/Finish Continues to Be an Important Concern
While the Covid-19 pandemic has intensified the need for effective vial filling machines and fill/finish procedures, this need will continue even long after the recovery phase of this crisis is underway. This is because the fill/finish process is so important to modern pharma and medication production as governments seek to secure better standardization and quality control for products and as manufacturers seek to keep costs low. Advances in technology and best practices are likely to make fill/finish more efficient and effective in the future, further easing the strain placed on manufacturers in the pharma and healthcare industries.