Healthcare Technology Featured Article

April 08, 2022

Fill and Finish Operations - Why Are They Outsourced So Often?




Fill and finish operations involve filling and sealing products into final-user containers with sterile procedures. These services are most useful for medical-grade products like cartridges, medicinal vials, and syringes to make sure they’re packaged in precise quantities and contaminant-free.

Why Are These Services Mostly Outsourced?

Aseptic/sterile filling and finishing services are generally outsourced to specialized biopharmaceutical manufacturing companies. It is mostly because of the niche equipment, trained technicians, and clean rooms that are required to carry out these operations.

The final steps for most biopharmaceutical products, medical cosmetics, and equipment requires specialized handling protocols to ensure uncompromised safety and sterility standards. Moreover, filling up vials with a consistently precise quantity and securely sealing them is also not possible without expensive, specialized equipment.

Investing in such machinery and still risking the possibility of inappropriately filling expensive biological products isn’t a cost-effective risk for almost any medical device or pharmaceutical company. Most of the niche medical-grade products are made out of costly raw materials in large quantities, so mishandling them due to a lack of expertise could result in huge financial losses.

So, instead of hiring specialist staff and buying high-cost equipment, it makes way more financial sense for companies to simply outsource the delicate final stages of their product manufacturing.

How Do Filling and Finishing Service Providers Get Lower Costs?

Companies that provide specialized aseptic/sterile filling and finishing  are able to profit off of their expensive equipment and high-cost specialist staff through economies of scale. Since they “file and finish” way more orders than the minuscule needs of a singular biomanufacturer, they’re able to split their fixed costs over a large amount of output.

So, while it doesn’t make much sense for a pharmaceutical company to heavily invest in those areas for their minor production needs, it’s perfectly viable for niche-based filling and finishing service providers who take bulk orders from many different pharmaceuticals and make full-time use of their high-cost equipment and staff.

Current Trends in the Filing and Finishing Services Market Sector

Here are some key trends prevalent in the current state of the filing and finishing service sector.

1. Pharmaceutical Companies Ubiquitously Outsourcing Their Filing and Finishing Needs

A whopping 75% of all biomanufacturers agree to have outsourced some or all of their filing and finishing activities.

Moreover, out of the top 24 biomanufacturing activities that are outsourced, filing and finishing services rank high at number 4 — even above common activities like toxicity testing.

2. A Trend of Automation in Filing and Finishing

Contamination is one of the biggest threats to avoid in filing and finishing, and human interaction happens to be the biggest risk factor for it. Hence, more and more parts of the filing and finishing activities carried out today are being automated thanks to advancements in the fields of robotics and artificial intelligence. Some examples of already automated aseptic filling and finishing activities are cleaning, system changeovers that are required for prefilled syringes, and loading raw materials.

3. Increased Use of Disposable Equipment

To further reduce contamination risks and meet higher cleanliness standards, premium fill and finish service providers are extending their use of disposable and single-use equipment throughout the procedure. Some examples include disposable connectors, manifolds, and filters.


 





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