Dollars and sense of the Aseptic Filling Workcell

How can a filling machine make or save you money? By getting rid of all of the friction and complexity of the “ways things are done.”

When a drug makes it to your filling line, the goal is to not mess it up. You try to remove risk as much as you can. That’s created a conservative environment where aseptic filling has followed the status quo for a long time.

As things have shifted to small-volume targeted injectables, the old model is killing your bottom line. Capital filling line projects based on conventional technologies are multi-year efforts that are often late and go over budget. The technologies themselves are inherently inflexible, causing high amounts of downtime in changeover, batch releases and other areas.

This blog gets into the dollars and sense going the Vanrx way—standardized Aseptic Filling Workcells that remove the friction from production and require fewer supporting resources.

Saving money on construction and supporting infrastructure

Installing a Vanrx SA25 Aseptic Filling Workcell will take up to 60% less space than a comparable modular isolator system. There is no additional footprint needed to add additional container formats at a later date.

Less capital cost

Have you ever seen a proposal for a filling machine? Most of them are pages and pages of different options, with the barrier system and filling machinery coming from two or more companies. Vanrx makes it simple—one price that gets you through the Site Acceptance Test (SAT) and a standard validation package included, with the option for our assistance to get through validation.

Less space and lower Grade C space

Compact, integrated designs take up less space vs. conventional technologies and nearly all of our customers put machines in Grade C cleanrooms, which cost less to build.

Simplified engineering with simple utilities

With standardized designs, you’re not taking on the risk and expense of designing a filling machine by committee, or coupling modules up in a way that may never have been done before. Vanrx provides standard machines with simple requirements–power, compressed air and an exhaust. Unlike conventional technologies, there is no connection between the upper plenum of the machine and complex HVAC systems.

Reach GMP faster

When you get an Aseptic Workcell up and running, the machine helps you both make and save money. 

The biggest thing to think about is how long it takes your company to reach GMP operations. What’s the opportunity cost of being early vs. being late? We covered this in another blog.

With standard, yet flexible machines, Vanrx offers industry leading timelines to reach GMP. For example, WuXi Biologics reached GMP within 15 months from their purchase order, with 7 different vial and syringe formats validated.

Operational savings

A conventional isolator-based filling system will take at least double the space of an SA25 Aseptic Filling Workcell and require several more operators.

Aseptic Filling Workcells support a very high utilization rate. Changeover and decontamination times are both under an hour, so companies can shift filling between drug products quickly. Within an hour of starting the machine, your team is filling drug products.

Fewer staff

Rule of thumb, two operators to get a machine ready, one to observe the filling process and two to unload or reload the container / closure carousel.

Bring new drug products online faster

This is recipe-driven automation. Since robotics handle nested vials, syringes and cartridges in the same way, it’s easy to add tooling and develop recipes for new drug products. Innovators needing flexibility or CDMOs looking to serve new clients love this. It means very little new tooling and definitely not another filling machine for another container type!

Recipe-driven automation means the single operator has a passive role of observation during the filling process. Electronic batch records mean save time in batch release and analysis.

Electronic batch records

No more paper. An Aseptic Filling Workcell has completely electronic batch records, which means your staff can reach batch release faster and with greater ease. The Workcell compiles a complete record of production, down to the individual unit.

Are there any areas where the Vanrx way costs more?

Upfront, the cost of investing in vials and press-fit closures with integrated stoppers is going to be higher than buying bulk vials, stoppers, and aluminum crimp caps, and then washing and depyrogenating them yourself. Vanrx’s component partners in the Matrix Alliance take care of nesting and sterilizing the containers and closures. All of the Matrix Alliance members can demonstrate through customer data that total cost of ownership is lowered by using pre-sterilized containers and closures.

Ready-to-use vials, syringes and cartridges have higher up-front costs than bulk, but offload the capital and operating expenditures of washing and depyrogenating containers. Vanrx’s partners in the Matrix Alliance can demonstrate that the total cost of ownership is lower with RTU.

All of the capex / opex associated with container and closure preparation, including equipment, time, personnel and energy is taken off of your plate.

Nested, pre-sterilized syringes and cartridges have been an industry standard for a long time, so customers do not notice a difference there. 

Get in touch

Contact Vanrx to see which of our systems would suit your needs and hear examples of how your peers have succeeded in taking this new approach to aseptic filling.