Standardization and flexibility? Yes.

What’s the common thread of all of the photos above? They are all the same machine. They are all highly flexible, capable of filling vials, syringes and cartridges. They all provide a closed robotic aseptic process designed to minimize risk. And you can buy them off the shelf.

The old paradigm of high-speed filling machines designed for a single format is clearly no longer suitable. An increasingly challenging competitive environment, emerging new modalities, and platform technologies with multiple development candidates can make it hard to keep up. But many manufacturers and their suppliers have only taken a half step towards solving the problem.

Many so-called “flexible” systems are adaptations of conventional technologies, with flexible features shoehorned in or custom designed to meet the needs of the customer. With the aseptic process, mechanical design and automation all in flux, it’s no wonder that many custom projects end up late, over budget or underperform expectations.

Are your current filling needs going to be the same 2 years from now? Five years from now? Conventional systems built to your specifications may seem flexible now, but leave the company buying the machine using a one-off years later. At that point, it’s a struggle to keep running and suddenly, you’re scoping another filling machine project to fill the gap.

It has always been thought that standardization and flexibility in aseptic filling are mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process so you didn’t have to choose?

Flexible by design

Vanrx Aseptic Filling Workcells offer flexibility at the core of a standardized system—from design to manufacturing to operations—so you are covered no matter what your aseptic filling needs and how they develop. Standardization means less risk, as advanced automation removes the need for human intervention and any possible issues are identified, solved and validated by other industry users.

The definition of flexibility is being able to move between clinical trial supplies and commercial drugs, between different container formats, and do it all on consecutive days. At the core of this flexibility is automation that universalizes material handling across vials, syringes and cartridges. If it comes in a nested format, a workcell can fill it.

As an example, CDMO WuXi Biologics had validated 7 different vial and syringe formats on a Vanrx SA25 Aseptic Filling Workcell within 15 months of their purchase order. They have continued to add formats to serve more customers.

This is a possible production calendar using an Aseptic Filling Workcell. Flexibility is supported by a combination of aseptic process automation, single-use consumables and ready-to-use, pre-sterilized containers and closures.

How is it done?

It is easy to say that flexibility should be designed into a standardized machine but how is it actually done? 

One of the most important elements of both standardization and flexibility is recipe-driven automation. The use of advanced robotics in Vanrx systems ensures accuracy and consistency in filling, while the ability to configure to different formats and products via a single human-machine interface (HMI) provides strong process control and repeatability.

Minimizing change parts and using a common method of material handling, plus integrated system design by a single company, enables flexibility, while maintaining the simplicity of standardization. 

Vapour phase hydrogen peroxide (VPHP) decontamination is essential to achieve flexibility. Quick decontamination and changeover times are crucial to change quickly between formats to fill different products on different days.

Like Roche/Genentech, you may have many drugs in different formats in your pipeline. You don’t know which will succeed or what might be needed in the future and therefore a common platform with flexibility designed into every aseptic of the process is needed.

A single HMI controls the recipe driven automation of the workcell. The closed robotic isolator system is fully integrated from a single company, Vanrx, who can design the system holistically to minimize risk / maximize flexibility.

Standardization helping flexibility

Standardization and flexibility actually complement each other in aseptic filling. In addition to increased sterility assurance risk, companies that choose modular or customized machines designed by committee cannot benefit from fleet-level improvements.

An aseptic process designed by experts with flexibility built-in, ensures that plants with standard systems can pivot between products and roll out fleet-level improvements to recipe-driven automation. This allows companies to scale out operations with multiple machines and enact a network strategy to deploy the same level of flexible production capacity to multiple areas of the company.

Having the same material handling method for vials, syringes and cartridges within a nest means that changeover is a simple process involving few change parts. Rapid decontamination and aeration times under 1 hour contribute to being able to switch between different drug products on consecutive days.

Using a standard system also allows you to join a community of users for support. The Vanrx User Group provides an invaluable resource for users to get together to exchange tips and troubleshoot issues with their standard machines.

Your science is unique but that doesn’t mean your aseptic filling needs are too. Think standardization with flexibility by-design and gain access to a new paradigm for aseptic filling.