VarioSys: The Latest in Innovative Modular Technology
An evolving industry landscape and the increase in complex and personalized parenteral drug products have led to increased demand for specialized and versatile aseptic fill/finish equipment.
Arriving early in 2022, with GMP production beginning in Q4 2022, Grand River Aseptic Manufacturing (“GRAM”) is preparing to offer a new VarioSys syringe and vial filler to stay innovative and ahead of ever-evolving industry needs.
Let’s dive into some of the factors behind GRAM’s choice to expand with state-of-the-art VarioSys technology and how it will pair with existing technology to help increase current capacity.
Trusted partners and experience
To start, GRAM turned to trusted industry experts and past partners, Bausch+Ströbel and SKAN, to help determine the best technology to expand their portfolio.
Experience is vital since sterile filling is a highly regulated business. SKAN only makes isolators, experts in their field, and Bausch+Ströbel are experts at advanced aseptic fill machines. VarioSys technology represents a combination of these two elements: an isolator made by SKAN and machine modules made by Bausch+Ströbel.
Every GRAM operator, technical specialist, and manufacturing team member needs to be an expert on the technology at hand. GRAM uses Bausch+Ströbel and SKAN technology for their other filling equipment, which offers staff the knowledge and hands-on training to transition easily from machine to machine.
Flexibility
VarioSys technology allows for the production of small commercial or clinical batches all the way up to a medium-sized commercial batch.
The VarioSys technology is designed to offer GRAM the most container flexibility for small commercial batches available on the market. The core technology of the VarioSys is similar to GRAM’s two fill lines and allows for an incredibly smooth tech transfer with the ability to scale up from a small-scale batch to a large-scale batch. Having two duplicate fill lines in the same facility enables GRAM to take small commercial batches and transfer them easily to large-scale production equipment.
The modularity of VarioSys also offers an incredible amount of flexibility for increasing and accelerating production needs. GRAM will be able to adapt as industry demands grow and evolve, enabling them to accommodate a wider array of products for their clients.
One room, multiple formulations
VarioSys technology offers the benefits of serving customers with many different needs and various presentations that can all be filled at the same facility, a huge advantage when you’re in search of a CMO. This technology accommodates the creation of bulk vials, syringes, IV bags, cartridges for devices, or auto-injectors and can even support the use of both plastic and glass.
The machine modules are simply slotted into an isolator on the “lock-and-key” principle and plugged in. This allows for an incredible amount of flexibility depending on individual application needs. The system is designed to provide the utmost flexibility in the production of medications by exchanging modules. The filling system that fits into the isolator is easy to remove and replace with new pieces of filling technology. This flexibility allows for the use of a vial filler, a syringe filler, a bag filler, and an aseptic formulation isolator, all using one room and one isolator.
Typically, you would need three isolators and three separate fill rooms to accommodate different filling technologies, but this combines it into one, a great perk for meeting the needs of an expansive portfolio.
A new industry standard
VarioSys technology offers standardized real-world solutions to past challenges, as well as increased flexibility for the future. The SKAN isolators create a fully integrated, sterile environment along with the added scalability to handle a wide variety of complex and sensitive sterile injectable products—all while optimizing the time to market.
By selecting the VarioSys technology, GRAM is expanding its portfolio with advanced, flexible, modular technology that sets them apart to biotech and pharmaceutical companies interested in an efficient scale-up of products. In a world of unpredictable demands, highly flexible equipment supported by the latest technology is the way of the future. Contact our team today to learn how the VarioSys technology can fit your individual fill/finish needs.