Band Aids aren’t meant to be used off-label
That may seem like a strange title at first glance. The point we are making is that conventional filling machines are fundamentally flawed. But instead of solving these problems, new technologies are invented to bandage the flaws, without solving the underlying problems.
So what are the fundamental problems of conventional technologies?
- You need glove ports because the aseptic process requires operator interventions. Then you spend hours and waste time interrupting production to perform interventions, training operators and testing the gloves’ integrity.
- You need complex air control equipment such as air handlers because the process is particle creating. Container-to-container contact, stoppering bowls and aluminum crimp capping all create particles and cosmetic issues on containers.
- You need 100% in-process fill volume checks that slow down the line. The conventional combination of pump and flow path does not have the accuracy, precision, or process capability to reduce the need for weighing.
We could go on and on…
At Vanrx, it’s not in our nature to stick a Band Aid on these flaws and carry on. We have a track record of recognizing and solving the underlying problems of aseptic processing in how we design and manufacture our machines. Our Aseptic Filling Workcells are designed by experts in biopharmaceutical manufacturing who have used conventional filling machines and know their flaws first-hand. Combine that with a view of what candidates fill companies’ pipelines and what their required filling scale and automation needs will be, and you have a recipe to create products that anticipate future needs.
Here are just some examples of the things we have invented to solve the underlying problems of aseptic processing.
Gloveless robotic isolator
This is our headliner: the first gloveless robotic isolator. Vanrx Aseptic Filling Workcells are fully closed, integrated systems for flexibly filling vials, syringes and cartridges with no human intervention. Designing such an innovative solution meant having in-depth knowledge of aseptic processing, the design flaws of conventional systems, and complex automation.
Bottom line for you: A gloveless robotic isolator provides you with better tools to bring complex therapies to patients faster. Removing the need for human intervention resolves issues with conventional systems around product quality, sterility assurance and flexibility. A completely closed system also means you don’t have to deal with glove ports, complex airflow, long installation timelines, and many more issues.
Vanrx Dynamic Peristaltic Pump
One of your biggest quality concerns is whether the right amount of drug product is filled into the container. Our experience told us that rotary piston pumps are accurate for low fill volume applications like ophthalmic pre-filled syringes, but posed a risk for particle introduction. Peristaltic pumps are gentle and easy to use, but not as accurate as rotary pumps at low fill volumes below 1 mL. Our newest introduction, the Dynamic Peristaltic Pump rethinks the mechanical design of a peristaltic pump with software improvements that give it rotary piston accuracy.
Bottom line for you: Extract higher batch yields from bulk drug product, making greater profits for your company and treating more of your patients. With the Vanrx Dynamic Peristaltic Pump your line will also run more smoothly because you have validated that weighing each vial is not required. That’s a win-win.
Conventional methods of decontamination can take up to 4 hours, with an extra 8-12 hours needed for aeration before filling can begin. We use a technique called Flash Vapour Phase Hydrogen Peroxide (VPHP) which focuses on immediate and rapid injection of smaller volumes of hydrogen peroxide into the isolator with a short dwell time. This results in less residual water vapour, and therefore a much shorter aeration time of just 10-15 minutes, meaning you can get back to filling faster.
Bottom line for you: Flash VPHP provides assurance of a 6-log kill of a biological indicator and enables you to turn batches over faster. The mechanical simplicity of the closed isolator also helps to keep the decontamination process fast and efficient.
Not your average supplier
At Vanrx, we pride ourselves on being unique. Our approach to designing technology and solving problems has never followed the status quo and we are constantly looking for ways to do better.
Do you have unique problems with your filling operations? We might already have a solution in the works to help you. Get in touch to find out.