There are a lot of deliverables to consider when scaling from research and development parameters to full-scale process manufacturing, with precision, quality, and compliance all coming to the forefront of planning and discussions.
All three of these areas must be managed to ensure consistency, where within the pharmaceutical industry in particular, moving to full manufacture is successful mainly due to precision dispensing and management of powder behaviour and structure.
From the transfer of knowledge to providing detailed and correct documentation, processes and quality systems must be put in place to ensure that the product developed in R&D is indeed the exact same product developed in manufacturing.
This means that the processes that work and are used in development must remain controlled and repeatable as manufacturing demand increases.
Challenges when scaling powder dispensing
We believe there are two main challenges to scaling powder dispensing:
1. Maintaining consistency
R&D processes are small, precision-led processes, where a small team is responsible for all aspects. Where maintaining consistency is optimised by smaller equipment and smaller teams, and managing critical powder behaviour changes is part of the development process.
Moving to manufacturing at scale and increasing sample volumes often means changing and adapting workflows, as what worked in R&D will most likely prove to be inefficient in manufacturing, leading to an increase in costs and a decrease in quality.
2. Poor communication
We understand that those working in R&D retain the knowledge and data; they know the powder formulations inside and out, and they understand powder behaviour and its operational conditions.
We also know that transferring this information, with clear data and methodologies, is not straightforward. Often incomplete documentation and insufficient communication between teams and departments lead to inconsistency and compromise quality.
Scaling from R&D to manufacturing
Moving from an R&D environment to full-scale manufacture costs millions. It’s not just about the product; it is scaling of the process, investing in the most suitable equipment, technology transfer, and process systems to ensure 100% accuracy.
Some of the key considerations to be aware of include:
Environment
During scale-up, environmental changes can happen to the powder being dispensed, such as humidity and electrostatic charges.
These changes must be taken into account during setup, with adaptations made, if required. Test for bulk density and compressibility, defining critical process parameters and acceptable tolerances.
Equipment
Within research and development, you will find equipment that allows for small free-flowing batches. In comparison, manufacturing handles large bulk volumes and as such, in some areas will require different equipment (quite often specialised automation equipment and systems).
Look to match energy with force when it comes to equipment and ideally keep compression force proportional across equipment sizes in order to keep consistency and accuracy.
Compliance
Regulatory compliance changes when scaling, and there is a lot more scrutiny placed on powder dispensing in particular when the process culminates in a product that is for commercial purposes.
Sharing of knowledge, information, and critical data within this area is essential. Everything must be documented and continue to be documented to meet compliance requirements.
Communication therefore should be open, honest, and above all encouraged between teams and departments.
Testing
Within all of these areas the key is to test, test, and then test again. Scaling will involve critical changes, and it is vital to test and validate that these changes keep the accuracy of the final product.
Gironex
Gironex understands powder dispensing. We understand the need for precision. We know processes must be optimised and the management of powder dispensing controlled.
That’s why our series of automated gravimetric powder dispensers are not only suitable for R&D lab work, but the equipment is also able to adapt to scaling.
Offering simplicity and efficiency, the Gironex Cube range supports powder dosing for container applications such as capsules, vials, and syringes, working within routine laboratory applications.
In addition, we also work closely with our automation partner to ensure moving from R&D to the manufacturing environment is seamless, with processes closely monitored and replicated from the lab to ensure precision, quality, and most importantly control.
There are numerous variables when it comes to achieving accuracy and consistency in powder dispensing; with the right equipment, scaling doesn’t have to be one of these challenges.
Do your current dispensing processes support future growth?
Book a consultation with us today to evaluate whether your existing dispensing processes can scale with ease and accuracy.
Speak to our team today.