1) Delivery Time
Delivery time can be the difference in a landing a contract, or even getting life-saving medication to a patient on time. A track record of on-time, as promised deliveries should be near the top of your list, if not at the very top.
2) What barrier technology are you going to be using?
Deciding on a barrier technology requires considering a myriad of different factors. Questions like: What product you are going to be filling? What is the size capacity of your clean room? What regulatory requirements do you need to follow? Do you need a full isolator, a RABS unit, another kind of barrier or combination of barriers? Keeping these questions at the forefront of your mind will be important when evaluating small-scale solutions.
3) Flexibility
Looking for flexibility within aseptic manufacturing will make it easy for you to scale up as your business grows. It’s a built-in solution for you to expand your drug product processing capabilities as well as an antidote for market uncertainty. Having the ability to quickly change and manage the different drug products you are currently processing help keep costs down significantly and make your business more agile as market conditions change.
4) Supplier Relationship
This step is three-fold when considering a small-scale solution: Aftermarket care, spare parts purchasing, and customer support.
The final purchase of your product doesn’t mean the end of your time and relationship with your supplier. That relationship should be like a flexible machine - Evergreen! What happens if you land a new contract, and you need new change parts for the machine? Or what happens if find yourself wanting to protect your investment a little more by having additional spare parts as a failsafe? Or if there’s a problem that you just can’t figure out?
Your supplier should be a partner. They should be helping you configure your machine to your process, or sending you those spare parts, and helping you solve any problem while teaching you how to do so as well.
5) Machine Optimisation
Like many things in the manufacturing world, there’s the “short-cut way” and there’s the way that will work and will last. Small-scale aseptic manufacturing is no different. Large machines that have been stripped and parred down to be smaller versions of themselves will never be as accurate, or as efficient as machines that were designed for small-scale production.
6) Product Waste
Product waste is something that requires both a proactive strategy and a retrospective check to make sure that waste is kept to a minimum. Utilising a 100% IPC system with zero-loss strategies that prevent containers from being over- or under-filled, optimised fluid paths, ultra-accurate pumps, and contamination control as well as covering the back end with full batch accountability and traceability in an electronic batch record (EBR) is the most effective way to ensure that your containers are being filled exactly as intended.
7) The cost of ready-to-use (RTU) units vs. bulk consumables.
When finding a small-scale solution, weighing the costs and benefits of RTU vs. bulk containers is going to be a vital part of the process. While bulk might seem more cost-effective up front, there are additional aspects of safety, production, and sterilisation to think about and pay for. Ready-to-use components and small-scale aseptic manufacturing are a match made in biopharmaceutical heaven. RTU’s keep ROIs high and machine downtimes low.
These 7 things to consider when looking at small-scale aseptic processing were put together to help you make the best decision for your company. At AST, we want to partner with you through this decision process to help you create something that is perfect for your business.