- The flexibility of breaking down a system into discrete component “modules” allows for quick changeovers, improved OEE, standardization, and reduced costs for both implementation and operation.
- Automation eases the transformation to wider-scale production in modular manufacturing and reduces the risk of human intervention, which further decreases downtime.
- POD and modular upgrades have many benefits but they do not operate in a vacuum.
- Plan for where you’ll store materials, such vials, stoppers, resins, etc. and any raw materials.
- Don’t overlook space for the utilities that support the pod or equipment.
- Also consider gowning and space for personnel to move around safely. Bring operators into planning stages who will point out practical details.
Related to this episode:
- Live from #PDAannual: Recent developments in blow-fill-seal technology have bolstered the use of BFS in aseptic processing, including temperature control and needle addition for pre-filled syringes.
- Modular manufacturing is on the rise in the pharmaceutical industry. Learn how flexibility allows manufactures to meet the needs of the growing and versatile injectables market.
- From the HCP Archives: No time for a full shutdown? You can still make functional changes or “bolt-on” capacity while processing pharmaceuticals, if you’re prepared. Read this article, "Implementing Upgrades While Operating Your Facility," to find out more.
- Keep up with the latest packaging and processing trends by subscribing to the unPACKed with PMMI podcast.
|Read the transcript below:|
Melissa Griffen: Hello, this is Melissa Griffen, contributing editor at Healthcare Packaging. Today on our Take Five with Healthcare Packaging video, I'm talking about the rise of modular manufacturing within the injectable space.
As explained in a Fortune Business Insights article, Forecasting the State of the Injectable Drug Delivery Market, three of the most important forces driving this market forward are the increased prevalence of chronic diseases such as diabetes, cancer, and auto-immune disorders, advancements in technologies, such as smart wearables, and the unexpected arrival and impact of the coronavirus pandemic. Increased hospitalization and worldwide immunization programs are also factoring into this forecasted growth.
Along with this growth is the continued evolution of injectables, from conventional injectable devices to prefilled syringes, auto-injectors, pen injectors, and wearables. As these continue to become more customized and self-administered, manufacturers need to stay ahead of the game by future-proofing their equipment. One solution is modular manufacturing, which has been on the rise in the pharmaceutical market for some time. Modular manufacturing offers the flexibility to break a system down into discrete component modules, allowing for quick changeover times, standardization, reduced costs in both implementation and operation, and improved overall equipment effectiveness. It also allows manufacturers to meet regional deployment demands.
Automation is another factor going into the versatility of modular manufacturing. Lower product volume is often required for auto and pen injector production, though, efficiently switching to wider scale production efforts can be necessary. Automation eases this transformation and reduces human intervention, further decreasing downtime. In certain drugs, the reduction of operator exposure can be an important step towards personnel safety. Using a modular format also means that individual modules can be replaced and updated instead of needing to change an entire production line.
Keren Sookne: Thanks, Melissa. I'm Keren Sookne with Healthcare Packaging Magazine. Today, we're talking one seriously big topic that often gets overlooked when implementing a prefabricated pod for pharmaceutical filling, but this also might help for any modular equipment upgrades, which are becoming so key for the flexible facilities that industry is striving toward.
First, what is a pod? A pod is a prefabricated clean room that's built completely offsite in a clean and controlled environment. It ends up delivered complete with walls, via truck, plane, or ship. Many experts say that for certain applications, this is really the way to go for agile modular facilities, particularly if you can't afford a long shutdown in processing.
This topic is something that came up at the 2021 PDA annual meeting recently, but it's something that I've heard time and again, either at conferences or in quiet conversations at lunch. People really tend to focus on the pod or that piece of new equipment, the filling technology, and its footprint in your facility—but you really have to consider the support systems. This pod is not going to work in a vacuum. You really have to consider, before that pod arrives at your facility, where are your raw materials going to be stored? This could be viles, stoppers, etc. In the case of blow-fill-seal, you may need to store over a thousand pounds of resin. It needs to be kept close by, so you have to plan for that space. The other thing is utilities. At the show, Len Posner noted that everybody focuses on the clean room, but you really have to look at how much space you need for utilities, especially considering that the projected square footage that you might think that you need can actually be exceeded pretty quickly in practice.
The really key takeaway today is just you have to look at what feeds your pod. This includes gowning areas as well, where are staff going to be moving in and out around the pod. It's really natural to get focused on that center piece of equipment, but you really don't want to play catch up later on with your support systems.
Hey, if this has happened to you, it happens. This is not specific to pharma filling. The couch that you buy might fit in your living room, but you can't get it up the stairs, or your coffee maker would be perfect in this corner, but there's no electrical outlet. This is one of the reasons why it's great to have some highly detail-oriented people on your teams to catch those finer points, to ensure that your pod can work in practice when it arrives at your facility.
Thanks, and see you next time at Take Five with Healthcare Packaging.