The pharmaceutical manufacturing industry rightly includes some mandatory sterility and cleanroom requirements. These are stringent requirements, and it makes sense: the potential risks are too high if there were a breakdown in the stringent safety standards that every product must meet.
As you can imagine, though, it can be tough to balance these critical protocols with attaining operational excellence. Value stream mapping needs to include these in the pharma industry.
For those well-versed in Lean Six Sigma principles, VSM is a common tool to help you identify inefficiencies, eliminate waste, and create streamlined processes. But in pharma, your VSM will likely become very complex, as you need to account for cleanroom classifications, gowning procedures, and sterilization protocols.
At eVSM, we "get" pharma manufacturing. We've been working with some of the top pharma companies for years. We know that cleanrooms, batch production, and stringent regulatory requirements add layers of complexity that other industries may not have to cope with. You can book a meeting here if you want help with your value stream map.
This complexity cannot be allowed to stand in the way of operational excellence. Here’s how you can better integrate sterility and cleanroom requirements into your VSM process without sacrificing compliance or efficiency.
Cleanroom Classifications: The Backbone of Pharma Production
Cleanrooms are categorized by ISO standards based on the number of particles per cubic meter of air, with ISO 5 being one of the strictest levels of cleanliness. These controlled environments are critical to sterile drug production, as well as for biologics like vaccines or tissues. Maintaining the required air quality, through HEPA filtration systems and controlled airflows, is a given. But as you dive into mapping your processes, the challenge is to reflect how different cleanroom classifications affect overall process flow.
For instance, materials and personnel need to move between cleanroom zones of varying cleanliness. Moving from an ISO 7 area to an ISO 5 environment requires gowning and decontamination, which can introduce delays. These are necessary transitions, but can appear as inefficiencies when viewed through a traditional lean lens.
The key in VSM is to make these steps visible, understanding that while they don't directly add value to the product, they are critical to ensuring product safety and regulatory compliance.
Mapping these flows allows you to spot any potential improvements in scheduling or streamlining personnel movement between zones without risking contamination.
Gowning Procedures and Personnel Movement: Minimizing Process Delays
There's a meticulous process for gowning in cleanroom environments. Employees must follow strict protocols for donning protective clothing, masks, and gloves before entering sterile zones. Each transition between cleanroom classifications brings a similar requirement, contributing to non-value-added time in your process map.
But of course, this time isn't wasted. In fact it's essential for maintaining sterility. Still, VSM can help you understand how these requirements impact overall production times, and where opportunities exist for optimization.
As an example, think about how operators move between cleanrooms of different ISO classifications, multiple times per shift. Each time they may have to undergo gowning and decontamination. The time spent here can really add up, especially if gowning areas are not designed for efficient flow. Mapping these steps helps you visualize where bottlenecks occur.
Value stream mapping can really help in these scenarios, and show whether you need to reorganize gowning areas for better flow, or schedule personnel more effectively to minimize transitions, to reduce delays while maintaining sterility.
Sterilization Procedures: Accounting for Extended Cycle Times
It's not only people that must take precautions before entering a cleanroom. The equipment and materials used in cleanrooms must be sterilized before use. This could be through processes like autoclaving (pressurized steam), chemical sterilization, or even radiation. Again, this sterilization is critical in the pharma industry. But the associated cycle times can be long—sometimes hours. Incorporating these steps into your value stream map ensures you are accounting for extended lead times and not underestimating process delays.
By visualizing sterilization as part of the process, you can better assess how it fits within your production timeline. You might see if there are ways to schedule sterilization better. Or maybe investing in additional equipment to reduce cycle times could deliver enough ROI to justify the cost. VSM provides clarity on how sterilization impacts overall flow and where efficiencies can be gained, which will mean you can make better decisions.
Environmental Monitoring and Documentation: Navigating Non-Value-Added Activities
Cleanrooms require rigorous environmental monitoring, and is one of the biggest challenges in pharmaceutical manufacturing. Because yes, it is critical to continually monitor the number of air particles, microbial counts, and surface cleanliness. But it can slow down production and add time-consuming documentation tasks to the workflow.
From a Lean perspective, these activities could be considered non-value-added—they don’t directly contribute to the product’s creation—but they are indispensable for compliance. When conducting VSM, you have to account for these tasks while also looking for ways to streamline them. Can monitoring and documentation be automated to reduce time? Can real-time data collection replace manual logging? Value stream mapping gives you a clear picture of where these non-value-added activities are consuming resources, allowing you to pinpoint areas where technology might offer relief.
Batch Processing: Balancing Lead Times with Regulatory Compliance
Pharmaceutical manufacturing often operates in batches, which adds further complexity to VSM. Between each batch, equipment needs to be cleaned, sterilized, and re-qualified to make sure of its sterility for the next run. And this mandatory process can't be skipped, but it could introduce significant downtime.
Value stream mapping these batch processes can help you identify opportunities to adjust batch sizes, reduce changeover times, or streamline cleaning procedures. You may find that smaller batches reduce lead times, or that better scheduling of batch production allows for continuous flow, even in a batch environment. The goal is to minimize the downtime between batches without compromising the cleanliness standards required by regulatory bodies.
Navigating the Intersection of Compliance and Efficiency
Sterility and cleanroom requirements are not optional in pharmaceutical manufacturing. With proper vsm software, you don't have to let the requirements hinder your pursuit of operational excellence. Value stream mapping, when done by people in the industry with a deep understanding of these unique constraints, can help you optimize your processes without sacrificing compliance.
At eVSM, we know that achieving the perfect balance between sterility and efficiency is no easy feat. But with the right approach to VSM, you can streamline processes, reduce waste, and ultimately improve both product quality and production times. Whether you’re looking to optimize gowning procedures, sterilization schedules, or cleanroom transitions, value stream mapping can help you visualize the path to a leaner, more efficient operation. Book a meeting with one of us today; we're all friendly and we thoroughly know pharma value streams.