At the end of the day, in a cleanroom: time is money. Cleanrooms are expensive to operate and, while they are running, they have a lot to do. Technicians gown up and put their expertise to work on various applications. But due to the nature of cleanrooms, SOPs and regulations must be minded. So there is constant documentation. This tedious documentation - when done by humans - not only slows down and impedes your workflow, but allows for human error. Thus, it is valuable to implement automations to improve your cleanroom workflow.
We have three primary considerations for improving your cleanroom workflow: decreasing contamination, improving production times, and freeing up personnel time to focus on what they do best.
Are you still manually testing your injectable products?
The United States Pharmacopoeia 788 (USP <788>) provides standards and guidance surrounding the production of water for injectables (WFI) that is developed in cleanrooms. According to the USP <788>, there are two acceptable tests for particles: light obscuration and microscopic assay. These are used to determine if the particle counts fall within the defined parameters. In normal production, water is first tested using light obscuration. Microscopic assay is typically used as a secondary testing measure.
Based on these guidelines, it is important to develop your testing plan with impunity. But it is also apparent that the testing can take a lot of time and manpower when done manually.
Not only is this time expensive to dedicate towards testing, but it impacts your workflow. It slows down production. Not to mention, those humans must dedicate their time to more tedious aspects of this process versus using their valuable skills on other tasks.
While this is how many cleanrooms still operate, there are tools that allow you to automate your testing of water for injectables. Automating your testing will improve your cleanroom workflow while reducing delays.
The next way you can improve your cleanroom workflow through automation is by introducing robotics throughout your process.
Humans are a major contributor to contamination in a cleanroom. In general, we account for around 75% to 80% of particles found in a cleanroom. This is because we are constantly shedding skin cells, hair, and microorganisms. We shed roughly 40,000 skin cells alone every minute.
Personnel in the cleanroom generate about 100,000 particles of 0.3 microns or larger through skin, hair, and clothing every minute when stationary. But when they move, the number of particles increases to over 5,000,000.
While robots can still shed particles from gasses, oils, belts, etc., their potential to shed particles is significantly lower than humans. Additionally, their particles being shed will be localized to specific areas where they are being used. This allows for better, more strategic monitoring.
With this basis, implementing robotics will help improve your cleanroom workflow in three primary ways: speeding up your processes, freeing up your personnel, and decreasing contamination.
Robots can work faster and more precisely than humans. While the production will still take time, they can speed up your production time by doing the mundane tasks.
Meanwhile, your personnel can be doing things that only humans can do. Your human workforce is your most valuable asset: they have skills and expertise that take years to develop. Their time is more valuable spent doing things other than mundane tasks.
Lastly, by decreasing contamination potential and centralizing that potential, robotics can allow for a decrease in downtime because of contamination.
Another way automation that can improve your cleanroom workflow is through paperless particle counting.
Did you know that 75% of life science companies still use a paper based system for particle counting? This involves an arduous process of printing out particle counters’ data, pasting or taping it onto a report, getting it signed off, scanning it into a digital copy, and manually entering the data.
This is a complex process that takes time: it takes time to complete these steps and prolongs the amount of time before the technicians and environmental manager gets their final evaluations. This means that a significant amount of time passes before an environmental concern is noticed and addressed.
By switching to a paperless system, you would decrease demands on human resources and improve responsiveness to an environmental anomaly. Not to mention, you would improve your data integrity and interpretation ability.
How Else Can You Improve Your Cleanroom Workflow?
These are three ways that you can make adjustments to improve your cleanroom workflow through automation, but we firmly believe that contamination is the biggest impediment to your cleanroom workflow.
While you can never prevent contamination completely, you can reduce the amount of time it takes you to determine if an environmental anomaly has occurred and react accordingly. You can also empower yourself to make fast, knowledgeable decisions based on data trends.
That is done through the use of a particle counter with powerful integration and paperless options.
We recommend a particle counter that has set industry standards for battery life time and recharge time, like the ApexZ.
The ApexZ also has set standards and led the way in integration options. With the ApexZ, you can have a paperless system in only a few weeks after purchase. This system would be easy to manage, change and update SOPs, and monitor from outside the cleanroom. It is designed to withstand powerful cleaning elements, such as VHP, and be easily cleaned itself.
More than anything, the ApexZ is designed with environmental managers and technicians in mind. It is supposed to alleviate the workload of mundane tasks of personnel so they can focus on what they do best.
Is the ApexZ right for you? Learn more here.