Did you know 75% of life science companies still use a paper based system in their cleanrooms? That means in an 8 hour shift, you need someone to look at as much as 5,000 individual count data samples which can yield up to 700 print outs. Each of these printouts needs to be reviewed.
But before they can be reviewed, there is a whole process they must go through.
When the particle counter prints out the information, someone must go retrieve the ticket. They have to rip it out of the machine, tape or paste it to a report or a photocopy of the report. Next, the report has to be signed off and scanned into an electronic copy.
And, finally, a lucky technician gets to manually enter all that data.
Organizations have to literally hire people just to be in charge of managing this paper-based system. We all know that environmental managers and technicians have a very critical job, but spending their time participating in an obscure art project takes their attention away from what truly matters: the data.
This process is exactly that, too: a kindergartner’s art project.
In our cleanrooms, we make incredible breakthroughs. We pave the way for tomorrow and create some of the most complex pharmaceutical and medical tools and products.
Why have we not embraced technology that will make our lives easier, data more secure, and improve our ROI?
Let’s look at some of the operational issues that can arise when we are using a particle counter in a cleanroom with a paper environment. For this example, we’ll consider the basic operations for an 8-hour pharmaceutical injectable fill operation.
This operation has 65 locations for particle counters that run for 8 hours in a Grade A Zone. It has an additional 90 tests over 9 hours in Grade B Zones. Lastly, it runs 100 tests for 2 hours in Grade C and D Zones.
This means that there are 670 particulate count sampler tickets that print out. To manage this load, there has to be at least 1 environmental manager and 5 environmental technicians. But they have to enter up to 5,000 data entries.
That means we are trusting that these 6 individuals will be able to accurately enter information 5,000 times a day, every day.
But let’s say that we’ll trust their data integrity completely. We’ll assume they are perfect humans who never make mistakes.
How much time does this take them?
On top of entering all this data, they are trying to analyze it at the same time. But by the time they get to a piece of data that is concerning, the problem could have happened hours ago. Everything that has happened in the cleanroom since that moment is now in jeopardy.
Using this paper system is clunky, outdated, time consuming, and expensive.
Transitioning to a paperless cleanroom reduces labor time and resources, human error, costs, and risks, while automating data collection, increasing data integrity, and improving processes.
Another benefit is the immediate Return On Investment (ROI) you see. While there is a cost in purchasing the equipment that will allow you to seamlessly transition into a paperless environment, the ROI is virtually instantaneous. Your team will immediately see a reduction in labor time and an increase in their ability to focus on analyzing data.
Moreover, they’ll be able to graph and track trends easily and instantly. Your team will be able to instantaneously identify any problems in the cleanroom and address them. Because trends are so easily noted, you’ll be able to identify if a one-off contamination episode is truly one-off or if there is an underlying cause, like a technician who repeatedly gowns improperly.
Lastly, going paperless decreases contamination risk. While the printers and papers used - if and when they are used in the cleanroom - are designed to reduce contamination, we eliminate a contention source any time we can prevent extra items going in and out of or being used in a cleanroom.
The good news is that this transition can be very fast! Within a few weeks of your order, you can have your new system up and running. That is because paperless particle counters, like the ApexZ3, are designed for usability and ease. They offer many integration options that make this process painless and seamless.
The first step is identifying the best particle counter for your operation. If you choose a particle counter like the ApexZ3, you will be able to easily integrate SOPs and workflows.
In the future, you simply upload the SOPS and workflows to a fleet of particle counters placed strategically in your cleanroom. You can now control these SOPs - and easily update and control them in the future!
The following series of graphics demonstrates an example scenario of a sterile manufacturing cleanroom transitioning to paperless processes using the ApexZ.
Take a moment to familiarize yourself with the cleanroom as it stands: it contains three zones with varying levels of classification depending on the application of the portion of the room.
From there, you should conduct a risk analysis to determine where your particle counters need to go. The following 3 figures demonstrate where this organization has chosen to strategically distribute their particle counters.