What does particulate data collection in your cleanroom look like? Let’s paint a picture together of the current system - or close to it - in the cleanrooms of around 75% of life science companies.
A particle counter spits out a printout with dozens of data points on it. A technician tears the printout from the particle counter and tape or paste it to a photocopy or report. They hurry it to the appropriate authority and get it signed off on. Next, they scan it to create a digital copy. Lastly, the data is entered into a system before the technician gets to hurry back and do it all again.
At what point, in this process, do you trust that the data is being correctly interpreted and processed?
According to the American Pharmaceutical Review, “Data integrity relates to any type of ‘data’, and the degree to which a collection of data is complete, consistent, and accurate. … No single type of data is exempt from data integrity concerns, and such concerns have been part of a growing focus from regulators across pharmaceuticals and healthcare.”
In a cleanroom, data integrity means that data is able to be backed up, traced, and authenticated. Cleanroom data integrity means that each piece of data can - without a doubt - be proven true.
This is done through creating fail safe systems with solid Stands of Practice (SOPs), segregation of duties, safety checks, and traceable systems and SOPs.
Particle counters record some of the most crucial data found in a cleanroom: how clean that cleanroom truly is. Particle counters’ data reveals contamination which can result in harm to the end user and yield loss.
Unfortunately, when humans are in charge of data entry, large amounts of human error can occur.
Humans are not perfect and this is clear when they translate data. Studies show that visual checking of data entries resulted in 2,958% more errors compared to double entering the data. Even if a more thorough method of data entry, such as double entering data, is used, humans are still susceptible to error.
Mistakes are exacerbated when humans are stressed or worried. In a stressful, high-stakes work environment, like a cleanroom, these mistakes are to be expected.
Not to mention double entering data is twice as time consuming as entering it a single time. Your manpower and human workforce is a valuable asset. Spending your team members’ expensive and limited time on a process that resembles a kindergartener’s art project with its cutting and pasting takes away from what makes them unique: their ability to track trends and make decisions.
This is not to call humans inept by any means. A cleanroom running for 8 hours can produce up to 5,000 individual count data samples. This means it can yield up to 700 print outs! This is an untenable amount of data for humans to sift through, evaluate, and enter. It should not be expected that humans can do this without error, every day.
Unfortunately, when cleanroom data is not kept on top of, there can be expensive, deadly consequences.
The best way to improve data integrity in your cleanroom is to remove humans from the equation wherever possible. The good news is that this process is surprisingly simple!
Not only is it simple but it allows you to…
- Mitigate operator sampling errors.
- Integrate your APC and MODA EM software with your validated EM SOPs.
- Simplify and automate your APCs configured on daily workflow.
- Seamlessly manage all user access based on your Active Directory.
- Develop compliance reports easily and on the fly and share with an auditor.
- Manage SOP revisions and easily update all your APcs within seconds.
- Save critical time when evaluating data.
- Quickly and simply identify trends and determine the cause of one-off contamination events.
- Be alerted immediately when there is contamination in your cleanroom.
- Use your teams’ time to complete valuable tasks, instead of time-consuming ones.
To improve your cleanroom’s data integrity, you need to transition to paperless particle counting.
This will create traceable SOPs and systems in your cleanroom. Outside of your data integrity, this paperless system will allow you to easily transform data into graphs to see data and trends. Thus, you are able to provide microdata analysis. Data visualization is easy, so you can see if a one-off event was truly a singular event or if there is a larger trend at play. This will improve your workflow as you will be able to make better, more informed, faster decisions from data you can trust.
There are multiple ways you can go paperless in the cleanroom! A few include…
- USB Transfer
- Barcode Reader
- LMS Express
- API and CIFs
- LMS Exchange
- PDF Report Exporting
We recommend using a particle counter that takes advantage of all these options and allows for multiple integrations, like the ApexZ.
Cleanrooms are complex beasts! It is difficult to stay on top of what works best and industry standards. But the good news is that we’ve done that for you.
Every month, we host a new webinar that breaks down complex topics and identifies ways that you can make your cleanroom better. This includes explaining regulations, requirements, classifications, industry trends, improvements, and more.