Are your manufacturing areas and clean rooms ready to start performing operations or can continue operations properly?
Since I started on this Clean Spaces App journey, a lot of people are asking me why the software doesn’t connect up to incubators, temperature sensors, calibrated tooling, etc. And a few have even told me that the Clean Spaces App can’t possibly compete with LIMs systems already out in the market, to which I say…you are correct.
We don’t want to.
You see, anyone who has built, qualified and validated as many cleanrooms as I have will know that the room itself is every bit as important as the products being made in them. The rooms are the “package” that allows you to perform your operations, not whether you have performed your operations successfully.
Data loggers are operations.
Incubators are operations.
Product data are operations.
Sterile filling is operations.
Coating is operations.
Packaging is operations.
Form-fill-seal are operations.
But the room in which these operations are to be performed is NOT operations. The rooms to be in a state of readiness from before operations begins, through the times that operations are being performed, to the times after operations are finished is Environmental Controls.
And to be sure, Environmental Controls covers a lot of different systems:
- Cleaning
- Disinfecting
- Particle Counting
- Microbial Growth Counting
- Pest Control
- Air Filters
- Purified and Ultra Purified Water
- Fire Extinguishers
- Audit Logs
- Charts and Graphs
Each of these categories above, are usually handled by operators, QA, facilities, etc. The different systems are all part of a collective set of activities that are needed to ensure that the facility itself is following the regulations directing manufacturers to qualify and maintain the rooms according to the FDA, ISO standards and the company’s own SOPs.
This is what Clean Spaces App aims to do…ensure that the facility follows the directives from regulatory agencies to ensure manufacturing, cleanrooms, and labs spaces are ready to begin operations and consistently meet expectations of those regulatory authorities. This, in turn, ensures that the products being made in these qualified facilities have proof – objective evidence – that the operations being performed in these rooms are safe, effective, and give the company the best chance at putting out product that meets specifications.
In looking over Warning Letters from the FDA, it is readily apparent that many companies either forget or fail to maintain objective evidence of each of these categories above because there is no software on the market that brings all Environmental Controls data together in a digitized format, ready for data analytics. Clean Spaces App is truly a first-of-its-kind software that is sorely needed in industry. And not just one industry…ALL industries that have to maintain controlled spaces to perform regulated activities.
Mark Proulx has been working in the Medical Device and Pharmaceutical industries for over 30 years. His company, Clean Spaces App LLC, has been involved in developing a patent pending cleanroom management application that automates the process of providing objective evidence to regulatory authorities for companies to prove cleanroom compliance by automatically recording, analyzing , and outputting the data that is collected by staff on a routine basis. Areas to be inputted and outputted are Cleaning, Disinfecting, Particle Counts, Micro Counts, Audit Logs, Charts and Graphs, and training tutorials. For more information on the app, go to: www.cleanspacesapp.com
