1 EMS (ENVIRONMENTAL MONITORING SYSTEM)
This is what a particle measuring system is used to offer to customers (Monitoring)
Frequently call FACILITY PRO as well as FMS (FACILITY MONITORING SYSTEM)
2 BMS (BUILDING MANAGEMENT SYSTEM)
Automation in the pharmaceutical world is managed by BMS (BUILDING MANAGEMENT SYSTEM) which are typically systems differently from EMS is a monitoring system
Can control many different things like security access, lighting, HVAC system, fire control
Widely used in a modern system or modern facility
3 LIMS (LABORATORY INFORMATION MANAGEMENT SYSTEM)
Software that handles samples by verifying of sample and quality of the product within the laboratory
Very important when we talk about Product Batch Release. Typically at the end of the measurement. Software from where you detect whether the product is ready to go can be released or not
Questions and Answers
What the main differences are and what particle measuring system offers to the pharmaceutical user?
The main product is Facility Pro and it combines the Acquisition of data from particle counter, Microbial sampler Environmental sensors such as temperature humidity pressure
EX With a number of different automation skills to connect with a filling machine to be able to start-stop in case of an alarm and as well reporting which is extremely important when you need to get your data out of your computerized system and being able to release your batch or why not identify any adverse condition and prevent those to happen again
The main difference between the BMS and with building management system is that they are the environmental monitoring system, they are in charge of handling your critical data. They are in charge of monitoring instead of controlling managing a bunch of other areas of the building
EMS (ENVIRONMENTAL MONITORING SYSTEM) and BMS (BUILDING MANAGEMENT SYSTEM) are very similar. Is this a correct assumption?
Answer: Sometimes this is misinterpreted. Considering BMS and EMS the same thing or overlapping may lead to mistakes and longer validation and difficult customization.
The recommendation is to choose the right one.
When someone is approaching a new cleanroom construction which one should they choose EMS or BMS?
Answer: Both because you can’t really build a modern facility without a BMS (Safety, fire control, lighting, HVAC system,..)
EMS is in charge of handling your critical data
BMS is in charge of controlling all the automation that is typically not critical for the release of the product
Each one for the specific application
Do you think there should be separate control systems or should it be all together in one?
Having 2 systems doesn’t mean that they are not able to talk to each other. Considering Having 2 systems is also a good way to approach any future development with a clear risk mitigation pathway in mind.
Relying on a single system may be nice when you envision that I have everything combined with this nice and user-friendly software but you should always think about what happened if this system failed or this system has a problem or even simpler if I need to upgrade this system If I need to do maintenance of this system. So, all of a sudden you may have the entire facility holding on or shut down. While adding those separated, first of all, give you more flexibility, give you better management of the data itself
EMS systems are really designed to provide data outcome and data quality so that’s another aspect to keep in mind
Is the term that somehow we would build that particle measuring system and our way to move a little bit aside from the common concept of data integrity, we always talk about data integrity how the data should be securely stored and inaccessible if you don’t have the right username and password and so on about CFR21 part11
Data quality is going further to the concept of transforming that huge amount of data into information (Can convert a single piece of data from a particle counter from a temperature of sensor microbial sampler into a multivariate analysis with the trend, report and so on then it’s the time when you get the information in your hand and the information help you to increase your knowledge, and prevent the adverse condition, improve your process, improve the quality of the product of your production). This is typically something the BMS is not designed for (It’s super good in handling complex automation and managing a different kind of system under customized environments). When we talk about Data, a dedicated system that knows what we are talking about, knows the standard, regulation, iso standard, GMP standard. When it’s time to handle those data according to the regulation that is where a dedicated system will play the difference