MIRRHIA FACILITY® – Environmental Monitoring for Pharma
MIRRHIA facility®
Centralize All Your Measurements
- A turnkey and qualified solution
- Multi-technologies & multi-sites
- GAMP 5 Category 4, FDA 21 CFR Part11, EU GMP Annex 11
When we look at deploying an Environmental Monitoring System (or EMS but also called FMS for Facility Monitoring System) in the pharmaceutical industry or in hospitals, we know that one of the biggest challenges will be to comply with the most stringent regulations. If we consider that the rules are extremely strict in the pharmaceutical industry, we’ve noticed that the regulations in hospitals have been reinforced and that more and more services within hospitals are monitored (such as fertility center, hospital pharmacy, operating room, etc.).
Another challenge is to provide our client with a solid and robust solution able to centralize all their data and access it in real-time with no data loss. What these industries want to get is a configurable, scalable, and expandable solution while being easy to deploy.
And when it comes to choosing a solid and robust EMS/FMS solution, Mirrhia meets all the criteria with MIRRHIA FACILITY®.
mirrhia facility®
What’s Great About it
MIRRHIA FACILITY® is an off-the-shelf solution, a packaged solution. Mirrhia combines the industrial robustness while offering state-of-the-art technology. Mirrhia offers the best of computing by being able to connect to traditional industrial equipment via a user-friendly and configurable web interface.
Here are some of the greatest benefits of our environmental monitoring system:
Contamination Control
MIRRHIA FACILITY® natively supports particle counters (mobile or stationary) and air samplers. This is a major asset in regards of your Contamination Control Strategy.
Compatibility
MIRRHIA FACILITY® is compatible with major brands of probes, sensors, and equipment. Its flexible architecture allows you to add any new material without interrupting your production.
Robustness
Thanks MIRRHIA FACILITY® and its combination of buffering PLCs and IO servers (redundancy & no data loss guarentee), you get full control over your entire installation.
Qualified Solution
MIRRHIA FACILITY® is an off-the-shelf pre-qualified software. It is GAMP5 Category 4 & 21 CFR Part 11 ready. The FAT (Factory Acceptance Test) of Mirrhia has already been executed.
Electronic Batch Records (EBR)
With MIRRHIA FACILITY®, you monitor your equipment and controlled environments and automatically publish your Electronic Batch Record also known as EBR.
User-friendly
Thanks to MIRRHIA FACILITY® and its ergonomic web interface, you’re free to adapt your configuration to the environment without any additional development.
mirrhia facility
A Unique Set of Key Features
- With MIRRHIA FACILITY®, you easily manage your sensors, your pressure cascades, and your particle counters that you control remotely.
- With MIRRHIA FACILITY®, you manage your mobile sampling campaign from A to Z in Mirrhia.Imagine one of your operators moving from one room to another with a mobile particle counter, scanning the areas he took the samples from, then coming back from his tour, connecting his counter to Mirrhia, and uploading all the collected information in just a second. Well, that’s now feasible with MIRRHIA FACILITY®.
- As formulated in the FDA 21 CFR Part11 and EU GMP Annex 11, the required audit trail is available in Mirrhia. It ensures data integrity by providing critical information about the entire lifecycle of a product. The reason for change is implemented in the system for full compliance.
- MIRRHIA FACILITY® ensures the easy tracking of your batches and environmental data. It monitors your equipment & environment. You can generate the environmental part of your Electronic Batch Record (EBR) automatically.
- MIRRHIA FACILITY® provides you with a task manager module associated to your environment meaning you can link tasks to your equipment, your room, etc. The task could be for instance cleaning a fridge. The other great thing with our task manager module is that you can generate qualified reports in case of audits.
- MIRRHIA FACILITY®’s predictive maintenance turns your EMS into a proactive solution. You detect incidents and out-of-control conditions before it happens while Mirrhia generates intelligent notifications helping you to anticipate and to prevent future deviations.
mirrhia facility®
An Infinite Connectivity
Equipment
Sensors and probes
MIRRHIA FACILITY® integrates all type of sensors (Radio Frequency, Wi-Fi and wired) and probes from a large range of brands available on the market, to monitor your equipment, air quality or rooms.
At Mirrhia, we provide, configure, and qualify all measurement components and instruments.
Particle counters
MIRRHIA FACILITY® manages most types of stationary or mobile particle counters either via Ethernet network or serial connection.
MIRRHIA FACILITY® supports most counters currently available on the market and could support without specific development any new counter with an Ethernet connection, regardless of its communication protocol.
As we want to respond to your needs, we propose a catalog with all the equipment that we provide you with and which is compatible with our EMS system. If you want to receive our catalog, contact us now.
Automate or PLC
Of course, we can’t talk about MIRRHIA FACILITY® without mentioning automate (or PLC) which is an industrial component used to communicate, control, and monitor automated processes. This ensures industrial robustness. Mirrhia is compatible with most type of PLCs and is therefore able to exchange analog and digital signals.
Alarms
When it comes to alarms, there are 2 things to mention here. First, how you get notified and then how you access the information regarding those alarms.
Notification
Alarms are natively managed in MIRRHIA FACILITY®: light beacon flashing, horn activation, alarm reporting to an external system (GTC type) and sending emails or SMS (text message).
To avoid temperature excursions which could damage your product, different sets of alarm thresholds and delays can be configured. Alarms can be disabled automatically (e.g., during decontamination phases).
Desktop popup notification are also available to ease your operators’ life and to allow faster interventions on site.
Consultation
Alarms are accessible through various screens according to your needs. You can choose the way you want to check it with different available views.
• Real-time alarms with filtering capabilities
• Alarm follow-up and acknowledgment with filtering capabilities
• Alarm history
• Alarm reports: configuration according to the needs of each user
Reports
A great asset of our solution is reporting. MIRRHIA FACILITY® is designed to run reports, to archive and to print it both automatically and on demand.
From displaying data to exporting it, we give you a large choice of format to pick from.
License
SCADA solutions have built a license scheme which fees increase based on the number of measurement points (aka tags) and the number of users.
Mirrhia proposes a simple and transparent license scheme that comes with no surprise. You connect as many users as you want through the web-based interface without any extra costs.
Mirrhia facility®
How Does it Work ?
You got it. Once MIRRHIA FACILITY® is running, you’re able to monitor everything and most importantly all your measurements are centralized in a robust and flexible solution.
With MIRRHIA FACILITY®:
- You keep full control over your sensors and check your sensors status and change their parameters online.
- You keep your pressure cascades under control to make sure your products are strictly confined.
- You manage and remotely control your particle counters with ease.
- You track the activity of each user (audit trail).
- You manage your mobile sampling campaign from A to Z in Mirrhia.
- You access your data quickly and easily via shortcuts and research tools.
And much more, etc.
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Get in Touch With Our Expert
Whether you have questions, feedback, or want to discuss your project with us for your company, our team is here and ready to answer.