Milestone in Cleanroom Digitalization: Moqlero Generation 9 is Live.
The release of Moqlero Generation 9 marks a significant advancement for the pharmaceutical industry. It is far more than just an update – it is the consistent evolution into the leading IT platform for automated, discontinuous cleanroom monitoring. In this special edition, we present the full range of functions and tactical advantages that make Moqlero the new industry standard.
The Vision of Cleanroom 4.0
In the highly regulated world of life sciences, environmental monitoring was long characterized by manual processes. Thermal paper printouts, handwritten logs, and the tedious transcription of data into Excel spreadsheets were commonplace. With Moqlero Generation 9, this is a thing of the past. Our vision is "Cleanroom 4.0": A connected ecosystem where data integrity is technically enforced, allowing experts to focus on analysis rather than data collection.
Technological Excellence: Cloud-Native and High-Performance
The architecture of Generation 9 was redesigned from the ground up. Based on a state-of-the-art AWS cloud infrastructure, Moqlero offers scalability and cost-efficiency unattainable by traditional systems. By switching to a serverless architecture, we reduced ongoing operating costs for server maintenance by up to 64%.
The Core: 12 Validated Measurement Methods
Moqlero is the Swiss Army knife for cleanroom measurements. We support 12 different, fully validated measurement methods covering all relevant parameters:
- Particle Monitoring & Classification: Fully automated routine measurements (In Operation) as well as classifications (At Rest) according to ISO 14644-1, where acceptance criteria can be flexibly configured by specialized personnel. Particle counters are configured, controlled, and read out fully automatically, with results evaluated and recorded directly in the system.
- Filter Integrity Testing (DEHS): Digital execution of integral measurements, scan tests, and leak tests (local re-measurements) according to ISO 14644-3. This process controls two measuring devices in parallel on the raw and clean air sides. Based on stored master data such as dilution factor, probe geometry, or scan speed, the system automatically calculates the required minimum upstream concentration. Evaluation is performed according to ISO 14644-3 and validated automatically through the corresponding separation rates. Additionally, the differential pressure for determining filter resistance is recorded digitally.
- Laminar Flow (UDAF) & Flow Velocity: Precise grid measurements for validating flow velocity and uniformity can be digitally recorded and evaluated. The system supports complex grid layouts and calculates statistical metrics live.
- Recovery Time & Cleanup Test (ISO vs. GMP): Moqlero differentiates precisely between Recovery Time determination according to ISO 14644-3 and the Cleanup Test according to EU-GMP Annex 1. Both methods are fully digitized and validated to prove the cleanroom's cleanup capacity after planned or unplanned contamination.
- Airflow Visualization, Overflow & Air Exchange: Digital documentation of smoke studies, overflow measurements, and calculation of volume flow and air exchange rates are integral parts of the system. All results are immediately visualized and evaluated.
- Physical Environmental Parameters: Supplementary physical parameters such as temperature and relative humidity can be captured directly at the measurement point and integrated into GxP reports.
Hardware Automation: Vendor-Independent Hub
One of Moqlero's strongest unique selling points is its manufacturer-independent device integration. We break the "Vendor Lock-in." Moqlero communicates bidirectionally with particle counters from Lighthouse, PMS, Met One, and Climet.
- Recipe-Push & Remote Control: Sampling recipes (volumes, times, alarms) are configured centrally and pushed to connected devices with a click. The operator starts the measurement directly from the Moqlero interface – technical configuration errors at the device are impossible.
- Zero-Count Verification: Before every critical measurement series, the system can mandate a zero count. Only after successful proof of a clean optical system is the device unlocked for the active order.
Enterprise Connectivity: SAP S/4HANA Integration
Moqlero is not a data island. Via our modernized SAP connector, we connect your process assurance directly with your business processes. Measurement orders from SAP are imported automatically; results are reported back immediately upon completion and electronic signature.
Compliance Without Compromise: GAMP 5 & ALCOA++
Security and compliance are in Moqlero's DNA. The system has been classified by independent bodies as GAMP 5 Category 4 (COTS - Commercial Off-The-Shelf). For you, this means a massive simplification of software validation (CSV), as you can rely on our extensive standard documentation and audited test protocols.
- Full ALCOA++ Conformity: Data is attributable, legible, contemporaneous, original, and accurate. Additional cryptographic signatures at the record level guarantee immutability according to FDA 21 CFR Part 11.
Smart-Task & Proactive Management
With the integrated Smart-Task module, Moqlero becomes a proactive assistant. The system automatically monitors calibration cycles for your entire fleet and sends timely email reminders. Expired devices are automatically locked for measurements to prevent OOS events due to invalid equipment from the start.
Sustainability and Efficiency through Paperless Maintenance
Digitalizing your cleanroom processes also contributes to sustainability. By completely eliminating thermal paper and manual reports, we reduce the ecological footprint while increasing operational efficiency enormously. Administrators no longer spend time scanning documents and can immediately use data for trend analysis and process optimization.
Conclusion: Ready for the Future
Moqlero Generation 9 is the result of over two decades of experience in cleanroom monitoring and feedback from hundreds of specialists worldwide. It offers a robust, scalable, and above all, future-proof platform that meets the highest demands of the pharmaceutical industry. While we are already working on revolutionary features for Generation 10, Generation 9 invites you to take the next step in your cleanroom's digital transformation today.
Contact us for a personal demo and find out how Moqlero strengthens your compliance and reduces your costs.
Experience the new performance class in monitoring – upgrade now to Generation 9.