A Quantum Leap for Contamination Control: Moqlero Generation 10 Sets New Standards in Cleanroom 4.0.
We are proud to announce the official roll-out of Moqlero Generation 10. This version marks not only a technical milestone but is the cumulative result of years of innovation and close partnerships with globally active pharmaceutical companies. In an era where regulatory requirements such as EU GMP Annex 1 2022 have massively raised the bar for sterile environments, Moqlero Generation 10 delivers the technological answer to the most complex challenges of the Contamination Control Strategy (CCS).
The Platform: High-Availability GxP Backbone in the Cloud
The foundation of Generation 10 is our cloud architecture.
Seamless SAP Integration: The Bidirectional Compliance Bridge
Moqlero Generation 10 acts as an integral part of your ERP. Via an API interface, the system synchronizes all relevant data and orders directly from SAP. This completely eliminates the error source of "manual transfer". Auto-Feedback-Loop: As soon as a measurement is completed on site, the signed logs and results are automatically reported back to SAP. This ensures the digital compliance chain remains seamlessly closed.
The Spectrum of Methods: 14 Ways to Total Control
With the introduction of special algorithms for EU GMP Annex 1, Moqlero now supports a wide spectrum of 14 dedicated measurement methods that go far beyond simple particle counting:
Particles
Classification and monitoring according to ISO 14644 in "at rest" and "in operation" states, including the determination of particle concentrations in gases.
Filters
Automation of filter/DEHS tests for differential pressure, filter scan tests, and leak tests or local secondary measurements. Parallel control of two particle counters and automatic calculation of the penetration rate including reporting and trending according to ISO 14644-3. Fully digital.
Air Measurements
Air exchange rate and overflow for the determination of air exchange rates (ACH) as well as digital documentation with deviation procedures.
Physical Environment
Temperature and humidity for the precise recording of room climate parameters as well as specialized compressed air measurements (residual oil content and pressure dew point/DTP).
Further Innovations
Digital special methods for cleanup duration (GMP Annex 1), recovery times, and laminar flow characterizations.
Trending & Analytics
Moqlero offers comprehensive trend analyses for all quality-relevant parameters: particle counts, filter integrity, differential pressure, physical environmental conditions as well as air exchange rates and overflows. This gives you full control over process stability.
Audit Trail & CSV Documentation
Integrated export function for audit trails in CSV format or as a PDF report. This enables a seamless review history and archiving according to 21 CFR Part 11. Software qualification and validation? No problem, we provide the documentation.
Deviation Management
Centralized recording and tracking of limit violations (OOS/OOT). Every deviation is documented directly in the process and enables a rapid response.
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Full logging of master data changes including GxP justification for an audit-proof history.
Automatic Reports & Documentation
Scheduled generation and automated storage of reports.
Digital Workflows & Electronic Signature
Implementation of digital approval workflows with electronic signatures for re-measurements and corrective actions.
Moqlero Generation 10 is much more than a tool – it is your partner for uncompromising GxP compliance in the digital age. We invite you to shape the future of contamination control together with us.
Stay tuned – Moqlero Generation 10 redefines the future of cleanroom compliance.