Critical Media Monitoring: Why Compressed Air Quality is Crucial.
In pharmaceutical manufacturing, compressed air is often more than just an energy carrier – it is a direct process component ("Direct Impact Utility"). Contamination by oil aerosols or moisture can contaminate sterile products and endanger entire batches. The ISO 8573-1 standard therefore defines strict purity classes for particles, water, and oil. Moqlero now seamlessly integrates this monitoring into your Contamination Control Strategy (CCS).
Precise Monitoring and Alarming
Track your compressed air parameters and benefit from the following features:
- Smart Alarming: The system allows for customer-specific definition of acceptance limits. In the event of a violation, direct notifications are automatically sent via email to the responsible personnel – enabling rapid countermeasures before product quality is compromised.
- Integrated Deviation ManagementNo alarm is lost. Every limit violation automatically generates a deviation record in the system. This opens a new workflow, which consists of evaluation and commenting of the incident as well as an electronic signature. Triggering a documented repeat measurement is possible.
Automated Reporting & Trending:
In addition to pure alerting, Moqlero offers automatically generated trend analyses. These visualize the long-term progression of dew point and oil content to detect creeping changes at an early stage. The creation of these complex evaluations is fully automated upon manual trigger.
Data Integrity according to ALCOA++
As with all Moqlero measurements, the highest data integrity according to ALCOA++ applies here. Raw data from compressed air sensors is cryptographically secured immediately upon acquisition and is therefore unmodifiable and protected against manipulation.
Audit-Ready Reporting (21 CFR Part 11)
Manual documentation effort is eliminated. Moqlero generates trend reports at the push of a button as well as event-based reports for compressed air quality. All reports are static PDF/A documents and fulfill the requirements of ISO 19005, GMP / GAMP 5, EU Annex 1 as well as FDA 21 CFR Part 11. Thus you are always ready for inspections and audits.