Moqlero Expands to the USA: New Production Site
September 08, 2026
Moqlero is expanding into the United States: one of the world's largest pharmaceutical groups is building a new multi-billion-dollar production site on a greenfield area, with completion by 2029. From the very first planning phase, Moqlero is designated as the platform for cleanroom qualification, recertification, and discontinuous monitoring.
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Documentation of Activities During In-Operation Measurements: Signature or Witness
September 02, 2026
Anyone working in the cleanroom during a measurement now documents their activity in a dedicated activity list per sampling location group. The type of confirmation is configurable: either a handwritten signature or confirmation by the operator performing the measurement acting as a witness. Activities can be described with up to 300 characters.
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PDF/A-3b as the Standard: Signed Reports Still Readable in Ten Years
August 26, 2026
Reports from Moqlero are now generated as PDF/A-3b according to ISO 19005-3 by default – with embedded fonts, an embedded sRGB colour profile and the PDF/A identification in the metadata. The cryptographic signature is additionally anchored in the document as a visible, clickable signature field. What this means for retention, how long term validation fits in – and where the limits are.
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ISO 14644-2: From Test Schedule to Risk-Based Monitoring Strategy
August 12, 2026
ISO 14644-2 answers the question that follows classification: how do you demonstrate that the cleanroom retains its qualified state? The standard requires a monitoring plan derived from a risk assessment and names maximum intervals for the periodic tests – overlaid, under GMP, by the test package and the shorter deadlines of EU GMP Annex 1.
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A New Instrument Interface – and a Foundation for All Future Ones
July 29, 2026
With the Lasair 5100, one more particle counter is fully integrated into Moqlero. The rebuild underneath matters even more: the interface framework has been unified so that new instruments can be connected considerably faster.
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ISO 8573-1: Reading Compressed Air Purity Classes Correctly
July 15, 2026
Compressed air that reaches the product is a critical utility – and under ISO 8573-1 it is assessed with three mutually independent purity classes: particles, water and oil. We show how the class designation is read, why class 0 does not mean "free of", and where measurement has to take place.
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Clean-up Test: Post-Measurements Now Always Take Place
July 01, 2026
Until now the post-measurements of a clean-up test were only triggered if the cleanliness class limit had previously been exceeded. From now on they run in every case – including the unremarkable one. The clean-up time still remains 0, but the evidence is complete.
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ISO 14644-3: Measuring Recovery Time Correctly
June 17, 2026
The recovery test is one of the most demanding procedures in cleanroom qualification: a defined initial concentration, a clean decay curve, a defensible 100:1 time. We explain the procedure according to ISO 14644-3, the typical pitfalls – and the difference from the clean-up period under EU GMP Annex 1.
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Filter Test Formula Display: Every Calculation Traceable at the Click of a Button
June 03, 2026
Every installed filter leakage test involves several calculations – from the upstream challenge concentration and the scan rate to the permitted penetration. Moqlero now displays these formulas exactly where the parameters are maintained: as a tooltip on the input field and in a dedicated formula window.
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ISO 14644-1: How Many Sampling Locations Does a Cleanroom Really Need?
May 20, 2026
Number of sampling locations, minimum sample volume and the removal of the 95 % confidence limit – the classification rules of ISO 14644-1 have become clearer since the 2015 edition, but in practice also stricter. An overview of the decisions that govern every classification measurement.
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Moqlero Featured in REINRAUM ONLINE Article: Trending under GMP Annex 1
April 20, 2026
The largest German-speaking cleanroom portal, REINRAUM ONLINE, has published a feature article on trending under GMP Annex 1 — and highlights Moqlero as a practical example of automated, Annex 1-compliant trending.
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New Acceptance Criterion for Airflow Direction Tests
April 07, 2026
Moqlero now offers a fourth acceptance criterion for the digital airflow direction documentation (smoke test): "Overflow Only". It allows highly critical areas to be assessed even more strictly – wherever only a clearly directed airflow may be accepted as a pass.
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Trending per GMP Annex 1: Compliance in Under One Minute
March 20, 2026
The revised GMP Annex 1 makes regular trend reviews a binding requirement. For many companies, this means a significant effort in creating and regularly reviewing trend reports. This is exactly what Moqlero offers six specialized trend types for, enabling complete, signed trend reports including comments and assessments to be generated in under one minute.
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Moqlero Featured in the Yearbook of the Largest German-Speaking Cleanroom Journal
March 05, 2026
Moqlero has been selected for the yearbook of the largest German-speaking cleanroom journal in the Know-How / Practical Examples category. A special recognition of our contribution to the digitalization of discontinuous cleanroom monitoring.
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Data Integrity by Design – How Moqlero Ensures Data Integrity from the Ground Up
February 27, 2026
Data integrity is not a feature you bolt on after the fact – it must be embedded in the system from the very beginning. Moqlero was built exactly this way: with cryptographic signatures, a seamless audit trail, and full ALCOA++ conformity as an integral part of the architecture.
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