Industry / Pharma and GMP
GMP Annex 1 — pressure cascade without validation stress
The revision of EU GMP Annex 1 (2022) tightened requirements for the continuous pressure cascade in aseptic areas. Gapless documentation, clear differential values, displays readable at any time. We deliver mechanical instruments that have met these requirements for over 30 years at Bayer, Novartis, and Vetter — without ever needing a software patch.
A
What GMP Annex 1 requires
- Controlled pressure cascade between cleanroom classes with documented minimum values
- Continuous monitoring and loggability of the differential pressures
- Alerting on excursion of limit values
- Risk-based validation of the measurement technology used
- Visibility of current values on site for operating personnel
B
Why the ring balance is GMP-audit-resistant
The measurement rests on a fixed weight and on geometry. Both quantities are documented in the design records and do not change. Drift is physically impossible. Re-calibration intervals can be generous, and validation documentation is manageable — no firmware, no software updates.
C
Technical parameters
D
Recommended products
Trusted by
Vetter-Pharma, Bayer AG, Novartis AG, EBEWE Pharma, WEISS-Pharmatechnik, RHÖN Klinikum Bad Neustadt. Some of these units have run for over 25 years without intervention.
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