Practical insights on pharmaceutical calibration, validation, environmental mapping, and engineering — from technicians who work in GMP facilities every day.
Practical insights on pharmaceutical calibration, validation, and engineering — written by the technicians who do this work every day.
Temperature sensor drift in a Glatt or ACG fluid bed is more common than most QA managers realize — and more consequential. Here's how we find it, document it, and fix it.
Every pharmaceutical manufacturer knows they need IQ/OQ/PQ — but many aren't clear on exactly what each phase proves and what happens if one is skipped or done poorly.
ICH Q1A gives you the conditions. FDA gives you the expectations. But how often should you actually requalify your stability chamber? The answer depends on more than just a schedule.
Proprietary SCADA systems from equipment OEMs are expensive to maintain, hard to integrate, and impossible to expand. Here's why Ignition by Inductive Automation is becoming the standard.
USP chapter 1079 sets expectations for pharmaceutical warehouse storage conditions — but the details on how to conduct a mapping study leave room for interpretation. Here's what we recommend.
OEMs like Glatt, Ohara, and ACG have excellent equipment knowledge — but their calibration and validation support isn't always their core strength. Here's how to bridge that gap.
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