How to meet GMP in twenty minutes

Published: 18-Nov-2004


Since September 2003 EU regulations have required pharma manufacturers to take larger air samples.

Where 1ft3 was adequate for portable particle monitoring, 1m3 is now required per zone, increasing the time needed to process the sample to 35 minutes. According to Particle Measuring Systems, the Lasair II 550L reduces these increased labour costs by using a flow rate of 50 litres/minute, thereby sampling 1m3 in just 20 minutes.

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Analysis

The case for a facility monitoring system

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In regulated manufacturing, monitoring environmental conditions and critical equipment is essential to protect product quality, yield, and patient safety. Facilities often use a Facility Monitoring System (FMS) to track factors like airborne particles, temperature, and humidity. Beyond regulatory compliance, FMS delivers real business value through reduced waste, improved yield, higher quality, and greater profitability

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Analysis

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In regulated manufacturing, monitoring environmental conditions and critical equipment is essential to protect product quality, yield, and patient safety. Facilities often use a Facility Monitoring System (FMS) to track factors like airborne particles, temperature, and humidity. Beyond regulatory compliance, FMS delivers real business value through reduced waste, improved yield, higher quality, and greater profitability
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