Particle monitoring to meet USP 797
by Particle Measuring Systems
This white paper by Particle Measuring Systems reviews the requirements for non-viable particle limits and the monitoring of areas where the product is exposed. It addresses U.S. Pharmacopeia 797, which describes procedures and requirements for compounding sterile preparations and defines critical site environments that must meet the international standard for cleanliness to ISO14644-1 Class 5, where no more than 3520 particles at 0.5 µm are present per cubic meter of sampled air. The supporting area and monitoring frequency, along with ISO classes, are also briefly discussed.
| Published: | 2006 |
| Format: | |
| Length: | 4 pages |
| Type: | White paper |
| Language: | English |
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