“A remote counting
system is generally less
invasive than portable
counting units”
- FDA Guidance for Industry
In addition to significantly improved data, there is a
secondary financial benefit to continuous monitoring key
areas. ISO 14644-2 permits the interval between formal,
and expensive, certification of areas to be extended beyond
the stated six months for ISO Class 5 areas and 12 months
for ISO Class 6, 7, 8, or 9 areas. Although the longest period
that regulators might be comfortable with a user not having
certified a key area would be about 24 months, this still
would mean only one certification over two years. For a grade
A, ISO Class 5 area, four certifications in 24 months is the
specified requirement.
Continuous or nearly continuous airborne particle
monitoring can be an effective aid to maintaining the stability
of a process and the quality of a product. Choosing the key
points where the product is exposed and vulnerable as sampling
points will provide solid information to help ensure the quality
of a product. |
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| specifications︰ | CGMP Pharm Particle Monitoring System
• 0.1-1.0£gm; 0.3-10 or 25£gm ·L²É¤l¶q´ú½d³ò¡C |
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