Laser Particle Size Analyzer - Pharmaceutical Processing

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Laser Particle Size Analyzer

for IQ/OQ validation

Good Manufacturing Practice (GMP) Regulations require that instruments used in the manufacture of drugs be validated for (IQ) Installation Qualification and (OQ) Operational Qualification. The Saturn DigiSizer provides IQ and OQ documentation for particle size analyzer. The validation of processes, process equipment, instruments, and computer products all fall under the General Principles of Validation set forth by the FDA. Validation of the instrument is achieved by reviewing thoroughly step-by-step methods, all aspects of each stage of installation and operation. Testing, documentation, and procedures are all formally reviewed.

Micromeritics
One Micromeritics Drive
Norcross, GA, 30093-1877

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