Documente Academic
Documente Profesional
Documente Cultură
of Tablet Compression
Tools and Press
PARTHIBAN ANBALAGAN
PHARMACEUTICAL MANUFACTURING
CONSULTANT
q ICH Guideline Q7
q Clearly define product contact q Dirty Hold Time / Clean Hold Time
surfaces
q API/Excipient contaminants
q Lubricants
q Cleaning agents
q Microbial contaminants
Source: https://natoli.com/products/punches-and-dies/multi-tip-punches/
Tablet chute
q Rinse sampling
q Solid residues
q Metal discoloration
Source: http://www.intertest.com/borescopes/-hawkeye-v2
q Functional locations
- Contact surfaces
q Difficult-to-clean
locations
q Sites of product
migration
q Volume
q Time
q Sampling solution
Source: http://www.biocontrolsys.com/products/view/MVPS
Source: http://www.pharmaceutical-technology.com/contractors/cleanroom
Source: https://natoli.com/products/tablet-presses/np-500/