We can deliver a complete package from development and execution of engineering studies and protocols for pharmaceuticals and biologics to creation of standard cleaning procedures, logs and training documentation.
CapabilitiesPharmaSys has extensive experience in developing defensible acceptance criteria and ensuring the execution is conducted in an orderly manner. Our highly skilled individuals can ensure that equipment-cleaning procedures are removing residues to pre-defined levels of acceptability. Our approach involves:
- A complete understanding of regulatory FDA requirements, guidelines and expectations.
- Selection and evaluation of effective cleaning methods and processes.
- Establishment of residue limits and calculation sample acceptance criteria.
- Selection of sampling and analytical methods.
- Simplification of the cleaning validation program.
- bioburden and pyroburden (analysis and sample recovery).
- detergent residuals (analysis and sample recovery).
- drug substance/product residuals (sample recovery).
- Solid Dose: encapsulating Equipment and Tablet Compression Equipment
- LCO: Blending Tanks/ Kettles, & Fillers.
- Parenterals: Portable Tanks, Vial and Ampoule Fillers, Lypholizers.
- Components: Stopper, vial and ampoule Washers.