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Cleaning Validation

• Cleaning validation ensures that specific cleaning processes consistently clean to pre-defined limits to prevent contaminants (product or cleaning process related) from leaving residues that will adulterate and adversely affect the safety and quality of the next product manufactured. Cleaning validation is documented proof of consistently and effectively cleansing a system or equipment item.

  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.

• Capabilities

• Concentric 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.
  Created SOPs and methods (analysis and recovery) for cleaning validation studies for: bioburden and pyroburden (analysis and sample recovery).
  detergent residuals (analysis and sample recovery).
  drug substance/product residuals (sample recovery).
  Drafted, executed sampling and testing cleaning validation engineering studies protocols for: 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