Cleaning Validation

Measuring drug residue concentrations requires a customised approach to method development and validation. Our expertise has benefitted numerous manufactures resulting in regulatory compliance and peace of mind.

Chemika has many years’ experience in providing analytical support for cleaning validation studies completed by manufacturers. Manufacturers typically require the surface concentration of drug residues be determined, usually by swabbing the surface and then determining the quantity of material contained on the swab.

Validation studies are performed to determine the recovery using quantification by surface swabbing followed by extraction and analysis of the extracts. Surface recovery can be highly dependent on the method of swabbing, including which solvent is used to moisten the swab and if surfactants are incorporated. To achieve suitable method performance methods are often required to be developed for each analyte and surface combination.

Given that swab recovery is dependent on the swabbing technique, the staff who complete the swabbing need to be trained in the procedure, and their competency evaluated. Chemika is able to offer on-site and off-site training and evaluation. A system has also been developed so that with the shipping of materials to a remote manufacturing site, operators can be trained and verified as competent without the need for interstate travel.