Cleaning Process Validation

Cleaning Process Validation

It is costly to create individual equipment or equipment tracks for each of our same form products with different content. Therefore, the production of different products is carried out in the same equipment.

GMP regulations require the validity of the cleaning processes used in cleaning procedures.

In cases where different products are produced using similar equipment, the process of making validity for the effectiveness of cleaning processes created for equipment is called cleaning validation.

Contamination sources can be active and auxiliary substances, detergents etc. in the production of drugs.

In the production of medical devices, fat, detergent, chemicals, microbiological pollution can be.

In order to ensure product quality, we should carry out cleaning validation studies that we can define as a whole of processes that show the effectiveness of cleaning processes and processes produced using the same method/equipment, showing that the amount of the remaining amount of the product left over from the previously produced product is within the specified limits with physical, chemical and microbiological tests.

The service content of the cleaning process validation work is as follows;

  • Creation of cleaning processes and selection of cleaning agents,
  • Preparation of master plans and determination of the validation approach,
  • Determination of cleaning validation equipment, qualification compliance checks.,
  • Creation of validation procedures,
  • Worst-case scenario product selection,
  • Selection of sampling points with risk assessment approach,
  • Calculation and formulation of acceptance criteria,
  • Documentation and reporting activities,

Regulatory organization publications for cleaning validation;

  • PIC’s Pharmaceutical Inspection Co-operation Scheme
  • ISO, ASTM, etc.
  • APIC (Active Pharmaceutical Ingredients Commite)
  • GMP publications
  • Pharmacopies ( EU, USP )