Cleaning Validation

The vast knowledge we have accumulated during dozens of years of experience is manifested in our expertise in planning and implementation of meticulous Quality Assurance and Control Processes in the area of Equipment Cleaning and Production Room Cleaning. 

 

 
Our services are executed with focus on the set goal, without overloading the manufacturing site or the production site, and without unnecessary costs and superfluous processes. 
 
Our expertise has been acquired in Cleaning Validationmanagement in the Pharmaceutical industry and the Medical Devices industry production lines. We have close familiarity with the unique requirements of each of these industries and have accumulated a vast experience in the strict standards of the European and the Israeli standardization, as well as the FDA. 
 
Cleaning Validation
 
Our expert services include:
  • Master Plan.
  • Optimal/best cleaning protocol 
  • Setting a process-specific required cleaning level
  • Well implemented "Worst Case" approach for residues of API's, cleaning agents, and microbial residues
  • Cleaning Validation Report for ongoing implementation at the production floor
  • Implementation of Cleaning Processes for Production Floor Employees with cutting-edge presentations
 
In addition we offer our expertise in all production processes:
  • Controlled changes in production lines 
  • Standardization change
  • Preparation of required documentation for regulatory inspections
  • Representative of the Manufacturing Site and the Company in External Regulation Inspections