We provide Physical Validation of Third-Party Equipment (Performance Qualification – PQ and Operational Qualification OQ) for the Pharmaceutical Industry, Medical Devices Industry and Primary Care Medicine Industry, among others.
Testing. The validation process includes testing with thermal and humidity profiles in order to verify and document that these tests are performed repeatedly and meet required acceptance criteria. Quoting Quality Management System Standard ISO 9001:2008 7.5.2: "It is necessary to validate processes where the resulting products cannot be verified using follow-up activities or subsequent measurement"
Defining the plan. To this end, and jointly with the customer, we define the requirements that must be covered by the validation plan that will be implemented.
In situ measurement. Later, our technicians coordinate a visit to your facilities. There, they study the distribution of temperature in the empty chamber and penetration of heat in different batches, using state-of-the-art, wireless and inherently safe measurement equipment that can adapt to any type of process or equipment and that is calibrated according to international standards.
Analysis and results. Lastly, the data obtained from the measurements taken in the chambers are processed using specific software, which generates a final report that is delivered to the customer along with the documentation that supports the work performed.
A validation plan consists of the following stages:
Is my equipment properly installed?
Documented verification that all important aspects of equipment installation are correct and meet manufacturer instructions.
Is my equipment operating correctly?
Documented verification that the equipment and subsystems are operating within the preset operating ranges. The results of each test must meet what is stipulated in the corresponding regulations.
How will be my batch behave?
Documented verification that a process works safely, effectively and repeatedly, within predetermined ranges.
Process validation is conducted using the following international standards as guidelines:
Steam Sterilization. Requirements for development, validation and routine control.
Ethylene Oxide Sterilization. Requirements for development, validation and routine control.
General requirements for characterizing a sterilizing agent and for the development, validation and routine control of a sterilization process. Low temperature STERRAD 100 S® plasma sterilization system.