Displaying items by tag: qualification
Qualification tests are carried out to guarantee optimum product quality from all manufacturing and pharmaceutical research companies. These tests verify whether ambient cleanroom conditions affect product quality. If environmental cleanroom parameters affect the product, reviews are conducted with regards how conditions can be reduced, so that high output standards are adhered to.
Cleanroom Validation Life Cycle
Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment.
Phase Two: Installation Qualification
The purpose of this Installation Qualification (IQ) phase is to confirm through verification that equipment — as installed — confirms to user requirements and design requirements. Verification is focused on the following items that should be called for in your IQ protocol:
Phase Three: Operation Qualification
The objective for this Operational Qualification (OQ) phase is to show through objective evidence that the cleanroom operates in conformance with design requirements and user defined requirements, and that it consistently operates within a defined range of conditions.
Phase Four: Performance Qualification
The purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom consistently operates within defined parameters to produce the defined, desired environmental outcome. Cleanroom performance qualification involves testing and monitoring of the following:
Qualification of an aseptic processing facility is a complex project including qualification of the cleanrooms in the facility, IQ/OQ/PQ of the equipment and utilities in the facility, airflow visualization studies, personnel training and qualification, aseptic process simulations, process validation, conformance runs, and other validation activities. This article focuses on the activities involved in certification and qualification of the cleanroom itself.