Knows air condition technology GmbH - qualification of RLT plants in pure areas

GMP fair pure areas are in the pharmaceutical, partly also in the food and Kosmetikindustrie of central importance, in order to make a germ-poor and/or even sterile working possible. This is reached among other things by special ventilation and appropriate structural measures e.g. during the execution of walls, covers and floors. The qualification of the room air-technical plant is a component of validating the pharmaceutical manufacturer for its pure space production plants. It serves the proof in agreement with the principles of good manufacture practice (GMP) that articles of equipment, materials and systems actually to the expected results lead. The following qualification steps know inclusive documentation for the construction units as regards ventilation as consultation, in addition, with a complete execution of the qualification and/or.Parameter to be accomplished: • qualification master plan/Qualification master plan (QMP) • risk analysis/Risk analysis (RA) • Design qualification/Design Qualification (DQ) • installation qualification/installation Qualification (IQ) • function qualification/operational Qualification (OQ) • achievement qualification/performance Qualification (PQ) • Requalifizierung/RH-Qualification (ReQ) each qualification documentation is divided in principle into three stages: 1. Flat/objective 2. Minutes/measurement and/or examination and documentation 3. Report/evaluation for all work must the current sets of rules and guidelines, e.g., valid for the project, PharmBetrV, AMG, European Union GMP manual, PIC, FDA guidelines, DIN standards (e.g. DIN EN ISO 14644) are considered, VDI recommendations (e.g. VDI 2083).To qualification services for plants of the whites air condition technology GmbH belong: • execution of prospektiven qualifications with the new or change of the condition qualified by systems and plants • retrospective qualification with plants already existing • examination of existing plants on GMP conformity • planning of the qualification over all qualification phases (DQ, IQ, OQ and PQ), definition of the acceptance criteria and the measurement range (number of measuring points, frequency of the sampling), inclusive production of the necessary qualification documentation • proof of the specified pure space conditions by different measurements, e.g. category of purity proof, determining the recovery time, filter leakage test • evaluation of the measurements and documentation • support with the preservation by regular Requalifizierung (in defined time intervals or after accomplished changes) • monitorings