Cell and tissue ISO-5 (grade B) laboratory as an example of a cleanroom facility and infrastructural aspects of facility management in the maintenance of the GMP laboratory

Abstract

The subject of this thesis is an analysis of cleanroom facilities, its functions, purpose, technical aspects and maintenance challenges. Also, the infrastructural side of facility management in the maintenance of the such GMP laboratory will be mentioned and examined. The primary hypothesis of this work is to study that introduction of the energy-saving mode of operation of the ventilation unit in an ISO-5 cleanroom laboratory at rest does not significantly affect the classification of air cleanness by particle concentration. Questions that will be answered in this thesis focus mostly on how the amount of particle concentration changes during the energy-saving mode of operation of the ventilation unit and how it affects the operating costs of the laboratory based on comparative analysis? Moreover, is the classification of air cleanness in line with the guidelines of the PN-EN ISO 14644 and EU GMP standard? Chapter one is an introduction to the topic. It will explain all the basic of what a cleanroom facility is. What is its purpose and what standards have to be used in order to work in such an environment? Chapter two is dedicated to the Jagiellonian Center of Innovation (JCI) in which Cell and Tissue Laboratory was developed and build. All technical aspects, such as cleanroom technology, HVAC, architecture, etc. will be described, based on a real example. Chapter three will describe all the challenges and difficulties that facility managers have to deal in case of running such a cleanroom facility. Aspects like GMP standards, 24h environment control and all other specialized services like IT, EMS, cleaning, maintenance, logistics, devices calibration, etc. will be examined. Chapter four will focus on an experiment that proves that introduction of the energysaving mode of operation of the ventilation unit have no significant effect on air cleanness by particle concentration. Also, an operating cost analysis will be introduced. Based on the data and the analysis outcome the optimization model will be developed. Furthermore, real savings emerged from the optimization of operating costs will be presented.