INTRODUCTION: Recent discoveries in cell therapy research present new opportunities for cellular products to be used to treat severe, and as yet incurable, diseases. It is therefore essential to implement a quality control programme in order to ensure that safe cells and tissues are provided. METHODS: In a preliminary phase of the setting up of a the cellfactory, monitoring was carried out monthly over a 6-month period in one out of three cell therapy laboratories and filter rooms in order to evaluate the microbial contamination of air and surfaces and the presence of airborne particulates. RESULTS: The mean total bacterial and fungal loads measured in the air in the centre of the filter room were 20.7 +/1 28.9 colony-forming units (cfu)/m3 and 9.2 +/- 15.4 cfu/m3, respectively, and 5.2 +/- 4.1 cfu/m3 and 6.8 +/- 13.4 cfu/m3, respectively, in the laboratory. The mean fungal load values recorded on the surfaces sampled in the laboratory were in 6 out of 18 cases higher than the reference values (5 cfu/plate). As to the results of particulate monitoring, with regard to the 0.5 microm particles, about 83% of the samples revealed values below the limit of 350.000 particles per cubic metre. CONCLUSIONS: In this set-up phase, monitoring was able to pick out structural and organisational flaws acceptable in a laboratory compliant with Good Manufacturing Practices class C (Annex 1), but not in a class B facility. Thanks to this preliminary monitoring phase, and by correcting these flaws, the clean room facility could achieve compliance to class B.
INTRODUCTION: Recent discoveries in cell therapy research present new opportunities for cellular products to be used to treat severe, and as yet incurable, diseases. It is therefore essential to implement a quality control programme in order to ensure that safe cells and tissues are provided. METHODS: In a preliminary phase of the setting up of a the cellfactory, monitoring was carried out monthly over a 6-month period in one out of three cell therapy laboratories and filter rooms in order to evaluate the microbial contamination of air and surfaces and the presence of airborne particulates. RESULTS: The mean total bacterial and fungal loads measured in the air in the centre of the filter room were 20.7 +/1 28.9 colony-forming units (cfu)/m3 and 9.2 +/- 15.4 cfu/m3, respectively, and 5.2 +/- 4.1 cfu/m3 and 6.8 +/- 13.4 cfu/m3, respectively, in the laboratory. The mean fungal load values recorded on the surfaces sampled in the laboratory were in 6 out of 18 cases higher than the reference values (5 cfu/plate). As to the results of particulate monitoring, with regard to the 0.5 microm particles, about 83% of the samples revealed values below the limit of 350.000 particles per cubic metre. CONCLUSIONS: In this set-up phase, monitoring was able to pick out structural and organisational flaws acceptable in a laboratory compliant with Good Manufacturing Practices class C (Annex 1), but not in a class B facility. Thanks to this preliminary monitoring phase, and by correcting these flaws, the clean room facility could achieve compliance to class B.
Authors: M L Cristina; M Sartini; G Ottria; E Schinca; N Cenderello; M P Crisalli; P Fabbri; G Lo Pinto; D Usiglio; A M Spagnolo Journal: J Prev Med Hyg Date: 2016-09