Environmental monitoring program for the manufacture of cell and gene therapies: start making sense

• Published in: Cytotherapy (Oxford, England) Vol. 21; no. 5; p. S41
• Main Authors: Sdrolias, A, Velickovic, Z, Kan, F, Barry, N, Keir, M, Vincin, H, Chen, A, Favaloro, J, Chu, G, Macpherson, J, Rasko, J
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.05.2019
• Subjects: Advanced Basic Science; Other
• ISSN: 1465-3249; 1477-2566
• DOI: 10.1016/j.jcyt.2019.03.381

Background & AimEnvironmental monitoring is essential to evaluate the effectiveness of contamination minimisation approaches for the manufacture of cellular therapies. An Environmental Monitoring Program (EMP) is used to test air, critical surfaces and personnel for contaminants that could impact the quality, safety and efficacy of cellular therapies. Periodic EMP provides a snapshot of cleanliness of the facility at a given time. Tracking and trending of EMP data over time allows a review of the control conditions in the facility. We have established an EMP to regularly provide information on the effectiveness and adequacy of environmental controls, cleaning and personnel practices and to demonstrate the state of control of our GMP facility. Here we report our EMP data and discuss techniques for trending and making sense of EMP data.Methods, Results & ConclusionMethods: We compiled the periodic quarterly EMP data collected in our GMP facility over three years. Non-viable air particles (0.5μm and 5μm) were sampled using Lasair III particle counter. Viable air particles were sampled using settle plates in the MIcroCapt Microbial Sampler. Surface sampling was completed using contact plates and swabs. Microbial testing of settle plates, contact plates and swabs was performed by a contracted TGA accredited laboratory and reported as Colony Forming Unit counts. All data was reviewed and conformance was confirmed with predetermined acceptance criteria based on the ISO 14644 cleanroom standard and PIC/s manufacturing area classification. Mean counts were calculated ± standard deviation to assess season, operator and location effects for 3 data sets.Results and ConclusionOverall we observed that our facility operated within specification for the 3-year period. Non-viable particle counts were elevated when sampling occurred in the month of December. This “seasonal’ occurrence occurred each year and coincided with the annual facility shutdown and maintenance period. During this time, there is increased access in and out of the facility due to the attendance of service engineers. Analysis of microbial counts reveal personnel and contractor training is essential to enforce correct gowning procedures. Control measures in place have been successful in maintaining the facility within the specifications outlined in PIC/S and ISO 14644. It is evident that engineering controls, laboratory design, cleaning, gowning and personnel training are essential for maintaining cleanroom standards in a GMP facility.