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The High Risk of Mold Contamination in Biopharmaceutical Facilities: Gypsum Wall Materials versus uPVC Wall
1BioProcess Resources LLC, Manorville, NY mwjornitz@hotmail.com.
Abstract:
Mold contamination in biopharmaceutical manufacturing is a serious patient safety, product quality, and regulatory risk. This paper reviews the mechanisms by which wall construction materials contribute to microbial ingress and colonization, compares traditional gypsum (drywall) construction with nonporous wall panel systems such as unplasticized polyvinyl chloride (uPVC)/modular panels, and documents regulatory actions, recalls, and plant shutdowns linked to fungal contamination. Drawing on industry guidance, inspection findings, and published case histories, it explains why gypsum-based "stick-built" walls pose higher long-term mold risk in many life-science environments and presents engineering, procedural, and design strategies to reduce risk (material selection, environmental control, inspection/monitoring, construction sequencing, and remediation policy). Practical recommendations are offered for facility owners, designers, and quality/regulatory teams who must justify capital choices and satisfy regulators.
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