title: A Review of the Aging Process and Facilities Topic.
abstract: Aging facilities have become a concern in the pharmaceutical and biopharmaceutical manufacturing industry, so much that task forces are formed by trade organizations to address the topic. Too often, examples of aging or obsolete equipment, unit operations, processes, or entire facilities have been encountered. Major contributors to this outcome are the failure to invest in new equipment, disregarding appropriate maintenance activities, and neglecting the implementation of modern technologies. In some cases, a production process is insufficiently modified to manufacture a new product in an existing process that was used to produce a phased-out product. In other instances, manufacturers expanded the facility or processes to fulfill increasing demand and the scaling occurred in a non-uniform manner, which led to non-optimal results. Regulatory hurdles of post-approval changes in the process may thwart companies' efforts to implement new technologies. As an example, some changes have required 4 years to gain global approval. This paper will address cases of aging processes and facilities aside from modernizing options.
authors.affiliation: G-CON Manufacturing, Inc., 8800 HSC Pkwy, Bryan, Texas 77807 mjornitz@gconbio.com.
authors.forename: Maik W
authors.initials: MW
authors.lastname: Jornitz
mesh_terms: D001702:Biopharmaceutics / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D003257:Consumer Product Safety; D003362:Cost-Benefit Analysis; D004059:Diffusion of Innovation; D004867:Equipment Design; D004868:Equipment Failure; D005160:Facility Design and Construction / Q000191:economics / Q000379:methods*; D006801:Humans; D061214:Patient Safety; D013678:Technology, Pharmaceutical / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D013997:Time Factors; D057188:Workflow
keywords: Aging facility; Drug shortage; Modular facilities; Post-approval changes; Single-use technology