By: Paul Valerio
Director of Technology
IPS-Integrated Project Services, LLC
Aging facilities in pharmaceutical manufacturing are a topic of much concerned discussion in the industry and in world healthcare circles, especially where sterile products are produced. Facility conditions and obsolete technologies pose risks to product quality and, therefore, supply of medicines to patients. Facility finishes, aging water systems, manual cleaning methods, and presence of gowned personnel in the aseptic environment performing open process manipulations all contribute to process risks.
Deteriorating and dated systems are not the only factors working against aging facilities. The world outside those old walls is changing and moving forward. New knowledge and advances in process technology and facility design have improved greatly in the industry compared to the basis against which older facilities were designed. These advances then raise the bar for regulators’ expectation of quality. They observe older construction methods being replaced with sealed modular wall systems that are more cleanable and less susceptible to environmental risks such as mold. Automation of processes is taking over manual steps in areas such as cleaning of vessels and parts, bio-decontamination of equipment, and automated loading of freeze dryers. Operations with fully gowned personnel performing aseptic manipulations adjacent to open sterile product in traditional Grade A clean rooms are replaced with those utilizing barrier systems. Isolator systems, in particular, are becoming simpler and more compact. Regulators expecting these advances in newer facilities organically raises the pressure on manufacturers operating aging facilities to replace or upgrade.
The improvements mentioned above for facility and process design represent advances in protecting sterile products, and they are good for business from a compliance standpoint. Advances in process technology also present opportunities for better profitability due to increased capability. New systems offer higher throughput and product yield through features like 100% in-process checking (IPC) and advanced dosing to utilize every drop of bulk product. Market trends toward specialized products have inspired creation of a new range of technologies capable of providing flexibility to fill numerous components in one suite, including vials, syringes and cartridges.
A compliant facility design coupled with advanced process technology creates capability to run efficiently with fewer process risks and deviations. That’s good business.
So, what does all this serious stuff have to do with Leapfrog? One form of “leapfrogging” in business is to profoundly advance in capability by taking advantage of progress already made by others. In recent years, impressive progress has been made in robust fill-finish process technologies in terms of performance and compactness. The ratio of opportunity to risk is more favorable than ever for manufacturers looking to progress their aging sterile product facility. Robust systems are available to enable just about any product portfolio, offering new business opportunities and multiple paths to return on investment.
Opportunity awaits, yet it is not so simple to seize it. Many organizations are so focused on making their older facilities function well that there is little time to keep up with current technology. Once organizations decide to pursue upgrade or replacement of aging sterile product facilities, simply transferring old processes to new equipment might provide just a fraction of the potential gain. Perhaps the greatest challenge in looking outside those old walls is grasping what new technologies are available and how to apply them. Creating the most successful future possible involves product portfolio strategy and research in several areas, one of them being currently available and emerging process technologies. Internal research and leveraging support from qualified process solution providers and design firms will help lead to a much needed leap ahead.