The biotechnology industry is undergoing important shifts, stemming from an increasingly complex regulatory environment and cost pressures caused by the consolidation of payers and the high investment costs of drug production. As these companies seek out solutions to advance their cleanroom facilities, trends, such as the growing use of closed processing, are emerging and evolving.
Pharma EXPO (Nov. 2-5; McCormick Place, Chicago) will be a resource for technologies and insights for biotechnology professionals to advance their understanding of regulatory nuances and new technologies for enhancing their cleanroom operations. However, it all begins with some basic steps.
Be aware of complex regulations
The difficulty with regulations as they relate to cleanrooms is twofold. First, requirements can vary from one application to another. For example, the number of particulates allowed to be in contact with injectable products—which carry the highest cleanroom classification—is lower than the number of particulates permitted to come into contact with inhalable solutions. Additionally, because manufacturers in different countries are overseen by regional agencies, they’re often subject to different guidelines for regulating the quality standards of cleanrooms. It can be challenging for facility managers to keep up with changing and varied standards, especially when a product will be distributed in several countries.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly, PIC/S), are international agencies representing 44 participating authorities, including the United States Food & Drug Administration (FDA). Various organizations worldwide also offer strategic guidance surrounding the use of cleanrooms in biopharmaceutical manufacturing, such as the National Institutes of Health (NIH) and the International Conference on Harmonisation ICH Q1–Q11 guidelines. Although facility managers cannot be taken to court for failing to follow these guidelines, certain regulatory bodies can still impose consequences.
Don’t sweat the cost pressures
Another challenge facing biotechnology professionals is the high cost of investment that accompanies the necessary changes they must make to their cleanroom operations to comply with international guidelines, anticipate regulatory shifts, and improve efficiencies. These cost pressures can tempt cleanroom facility and procurement managers to turn to lower-quality suppliers with less expensive products.
In these instances, great care must be taken to ensure that the components—such as single-use technologies, which represent a fast-growing category of solutions in the market—are cleanroom packaged and meet the necessary standards. Otherwise, manufacturers can risk costly contamination issues that do not just jeopardize the sterility of the cleanroom facility, but also pose possible dangers to patients. It is critical for procurement personnel of a cleanroom facility to put any suppliers through the proper channels of qualification. Additionally, these companies can enlist outside experts and consultants to perform thorough audits of new suppliers before risking any regulatory infractions or contamination issues.
Leverage closed processing to stay current
Changes in technology and science mean what was considered compliant in the past might not hold true today. As always, the pharmaceutical industry must stay current. This has, in part, moved the industry toward implementing closed processing systems from once-prevalent open systems of product transfer. Today’s biotechnology industry is moving increasingly towards closed processing systems such as isolators. Isolators substantially reduce the problems that come with the use of open systems, such as contamination. By relegating certain tasks, such as the use of vaporized hydrogen peroxide (VHP) as a sterilant to isolators, companies can minimize the risk of contamination or operator injury while also simplifying monitoring activities.
Search out resources on best practices
Life science industry manufacturers do not have to address their cleanroom challenges in a vacuum. There are many resources available that offer solutions and best practices on advancing their cleanroom operations. For example, the International Society for Pharmaceutical Engineering (ISPE) recently published a guide on sterile manufacturing facilities, “ISPE Baseline Guide: Sterile Product Manufacturing Facilities (Second Edition),” which addresses risk-based manufacture of pharmaceutical products.1 ISPE maintains a library of regulatory resources and offers training sessions to help cleanroom facility managers stay up-to-date on the latest standards and solutions available to them.
References
1. http://www.ispe.org/baseline-guides/sterile-manufacturing
PMMI, the Association for Packaging and Processing Technologies, represents over 650 packaging and processing supply chain companies that provide a full range of packaging and processing machinery, materials, components, and containers. www.PMMI.org
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Fla., and offices in Brussels, Belgium; Singapore; and Shanghai, China, and is publisher of Pharmaceutical Engineering Magazine. www.ISPE.org
This article appeared in the September 2014 issue of Controlled Environments.
