Each sector of the pharma industry is fraught with challenges and weighty regulations; aseptic processes and techniques are no exception. Yet, it is from these challenges that innovations are born. Never has the industry been so determined in ensuring patient and personnel safety, be it through installing RABS, isolators, closed vial technology or updating (again) Annex 1. In acknowledgement of this determination, a recent survey conducted by Pharmaceutical Technology Europe found that 51% of industry representatives believe that current aseptic techniques and technologies are adequate to ensure patient/personnel safety.1
Regulators worldwide have, however, continued to place a greater emphasis on the importance of implementing aseptic techniques in all aspects of pharmaceutical manufacturing. These increasing demands have naturally led to a greater number of patent filings worldwide for aseptic and sterile conditions and applications, with the number of innovative patent applications rising from 2 in 1973 up to 162 in 2009.2 The US has consistently accounted for the lion's share of aseptic patent applications; however, worthy of note is the steep rise in the number of applications that have originated in China; in 2003, China ranked 18th of 22 countries that filed a patent for aseptic applications, with just one patent application made. Five years later, in 2008, China ranked third of the 20 countries that had filed patent applications (with 21 innovative patents filed).2 This clearly demonstrates China's commitment to improving its pharmaceutical manufacturing facilities in line with the West, the aim being to grow its national pharmaceutical industry and to boost its presence in the global market. Showing a commitment to aseptic techniques and processes is sure to boost confidence in Chinese manufacturing standards.
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Implementing aseptic processes is no easy task and this month we spoke with several experts about some of the key challenges that companies face when aiming for quality and compliance in contamination control. We also report on some of the primary concerns of the regulators and where they believe the pharmaceutical industry is falling foul of regulations. Meanwhile, we discuss some of the latest technological innovations that are helping companies in their quest for aseptic excellence.
2. Derwent World Patents Index; Thomson Reuters IP Solutions.