One of the most significant challenges facing today’s parenteral drug manufacturer is how best to evaluate and implement advanced aseptic technologies to maintain a robust regulatory compliance profile while optimizing cost of good sold.
The past 15-20 years has seen the introduction and maturation of a number of “new” technologies that offer tangible benefits and quality improvements for aseptic pharmaceutical fill/finish, such as barrier isolators, 100-percent checkweigher, single-use disposable fluid path technologies, etc. Many of these technologies have matured to the point where the question is no longer whether these technologies are ready for prime time; their use in dozens or hundreds of commercial facilities is proof.
The question now is more pointed: “Is your company ready for these technologies?”
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