Prefillable Syringe Systems

Hlobik, Tibor
January 2011
Pharmaceutical Processing;Jan2011, Vol. 26 Issue 1, p14
The article focuses on the integration of prefillable syringe system in the U.S. market, which gives rise to pressures faced by drug manufacturers concerning their packaging decisions, such as by the U.S. Food and Drug Administration (FDA). It says that prefillable syringe market begun a trend toward patient-administered drug delivery for treatment of chronic diseases and home-use. It adds that the use of high-quality components allows for more efficient and reliable manufacturing processes.


Related Articles

  • Time to Show Your Work …. Nair, Ajith // Pharmaceutical Processing;Aug2012, Vol. 27 Issue 7, p36 

    The article presents the author's views on how the U.S. Food and Drug Administration (FDA) guidelines on manufacturing process validation are relevant to pharmaceutical packaging. He states that the guidelines reflects the agency's desire for a robust manufacturing process. He adds that the FDA...

  • Implementing Process Validation Guidances. Calcott, Peter H. // Contract Pharma;Mar2013, Vol. 15 Issue 2, p54 

    The article discusses how to implement the Process Validation Guidances which was released by the Food and Drug Administration for the pharmaceutical industry in the U.S. It mentions that the rationale and reasoning for process validation is described in the guidance. It describes three...

  • RIGHT NOW ON PHARMPRO.COM.  // Pharmaceutical Processing;May2014, Vol. 29 Issue 5, p11 

    The article offers developments related to pharmaceutical processing. It presents a blog discussing smart packaging, and the effect of big data on manufacturers. It claims that the ability to coat tablets well is often considered more of an art than a science, and cites the mitigation of supply...

  • RARE RIVALRY. Lewis, Tanya // Medical Marketing & Media;Apr2013, Vol. 48 Issue 4, p46 

    The article reports on the intense rivalry of Kynamro and Juxtapid drugs in the U.S. for treatment of ultra-orphan disease. It notes that the Food and Drug Administration (FDA) approved Genzyme Corp.'s Kynamro for homozygous familial hypercholesterolemia (HoFH) on January 29, 2013 while Aegerion...

  • Age-Related Disorder. Lowe, Derek B. // Contract Pharma;Jan/Feb2013, Vol. 15 Issue 1, p30 

    The article focuses on disorders associated to aging and the discovery of drugs for these diseases by pharmaceutical companies in the U.S. It notes the scrutiny whether a drugmaker intends to sell medication for unapproved uses. It considers the ability of the Food and Drug Administration (FDA)...

  • Will medications be safer in the future? Erickson, Amy K. // Pharmacy Today;Nov2010, Vol. 16 Issue 11, p40 

    The article focuses on issues faced by the U.S. Food and Drug Administration (FDA) concerning safety and quality of drugs manufactured abroad. It highlights on the regulatory system implemented by FDA to ensure that products made outside the U.S. meet the standards of the pharmaceutical...

  • The Metrics of Quality Culture. Harrison, Andrew; Schniepp, Susan // Pharmaceutical Technology;Sep2015, Vol. 39 Issue 9, p22 

    The article discusses the guidance for quality metrics proposed by the U.S Food & Drug Administration (USFDA). Topics discussed include passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) to prevent drug shortage, use of the guidance by pharmaceutical industries to...

  • FDA's Process Validation Guidance. Calcott, Peter // Pharmaceutical Processing;Aug2012, Vol. 27 Issue 7, p42 

    The article presents the author's views on the U.S. Food and Drug Administration's (FDA) process validation guidance which was issued in 2011. He examines whether the guidance has created traction or whether the pharmaceutical industry is still unsure of what to do with it. He comments that the...

  • The Validation Master Plan. Chatterjee, Bikash // Pharmaceutical Processing;Sep2011, Vol. 26 Issue 8, p14 

    The article describes the validation master plan (VMP) and three stages of the U.S. Food and Drug Administration's (FDA) new process validation guidance for pharmaceutical processing. It discusses the three stages of the process validation guidance including process design, process qualification...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics