The essentials of United States Pharmacopeia Chapter <51> antimicrobial effectiveness testing and its application in pharmaceutical compounding.

نویسندگان

  • Nicole Vu
  • Kevin Nguyen
  • Thomas C Kupiec
چکیده

Antimicrobial preservatives are excipients added to multi-dose containers of both sterile and non-sterile drug products. Antimicrobial preservatives are used primarily to inhibit growth of microbial contamination occurring during the period of use. Demonstration of antimicrobial preservative effectiveness is required for these functional excipients. This article reviews key factors for consideration in the selection of preservatives, principles of the preservative-effectiveness test, and the significance of requirements for preservative-effectiveness testing in the compounding practice.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Quality-Control Analytical Methods: Chemical Testing Aspects of USP chapter 797 for Compounded Sterile Preparations.

The regulations set forth by the United States Pharmacopeia (USP) Chapter <797>, in effect since January 1 of 2004, have generated a great deal of interest because they have established the first practice standards of sterile pharmacy compounding in US history that are enforceable at both the federal and state levels. United States Pharmacopeia Chapter <797> expands the scope of facilities gove...

متن کامل

Quality-Control Analytical Methods: Microbial-Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations.

The standards set forth by the United States Pharmacopeia (USP) Chapter 797 have now been in effect since January 1 or 2004. As the first practice standards of sterile pharmacy compounding in US history, they have "attracted both respect and criticism" because they have also been cited as a practice expectation by the Joint Commission on Accreditation of Healthcare Organizations. USP 797 expand...

متن کامل

Development of the antimicrobial effectiveness test as USP chapter <51>.

The antimicrobial effectiveness test first appeared as a USP General Chapter in the 18th revision, official September 1, 1970. This chapter, at the beginning, was designed to evaluate the performance of antimicrobials added to inhibit the growth of microorganisms that might be introduced during or subsequent to the manufacturing process. As Good Manufacturing Practices (GMPs) became a governing...

متن کامل

A Primer on USP Chapter 797 "Pharmaceutical Compounding-Sterile Preparations," and USP Process for Drug and Practice Standards.

David W. Newton, BS, PhD, FAPhA Bernard J. Dunn School of Pharmacy Shenandoah University Winchester, Virginia Lawrence A. Trissel, BS, RPh, FASHP M.D. Anderson Cancer Center The University of Texas Houston, Texas Editor’s Note In January 2004, Chapter <797> in the United States Pharmacopeia 27 became the first practice standards for sterile pharmacy compounding in US history that may be enforce...

متن کامل

Survey of sterile admixture practices in canadian hospital pharmacies: part 2. More results and discussion.

BACKGROUND The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly ...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • International journal of pharmaceutical compounding

دوره 18 2  شماره 

صفحات  -

تاریخ انتشار 2014