Month: June 2017

Achieving a Higher Standard of Practice for Sterile Compounding: What is your strategic direction?

  Sterile compounding, a critical component of hospital care delivery, has come under greater scrutiny in recent years following high-profile mishaps causing preventable patient injury. In response, the industry continues to up the ante on compliance with the United States Pharmacopeia (USP) 797 guidelines—the accepted standard that defines minimum practice standards for compounded sterile preparations.In …

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Pharmacy co-founder blamed for meningitis outbreak that killed 76 gets 9 years in prison

  The co-owner of a pharmacy responsible for the deaths of 76 people was sentenced Monday to nine years in prison after he tearfully apologized to victims who described watching their loved ones die or enduring excruciating physical pain from a 2012 nationwide fungal meningitis outbreak caused by contaminated steroids. “I am so sorry for …

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Alvogen Issues Voluntary Nationwide Recall

Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into …

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Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects. Part 1 of …

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Brown’s Compounding owner charged with selling unapproved drug

The owner and founder of a large compounding pharmacy that sold pain creams around the country and once employed more than 100 workers has been charged with introducing an unapproved drug into interstate commerce. Darby C. Brown’s company, Brown’s Compounding Center, on Wednesday was charged separately in federal court with health care fraud. Brown illegally sold …

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An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilit

Part of the Cleaning Validation for the 21st Century series By Andrew Walsh; Ester Lovsin Barle, Ph.D.; Michel Crevoisier, Ph.D.; David G. Dolan, Ph.D.; Andreas Flueckiger, MD; Mohammad Ovais; Osamu Shirokizawa; and Kelly Waldron Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the …

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Immediate Benefits Of Real-Time Microbial Monitoring

Companies producing medicines and biotech products are concerned with airborne microbial contamination. They need to ensure that products and people are kept safe. The traditional, accepted method to test for microorganisms at critical locations in a process is the use of Active Air Samplers or Settling Plates. Typically, 1-meter-cubed samples are taken onto agar plates …

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