Product Spotlights
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Posted: November 20, 2024
It's been one year since the revised United States Pharmacopeia Chapter <797> was implemented. Over the course of the year, we have received feedback that many teams have faced challenges with the increase in environmental monitoring requirements and frustration over how this has affected their facility. Many pharmacies contract with third-party vendors to conduct their air sampling and other...
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Posted: July 17, 2024
Personnel are a significant source of contamination in aseptic manufacturing, and reducing human intervention in critical zones is essential to ensure higher product purity. Isolators and RABS (Restricted Access Barrier Systems) work to control contamination during pharmaceutical production. Because these systems are equipped with a variety of sophisticated protections and physical barriers, they can...
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Posted: May 06, 2024
Environmental monitoring (EM) in pharmaceuticals refers to the process of assessing and controlling the environment within manufacturing facilities, particularly cleanrooms, to ensure that they meet cleanliness and safety standards, as even minor environmental contaminants can compromise product quality and safety. ...
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Posted: March 25, 2024
It's important to be familiar with the guidelines outlined in USP <800> for employees who work or manage a healthcare facility where hazardous drugs are handled. USP <800> requires healthcare facilities to develop comprehensive policies and procedures for handling hazardous drugs, including exposure control, storage, and waste disposal.
Following...
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Posted: February 19, 2024
Learn how this innovative technology revolutionizes air sampling in various environments, ensuring precise and reliable results for microbiological analysis. Elevate your sampling experience with TRIO.BAS™ and stay ahead in quality assurance...
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Posted: January 16, 2024Dive into the evolution of portable microbial air samplers in our latest blog! Explore the rich history and technological advancements, featuring an exclusive interview with the founders of Orum International. Uncover the journey of innovation in microbial air sampling. Read more for insights into the past, present, and future of this crucial technology...Read More
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Posted: October 17, 2023Coming November 1, 2023, several updates to the USP <797> guidelines will go into effect, bringing significant changes to the practice as well as your facility. Cost of additional supplies, increased points of failure, as well as more time required to manage competencies will all be new challenges to consider...
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Posted: February 14, 2020
The new generation of active viable microbial air samplers represent a new approach to maintaining environmental control. The TRIO and the RABS ISOLATOR instruments are made by Orum International and distributed by Hardy Diagnostics.
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Posted: September 10, 2019
Self-policing has long been the standard for the industry, although
several entities have a say in what constitutes Best Practice in the
manufacturing and production of cosmetics and personal care products.The FDA’s (Federal Food, Drug, and Cosmetics)
oversight is mainly focused...