Pharmaceutical
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December 09, 2024Posted: December 09, 2024Read MoreCleanrooms and the protection of product carry two risks from contamination: particle deposition and particle dispersion. Airborne particle contamination in the healthcare and pharmaceutical sectors is a major topic of concern due to the risk of introducing particles, as impurities into products, and due to the potential to transfer microorganisms. Air quality assessments are partly based on the amount...
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November 20, 2024Posted: November 20, 2024Read MoreIt'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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October 11, 2024Posted: October 11, 2024Read MoreIn December of 2022, President Biden signed the Modernization of Cosmetics Regulation Act (MoCRA) into law, ushering in new regulations that significantly expanded the authority of the FDA over personal care companies. There have been years-long efforts to increase the FDA's oversight of the personal care and cosmetic industry, stemming from growing concerns regarding product safety. In 2018, there...
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September 16, 2024Posted: September 16, 2024Read MoreWhen performing Growth Promotion on new batches of media, one of three plating techniques can be used: Spread Plate, Pour Plate, or Membrane Filtration. Each method aids in enumeration of the cells in the inoculum, but each is different in technique. Below we offer our Top 5 Best Practices for each plating method to help you ensure proper growth promotion of your agar media...
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August 21, 2024Posted: August 21, 2024Read MoreA 503B compounding facility, also known as an outsourcing facility, is a type of pharmaceutical compounding business that operates under section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. The concept of a 503B pharmacy was introduced with the passage of the Drug Quality and Security Act (DQSA) in 2013. These facilities can manufacture bulk pharmaceuticals and are the only pharmacies...
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July 17, 2024Posted: July 17, 2024Read MorePersonnel 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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June 19, 2024Posted: June 19, 2024Read MoreThe Massachusetts man at the center of an infamously deadly 2012 national meningitis outbreak, Barry Cadden, pleaded no contest to 11 counts of involuntary manslaughter in Michigan and was sentenced last month to at least ten years in prison for his part in the deaths of 11 Michigan residents....
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May 06, 2024Posted: May 06, 2024Read MoreEnvironmental 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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March 25, 2024Posted: March 25, 2024Read MoreIt'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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February 19, 2024Posted: February 19, 2024Read MoreLearn 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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January 16, 2024Posted: 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 -
October 17, 2023Posted: October 17, 2023Read MoreComing 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... -
February 27, 2020Posted: February 27, 2020Read MoreCannabis has many
different modes of delivery and applications for use. The most common ways that
cannabis is used in our society today are: a smokeable, an edible, an oil or
infused product. According to most market researchers, flower products and
concentrates are the top sellers, with edibles and cosmetics also representing
a solid segment of the market.[1]... -
February 14, 2020Posted: February 14, 2020Read MoreThe 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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September 10, 2019Posted: September 10, 2019Read MoreSelf-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...
