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Industry Insights

  1. September 16, 2024

    Back to Basics: Best Practices for Plating Techniques used with Growth Promotion Testing

    When 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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  2. August 21, 2024

    The Critical Role of Sterility Testing in 503B Compounding Facilities

    A 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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  3. June 19, 2024

    Closure for 2012 Meningitis Outbreak: Sentencing Delivered

    The 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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  4. May 06, 2024

    Keeping it Clean: Environmental Monitoring in the Pharmaceutical Industry

    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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  5. March 25, 2024

    USP <800> - Handling Hazardous Drugs; Are You Compliant?

    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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  6. February 19, 2024

    Reviewing the Benefits of the TRIO.BAS™ Gas Sampling Systems

    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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  7. January 16, 2024

    The Evolution of Environmental Microbial Air Sampling

    Dive 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...
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  8. October 17, 2023

    Upcoming Revisions to USP <797>

    Coming 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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  9. February 27, 2020

    Is that really pharmaceutical grade cannabis?

    Cannabis 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]...

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  10. February 14, 2020

    Are Three Heads Better Than Two?

    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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  11. September 10, 2019

    Regulatory Standards for the Cosmetics and Personal Care Industry

    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...

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  12. May 14, 2019

    The Changing Face of Safety Practices in the Cosmetics and Personal Care Industry

    The English
    translation for the French phrase “Il
    faut souffrir pour etre belle
    ” is: “You must suffer to be beautiful.”
    Throughout history, the definition of beauty has changed from one era and
    society to another. A decade of shaved and precisely drawn in eyebrows gave way
    to a natural, full and almost unruly look. Glued on mouse fur brows were once
    ...

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  13. October 20, 2017

    Filthy Pharmacy: How Carelessness Cost Lives and Prompted New Industry Guidelines

    Compounding Pharmacies are specialized pharmacies able to address specific health needs in a way mass produced pharmaceuticals cannot. Compounded medications offer customized solutions for patients' unique conditions. The value of these facilities is significant for those who have experienced an enhanced quality of life or life-saving benefits from compounded medications.

    ...
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