Category Archives: FDA

Revisiting the Unsanitary/Insanitary Conundrum of Custom Biopharmaceuticals

Machine for making capsules

Compounding the Problem? If we were called upon to characterize last year in just two words, we would undoubtedly select unprecedented and pandemic as the most obvious watchwords of 2020. And at this point in time their definition is abundantly clear. But, as we start 2021, a couple of terms have resurfaced that apparently remain [Read More…]

How Cleanroom Technology is Rescuing our Blood Supplies

lab-grown-blood

Lab Grown Blood Throughout human history, we have searched for ways to prolong our lives. Whether it be through cleaner living, exercise, scientific advancement, or improved diet, humans are a species in perpetual search for an elixir of life, a fountain of eternal youth. And this impulse makes it into our history and cultural mythos [Read More…]

COVID-19, Stress, and the Fall of Zantac

stomach fire. excessive acidity, indigestion, stomach disease, gastric ulcer, severe abdominal pain. 3D Rendering

Fire in the Belly With the global situation as it is right now, flicking on the TV, tuning into the radio, or scrolling through a social media feed is enough to send most of us into a tailspin. Between being quarantined and socially distant, home schooling kids in addition to full-time work, fears about job [Read More…]

Update: Kicking Back with Kratom – and Salmonella?

Leaf with pills

When Berkshire wrote Kicking Back with Kratom and Salmonella our main focus was clearly salmonella poisoning. “As of March 18, 2018, more than fifty cases of salmonella have been identified  by the CDC across 27 states with patients ranging in age from 67 down to just 6 years old. Sixty percent of the affected were male [Read More…]

Goop Believes the Little Things Count – Truth in Advertising, Not So Much

fruitloopery

Fruitloopery In a Napa County Superior Court this month, actor Gwyneth Paltrow’s lifestyle brand, Goop, accepted civil penalties in the amount of $145,000 for unsubstantiated health claims regarding some products sold on the company’s website. The online ‘wellness empire’ was found guilty of misbranding and false advertisement in a suit brought by the California Food, [Read More…]

Contamination Control vs Embryotoxicity

Mitochondria, a membrane-enclosed cellular organelles, which produce energy Mitochondria , Cell energy and Cellular respiration Mitochondrial disease Mitochondrial DNA

When you hear the phrase ‘designer babies,’ what springs most readily to mind? It’s an emotionally, socially, and politically loaded term that’s come to represent much of what’s ethically questionable in genetic research. Perhaps we might think of the movie Gattaca (that we referenced last week) in which genetics equal destiny. Or the 2003 German [Read More…]

Smoking Kills – But Maybe Not in the Way You Think

Doctor is comparing electronic vaporizer and conventional tobacco cigarette.

Almost two years ago, we wrote a short article on the FDA regulation of a nascent industry, one that has the FDA sounding the alarm regarding contamination from carcinogens and the vaporizing of metal nanoparticles. Despite our concerns – and those of the FDA – this industry is still around, growing, and has set its [Read More…]

How The Promise of Stem Cell Therapy Can Blind Us to its Danger

stem cell therapy

In the Worlds Fair Exposition of 1893, one young entrepreneur, Clark Stanley, stood before an excited crowd of onlookers and plunged his hand into a sack of live rattlesnakes. Pulling out an unfortunate herpetological victim, he sliced it open and, in a technique that was about as far from aseptic processing and devoid of microbial [Read More…]

How Contaminated Cosmetics Are No Superficial Problem

collection of different cosmetics

Throughout human history, we have maintained a conflicted relationship with our bodies. We don’t just mean the struggle to lose a pound or two, or the issues some of us face with physical dysfunction. It goes so much further than that, as news headlines frequently remind us. But there’s a way in which our bodily [Read More…]

Cleanroom News: Top 10 Articles of 2017

top 10

Last year, we dipped our corporate toes into the pool of industry analysis, tentatively creating articles that we thought might be of interest to our customers, partners, and the broader contamination control community. We expected that only a handful of readers would return week after week to see what scientific curiosity had caught the eye [Read More…]