Category Archives: FDA

Cleanroom News, Cleanrooms, FDA

Regulatory Limits – What Is the Role of the FDA in International Trade?

Posted on by Berkshire Corporation
Black Spiders
12
Oct

Quick question: When are ‘highly purified phospholipids’ not highly purified phospholipids? Short answer: Perhaps when they are manufactured by Nippon Fine Chemical of Hyogo, Japan. There is much talk within the regulated industries of the critical importance of contamination control, purity, and sterility for pharmaceutical or food-related substances. Anything that eventually becomes part of our [Read More…]

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Cleanroom News, FDA, Nanoparticles

Nanoparticles: What the Eye Doesn’t See…

Posted on by Berkshire Corporation
Baby Milk Formula
05
Oct

There is little that’s more central to human health than the food that we eat. With each bite, we ingest the vitamins, minerals, fiber, starches, proteins, and fats that we need to fuel, re-build, and maintain our bodies. Each meal provides us with an opportunity to either nourish ourselves or to stress our systems with [Read More…]

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Cleanroom News, FDA

How is the FDA Regulating the E-Cigarette Industry?

Posted on by Berkshire Corporation
Esigs and Juices
08
Jun

Way back in the murky distant mists of time, a trip to your primary care physician might include him listening to your heart, giving you a quick tap on knees to test reflexes, a guffaw about your three martini lunch, and a lungful of second hand smoke from the cigarette burning down in a glass [Read More…]

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3D Printing, Cleanroom News, FDA

How the FDA is wrestling with bio-medical 3D-printing.

Posted on by Berkshire Corporation
3D printing human heart
01
Jun

In a science-fictional universe way ahead of us in the future, there is no industrial complex as we know it today. No sprawling manufacturing campuses or security-patrolled warehouses crammed with shelved inventory. Everything we use on a day-to-day basis is created on demand, at the very moment it is required. All of our homes are [Read More…]

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Cleanroom News, FDA

There’s Clean…and then there’s ‘Cleanroom Clean.’

Posted on by Berkshire Corporation
Sterile SatPax
25
May

When it comes to cleanroom and controlled-environment news, the stories we read in the press can often be dramatic. Last week, we reviewed a dire situation with ebola where sub-standard gowns, gloves, and glove liners were jeopardizing the lives of medical personnel by allowing bodily fluids to permeate through to the wearer’s skin in a [Read More…]

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Cleanroom News, FDA

When Standard Operating Procedures Aren’t Enough

Posted on by Berkshire Corporation
Standard Operating Procedures
19
May

Although the FDA sometimes has a reputation as a stickler, it’s clear that the Food and Drug Administration often demonstrates a lot of patience, too—except when a company refuses to update their operating procedures to make required fixes to bring their standard operating procedures. Listen: we get it. No one likes to hear phrases like [Read More…]

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Cleanroom News, FDA

Contamination Control News: It’s the Difference Between Life and Death

Posted on by Berkshire Corporation
12
May

Ebola. Even that small collection of letters on a page is enough to strike fear into most people. And rightly so. In a recent outbreak of the disease in Liberia, a small West African nation bordered by Sierra Leone and Ivory Coast, ebola killed more than five hundred people. And while that in itself should [Read More…]

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Cleanroom News, FDA

Contamination Control News: Compounding the Problem

Posted on by Berkshire Corporation
04
May

Question of the Week: When does owning not one but two slick websites make up for the absence of ethics in aseptic processing? Answer: When it comes to a compounding pharmacy – never! Yet Professional Arts Pharmacy, a compounding pharmacy based in Baltimore, MD, seems to think that it does. With a confidence-inspiring main website [Read More…]

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Bio-Technology, Cleanroom News, FDA

Contamination Control News: Examining the Scope of the Problem.

Posted on by Berkshire Corporation
Scope of the problem
27
Apr

Imagine the scenario: after experiencing weeks of sudden and unexplained pain in your stomach, your doctor – suspecting ulcers – refers you to the hospital for tests. Or perhaps you rush your toddler to the ER after he swallowed part of his favorite action figure. In either of these cases, your immediate future involves getting [Read More…]

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Cleanroom News, FDA

Contamination Control News: Do You Dare To Go Bare?

Posted on by Berkshire Corporation
Taking of the Gloves
20
Apr

The food processing and healthcare industries are often linked in the media, and in the mind of the general public, for obvious and frequently deeply unpleasant reasons. And when stories break, they’re usually rooted in failures by the former that necessitate intervention by the latter. Let’s recall the recent case of the seafood processing plant [Read More…]

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