Tag Archives: Pharmaceutical

Cleaning & Disinfection, Knowledge Base

Cleaning A Contaminated Personnel’s Behavior – Decontamination Tools For Quality Managers: Part 2

Posted on by Berkshire Corporation
Cleaning A Contaminated Personnel’s Behavior
12
Oct

In this post we will continue with the next part of our series Cleaning A Contaminated Personnel’s Behavior Decontamination Tools for Quality Managers, to see how we can eliminate the cause of nonconformity and also prevent the occurrence of the same undesirable situation in the future. You can find Part 1 of the series here. Download Part [Read More…]

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Cleaning & Disinfection, Knowledge Base

Cleaning A Contaminated Personnel’s Behavior – Decontamination Tools For Quality Managers: Part 1

Posted on by Berkshire Corporation
11
Oct

Every time a Quality Manager notices nonconformities related to personnel’s behavior, he needs to find a rapid solution to correct it. This does not always come easy, as the QA Manager has to be firm in eliminating the cause of the nonconformity and, at the same time, have a diplomatic approach, targeting the staff’s awareness [Read More…]

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Aseptic Cleaning, Berkshire Products, Knowledge Base

Gamma Irradiated vs. Validated Sterile

Posted on by Berkshire Corporation
27
Sep

Gamma Irradiated refers to a product that has been irradiated at some predetermined dose which is felt to kill the bioburden. Sterility testing is usually not performed nor quarterly audits for continued validation. The Sterility Assurance Level (SAL) cannot be predicted. A higher dose of radiation may be delivered to the product than may not [Read More…]

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Berkshire Products, Knowledge Base

Cost Savings: At What Cost? Part I

Posted on by Berkshire Corporation
19
Sep

Knitted brows, serious faces. Movement with a strong sense of purpose. No wasted motion. An atmosphere of crisis. Palpable intensity. Something is amiss. Direction from management is clear: “Find the contamination source and fast!” The drop in yields was unmistakable and seemed to come out of nowhere. Something had changed and two weeks of intense [Read More…]

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Berkshire Products, Knowledge Base

Cost Savings: At What Cost? Part II

Posted on by Berkshire Corporation
19
Sep

In Part I we saw the consequences of using low-cost (likely off-spec) raw materials or consumables – the expenditure of many resources and man-hours to track down contamination sources. Unfortunately, this scenario plays out all too often when sub-standard wipers are substituted (to “save money”) for a previously specified branded product that had been performing without incident [Read More…]

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Cleanroom News, Cleanrooms

When is a Pharmacy Not a Pharmacy? Or ‘A Horse of a Different Color.’

Posted on by Berkshire Corporation
07
Sep

Back in the ‘Old Country,’ polo is considered the ‘sport of kings.’ On any given day, weak sunshine bathing the pitch in a pale golden glow, the upper crust of the English horsey elite will gather for this centuries-old game of speed and tactic. Dukes and earls rub shoulders with up-and-coming titans of industry and [Read More…]

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Cleaning & Disinfection, Knowledge Base

I Can See Clearly Now – Microfiber Wipes Part 2

Posted on by Berkshire Corporation
microfiber-650-320
31
Aug

In Part I of “I Can See Clearly Now”, we described the physical construction of microdenier fibers incorporated in fabric used for cleaning eyeglasses. These same fibers can also be employed as the base material for cleanroom wipers. Note however, that microdenier cleanroom wipers are orders of magnitude cleaner than the microdenier fabric used for cleaning eyeglasses. [Read More…]

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Cleaning & Disinfection, Knowledge Base

I Can See Clearly Now – Microfiber Wipers Part 1

Posted on by Berkshire Corporation
30
Aug

If you’ve purchased a new pair of prescription glasses in the last twenty years, chances are you were given a cleaning “cloth” to keep them in pristine condition.  Actually, “cloth” is not best description since the material doesn’t contain any cotton – the word that most often comes to mind when we say “cloth”.  Better [Read More…]

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Cleaning & Disinfection, Knowledge Base

Isopropyl Alcohol (IPA): Still the #1 Choice in Cleanrooms

Posted on by Berkshire Corporation
IPA2
11
Jul

The most common liquid used for cleaning surfaces in the cleanroom is IPA, primarily because of its purity and consistency. Cleanroom operators sometimes ask if denatured alcohol can replace IPA in the cleanroom.  The simple answer is No.  Here’s why. Denatured alcohol is used for non-critical applications such as fuel for stoves, shellac thinner, and [Read More…]

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Aseptic Cleaning, Cleaning & Disinfection, Knowledge Base

USP <797> News: Seeing is Believing

Posted on by Berkshire Corporation
usp800
17
May

In contamination control, there are generally two types of contamination problems: complex problems that even those who are dedicated to cleaning out sometimes miss, and outright negligence. Sometimes, an issue as simple as not knowing the proper contamination control procedures can lead to contamination that gets the FDA on you. That was the case recently [Read More…]

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