Tag Archives: Medical Device

Aseptic Cleaning, Cleaning & Disinfection, Knowledge Base

How Many Passes With a Cleanroom Wipe Will Get a Surface Clean and Sterile?

Posted on by Berkshire Corporation
Cleanroom Wiping How Many Passes
14
Dec

Answer: Berkshire cannot provide specific recommendations regarding how many swipes/passes of a wiper on a surface will make the surface clean or free of microorganisms.The main reason for this is each situation where wipers are used is different and has many variables, each of which will have an impact on the outcome of any cleaning. [Read More…]

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Cleanroom News, Cleanrooms

Brain-machine Implants From a Cleanroom

Posted on by Berkshire Corporation
brain machine implant
03
Dec

It is the stuff of science fiction and of conspiracy theory. Brain-implantable chips that monitor our health, overcome physical limitations, improve memory, or track us, control our thoughts and manipulate our actions. Or even change the way we perceive and interact with reality. A technology to improve the lives of those living with a disability [Read More…]

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Aseptic Cleaning, Cleaning & Disinfection, Knowledge Base

What is a Low Endotoxin Cleanroom Wipe?

Posted on by Berkshire Corporation
Low Endotoxin
07
Oct

A low endotoxin cleanroom wipe has a guaranteed endotoxin limit of <20 EU/device – <0.5 EU/mL. This is especially important when you read the FDA Guidance for Industry: Pyrogen and Endotoxins Testing.  A 3rd party lab should perform the testing and the testing must be on a lot to lot basis. Printed documentation must be [Read More…]

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Aseptic Cleaning, Cleaning & Disinfection, Knowledge Base

Has Berkshire or a 3rd Party Performed Any Microbial Efficacy/kill Studies on the Satpax® Line of Presaturated IPA Wipers?

Posted on by Berkshire Corporation
Satpax Canister
18
Apr

Question: Has Berkshire or a 3rd party performed any microbial efficacy/kill studies on the SatPax® line of presaturated IPA wipers? Answer: An efficacy/kill study has not been performed by Berkshire or a 3rd party lab for SatPax®.  Because of the number of variables involved when using wipes, it would be very difficult to produce meaningful [Read More…]

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Cleanroom News, Contamination Control

Can Ethylene Oxide Ever Be Considered Safe?

Posted on by Berkshire Corporation
EtO-Sterilization
03
Apr

Let’s face it, no-one is getting any younger. Even the fittest, most active and health-conscious among us will confront a health challenge at some point in our life and, as we age, those concerns tend to become more complex and require more careful treatment. Where youngsters can get away with the trauma of the occasional [Read More…]

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Cleanroom News, Cleanrooms, Contamination Control

Colorful Cleanrooms and Cochlear Implants

Posted on by Berkshire Corporation
Conceptual image about human hearing
28
Nov

Just a couple of decades ago, the concept of biohacking – deliberately blurring the biological line between man and machine – was little more than just that: a concept, confined mainly to the avant garde of science fiction and futurism. And this was with good reason. When we think of enhancing human abilities with the [Read More…]

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3D Printing, Bio-Technology, Cleanroom News

How the Humble Inkjet Printer is the New Go-To in Organ Transplantation

Posted on by Berkshire Corporation
2d_3d_organ_printing
26
Sep

From the perfect Super Venti Flat White (yes, it is ‘a thing’) crafted for us at the Starbucks drive-thru to the tailored Tesla designed to indulge our most whimsical aesthetic consideration, the world is becoming increasingly customized whether we like it or not. And however we perceive this transition – good, bad, or indifferent – [Read More…]

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Cleaning & Disinfection, Knowledge Base

Human-Generated Particle Contamination

Posted on by Berkshire Corporation
particle contamination
25
Jul

CLEANROOM PERSONNEL Cleanroom garments cannot contain all human detritus Particles (µm) travel up through the garments toward the head Particles (µm) fall down the legs during activity Gowning SOPs and continuous training is crucial  

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Aseptic Cleaning, Cleaning & Disinfection, Knowledge Base

Proper Wiper Folding and Surface Cleaning Video

Posted on by Berkshire Corporation
Cleanroom Wiper folding
12
Jul

Berkshire’s Guide to properly fold and use a low-linting wiper for maximum efficiency and effectiveness in a controlled environment.   Download our Cleanroom Proper Wiper Folding and Surface Cleaning Poster Today! Shop our Cleanroom Wipes

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Cleaning & Disinfection, Knowledge Base

How Small is a Micron?*

Posted on by Berkshire Corporation
how_small-is-a-micron
20
Jun

HEPA VS. ULPA IN A CLEANROOM 1. This large circle represents the cross section of a human hair, with an average visible diameter of 75μm. 2. This smaller circle, still visible to the human eye, represents a 50μm diameter particle. 3. This represents a 0.3μm diameter particle. HEPA filters remove over 99.97% 4. This represents [Read More…]

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