Tag Archives: Medical Device

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

Cleanroom Wiping How Many Passes

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…]

Brain-machine Implants From a Cleanroom

brain machine implant

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…]

What is a Low Endotoxin Cleanroom Wipe?

Low Endotoxin

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…]

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

Satpax Canister

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…]

Can Ethylene Oxide Ever Be Considered Safe?

EtO-Sterilization

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…]

Colorful Cleanrooms and Cochlear Implants

Conceptual image about human hearing

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…]

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

2d_3d_organ_printing

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…]

Human-Generated Particle Contamination

particle contamination

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  

Proper Wiper Folding and Surface Cleaning Video

Cleanroom Wiper folding

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

How Small is a Micron?*

how_small-is-a-micron

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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