What is Delta P? The Differential Pressure (DP) is a test that measures how easily air is passed from one side of the mask to the other. This indicates how easily the wearer can breathe through the mask, and is in indicated by Delta P. Higher DP indicates air is more difficult to push through. [Read More…]
Tag Archives: Medical Device
Can I Relaunder Cleanroom Wipes, and Use Them Again? Virtually all cleanrooms use wipers once then discard them. In an effort to save money, some cleanroom personnel have considered relaundering wipers. It is instructive to learn why relaundering wipers may not be a viable approach. Three factors are paramount: Levels of contamination on the wipers [Read More…]
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…]
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…]
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…]
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…]
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…]
he final step in the manufacture of sterile wipers (either dry or pre-wetted) is gamma irradiation to destroy all viable organisms that may be present on the wipers or on associated packaging. A source of confusion that often arises is how best to introduce packages of sterile wipers into the sterile suite. Most users understand [Read More…]
“Lint Free Wipes” is a term that has evolved in the semiconductor industry since its infancy. It is a descriptive way of saying the application requires a very low-linting solution. A search on the internet returns many related searches for Lint Free Wipes. The only problem is that there is technically no such thing as [Read More…]
Before we address wiping techniques, we might well question the need for wiping. After all, if capillary forces hold particles to surfaces strongly enough that the particles can’t easily get airborne, why the great concern to remove the particles by wiping? The simple answer is embodied in two words: Contact Transfer. That’s the means by which [Read More…]