Tag Archives: Medical Device

Is The Validation Process The Same For Sterile Pre-Saturated Vs. Sterile Dry Wipes?

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Is the validation process the same for sterile presaturated vs. sterile dry wipers?  Yes, the validation process is the same for presaturated vs. dry as they both follow ANSI/AAMI/ISO 11137, Sterilization of Health Care Products.  The product is saturated, packaging is sealed and then the cases are sent to be irradiated. The cases are irradiated wet. [Read More…]

Q&A – What is the Delta P of Berkshire’s Face Masks?

clean-room-mask

Q&A – What is the Delta P of Berkshire’s face masks? 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 [Read More…]

Can I Relaunder Cleanroom Wipes, and Use Them Again?

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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…]

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

Cleaning A Contaminated Personnel’s Behavior

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. Fill out [Read More…]

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

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 vs. Validated Sterile

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…]

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

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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…]

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

3D printing human heart

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…]

Rites of Passage for Sterile Wipers

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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…]

The Truth About “LINT-FREE” Wipes

Lint Free Wipes

“Lint Free Wipes” is a term that evolved with the semiconductor industry since it’s infancy and is a descriptive way of saying the application requires a low-linting solution. A search on the internet returns a plethora of web related searches for Lint Free Wipes. The only problem is that there is technically not such thing [Read More…]

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