We are building an ISO Class 7 (formerly Class 10,000) modular cleanroom on our university campus. Our students will wear bouffants, shoecovers, and frocks. Is there a gowning protocol for frocks? We also need procedures for cleaning the modular cleanroom and working in the cleanroom.
During the November, 2011 ASTM meetings in Tampa, FL, we observed a number of trends, particularly in the standards and guidance documents that impact medical device manufacture and maintenance.
Sacrificial soils are materials added to a soiled surface to help that surface become less soiled.
The Dale Carnegie blog offers practical advice on ways to build and maintain effective communication with your team/staff. These tips can put your team on the right track and help you stay there.
f all soil and cleaning agent components are soluble, rinsing is dilution.
One tool that we have found quite useful in supporting high facility on-stream time and process yield factors, as well as sustainability, is the equipment or hardware FMEA (Failure Modes and Effect Analysis). The FMEA exercise will provide the facilities team with a prioritized “risk burn-down” plan for ensuring readiness and can serve as a convenient basis for capital and operating expense budget creation and execution.
Selecting the right kind of ESD (electrostatic discharge) flooring is always a challenge, and in controlled environments, the stakes are particularly high.
Here is a familiar demand: “Show me where in the regulations it says to do that!” If you’ve spent any time in Quality, working on a facility or equipment project in the pharmaceutical industry, you have certainly had that put to you at some point.
The Joint School of Nanoscience and Nanoengineering (JSNN) began with a simple but powerful idea: to create a facility where nanoscience and nanoengineering could be accessible to everyone.
Last month’s column laid the groundwork for developing a functional Disaster Recovery Plan. We reviewed key components of a disaster recovery plan and critical planning, discovery, and organizational steps one must take to develop a plan that functions beyond becoming a dust magnet on your bookshelf.
Barbara Kanegsberg with special guest columnist Dr. Kevina O’Donoghue Reviewed by Ed Kanegsberg
When asked about the most important factor in manufacturing, many employees put people ahead of production. It is important that our priorities are right on this one. Breaches in cleanroom protocol must not be allowed to result in an unsafe product. At the same time, skilled, educated cleanroom employees are essential for production of quality product.
Unfortunately, no. There is no absolute truth in measurement. Measurement is really about probability. The percentages of times the measurement will be different are the uncertainties of that parameter.
This column reports on three unrelated outcomes about which you need know to manage critical cleaning work, and points out their significance.
That’s a tough one, but for simple, relatively small cleanroom projects there are a few things that you can do to help ensure everyone bidding the job is “singing from the same song sheet.”