ASTM Medical Device Committees: Standards Evolution
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.
Cosmetics and Cleanrooms
Barbara Kanegsberg with special guest columnist Dr. Kevina O’Donoghue Reviewed by Ed Kanegsberg
Superfluous or Essential: Part 2
In the first installment, we discussed how to avoid superfluous materials and activities in cleanrooms.
Superfluous or Essential: Part I
An art exhibit in London inspired us to ponder changing views about the definitions and implications of soil, residue, contamination, and especially the design and operation of controlled environments.
GC/MS – A Second Opinion
The suggestion is often heard in troubleshooting or, proactively, in validating critical cleaning processes.
Ozone O-O-O My!
The world has a love/hate relationship with ozone. Ozone (O3) is a “super” oxidizer, almost as reactive as fluorine. This reactivity makes ozone either desirable or undesirable, depending on the situation.
The Fourth State of Matter—Part 2
Plasma, the fourth state of matter, is a powerful tool for critical cleaning, controlling contamination, and achieving the appropriate surface quality.
The Fourth State of Matter
We usually think of three states of matter: solid, liquid, and gas.
Medical Device Cleanliness Standards—ASTM Update
Surface quality and cleanliness are critical for medical devices. As people live longer and continue to be more active, higher and more reliable device performance is expected.
Ultrasonics: Sound or Fury?
“We know our ultrasonic system is working properly, because it’s making plenty of noise. Why is the cleaning process ineffective?” This recurring question has vexed manufacturers for decades.