WHILE THE DIZZYING ARRAY of FDA regulations and changes may seem overwhelming, there is a checklist that can help you stay sane and in compliance.

Q&A with Randy Mcleod, Senior Vice President of New Technology at Pall Corporation about the considerations for supplying water of various levels of purity for laboratories needs.

In critical cleaning for medical, dental, electronic, and pharmaceutical applications, the priority is movement of the water mass without leaving non-aqueous residues (water spots). That’s why evaporation is often a poor approach toward removing water—non-volatile minerals get left behind as water spots.

Categories of air samplers and factors to consider when choosing one.

While there have been improvements in materials and methods of ESD control over this period and some factories have done a better job than others in implementing them, the fundamental capability of the methods has not changed appreciably.

If your business is pharmaceuticals, you assume validation as a part of critical cleaning. So then, are you using a validation strategy? Do you validate the performance of your cleaning system?

Following challenge studies, there is a need to decontaminate the Challenge Room and its contained BFS machine. Given the nature of the Challenge Room and the complex construction of the BFS machine, chlorine dioxide gas waschosen for decontamination purposes.

Because computer chips are so susceptible even to the tiniest speck of dust, cleanrooms, historically, have been difficult areas to protect from fires. Contamination from a fire, no matter how small, could potentially put a chip maker out of business for weeks—if not permanently.

It was a time when we took a chance for us all. We, the US and 24 other countries, choose to believe the then-immature atmospheric science, abandon a highly-sophisticated and profitable technology, form an agreement called the Montreal Protocol (MP), and accept the unknown in order to "save the planet."

“The beginning of wisdom is to call things by their proper name.” We have opted to take this advice. That is why we will be changing the name of A2C2 to Controlled Environments.

The stages of operational transition will have a direct impact on the HVAC systems required to support the different manufacturing environments.

A manufacturing manager for a biotech firm told me that they use a phenolic disinfectant exclusively for one month and then switch to a bleach solution for one month. He said he was not really sure where the rationale originated, but knew that it had been validated.