Here is a list of the five must have qualities of an effective manager according to a blog by Roberta Matuson, President of Human Resource Solutions. She states that this list was put together as a result of working for some pretty ineffective managers.
Question: What are the key elements I should include in my facility maintenance plan to ensure a “clean power” supply?
Twenty five years ago, the concept of using an isolator in pharmaceutical and hospital applications was only a far out thought.
Outsourced rep-PCR Technology Delivers Accurate, Affordable Microbial Identification
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.
Don’t be afraid to monitor particle counts and control airflow. Old-school thinking was “don’t ever mess with airflow, even by the slightest amount, because the sky will fall and product yield will drop. Therefore, active particle monitoring is unnecessary.”
“How do I check for leaks in an isolator?”
Probably the biggest challenge in maintaining manufacturing area cleanliness—and a significant energy user—can be found in the recirculating air system.
If you as a manager or team member are asked for help, do not simply reply, “Sorry, I don’t have time.” That says that you consider your tasks to be more important than theirs. Everyone has the same number of hours in the day. Prioritizing and giving help when needed is important.
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.
It seems that almost everyone is caught up in some sort of crisis or conflict, be it at work or at home. It might be stress around processes, deadlines, budgets and job security, or personal relationships and unresolved conflicts. But it doesn't have to be this way.
Facility monitoring and the routine periodic documentation of this information are vital to maintaining the cleanroom facility at optimal operational efficiency.
Simple, Mobile, and Cost Effective Softwall modular cleanrooms are designed for functionality and reduced cost while providing all the flexible benefits of modular construction.
A Brief Information Outline
The issuance of the new FDA Process Validation Guidance in January of this year is a significant event for several reasons.