Over the years I have been writing about the indicators of change both within the FDA and the industry. Few can argue with the fact that in today’s society, change is inevitable.
Cleanrooms in healthcare and pharmaceutical facilities must be kept in a state of microbiological control. This article outlines eight key steps for keeping a cleanroom clean.
Kanegsberg and Kanegsberg, Handbook for Critical Cleaning: Book I: Cleaning Agents and Systems & Book II: Applications, Processes, and Controls
Verify a garment’s performance while identifying potential threats.
Before you hold your next meeting, be sure you and the others at the meeting know why it’s being held. Meetings can drag on and feel like a waste of time if the goals are not clear to all in attendance.
Air showers are just one factor in ensuring good cleanroom performance. Proper worker training, documented procedures, and a well-maintained system will increase production yields and reduce product defects and costs.
If you think that a Material Safety Data Sheet (MSDS) provides adequate information to determine if a process chemical could be hazardous to your product, think again.
Productivity guru Gina Trapani says "Do the Most Important Thing First." She calls this "running a morning dash." When she sits down to work in the morning, before she checks any email, she spends an hour on the most important thing on her to-do list.
Does your business plan include the development of an area in your plant or laboratory for clean manufacturing or other procedures? Are you concerned that you make the right purchase? Do you want to make sure you consider the right factors when you evaluate different models?
Innovative design was the linchpin of a dramatic renovation that transformed a vacant telecom atrium office building into a state-of-the-art life sciences company headquarters. Creative process and meticulous planning combined to create a facility with the dexterity to meet a range of specific, strict criteria.
Cleaning thin films and addressing the impact of debris on yields, production, and quality.
An interview with Wayne McGee, owner of PortaFab Modular Building Systems, and Tim Loughran, owner of Cleanroom Construction Associates.
The New Year marked an exciting change for Controlled Environments Magazine as Advantage Business Media—publisher of leading scientific and laboratory magazines, websites, newsletters, and digital publications—acquired Vicon Publishing Inc., the magazine’s parent company. Vicon Publishing will be named Vicon Business Media Inc.
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.