Lean is one of the most popular principles applied in the manufacturing industry today. Developed within the Toyota Production System, these concepts are now widespread throughout all manufacturing sectors. The basic concept is to eliminate anything that does not add value, or that which is waste. Waste comes by way of materials, efforts, and time. […]
Month: April 2014
Proper Monitoring of the Cleanroom Environment: Reminders
Cleanrooms have to meet all relevant regulatory requirements that are mandated for the products being manufactured. These are agencies like the Institute of Environmental Sciences and Technology (IEST) and the International Organization for Standardization (ISO). In order to ensure continued compliance, manufacturers need to understand what environmental factors cause contaminates, and they need the proper […]
What a Closed-Loop System does for the Cleanroom
One of the most important elements of a cleanroom environment is the flow and control of air. This is crucial to retain filter efficiency as well as keep humidity at a desired level. There are a few kinds of fan filter systems available for cleanrooms. Controlled environments that don’t have closed-loop systems can create challenges […]
The Core Elements of the Validation Master Plan
Validation is documented evidence that declares a process or system will consistently meet a predetermined specification. It is a series of documented tests and gathered information that proves a system will produce a product that meets all specifications and standards. Validation is FDA-mandated for the pharmaceutical, bio-pharmaceutical, medical device, and food manufacturing industries. The facility […]
The Present and Future of Cleaning Cleanrooms
Pharmaceutical industry experts predict an evolution in cleanroom cleaning between now and 2020. They speculate that materials, techniques, and even guidelines used to clean will all look different. However, the current state of the industry suggests that cleanroom workers are not even up to par in cleaning for today’s standards. This matter urgently needs to […]