Cleaning a cleanroom sounds redundant, but routine maintenance and cleaning are a big part of what keeps these environments compliant. Of course, cleaning procedures will differ according to required cleanliness levels, processes occurring in the cleanroom, and the individual company. However, experts agree that there are some universal steps to follow. 1. Establish Environmental Monitoring […]
Author: Gerbig
Printed Circuit Boards and Cleanrooms
As you may have noticed, we depend on more and more electrical and electronic equipment every year. We rely on this equipment for providing everything from safety to entertainment. Almost all of this equipment relies on printed circuit boards (PCBs). The electronic circuit board manufacturing process is very delicate and requires precision. For some high-density […]
Lean Manufacturing in the Cleanroom
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. […]
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 […]
Using Air Showers in Cleanrooms
There are many different components to a cleanroom that keep particulates out of the air. Among them are garments. While workers must wear special garments to protect cleanroom material, the garment is often not enough. Air showers in cleanrooms are used to clean gowned personnel before entering a workspace and after leaving a hazardous workspace. […]
How Does Outdoor Humidity Affect the Cleanroom?
One of the most costly and important factors in building a cleanroom is air control. Cleanrooms are pressurized and use advanced filters that remove contamination-causing particulates. These airborne contaminates are not the only environmental issue in the cleanroom, though. Humidity control is of the utmost importance in a cleanroom. Too much humidity can encourage bacteria […]
Developing your Internal Audit of the Cleanroom and Controlled Environments
Customer and registration audits can be stressful, and even more so when a company questions its preparedness. By issuing several internal audits throughout the year, these second and third party audits will be more successful. Additionally, employees will be better experts in policies, procedures, and instructions. Jan Eudy wrote a thorough article on the topic […]