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 […]
When is a Modular Cleanroom the Best Option?
As cleanrooms continues to evolve, standard cleanrooms are not always the best option anymore. Many companies are finding that modular designs best fit their needs. Modular cleanrooms offer more flexibility, little disruption, and they often cost less than a conventional cleanroom. However, they are not always a fit. Here are some pros and cons to […]
Gerbig Engineering Company, Burnsville, MN has completed a procine extraction facility
Gerbig Engineering Company, Burnsville, MN has completed a procine extraction facility consisting of several ISO class 7 cleanrooms. The facility takes in special porcine organs and processes them such that they contain no porcine cells. The organ is then ready for implantation into humans. The Miromatrix Medical technology has the potential to enable the creation […]
Successfully Developing an ESD Program
Contaminates are attracted to charged surfaces, meaning electrostatic discharge (ESD) can devastate product, equipment, and potentially the reputation of a company. The right program to eliminate ESD will benefit productivity, profits, employees, and consumers. Controlled Environments Magazine offers some great resources on ESD, including Richard Bilodeau, PE’s article, “Championing an ESD Control Program.” “The bottom […]
A Quick Guide to Disposable Cleanroom Garment Considerations
There are many considerations cleanroom operators must make when deciding on a garment for the cleanroom. Different uses and requirements will dictate whether disposable or reusable is more appropriate as well as what material is needed for the application. For medium to high-risk environments, disposable garments tend to be more cost-effective. We will focus on […]