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How Do your Cleanroom Habits Compare to Others?

by Gerbig in General Cleanroom. Comments Off on How Do your Cleanroom Habits Compare to Others?

Controlled Environments recently surveyed over 140 readers to uncover trends in the cleanroom business. Some of their findings might surprise you. Here is a snapshot of what they found:

What kind of facility?

Almost a quarter of respondents work in pharmaceuticals, and other popular industries included medical devices, aerospace, manufacturing, biotechnology, validation, and research.

Retrofitted facilities: 53%

New/custom-built facilities: 37%

Turnkey facility: 10%

Costs

When looking at the big picture, any facility manager is going to base decisions on cost at some point. When is cost most likely to be the biggest concern, and when is it not?

Purchasing items for the cleanroom: 46% say longevity and quality is most important, whereas 35% prioritize cost, and 8% want the newest models available.

Supplier/distributor for equipment supplies: 35% consider cost most important; 26% are most concerned with vendor reputation/reviews, and 11% choose the same company every year.

Along the line of … Read More »

How Cleanroom Contamination Risks Differ by Industry

by Gerbig in General Cleanroom. Comments Off on How Cleanroom Contamination Risks Differ by Industry

What is the difference in cleanroom contamination concerns amongst the industries, and what is the best way to ensure compliance?

Contamination to the product in any cleanroom is very costly. Contaminated products can’t be sold, so the investment in raw materials and labor is completely lost, and starting over means duplicate costs.

The two sources of contamination are particulate and microbial. Most commonly, humans are the vehicle for contaminates. In any case, sources and entry paths don’t vary significantly by industry.  What is different amongst the industries is tolerable versus intolerable levels of contamination.

A high-tech manufacturer makes microscopic products that can’t accept any particulate contamination at all. The tiniest speck of dust would look enormous on a microchip. However, the focus for these products is the sterility of the chip. Mold, fungus, and other forms of contamination are of no concern. A … Read More »

8 Steps to Successful Cleaning and Cleanroom Disinfection

by Gerbig in General Cleanroom. Comments Off on 8 Steps to Successful Cleaning and Cleanroom Disinfection

Cleaning and disinfection are two separate but equal processes in cleanroom compliance. Know these 8 steps.

Our last two posts addressed some common concerns and issues in choosing cleanroom disinfectants. Achieving the appropriate microbiological cleanliness levels for a class of cleanroom is paramount to industries like medical device assembly and pharmaceutical manufacturing.  Disinfectants and applicators are only two pieces of the puzzle. Here are 8 steps to keep in mind when ensuring your cleanroom is kept clean.

 

Know the difference between cleaning and disinfection. Cleaning surfaces is basically removing soil, like dirt, dust, and grease. Detergents are typically used in this process, and it must be completed before disinfection. Chemical germicides used to disinfect eliminate vegetative microorganisms. Both steps are important, and they must be done in the right order.
Choose the right agents. Between class, purpose, and equipment, cleanrooms differ in … Read More »

The Most Overlooked Step in Cleanroom Disinfectant Programs

by Gerbig in General Cleanroom. Comments Off on The Most Overlooked Step in Cleanroom Disinfectant Programs

Disinfectant programs for cleanrooms rely on more than the solvents themselves. Don’t overlook this important piece of the puzzle.

In our last article, we covered a six-step checklist for choosing disinfectants for your cleanrooms. When it comes to controlled environments, however, it’s necessary to create a disinfectant program.  While the solvents and solutions themselves are key, they will not do their jobs properly if you overlook another important element: the applicator.

One of the most overlooked steps in developing a disinfectant program is careful consideration of the proper tools used to apply the solution(s). This is a grave mistake. Using the wrong applicator can compromise the integrity of the active ingredients.

Even the smallest variables can cause improper disinfection surfaces. They can range from the fibers of the applicator to protocol for applying solutions. Of course, how facility workers interpret and implement … Read More »