Category Archives: Cleanrooms

Cleanrooms

Top 5 Questions to Ask Yourself When Designing a Cleanroom

Considering the countless designs and operating regulations, specifying the right clean room for your application is not a simple 1-2-3 process. But as with other capital purchases, a checklist of critical questions can help guarantee a decision that meets your expectations. Here’s what our clean room specialists first evaluate when designing a controlled environment:

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How to Make the Most of Your Cleanroom Gowning Space

Gowning procedures are vital to cleanroom compliance, and a poorly designed gowning room can make following protocol challenging. Several factors contribute to the layout and furnishing of a functional gowning space, most notably the cleanroom’s application and your budget. Below, we breakdown of each area within and surrounding an “ideal” gowning room.

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The Importance of Airflow Uniformity

In a critical environment, FDA, ISO, and cGMP requirements rule! Cleanliness relies considerably upon fan/filter units (FFUs), and a poorly designed FFU can mean the difference between a clean space and a non-compliant room. Some commercial FFUs appear to meet minimum standards of cleanliness but, by failing to create uniformity in velocity and flow, instead contribute to an unclean work place and negate the clean environment you’ve worked so hard to create.

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What Makes a Room Suitable for Aseptic Processes?

Biological contaminants are ubiquitous. Microorganisms such as bacteria or fungi roam free in most environments and can cause disease. A major goal of aseptic applications, including surgery, pharmaceutical compounding or medical implant packaging is to prevent contaminants and the potential for disease, so how do we create the ideal setting?

Building a microorganism-free space is exactly what regulatory guidelines aim to achieve. Asepsis is the objective, and certified facilities are bound by regulations that dictate design and protocol for optimizing aseptic processing.

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Should Vape Manufacturers Be Regulated By The FDA and Require Cleanrooms To Prevent Contamination?

The Wells Fargo Securities Tobacco Talk recently conducted a survey of tobacco wholesalers representing over 25,000 retail locations and discovered these wholesalers held the solid belief that e-cigarettes are not just a “passing fad.” In fact, they expect the vaping industry to bring in over $1 billion over the next few years.

With the vaping industry expanding almost exponentially and economic experts predicting the popularity of “vaping” to outpace supply, the question of when–not if–the FDA will begin aggressively pursuing implementation of regulatory standards raises even more problems for vape manufacturers who currently produce e-liquids in unregulated environments.

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