Cleanrooms

Cleanrooms are a large investment, putting a lot of responsibility and pressure on the owner and project engineers. As with any large investment, the aspiration is to formulate the perfect design the first time. While those expectations may be high, facilities can reduce time and expenses with careful planning and strict project management practices. There are also many considerations to make in the cleanroom’s pre-planning stage. Such as?

The first step in planning a cleanroom is to concretely identify the primary goals and applications. Often this depends on the industry for which the cleanroom will be used. There are several questions to answer: How will the cleanroom be used? What ISO cleanliness regulations must be met? What equipment is needed (e.g. hoods, gloveboxes, storage cabinets or packaging machinery)? What is the maximum number of workers that will be inside the room at peak time? A regu

Pharmacy compounders have a lot of factors to consider when making the decision to go into the business of mixing individual prescriptions, particularly those considered “hazardous.” It can be a lucrative operation, but one which is closely overseen. For good reason, though: mistakes in the recent past have taught us that sloppy procedures, partly resulting from a lack of regulations, can have deadly consequences.

Once you’ve make the commitment to move forward with your compounding pharmacy business model, you have to understand your responsibilities (and the associated costs) regarding equipment and furnishings. What used to be true for minimum “engineering controls” is no longer good enough, and regulators will make sure that pharmacies comply.

 Click here for more USP resources. Find out what is required, base

Particles, particles everywhere! What is a lab to do? Sources of these contaminating specks are many: equipment, room materials, unfiltered air, bacteria and mold, clothing, and (the biggest culprit of all) people. Facilities make heroic efforts to keep the adulterants at bay, but some amount of contaminants will find their way into the controlled space.

Until processes become fully automated, personnel will still need to step into cleanrooms to perform application-specific tasks and service equipment. Best practices guide these workers, but it’s impossible to contain every particle that’s just begging to float around the room or land on surfaces.

Flammable gasses and vapors possess the potential to cause devastating damage to personnel, property and the environment. To minimize this danger, organizations including Occupational Safety and Health Administration (OSHA) and the National Fire Protection Association (NFPA) develop standards, such as the National Electric Code (NEC), by which many industries operate. Explosions still occur, but damage can be minimized by using documented protocol for managing them. Companies involved with pharmaceutical development and manufacturing, fuel, chemical manufacturing, food manufacturing, aviation, and other high-risk applications have to abide by these established safety practices.

In each group of flammable-material type (gas/vapor, powder or fiber) the NEC categorizes risky environments based on this basic formula: material’s duration of use + its flammability potential = likelihood for fire.  Equipment is designed

Windows give us a view of the environment on the “other” side of the wall, whether looking out from an enclosed room, or looking into it. In a controlled cleanroom, windows are a source of ambient light, and help to “expand” the space, making it feel less restrictive and relieving worker claustrophobia. Practically speaking, they also allow personnel to see when the critical environment is in use, and what activities are being performed.

Windows are more complex than a simple pane of glass. Anyone responsible for wiping down a cleanroom can appreciate how troublesome nooks and crannies can be! Contaminating particles can collect on framing, sills and fasteners, complicating the sanitizing process. Terra’s stainless steel BioSafe® cleanroom windows are designed to reduce cracks and horizontal surfaces, making disinfection easier and faster.

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:

How will my clean room be used?

The processes taking place in a cleanroom determine functional characteristics. For instance, static sensitivity or chemical processing dictate specific types of construction materials. Perhaps your needs can be met with a softwall cleanroom that features full-view plastic panels, or maybe you need an all-steel modular cleanroom for ultimate cleanliness. The number of personnel, their frequency of access, approved garbing protocol and necessary application equipment have a significant