Transferring items into and out-out rooms is something we all take for granted. It’s easy to pick up a folder and deliver it to an office down the hall, or load up a cart with paperclips and staples destined for the supply cabinet. Once you work in a cleanroom, however, this simple task turns into a “process.” Strict requirements govern the steps that personnel take for otherwise simple actions.
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.
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.
Materials get transferred into and out of cleanrooms all the time. The value of pass-through chambers is well-known, and labs count on them for continuity of their workflow and certification status. Without an efficient method of clean movement between rooms of different classifications, some facilities would be out of business.
While personnel can enter and exit the room through designated doorways, it’s not feasible for them to bring samples, supplies, carts and equipment with them. Besides the cleanliness problem of excessive object handling, the donning and doffing of garb would be time-consuming and expensive.
Softwall cleanrooms serve to provide clean-enough enclosures, while also giving your budget a break. They are flexible in more ways than the obvious, as we’ll explore below. Applications within component manufacturing, device packaging, quality assurance testing, mobile forensics labs and other controlled processes are well-suited for these plastic enclosures that comply with ISO 7 cleanliness rating. Continue reading
“Vacuum” means the complete absence of matter. In order to create vacuum conditions, pressure within a given space must be lower than the surrounding environment. The quality of the vacuum is dependent upon several factors, including the number of particles within a given space. The inertia of moving particles exerts pressure, so fewer particles means lower pressure. Scientists have given up on the idea that a perfect vacuum is even possible; space is the most ideal vacuum we know of, but hydrogen atoms, energy waves and other moving particles are still present.