1. What USP 797 Means and How to Make Sure Your Cleanroom Complies

    USP 797 governs and regulates not only the clean room itself, but everything that happens in that cleanroom from cleaning methods to monitoring of sterility. First issued in 2004 and revised in 2008, USP 797 sets standards "for the design of and the procedures used in sterile compounding areas", according to usp797.org. Though usp797 is generally universal in its regulations, state and organizations also have written standards and should be consulted also. A major component affected by these regulatory standards is the cleanliness of a usp797 clean room. Only staff trained in high-level disinfection should be allowed to clean the area and dressed in appropriate personal protective equipment. This equipment should be donned before entering t…Read More

  2. Setting the Highest Standards

    Its almost a mantra of any business focused on setting themselves apart from their competitors. "We set the highest standards...." But what exactly does that mean? What standards are they setting? Industry standards? Business standards? Personal standards? And to what level is the highest? A standard of excellence can mean something completely different to one organization as it does to another. Has the statement "setting the highest standards" become a business cliche? From our business ethics to our customer service, from design and construction to follow-up and maintenance, at TCA Clean Rooms our standard is simply the best. We stand behind everything we do with a passion. We want only to be the best in building USP797 cleanrooms. Plain …Read More

  3. Experience that Matters when it Comes to USP797 Cleanrooms

    As a compounding pharmacy, you have a plethora of choices regarding contractors who specialize in USP797 cleanrooms and having them comply with regulations. There are literally thousands of these builders throughout the country. And many of them will tell you that they have the experience that counts in building modular clean rooms. But is it the experience that counts? Basically, most building contractors can, for most accounts and purposes, construct your clean room. But understanding the special needs of a modular cleanroom often goes overlooked. Does that contractor guarantee that the finished cleanroom will comply with USP797 regulations and meet the requirements of ISO class certifications? Will their pre-fab cleanroom fit your workfl…Read More

  4. Experience Where It Counts

    Having a general contractor build your USP 797 cleanroom would be akin to asking the neighborhood donut shop to bake your wedding cake. The basic knowledge is generally there but its the ever-important details, no matter how small, that make the biggest differences in quality. TCA modular clean rooms are specialized because those details are considered in the design and we have the experience and knowledge that allow us to know just what details matter the most. TCA's owner has worked within the pharmacy industry with infusion, hospice, home health and compounding experience. That extensive knowledge makes all the difference in planning and designing a cleanroom that not only meets USP 797 requirements but those of the pharmacy users themse…Read More

  5. Complying with USP 797 Cleanroom Requirements

    With new government regulations seemingly being added every year or so, its hard to keep up with just what is required of a compounding pharmacy. At TCA we want to try to clear some of the muddy waters surrounding cleanroom requirements of USP 797 Specifically, USP 797 calls for "a separate area for compounding that meets a defined level of cleanliness and monitoring to ensure that control is maintained". With the founder of TCA having an extensive background as a registered pharmacist, it only makes sense to contract us to design and construct your ISO5-7 certified cleanroom. Not only do we understand the requirements listed in USP797, we also understand the challenges of running a pharmacy. We bring the expertise of both into building you…Read More