1. Want a Thriving Business? Focus on Meeting Clean Room Regulations!

    Your pharmaceutical business involves using a clean room to handle and process what the FDA considers dangerous drugs. You have heard about the proposed changes with the new clean room regulations under USP Chapter 800, but haven’t made any changes to reach the new compliance since it’s not yet finalized.The standard guidelines for USP 800 will become regulation and you will need to have them in place for your business to thrive. Practically, you want your business to thrive, but you don’t know where to start in implementation of the proposed standards. Should you start making changes now? Or wait until the new standards are put in place by the federal government. We also want you to succeed, by being available to help you stay compli…Read More

  2. Using Your Clean Room On a Daily Basis

    As a compounding pharmacy manager you've done your homework regarding your level of compliance and your USP797 clean room. You're ready to now move on to the finding the right contractor to build your modular clean room. Now there are a lot of choices out there, many very good, but consideration for actually operating within your clean room is just as important as the clean room itself. Being able to seamlessly transition your staff to working within the clean room, with as few functional hiccups as possible is key to the overall success of the planning and implementation of that modular clean room. Its imperative that you make sure that the designer and installer understand your business more than they understand the clean room itself. At …Read More

  3. Why Cleanroom Sanitation Remains Important

    According to the PEW Charitable Trusts study of 2013 there were 20 compounding pharmacy errors that resulted in 87 deaths in the years following 2001. The study points to contamination of sterile products as the most common error. These contaminations also caused various adverse reactions among those affected including instances of fungal meningitis, blindness, bacterial bloodstream infections and systemic inflammatory response syndrome. In September of 2012, a fungal infection was spread by tainted epidural steroid injections produced and packaged by the New England Compounding Center in Framingham, Massachusetts. These doses were distributed to to 75 medical facilities in 23 states and administered to more than 13,000 patients between May…Read More

  4. Challenges Pharmacies Face In Complying with USP797

    After  the revamp of USP 797 in 2008, pharmacies found themselves, once again, confused about the guidelines and just what they exactly meant. This confusion resulted in less pharmacy and hospital compliance to USP797 clean rooms and the operations within. In 2011, the United States Pharmacopeia developed a survey to evaluate compliance rates and issues regarding the ability to comply to USP797. The results of which, they hoped, would provide a baseline from which to measure progress. USP repeated this survey in 2012 and found improvement in certain areas when compared with 2011 results. With a 7.3 percent response rate,  only 950 registered for the survey of which 412 actually participated. This was a drop in participants by 64 percent f…Read More

  5. Making Sure Your Modular Clean Room is Sterile

    Getting to the nitty-gritty, so to speak, of the guidelines of USP 797 clean room requirements isn't very easy. So, at TCA we just wanted to take a few minutes to help break through the mumbo-jumbo of government language and get to what you really need to know; as we did in previous blogs in regards  to cleaning requirements within the clean room itself. Air quality takes precedence in sterility regulations as USP guidelines point out that contamination through airborne impurities is more likely than through floor or surface matter. Environmental sampling of air quality is therefore needed to check for particulates, this should be a part of a routine action plan. Refer to USP797 Table 1 for matter limits. The guidelines call for measuremen…Read More

  6. Further Cleaning Requirements for USP797 Clean Rooms

    We touched somewhat on cleaning procedures and personnel requirements included in USP 797 clean room regulations but further spelling out of other requirements is called for. We'll go into further details regarding cleaning supplies methods and disposal of waste. Use of non-shedding cloths like microfiber wipes and gloves are both required and need to remain exclusive to the clean room to prevent contamination to other areas. Any tools used must be cleaned before being brought into the area and disinfectants should be approved by the infection control department in hospitals. Staff should clean from the furthest point in the clean room toward the exit door, cleaning countertops shelving and storage bin surfaces with germicidal disposable wi…Read More

  7. 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

  8. 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

  9. 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

  10. 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