1. How Clean Rooms Can Help Avoid Unnecessary Deaths

    In 2012, there was an outbreak of fungal meningitis because of poor handling at a compounding lab for a pharmaceutical company. The source was an injection epidural steroid that was then sent out to 23 different states. Because the guidelines for safe handling within a clean room were not followed, 14,000 patients were exposed to the contaminated drug and at a recent count 64 people have died and 751 have been treated for persistent infections. Unfortunately, this is possible if the guidelines in a clean room facility are not strictly adhered to. Clean rooms are set up with strict regulations to maintain the cleanliness during the manufacturing process of materials. The clean room exists to help keep contamination from happening. The newest…Read More

  2. Be One Step Ahead of the Standards with a USP 800 Certified Clean Room

    Upcoming changes for USP 795 and 797 clean rooms will be made through USP 800. They will be incorporating the information currently in place and adding to it to insure proper handling of hazardous drugs in healthcare facilities and settings. This will help protect both the handler and the end product from contamination. OSHA standards for the clean room are a large priority in the new. Keeping hazardous drugs secure and separate from others is crucial in the creation of the compounds. The new standards will address this. Part of avoiding contamination is having a clean room that’s compliant with USP 800. The other part is to follow the standard guidelines, wearing personal protective equipment, having proper training for compounding perso…Read More

  3. The Importance of Proper Attire in the Clean Room

    Humans are one of the most common contaminates in a clean room. Even the slightest bit of dust, hair, perfume, etc. can contaminate a clean room. To maintain the integrity of the room, the garb or apparel one wears into the room is imperative. Depending on the type of clean room and facility, the level of cleanliness will vary as will the apparel worn by those working in the room. For example, the regulations may be different if it is a USP 797 or USP 800 clean room. As you are getting dressed in the regulated garb, please take note to follow protocol for the order so as not bring any unnecessary contaminates into the clean room. The apparel can either be disposable or launderable depending on the needs and requirements of the clean room. A…Read More

  4. Maintaining your Clean Room Environment After Manufacturing

    At Travis Clean Air, we can build you a modular clean room with an ISO 5-7 Certified environment and guaranteed in writing to pass inspection under USP 797 upon installation. We're now consulting for USP 800. After we build the room to your specifications, it will be your responsibility to keep the room sterile. Without proper practices in place, the room will not remain sterile. The filters need to be replaced on a regular basis. Entering and exiting procedures must be followed to the letter. To assure bacteria and microbes that may contaminate any medicines manufactured don’t enter the room, start with these tips. Proper hand washing needs to take place before entering the room. Wearing the proper garb is essential. Hair nets, beard ne…Read More

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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