1. USP 797 REVISIONS… HOW WILL YOUR PHARMACY BE AFFECTED?

    With the new revision of USP<797> on its way, many pharmacists are concerned about how these new regulations will affect their business. But what exactly has changed within the new revision? Among the most significant changes is the removal of low, medium, and high risk CSP categories. These designations have been replaced with category 1 and category 2 CSPs. The categories are now dictated by the BUD and the environment in which the product was compounded. The chart below shows the major differences between category 1 and 2 CSPs: Another major change within the new USP<797> revision is the frequency at which environmental and personnel viable monitoring must be done. Current USP<797> protocols state that media fill testin…Read More

  2. Modular Acrylic Cleanroom

    Mississippi Baptist Medical Center (MBMC) is a 620-bed, full-service hospital located in Jackson, Mississippi. MBMC’s primary service areas include cardiology, oncology, and women’s services, with additional areas of expertise, such as specialty surgery, radiology, urology, and behavioral health. The pharmacy provides complete IV admixture services, compounding about 900 preparations per day, including total parenteral nutrition (TPN) and chemotherapy agents. When USP <797> was originally published in 2004, the problem MBMC and many other facilities faced was the chapter’s standards were a moving target and subject to change during the recently completed revision process. Even so, we were required to take interim measur…Read More

  3. FDA Posts Notice stating a Change in Procedure for Certain Human Drug Compounding Facilities

    After input from stakeholders the FDA posted a notice announcing a change in inspections of 503 (A) Human Drug Compounding Facilities effective August 1, 2016. The investigations will consist of an initial assessment to see if the pharmacies are operating as a 503 (A) facility. If it is concluded that the facility is not operating as a 503 (A) facility the investigator will place the pharmacy on the list of non-compliance 483 and require the pharmacy to meet CGMP requirements. “The FDA investigators now will make a preliminary assessment regarding the firms compliance with certain conditions of section 503A before closing an inspection” as a response to the stakeholders input. To read the entire notice click here: http://www.fda.gov/dow…Read More

  4. USP Releases Notice of Revision to USP Chapter 800 Hazardous Drugs

    April 15th, 2016 The USP expert committee proposed a revision to USP 800, 5.3 FACILITIES AND ENGINEERING CONTROLS Compounding. The revision states that the C-SEC used for both sterile and non-sterile hazardous compounding would not need to be externally vented through HEPA filtration. The revision to USP 800 was set to be official May 26th, 2016. Click HERE to review the notice in full detail: http://www.usp.org/usp-nf/notices/hazardous-drugs-handling-healthcare-settings…Read More

  5. Reasons You’ll Benefit From a Modular Clean Room

      If you're thinking of installing clean rooms in your business, you are likely simply concerned with complying to safety laws and regulations. However, there are several benefits - aside from safety benefits - to installing a modular clean room: Adaptability Modular clean rooms are adaptable. Travis Clean Air’s clean rooms are modular and mobile - which means freedom in the programming and design of your clean rooms. Since our clean rooms are modular, room configurations can change or expand to meet the changing and expanding needs of your business. Moreover, if your business moves, you can take your modular clean rooms with you to your new location. There, you’ll be able to reassemble and readapt the structure to a new environmen…Read More

  6. New Changes Come With USP 800 Clean Rooms

    Here at Travis Clean Air, we're really excited about the new USP 800 Clean Rooms. We are not only fully committed to serving your clean room needs by providing the best possible clean room solutions out there today, but we're also totally committed to backing up the clean rooms with excellent customer service. We first assess your needs, then we find ways to accommodate your space, we help you select color and design, and then we build your clean room to exact specifications right here in our Loveland, Colorado facility. After that, we deliver the clean room directly to you to ensure proper and safe installation. There are a few changes that come with the USP 800 Clean Rooms. Here's what you can expect: Compounding supervisor.  With the i…Read More

  7. 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

  8. What Our USP 800 Clean Rooms Mean To You

    Here at Travis Clean Air, we hold ourselves and our products to a very high ethical standard. From needs assessment and design, to construction, to delivery and follow-up, we ensure that there's excellence at every turn. We don't just focus on USP 800 Clean Rooms that will fit your space, we think about all sides of the situation and everything in between to ensure that you have receive a personalized customer experience. Not only will you get the best USP 800 Clean Rooms possible, but you'll get the great service we provide to back it up. With the new USP 800 Clean Rooms, we've had a lot of questions. The USP 800 Clean Rooms are an update from the USP 797 regulations regarding the handling of hazardous drugs in compounding pharmacies, hosp…Read More

  9. 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

  10. Our USP 797 Clean Rooms Will Lock-In…

    In the development of our USP 797 Clean Rooms, we spare no expense in any regards. We know that they have to be not only sealed tight when put together, but they have to be federally compliant to the measures set forth by their strict guidelines. We are building rooms that can not let the slightest of molecules in, as just one small piece of hair can be completely destructive. There are several classes of air cleanliness, especially when airborne particulates are analyzed at different levels. The meticulously strict protocols we abide by during construction are some of the toughest protocols to follow in any manufacturing industry. Our USP 797 rooms need to be clean for many reasons: They need to be ready for advanced chemical testing They …Read More