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. Staying Safe in the Medical Industry

    Our USP 800 Clean Rooms provide our clients with the ultimate control over their work environments. That control is an assurance that workplace accidents don’t happen. It’s that precaution that is essential for certain medical industries. Here’s why USP 800 Clean Rooms are ideal for maintaining safety in the medical industry. Modular Clean Rooms in the Medical Industry In the fields surrounding modern medicine, researchers and doctors work closely with pathogens. Some pathogens are excellent at proliferating and infecting individuals, others are extremely harmful or deadly, and certain pathogens are both prolific and deadly. It’s essential, whenever dealing with a pathogen, to control the environment, reduce the risk of spreading a …Read More

  6. Staying Safe in the Biotech Industry

    In the biotech industry, worker safety can come down to preventative measures. There are necessary precautions to heed when working with living materials. Without precaution, pathogens can infect the living material, biotech workers, or biotech product consumers. That’s why modular clean rooms are essential for the safety of workers involved in the biotech industry who deal with living materials on a day to day basis. Modular Clean Rooms in the Biotech Industry In the biotech industry, products may be produced by living material or products may be the living material itself. For instance, bacteria can be a catalyst to produce certain chemicals or pharmaceuticals. When a pathogen (a bacteria, virus, or other harmful microorganism) enters a…Read More

  7. Clean Room Industries Part II

    To continue our last blog on industries that require clean rooms to operate, we’ll be diving into three more codependant industries: nanotechnology, biotechnology, and telecommunications. As with our last blog, we’ll be dissecting why our modular clean rooms may be necessary for these industries. Nanotechnology Nanotechnology concerns itself with extremely small components. Quite literally, nano refers to the size of particles being dealt with in this field, and it is limited to particles that are less than 100 nanometers in dimension (a human hair, by the way, is about 100,000 nanometers in width). Often, nanotechnology industries refer to those who manipulate light or manipulate matter on a molecular or atomic level. In these industri…Read More

  8. Clean Room Industries Part I

    There are numerous industries that rely on clean rooms to allow for the performance of tasks necessary to their individual fields. These industries rely on clean rooms to avoid any harmful contaminants that may hinder the production of products, or may hinder the safety of employees. For this and our next blog, we’ll be talking about the various industries that rely on our modular clean rooms here at Travis Clean Air and why these industries need a controlled environment. Medical & Pharmaceutical Fields In the medical and pharmaceutical fields, sanitation is a must. Environmental contaminants, including harmful bacteria and viruses, may slight product quality. Our modular clean rooms are ideal for maintaining a sterile working environ…Read More

  9. What Makes a Clean Room Modular?

    Modular design encompasses design where components are combined to make a whole. When we design our clean rooms, we rely on modular components to build a clean room piece by piece. Modular design is especially useful for building clean rooms because modularity lends itself to adaptability. We can build large clean rooms, small clean rooms, intricate clean rooms, clean rooms with short ceiling height, and clean rooms with tall ceiling height. Moreover, modular design is useful in the sense that we can install different components that may be necessary to a client's specific needs. Here are a few of the components we can add throughout a clean room atmosphere: HEPA Filters Depending on the utility of a clean room, one or more filtration units…Read More

  10. Further Clean Room Facts

    In our last blog, we’d discussed some facts and figures surrounding clean rooms. Today, we’ll be continuing our blog line with further clean room facts. Laminar Flow Was a Big Leap Laminar flow aids in reducing harmful particulates. Through the advent of laminar flow technology, particulate influence is largely reduced. So what is laminar flow, and how does it work? Laminar flow describes the unidirectional flow of air throughout a space. Traditionally, laminar flow is used in some clean rooms to maintain the cleanliness of air. Air is forced downwards (unidirectionally), and recycled or pumped out of the room. Laminar flow is made possible with the use of ventilation systems and air pumps. What Do Clean Rooms Prevent? Clean rooms aim t…Read More