![]() ![]() A hands-free sink must be available for handwashing, and an eyewash station and/or other emergency or safety precautions must be established. The room temperature must be designed to maintain 68 degrees with relative humidity between 30 and 60 percent. The room pressure is to be maintained at a positive pressure relative to the sterile buffer room. (The ISO classification system identifies ISO 1 as being the cleanest air, while ISO 9 is the dirtiest. The environmental condition must meet ISO Class 7 air quality. A line of demarcation is identified, which is not an actual physical separation in this room, but it designates an area for personnel gowning and wash.Īirflow rates in the amount of 30 air changes per hour (ACH) with laminar airflow distribution are required with HEPA filters to capture particles that may promote microbial growth. The ante room is adjacent to the clean room, where technicians perform support tasks and are equipped with items such as a sink, cabinets and a bench. Many other design considerations can come into play. This is one possible layout within the new standards. USP 800 establishes design guidelines for the creation of a sterile environment to prevent unintended physical, chemical and microbial contamination of drugs while improving quality and variability in intended strengths.įacility and engineering controls are summarized in the sections below with the purpose of establishing contamination control areas for operational practices for the receipt, storage, handling and compounding of HDs. The National Institute for Occupational Safety and Health (NIOSH) maintains a list of HDs used in health care. ![]() These code changes were created to promote and protect patient safety and health care personnel who handle hazardous drugs (HDs) known to cause infertility, miscarriages, genotoxicity, leukemia and other forms of cancer. Pharmacopeia General Chapter 800 (USP 800) and enforced by the Food and Drug Administration (FDA) and state pharmacy boards will be enacted Dec. Exposure can occur during any aspect of handling hazardous drugs, such as transport, storage, compounding, disposal or even treating patients.Īs a result, sweeping changes are occurring within the industry including major changes in the design, construction and operation of pharmacies. health care workers are potentially exposed to hazardous drugs in the workplace each year, according to the Centers for Disease Control and Prevention. Pharmacy Safety Standards, Hazardous Drugs and Mechanical Design: What You Need to Know ![]()
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