Aseptic Enclosures – Blog
Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving. Under the current regulations as well as the upcoming USP <800> the hazardous materials are usually ordered …
Whether isolator or cleanroom-based working areas, if we’re talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk. The first known is actually outside of the cleanroom and is the pre-cleaning station. In the hazardous drug area, we like to see packages from shipping and receiving brought …
Exposure to Hazardous Materials during Shipping and Receiving Read More »
According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the …
Revised 503B Guidance for Outsourcing Compounders Read More »
Most of the typical cleanroom protocols are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focal point of any protocol program is to protect the integrity of the cleanroom, the products, and processes …
Working in the healthcare industry exposes individuals to diseases and infections that can be transmitted from one person to another. Universal Precautions were guidelines developed regarding infection control that were designed to protect healthcare workers from diseases that are spread through blood and various body fluids. These were applied to the workplace when workers were …
Workbenches are used in many industries including those engaged in manufacturing, assembly, packaging, and shipping. Industrial-quality workbenches are also found in laboratories, educational institutions, research centers, and healthcare facilities. Whether they are subjected to light, medium, or heavy use, these furnishings may become more functional when certain accessories are added. Some accessories are designed for …
Basic cleanroom protocol programs are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the …
Attaining compliance with USP Chapters is of great concern within the practice of sterile compounding, as the process can be quite daunting and also expensive. This is especially true in small and/or rural facilities. Having more than one large project occurring at a given time requires a division of focus, and there is a risk …
Developing a Robust Compounding Strategy is critical to ensuring patients have access to properly compounded medications, but because each organization’s needs differ, a one-size-fits-all solution cannot be applied to every hospital. A careful evaluation of the institution’s requirements, the available infrastructure for compounding medications in-house, and any registered 503B compounding facilities in the vicinity …
The degree of danger that pharmacy workers are subject to depends on the kind of pharmacy they work in and its location. Pharmacists can be employed in community-, retail-, and hospital-based pharmacies, among others. Each of these workplace settings brings different hazards that need to be addressed to prevent harm. 1. Biological HazardsContact with patients …
Aseptic Enclosures located in St Louis, Missouri manufactures a wide range of Air Filtration equipment for Aseptic processing and Containment applications.
Hours: 8:00am to 5:00pm
Central Time, Monday-Friday
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