Research News Archives - AsepticEnclosures

Exposure to Hazardous Materials during Shipping and Receiving

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Whether isolator or cleanroom-based working areas, if we’re talking about both sterile and hazardous sterile preparations we recognize the first source of Exposure To Hazardous Materials . 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 …

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ViTralizer – Virus Neutralizing System

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ViTralizer – Technology that’s clinically proven to kill viruses such as COVID-19 and Flu. “Greatly reduce infection risk!” “Sanitize any public, residential, or office area.” Using the “ViTralizer” allows you to easily sanitize and make the space far safer for your families, clients, employees, patients, passengers, etc. A great advantage of our system is its …

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Revised 503 b compounding pharmacy guidance

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According to the Federal Register Notice that announced the 503 b compounding pharmacy revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to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 …

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Basic Cleanroom Protocol

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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 …

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Basic Cleanroom Protocol

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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 …

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Ensuring compliance with USP

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Ensuring compliance with USP Chapters is a significant concern in the field of sterile compounding, particularly for small and rural facilities. This process can be both daunting and expensive, especially when managing multiple large projects simultaneously. The division of focus among these projects poses a risk of negatively impacting the desired end goals. To tackle …

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Developing a Robust Compounding Strategy

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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 …

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Trends in USP Compliance

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With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting …

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Can an Isolator still be used without a Cleanroom?

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Can an Isolator still be used without a Cleanroom? The answer is complicated. Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions. Usually, the certifier will conduct particle tests and airflow studies while a …

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Cleanroom Training and Evaluation

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As cleanroom experts, we also provide on-site clean room training. This on-site training can be implemented in several ways. We have done short courses, that largely involves lecture only in as little as one day on-site. Depending on the number of people, a full training and testing class can take as long as two …

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Research News

Exposure to Hazardous Materials during Shipping and Receiving

ViTralizer – Virus Neutralizing System

Revised 503 b compounding pharmacy guidance

Basic Cleanroom Protocol

Basic Cleanroom Protocol

Ensuring compliance with USP

Developing a Robust Compounding Strategy

Trends in USP Compliance

Can an Isolator still be used without a Cleanroom?

Cleanroom Training and Evaluation

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