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USP 797 IV Room Requirements

Understanding USP 797 IV Room Requirements for Safe Medication Compounding

17 Comments / Blog, Compounding, Compounding News, Compounding Solutions, Contamination Control, Healthcare News, Hospital Industry News, Infection Control /

Wednesday March 29, 2023

In healthcare, medication compounding plays a critical role in patient care. However, the process of compounding injectable medications carries a certain degree of risk, which is why the United States Pharmacopeia (USP) has set forth guidelines and standards for safe and effective compounding practices. One such standard is USP 797, which outlines the IV room […]

Understanding USP 797 IV Room Requirements for Safe Medication Compounding Read More »

In healthcare, medication compounding plays a critical role in patient care. However, the process of compounding injectable medications carries a certain degree of risk, which is why the United States Pharmacopeia (USP) has set forth guidelines and standards for safe and effective compounding practices. One such standard is USP 797, which outlines the IV room

risk of exposure to hazardous drugs

Risk of Exposure to Hazardous Drugs

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Wednesday February 17, 2021

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

Risk of Exposure to Hazardous Drugs Read More »

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

Exposure to Hazardous Materials

Exposure to Hazardous Materials during Shipping and Receiving

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Wednesday December 16, 2020

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

Exposure to Hazardous Materials during Shipping and Receiving Read More »

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

sterile compounding

Sterile Compounding USP 797 Solutions

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Wednesday October 14, 2020

  Sterile compounding is an essential element of patient care. Hospitals and clinics need to evaluate the best way to optimize care and meet regulatory and safety requirements while managing the costs of these important medicines. Our team of experts can help you evaluate external sources and the opportunity and requirements of insourcing this critical

Sterile Compounding USP 797 Solutions Read More »

  Sterile compounding is an essential element of patient care. Hospitals and clinics need to evaluate the best way to optimize care and meet regulatory and safety requirements while managing the costs of these important medicines. Our team of experts can help you evaluate external sources and the opportunity and requirements of insourcing this critical

pressurize an anteroom

How to pressurize an anteroom?

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Wednesday October 7, 2020

  There are several techniques to pressurize an anteroom in healthcare and laboratory applications. When anterooms are present, such as those used for isolation rooms and pharmacies, it is not always clear how the anteroom should be pressurized in relation to the adjoining room and hallway. Airborne Infection Isolation (AII) patient rooms are designed for negative

How to pressurize an anteroom? Read More »

  There are several techniques to pressurize an anteroom in healthcare and laboratory applications. When anterooms are present, such as those used for isolation rooms and pharmacies, it is not always clear how the anteroom should be pressurized in relation to the adjoining room and hallway. Airborne Infection Isolation (AII) patient rooms are designed for negative

503 b compounding pharmacy

Revised 503 b compounding pharmacy guidance

1 Comment / Blog, Company News, Compounding News, Hospital Industry News, Pharmaceutical Industry News, Research News /

Tuesday September 15, 2020

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

Revised 503 b compounding pharmacy guidance Read More »

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

Basic Cleanroom Protocol

Basic Cleanroom Protocol

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Tuesday September 15, 2020

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

Basic Cleanroom Protocol 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

What Are Universal Precautions?

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Monday August 24, 2020

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

What Are Universal Precautions? Read More »

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

Basic Cleanroom Protocol

Customize Industrial-Quality Workbenches

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Tuesday August 11, 2020

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

Customize Industrial-Quality Workbenches Read More »

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 - Hospital Industry News

Basic Cleanroom Protocol

Leave a Comment / Blog, Compounding News, Hospital Industry News, Pharmaceutical Industry News, Research News /

Wednesday April 17, 2019

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

Basic Cleanroom Protocol Read More »

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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