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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

ON-SITE EVALUATION OF FACILITY

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Wednesday September 30, 2020

  When it comes to cleanroom design, fabrication, installation, pricing, and customer service, we do clean rooms right. The importance of understanding your current situation is always a great starting point for any type of project. So our pharmacy project engineers are now conducting on-site visits for inspection and evaluation of your cleanroom areas in

ON-SITE EVALUATION OF FACILITY Read More »

  When it comes to cleanroom design, fabrication, installation, pricing, and customer service, we do clean rooms right. The importance of understanding your current situation is always a great starting point for any type of project. So our pharmacy project engineers are now conducting on-site visits for inspection and evaluation of your cleanroom areas in

Regulation for Compounding Aseptic Isolators

1 Comment / Compounding News, Pharmaceutical Industry News /

Wednesday September 23, 2020

Prominently featured in the pharmaceutical manufacturing industry, a barrier isolator creates an aseptic environment for compounding parenteral (injectable), ophthalmic, and inhaled medications.  Due to the significant risk posed by microbiological contamination, the critical area where the compounding takes place requires protection beyond that of a typical laboratory glovebox. Since the first publication of USP’s General

Regulation for Compounding Aseptic Isolators Read More »

Prominently featured in the pharmaceutical manufacturing industry, a barrier isolator creates an aseptic environment for compounding parenteral (injectable), ophthalmic, and inhaled medications.  Due to the significant risk posed by microbiological contamination, the critical area where the compounding takes place requires protection beyond that of a typical laboratory glovebox. Since the first publication of USP’s General

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

USP 797 & 800 Compliant Design Services

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Tuesday September 8, 2020

The Aseptic Enclosures pharmacy and cleanroom design and development team understands that a highly functional pharmacy begins with a soundly planned design. Our design team with combined years of experience and sophisticated design software with a collaborative approach is the perfect solution to ensure that your project will meet the required ISO or USP specifications.

USP 797 & 800 Compliant Design Services Read More »

The Aseptic Enclosures pharmacy and cleanroom design and development team understands that a highly functional pharmacy begins with a soundly planned design. Our design team with combined years of experience and sophisticated design software with a collaborative approach is the perfect solution to ensure that your project will meet the required ISO or USP specifications.

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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Aseptic Enclosures located in St Louis, Missouri manufactures a wide range of Air Filtration equipment for Aseptic processing and Containment applications.

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