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September 2020

ON-SITE EVALUATION OF FACILITY

Leave a Comment / Blog, Company News, Compounding, Compounding News /

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Register Notice that announced the 503 b compounding pharmacy revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to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

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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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