September 2020

Regulation for Compounding Aseptic Isolators

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 …

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503 b compounding pharmacy

Revised 503 b compounding pharmacy guidance

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Register Notice that announced the 503 b compounding pharmacy revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to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

Basic Cleanroom Protocol

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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USP 797 & 800 Compliant Design Services

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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