Compounding News

How to pressurize an anteroom?

  There are several techniques for managing safe and reliable pressurized rooms 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 …

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ON-SITE EVALUATION OF YOUR FACILITY

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 your …

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Updated 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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Revised 503B Guidance for Outsourcing Compounders

According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to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

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Basic Cleanroom Protocol

Most basic protocol programs for cleanrooms 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 …

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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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What Are Universal Precautions?

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 …

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Biosafety In The Laboratory: Prudent Practices for the Handling and Disposal of Infectious Materials.

A— GUIDELINES FOR HANDLING PATHOGENIC MICROORGANISMS In 1984, the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) jointly published a set of guidelines for the safe handling of pathogenic microorganisms[105 ]. These guidelines, developed over a period of several years in consultation with experts in the field, remain the best judgments available; …

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Customizing Industrial-Quality Workbenches for Your Needs

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 …

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WARNING LETTER- Stason Pharmaceuticals, Inc.

July 8, 2020 Dear Mr. Fan: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Stason Pharmaceuticals, Inc., FEI 1000160561, at 11 Morgan, Irvine, from October 3 to 25, 2019. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal …

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