Research News

Exposure to Hazardous Materials during Shipping and Receiving

Whether isolator or cleanroom-based working areas, if we’re talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk.  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 …

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ViTralizer – Virus Neutralizing System

ViTralizer – Technology that’s clinically proven to kill viruses such as COVID-19 and Flu. “Greatly reduce infection risk!” “Sanitize any public, residential, or office area.” Using the “ViTralizer” allows you to easily sanitize and make the space far safer for your families, clients, employees, patients, passengers, etc. A great advantage of our system is its …

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According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to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

Attaining compliance with United States Pharmacopeia (USP) Chapters is of great concern within the practice of sterile compounding, as the process can be quite daunting and also expensive. This is especially true in small and/or rural facilities. Having more than one large project occurring at a given time requires a division of focus, and there …

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Developing a Robust Compounding Strategy

Developing an effective compounding strategy is critical to ensuring patients have access to properly compounded medications, but because each organization’s needs differ, a one-size-fits-all solution cannot be applied to every hospital. A careful evaluation of the institution’s requirements, the available infrastructure for compounding medications in-house, and any registered 503B compounding facilities in the vicinity with …

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Trends in USP Compliance

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting …

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Compounding Solutions

Can an Isolator still be used without a Cleanroom

The answer is complicated. Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions.  Usually, the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials. However, the revised version of …

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