Pharmaceutical Industry News

Developing an effective 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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Reducing risks of exposure to HDs

Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving. Under the current regulations as well as the upcoming USP <800> the hazardous materials are usually ordered …

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What is the StageThru800?

This StageThru800 is a negative pressure, isolated, Pass-through, CVE  device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area. his equipment is designed to provide a protective barrier for the operator.  It is not iso-classified.  It is not appropriate for …

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Upcoming Webinar: How to get a clean-room in less than 5 months

At Aseptic Enclosures, we are planning a presentation to review the design/build process for our Mobile cleanroom suites.  Our typical application has been pharmacy USP 797/800 compliant builds. This Zoom session will be held next Thursday, 01/07/2021 at 10:00 am Central.  It will last approximately 35 minutes + Q&A time.  The ZOOM invite link is https://zoom.us/meeting/register/tJYrcO2qqTgiHdYdKUsBx2YY2F_JIH35bx_2 We will …

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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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Sterile Compounding USP 797 Solutions

  Safely compounded sterile medications are 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 …

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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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