Pharmaceutical Industry News

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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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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Primary Engineering Control Devices for Premier, Inc. GPO

With two in house agreements with Premier, Inc. Aseptic Enclosures now allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier. The base of the supplying contracts covers a wide range of Primary Engineering Control Devices (I.V. Hoods, Isolators, Bio-Chemical Hoods, and Laminar Work Benches) in addition to Pharmacy Planning and …

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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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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 …

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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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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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