FDA News

Aseptic Enclosures – FDA News

Time to Start your Compliance process

Complying with all the current compounding regulations can seem like a steep hill to climb for health facilities professionals. Trying to understand all of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies ahead make navigating …

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Choosing Engineering Controls Under USP 800

The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer these …

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StageThru 800

The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) 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. This equipment is designed to provide a protective barrier for the operator.  It is not iso-classified.  It …

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XLTC800 for Tablet Pressing

  Here in Aseptic Enclosures we have encountered a project where we were called upon to come up with a solution that will provide ISO class 5 conditions for compounding tablets. The issues we had successfully overcome were: increasing safety of the pharmacist, assuring sterility of the product, limit particulate emissions and avoid risks for …

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Pharmacy Planning and Design Projects

  When it comes to clean room design, fabrication, installation, pricing, and customer service, we do clean rooms right. Whatever you’re looking for in a clean room, from economical soft wall installations to the top of the line hard wall construction for permanent use, our clean room value is second to none. We sell our …

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Containing Bloodstream Infections

Pharmacy compounding is the process of combining drug ingredients to prepare medications that are not commercially available or to alter commercially available medications to meet specific patient needs such as dye-free or liquid formulations. Pharmacists traditionally have prepared medications to fulfill individual prescription requests or manipulated reasonable quantities of human drugs on receipt of a …

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Compounding Aseptic Containment Isolator from Aseptic Enclosures

We would like to start the New Year by introducing our Compounding Aseptic Containment Isolator. These close isolators provide a better physical barrier to protect the health of laboratory workers, maintain the sterility of experimental materials, and prevent the contamination of the environment. Closed containment cabinets are safer to use in research laboratories to provide a clean …

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Portable Compounding Cleanrooms

  Aseptic Enclosures, manufacturers of Mobile Compounding Cleanrooms, in compliance with FDA, USP 797 & USP 800 standard. Many hospital pharmacies are undergoing major renovations to be in compliance with new standards. However, they must continue vital drug preparation without interruption. Aseptic Enclosures Mobile Cleanroom allows the hospital to maintain separate, on-site sterile drug compounding …

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Cleaning Compounding Aseptic Isolators

  Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine. Since the June 1, 2008 revision of USP general chapter 797, pharmaceutical compounding personnel have been held responsible for the cleanliness of their sterile compounding areas, including biosafety cabinets (BSCs), compounding aseptic isolators (CAIs), compounding aseptic containment isolators …

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Why Sterile Alcohol?

  FDA reminder of safe non sterile alcohol prep pad use The FDA is reminding healthcare professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin. This reminder comes in light of the recent recall of Triad Group alcohol prep pads and swabs due to concerns …

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