Monthly Archives: December 2015

  1. Be Prepared: New Rules for Compounding Aseptic Isolators

    Be Prepared: New Rules 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 Chapter <797> Pharmaceutical Compounding—Sterile Preparations, compounding aseptic isolators (CAI) have offered the most economical alternative to constructing a dedicated cleanroom for sterile compounding. However, pharmaceutical compounding standards have undergone a major overhaul in recent years, including a developing revision of USP 797.

     

    Below are the answers to three common questions regarding the future of isolators in compounding pharmacies.

    What is the new d

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  2. When Grounding Isn’t Enough for Static Control…

    When Grounding Isn’t Enough for Static Control…

    High-tech industries have long been plagued by an unseen foe. From semiconductors to medical devices, manufacturers are forced to accept high product rejection rates due to particle contamination or critical defects. Oftentimes, contamination issues and product damage in these industries can be traced back to uncontrolled static electricity. When static is allowed to build-up, it becomes a double threat to a cleanroom, increasing the chances of ESA-induced contamination and electrostatic discharge (ESD) damage.

     

    ESA Contamination in Cleanrooms

    Electrostatic attraction (ESA) is the phenomenon that causes dust to stick to the glass screen of an old vacuum tube television. When particles become statically charged by friction or contact with another material, they adhere to surfaces that have the opposite charge. While this may seem harmless in the example of the TV monitor, the semiconductor industry works on

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  3. Under the Microscope: What are Hoods?

    Under the Microscope: What are Hoods?

    Whether you’re using a laboratory hood to limit exposure to chemical fumes or you require a particle-free work environment, all components of your hood work in tandem to attain optimal functionality. Hoods are enclosures, sometimes called work benches, work stations, or cabinets, that either blow filtered air down onto the work surface (positive pressure) or exhaust filtered air to the outside (negative pressure), based on the nature of the application. Below is a guide to understanding the different components of your cleanroom hood.

     

    Sash/Shield

    The sash or shield, located on the face of your hood, is a transparent panel that shields internal samples from contamination while providing some protection to the outside environment. For personnel to reach inside the hood and perform work, the sash is raised. When the sash is completely closed, UV sterilization can be accomplished safely. Since ope

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