Basic Cleanroom Protocol


Most of the typical cleanroom protocols 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 focal point of any protocol program is to protect the integrity of the cleanroom, the products, and processes …

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Cleaning Program under the Revised Propositions The proposed revisions to USP <795>, USP <797>, as well as proposed USP <800>, all include sections devoted to cleaning and surface sampling. Proposed/Revised USP <795> defines cleaning as: The process of removing soil (eg, organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically …

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Compounding pharmacies come in many different shapes and sizes. They can consist of a pharmacist creating a drug under a doctor’s prescription or they can be pharmacy-type facilities that compound drugs and sell them like a manufacturer. Sporadic and serious infection outbreaks have been linked to compounding pharmacies outside of the hospital setting.1 These problems date …

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The primary purpose of cleanroom gowning is to protect the products and the processing environment from human contamination. Cleanroom gowning greatly reduces the microorganisms released by personnel. All personnel should be properly gowning qualified before entering the cleanroom, and the qualification should be performed by a trained analyst. The degree of gowning should get more …

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The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and …

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Schedule Your On-site Facility Evaluation Last chance to set up an on-site meeting with our Pharmacy Projects Manager. Joe Skorcz will be on tour in the Minneapolis area performing visits for Aseptic Enclosures’ pharmacy design evaluations. If interested in scheduling a meeting and having our Engineer come and evaluate your facility’s day to day operations …

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