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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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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 using water with detergents or enzymatic …

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Preventing Contamination In Compounding Facilities

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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Personnel Aseptic Practices Training

Personnel Aseptic Practices Training 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 …

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Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan Tablets

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets …

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Updated Guidance for Compounding Facilities 503B

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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Happy New Year

The team at Aseptic Enclosures wishes you peace, joy and prosperity throughout the coming year. Thank you for your continued support and partnership. We look forward to working with you in the years to come. Happy New Year. May you soar into the new year filled with health, happiness and prosperity.

Schedule an on-site visit for an Aseptic Enclosures’ evaluation of your facility

  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 get in touch with …

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