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New Weapons Against HAIs

Innovative new methods of combating Hospital Acquired Infections are Now Being Released - Click here to read the complete article in .pdf format.

Pharmaceutical Technology - Evaluating Disinfectant Efficacy of a Silver-based Dissinfectant

(May 2015 Volume 39 Number 5) - Pharmaceutical Technology (PharmTech.com) - "Evaluating Disinfectant Efficacy of a Silver-based Disinfectant," by John M. LindsayA disinfectant composed of a low-concentration suspension of silver ions is a quick-acting sporicidal disinfectant that is non-corrosive, is skin-safe (non-toxic), and is not a respiratory irritant. The disinfectant was evaluated at the Aseptic Training Institute (ATI) at the Johnston Community College Work Force Development Center in Clayton, NC. Six microbial preparations were used as challenge organisms for the disinfectant on four different surface materials. In addition, the effectiveness of the disinfectant was evaluated in situ by collecting environmental samples after intentionally contaminating and cleaning a facility and equipment. The author reports the results of these evaluations and concludes that the disinfectant is completely sporicidal with only a one-minute contact time. Click here to view the entire article in .pdf format.

(October 2014) - "Determining Facility Mold Infection," by Jim E. Akers and John M. Lindsay

Consistent mold presence at high recovery levels indicates facility infection. With the publicity surrounding the recovery of mold from pharmacy compounding facilities and formulated products connected to patient fungal infections and deaths, there has been a heightened awareness and concern for fungal recoveries in all manufacturing facilities. One comment often heard is that the presence of bacteria in a drug or biological manufacturing facility is expected, because these microorganisms are constituents of normal human flora, but the presence of mold in such facilities is presumed to be atypical as fungi are not considered constituents of human flora. Molds, however, are often found on healthy human skin and associated with hair. At any given point in time, humans may carry dermatophytic molds typically of the genera Trichtophyton, Microsporum, or Epiderophyton. Although mold are not present in or on humans in the numbers that bacteria are, they certainly can be found. Click here to view the entire article in .pdf format.

Swine Flu Pandemic Articles of Interest

The Microbiology Network (www.microbiol.org) has posted a webpage titled, "Swine Flu Pandemic Articles of Interest."  This webpage will only be available for a short time.

The Guidance for Industry for Sterile Drugs Produced by Aseptic Processing Released

On September 29, 2004, the FDA issued the final guidance for industry Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice.  This guidance replaces the 1987 Guideline on Sterile Drug Products Produced by Aseptic Processing.  The guidance recommends "building quality into products" through science-based facility, equipment, process, and system design for sterile drug manufacture. 

Among the sections of the guidance that address risk-based approaches are those relating to key roles played by personnel, design, environmental control, and media fills in an aseptic processing operation.  You can access this document in .pdf format by clicking here.

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Aseptic Solutions Offers Presentation and Training Models

Blueprints are useful, but unless you are trained on reading them, they can sometimes be difficult to understand.  However, 3-D scale models are easy to understand and provide a hands-on training approach that is pleasant to view.  Regardless if the model is for an idea (proposed fill line, expansion, isolator, etc.), a specific isolator or for an entire Cleanroom, Aseptic Solutions, Inc. provides clients with high-quality 3-D models for presentation, training or used for identifying areas within your aseptic processing area that may be susceptible to contamination.  We provide finely crafted acrylic models with the utmost accuracy and attention to detail.  We work closely with your internal resources to identify important components to be included in order to make your model as realistic and useful as possible.  For more information on our modeling program and to view pictures, click here.

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Revision of Annex 1 (Manufacture of sterile medicinal products) to the EU GMP Guide

The revision of Annex 1 to the EU GMP Guide Volume 4 (http://pharmacos.eudra.org/F2/home.html) has been adopted by the Ad hoc GMP inspectors Working Group at their meeting on 28-29 April 2003. The amendments only concern section 3 harmonizing where appropriate the environmental standards for clean rooms laid down in the GMP Guide with those laid down in international standards (e.g. EN/ISO 14644-1) together with a minor change to section 20. The remainder of the annex is unchanged. The Pharmaceutical Committee has adopted the revised version at its meeting on 15 May 2003 fixing 1 September 2003 as date for coming into operation.  You can view and save the .pdf file by clicking here.  If you have difficulty opening the .pdf file, click here to download the latest Acrobat Reader program. 

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Last modified: September 08, 2009