Cryologics, Inc. eNewsletter


Fall 2015

Welcome to the Fall 2015 issue of our eNewsletter!  This issue highlights two important Parenteral Drug Association Technical Reports.   Released this July, TR No. 70, "Fundamental of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities", is the first comprehensive guidance from the PDA which focuses specifically on several aspects of a firm's cleaning and disinfection program.  The second, TR No. 22, "Process Simulation for Aseptically Filled Products", continues to be an invaluable scientific and regulatory guidance four years after its publication.
PDA Technical Report No. 70
Fundamental of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities
Co-authored by such recognized industry Subject Matter Experts as Art Vellutato, Barry Friedman, and Jim Polarine, TR 70's comprehensive chapters include Regulatory Expectations, Control of the Environment, and Cleaning and Disinfection.  Importantly, regarding the use if in-house isolates in disinfectant efficacy testing, TR 70 states: "Recoveries of microorganisms from environmental monitoring samples should be identified to genus and species level when exceeding alert or action levels, and periodically when limits are not exceeded. Organism identifications should be evaluated to determine the most frequently occurring organisms. Representative organisms should be preserved and included in the panel of organisms in efficacy testing of antimicrobial agents used in the facility."   Be sure to visit our bibliography for additional regulatory and industry references on this topic.
PDA Technical Report No. 22  
Process Simulation for Aseptically Filled Products
Published in December 2011,  TR 22 states: "The growth promotion properties of the incubation media should be evaluated using pharmacopeial methods. The inclusions of tests for environmental organisms or those isolated from sterility test positives are recommended."  The use of in-house isolates in qualification of QC Microbiology media is a longstanding regulatory expectation.  In 1993, the FDA published its FDA" Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories", stating that the challenge with organisms from "normal flora" is "good practice ".

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In This Issue
PDA Technical Report No. 70
PDA Technical Report No. 22
Product Spotlight

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