DISINFECTION QUALIFICATION TESTING— CONSIDERATIONS FOR THE ASEPTIC AND CLEANROOM MANUFACTURING ENVIRONMENT

TRADELABOR has more than 20 years of experience in the control and treatment of air, working with an experienced and qualified technical staff and with the most advanced technology in this area, which together guarantee the quality of the services provided.

 

 

Disinfection and sanitization in the pharmaceutical and controlled manufacturing spaces refer to the killing, inactivation, removal or reduction of contaminating microorganisms to levels considered safe per industry standards and regulations. The terms “cleanroom disinfection qualification”, “disinfection
validation”, and “cleaning validation” are often used in the pharmaceutical and aseptic manufacturing industries interchangeably. While these terms seem to define the same thing, they are actually rather different. In fact, validations build upon qualifications.

Disinfection qualifications formally evaluate the efficacy and suitability of antimicrobial products and procedures used to eliminate contaminant microorganisms on various surface types and components within an aseptic, sterile or otherwise controlled manufacturing environment. Disinfection qualifications are critical in assuring the microbial control of a manufacturing environment by qualifying the appropriate use and effectiveness of disinfection products and procedures.

Disinfection qualifications are not disinfection validations. A disinfection validation assures that the sterile, aseptic and even non-sterile manufacturing environments are under microbial control as measured by a comprehensive and continuous environmental monitoring program.

Furthermore, disinfection qualifications are not cleaning validations. Cleaning validations are studies designed to measure a procedure’s effectiveness at removing by-products or residual chemicals which may result during the manufacturing process.

 

 

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Continue at:  https://www.americanpharmaceuticalreview.com/media/28/Document/DisinfectionQualifcationTestingConsiderationsfortheAsepticandCleanroomManufacturingEnvironmentATSLabs.pdf

 

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