Parenteral Drug Association Technical Report 70 (PDA TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities, defines contact time as, "The minimum amount of time that a sanitizer, disinfectant, or sporicide must be left in complete (wet) contact with the surface to be treated in order to be effective". This is a finding that is agreed with many regulatory organisations. evaluated the bactericidal activity of registered disinfectants after the disinfectant dried on the surface and found that there was no additional bactericidal efficacy after the surface dried. Therefore, it is required to demonstrate that these parameters do not affect the disinfectants' efficacy in the cleanroom.Ī study by West et al. These parameters are generally not tested during the disinfectant qualification (in vitro). Temperature and humidity in the cleanroom.The wet contact time and the inactivation of microorganisms in the cleanroom (real-world setting) generally depends on: The wet contact time during in vitro testing generally depends on: This qualification is based on the wet contact time, log reduction acceptance criteria, disinfectant concentration, water quality, surface types, and the microbial kill. Pharmaceutical manufacturers must then demonstrate disinfectant efficacy on their cleanroom's surfaces.ĭifferent surface coupons representative of surfaces in the cleanrooms are used to qualify the disinfectants. Wet contact timeĭisinfectant manufacturers must register their disinfectants based upon a specific wet contact time, microbial kill, and disinfectant concentration in compliance with the relevant authority's regulations. Manufacturers are also required to validate the disinfection process by utilising the qualified disinfectant wet contact time in the real world (in situ testing) to demonstrate the effectiveness of the cleaning and disinfection programme as seen in figure 1. The regulatory guidance and industry technical documents require (bio)pharmaceutical manufacturers to qualify a disinfectant wet contact time (in vitro testing). Consequently, the facility surfaces need to remain wet with the disinfectant for the contact time that was qualified during the in vitro coupon studies.ĭisinfectant chemical reactions need water as a solvent to allow the reaction to occur Therefore, the minimum contact time is the time needed for the disinfectant to achieve the necessary log reduction. The appropriate wet contact time is determined during disinfectant qualification (coupon studies), by demonstrating an effective log 10 reduction of microorganisms against a specified wet contact time. Disinfectant contact time is commonly known as "wet contact time", "contact time," "dwell time," or "action time." This article emphasises the importance of this wet contact time for effective disinfection. sporicide or sanitiser) for use in a classified area. Wet contact time is one of the critical parameters in choosing a disinfectant (a chemical agent used for microbial reduction purposes, e.g.
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