During stability, product Testing is performed to guarantee the item will continue to fulfil specified criteria of quality and strength through its expiration or shelf-life in the temperature and humidity required by specific niches. This guide won’t deal with another stability requirement of continuing efficacy during consumer use that is carried out by in-use testing, an important subject for another report. Throughout stability, product testing Is performed to make sure the item will continue to fulfil specified criteria of quality and strength through its expiration or shelf-life in the temperature and humidity required by specific niches. This guide won’t deal with another stability requirement of continuing efficacy during consumer use that is carried out by in-use testing, an important subject for another report.
Since Microbial Limit Testing MLT, to include Microbial Enumeration TAMC and TYMC and Evaluation for Specified Organisms; and Antimicrobial Effectiveness Testing AET, if appropriate, are characteristics that define the quality of a product, these evaluations should be considered and included as part of the equilibrium program for both establishing expiration, and encouraging on-going business stability. The necessary testing for microbiology is a little ambiguous as written in ICH 6QA1 that, thankfully, leaves room to specify testing requirements which make sense for the item under study. There have been diverse opinions Regarding the amount and kind of testing that is needed to encourage the stability of the microbial characteristics and efficacy of many antimicrobial preservatives. Many applications have instituted testing at all of the periods and temperatures necessary for analytical analysis.
In certain cases, for international markets, this has included tests for MLT and/or PET at 0, 1, 3, 6, 9, 12, 24, 36 weeks at 25°C /60%RH, 30°C/60%RH, 30°C/percent 65RH, 30°C/75%RH; with added accelerated requirements of 40°C/75%RH. All this testing may amount to a lot of costly, time consuming work Once the answer to microbial equilibrium question could be answered much more easily. The First three methods staining properties, cell morphology and colony morphology are simple, quick and inexpensive to execute within the microbiology lab, supplying adequate conclusion of micro-organism identification to the genus or family level for regular bioburden testing. The three remaining microbial characterisation methods use of selective culturing, biochemical properties and genetic sequence data are more time-consuming, require specialist equipment or media and are therefore more expensive. However, they can establish the identification of the micro-organism to species or sub-species degree, providing more thorough analysis.