To be compliant with the "electronic records" section of 21CFR11, stored audit trail files must be human-readable once opened on acomputer or another device which is able to display such stored files..
With the PC-Tool for Audit-Trail Analysis, Novasina has not just fulfilled this requirement and is fully compliant with the 21CFR11 regulation, moreover, additional and useful functions have been added to filter the entries and also to print them on a respective printer or create a pdf.
The files are encrypted and a data integrity check during import into the PC-Tool will immediately detect tampering or file renaming or other unwanted file changes.
The PC logging software stands out with easy useability. Certain Novasina aw-meters (LabMaster-aw neo, LabMaster-aw standard und advanced as well as LabTouch-aw advanced) can be directly connected to a computer by USB and/or RS232 interface. Measurement values can be recorded or protocolled on a PC by means of NovalogMC.
Humidity standards are used for verification and calibration of water activity meters. Our SAL-T humidity standards are about over-saturated salt solution according (Greenspan report, 1977). Although a defined air humidity is created over the surface of those standards which can be used for verification or calibration of a water activity sensor. The unique design of the salt standard allows re-use over a period of 3-5years (field experience) or even longer, depending on handling. This fact brings maintenance costs of a Novasina water activity meter to low levels.
Certain volatile compounds as glycerin, alcohol and others will temporarily or permanently harm the Novasina sensor and/or will adulterate the measurement result. As a consequence, it might happen that the user thinks, the product is safe as water activity is below the limit, but as value is spoiled by volatiles, the real water activity value is higher. To avoid such uncomfortable situations and to get the real water activity value on display, chemical protection filters have to be used. Those filters have to be exchanged on a six to twelve month base, depending on the amount of volatiles in the sample and the amount of measurement performed per day. An exchange of the filter is an easy task and just takes one minute.
The selection help below should guide the user and finally show him the correct filter to be used for measuring the samples.
Sorption isotherm curves are helpful and one of the most powerful tool to understand processes as change in texture, crystallization and re-crystallization, phase transition, optimization of packaging and storage conditions of a procduct. They support as well stability modelling and defining specific water activity limits for a product to ensure product stability and best shelf-life period.
The Novasina sorption isotherm set can only be used with a LabMaster-aw and allows a record of a simple curve at 11 points max. in the range of 0.04-1.00aw.Those curves are suitable for a first glimpse on the relation of water activity to moisture.
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Download manual LabMaster-aw neo :