The KEOFITT® Sampling Bags have all been developed as single-use solutions to the cumbersome and difficult task of taking a representative sample and bringing it safe and clean from the sampling point to the laboratory.
At the same time the KEOFITT® Sampling Bags offer convenience and safety in use and higher efficiency in the work process. No prior assembly or cleaning of any components; no glass or metal component is introduced to the production area.
All KEOFITT® Sampling Bags are made of medical grade plastics complying with all relevant FDA, USP and ISO regulations for both the food and the pharmaceutical/biotech industries.
The KEOFITT® Sampling Bags are delivered separately packed and sterilized by irradiation. In each carton a Radiation Certificate and a Certificate of Conformity are enclosed.
The KEOFITT® Sampling Bags are manufactured following strict in-process testing including a test for endotoxins.
The proper performance of all KEOFITT® Sampling Bags is supported by a number of validation documents covering SIP’ability, biocompatibility, extractables, USP Class VI, endotoxins, mechanical and chemical properties etc.
The KEOFITT® Aseptic System enables the user to take a truly representative aseptic sample. It protects the sample against airborne contamination, while extracting the sample, during transportation and storage.
The standard operating procedure involves steaming the sampling valve with the KEOFITT® Aseptic System connected, in order to sterilize the sampling valve and the connection between the sampling valve and the KEOFITT® Aseptic System. This procedure ensures the sterilization of the whole flow path in a closed circuit.
The KEOFITT® Aseptic System is based on KEOFITT®'s guarantied high quality, microbiologically safe valve design. It shall be used with PP sampling bottles (# 260325 / 260525 / 260625 / 260725 / 260825), which are autoclavable, robust and translucent.