Main view of GST company is quality assurance policy, GST company makes every
effort for developing and keeping of Oxygen-18 water quality. The commitment to
quality is achieved by the implementation of Good Manufacturing Practice (GMP)
and ISO 9000 standards.
The process of fractional distillation of natural
purified water is used for the enrichment of the Oxygen-18. Enrichment process
is carried out in a numbers of high distillation columns which are filled in
with special packing material. After distillation normalization step takes
place, where the water is electrolyzed. Enrichment ultra-filtration is a last
step.
The final product is dispensed into pre sterilized vials with rubber
stopper and sealed with an aluminum cap. Packiging process is performing in the
special "clean room".
Main parameters of enriched Oxygen-18 water are tested
routinely during the production process. The quality of each final batch of
Oxygen-18 water tested by a special technique and for each batch new quality
certificate is made.
Isotope content by mass spectrometer
Ihe
chemical content of water specimen by the mass spectrometer with
inductive connected plasma ICP MS. The HP-4500 ICP MS manufactured by Hewlett
Packard device is applied.
Deuterium by mass-spectrometer
DELTA.
Tritium by Liquid Scintillator
Analyzer.
TOC (Total Organic Carbon) measures at the plant
by TOC-VE Analyzer Shimadzu.
pH: by pH
meter.
Conductivity: by Conductometer.
Pyrogenicity is
determined on the plant by using LAL test for endotoxin
detection.
Sterility is approved by tests conducted according to
requirements of USP XXV.
