Biont (Slovakia)

Fish introductions can result in their establishment in the wild, with invasion risk assessments identifying those non-native species with a high probability of developing invasive populations. The North American fathead minnow Pimephales promelas was imported to Europe for decades for both ornamental and scientific (toxicology research) purposes. In North America, the fathead minnow has been introduced widely into areas outside of its natural range, where it has expressed considerable plasticity in life-history traits when establishing new populations. In Europe, established populations are present in the wild but remain limited in number, with the paucity of life-history data on these European populations leading to their risk assessments being based on minimal data resulting in low confidence. The aim here was to overcome these data deficiencies by analysing the life-history traits and morphologies of four European P. promelas non-native populations (two in England and one each in the Netherlands and Belgium), with risk screenings completed based on these data. All populations consisted of small-bodied individuals (<80 mm), with individuals present up to age 4 years. Maturity was from age 1 year, with female absolute fecundity recorded to 843 eggs/female, although as a male nest guarding and batch spawning species, it remains unclear as to how many eggs are laid per reproductive season. Application of the Aquatic Species Invasiveness Screening Kit indicated scores around the high-risk category, suggesting that if allowed to spread and establish further fathead minnows could become highly invasive in Europe.

Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of (18)F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade "A" isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade "A" isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [(18)F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems.

In this work, the optimalisation of e-beam parameters and the writing strategy have been performed. Various positive and negative e-beam resists have been evaluated for high resolution e-beam lithography and pattern transfer. Both, lift-off method and ion beam etching have been investigated for the pattern transfer into thin Pt and MoC layer on saphire substrate.