Vid tillverkning av produkter avsedda för medicinalt bruk är det viktigt att minska mängden av korskontaminering som kan överföras från tillverkningen av en produkt till en annan. Genom att utföra en rengöringsvalidering utvärderar man rengöringsprocessens effektivitet och fastställer vad som behöver göras för att hålla sig inom de nivåer som krävs. I detta examensarbete planeras och genomförs en förstudie till en rengöringsvalidering av det produktionssystem där handdesinfektionsmedlet AHD 2000 tillverkas. Inledningsvis genomfördes en genomgång av produktionssystemet och ett antal så kallade kritiska punkter valdes ut. Dessa punkter är områden där rengöringsprocessens effektivitet bedöms kunna variera. För att mäta effektiviteten genomfördes tre olika tester: svabbtest, sköljtest och en visuell kontroll. För svabb- och sköljtestet analyserades provernas totala organiska innehåll (TOC) och dess förbrukning av kemiskt bundet syre (COD). Erhållna analysresultat jämfördes med beräknade gränsnivåer, dvs. nivåer som kan accepteras för de två testerna. Dessa gränsnivåer är beräknade baserat på en generell nivå som vanligtvis ligger på mellan 10-500 ppm av tillverkad batch. För den visuella kontrollen gjordes en fysisk inspektion för att bedöma synliga spår av produktrester. Resultatet för svabbtestet visade att alla provsvar vid respektive kritiska punkt låg under den beräknade gränsnivån vilket betyder att kriteriet för svabbtestet är uppnått. För sköljtestet hamnade provresultaten något över den beräknade gränsnivån men har trots det bedömts vara inom rimliga gränser. Vid den visuella kontrollen noterades inga synliga spår och detta kriterium var alltså uppfyllt. Slutsatsen är alltså att alla tre kriterier för validering av rengöringsprocessen är uppfyllda vilket betyder att rengöringsprocessen är tillräckligt effektiv för att avlägsna spår av tidigare tillverkad produkt. / When manufacturing products for medicinal use it is essential to reduce the level of cross-contamination. By carrying out a cleaning validation study the effectiveness of the cleaning process is evaluated to see what needs to be done to reach the criteria that are demanded. The main purpose of this thesis has been to plan and execute a pilot study for a cleaning validation of the production system where AHD 2000, a hand disinfection product, is being produced. A physical inspection of the production system was undertaken and several so called critical areas where pointed out where it is possible that the cleaning process varies in its effectiveness. To evaluate its effectiveness three different sampling methods was undertaken; a swab test, a rinsing test and a visual inspection. To evaluate these tests, analysis of the samples from the swab test and rinse test was studied where the level of total organic carbon (TOC) and chemical oxygen demand (COD) of the samples where measured. Acceptance criteria for the two sampling methods were calculated in order to know which levels of maximum carry over from a previous product that could be accepted. The accepted limits are based on a general limit, usually these limits are in the range 10-500 ppm of a previously manufactured batch. For the visual inspection a physical exam of the critical points was performed where signs of visible residue were noted. The results from the swab test for all critical areas were below the acceptance criteria and thus the criteria for the swab test was accepted. As for the rinsing test the results were slightly above the acceptance criteria but were regarded as acceptable. The visual inspection showed no signs of visible traces of product. Based on the results, the three criteria are therefore satisfied and the cleaning process was regarded to be effective enough to remove traces from a previously produced product.

The project examines the possibilities to develop a local and sustainable model for food production in Uppsala with focus on diet, farming methods and different types of greenhouse installations. With the simulation software VIP energy 3.1.1 the energy balance and temperature development of greenhouses of different materials were calculated for different operating cases. The results were also compared when the greenhouse was installed stand-alone or integrated to the wall of a small standard or passive house. With a starch based diet and biological farming methods research suggests it is possible to produce food efficiently without compromising the environment or our health. The yearly food needs for a family of four that follows the suggested diet was estimated to 4362 kg and the outdoor land required to produce it was calculated to 4676 m2 through organic yield statistics. The area could however be reduced to 2813 m2 if the only starch staple in production was potatoes. The tender growing season in a greenhouse constructed with a covering of 5 mm glass or 5-16Ar-5 mm was calculated to 85 and 148 days respectively. The energy use required for year round production of mushrooms in the respective greenhouses was calculated to 53 or 16 kWh/m2,year. Half hardy plants required 399 or 173 kWh/m2,year and tender plants 953 or 358 kWh/m2,year. When the greenhouses were connected to the wall of a small house the heating demand could be reduced by up to 22 % depending on the operating case.