Prevence kontaminace HHP osetrenych

Prevence kontaminace HHP osetrenych nadorovych bunek zivymi nadorovymi bunkami Nalezy, ktere vedly k vyssimu riziku kontaminace HHP osetrene bunecne supenze die Root cause
investigation - CAPA-SP-PR-11/2014 Non released lots of apoptotic cells due to positive results in clonnogenic assay :
• Nedostatecny uklid laboratore po ukoncenf prace s zivymi bunkami a zahajenfm prace s HHP osetrenymi bunkami
• Pouziti stejneho media CellGro na redeni zivych i HHP osetrenych bunek
• Pouziti stejnych automatickych pipet a pipetmanu
• Pracovnfci si nemenf rukavice
• V laminarnfm boxu zustava lahev na odpad s odpadem obsahujfdm zive bunky
• Nejsou otreny dezinfekd pomucky pouzfvane na praci se zivymi bunkami (stojanky, nuzky) Revize systemu uklidu
• v ramci mesfcnfch uklidu se hyba s pestovanymi bunkami,coz nenf doporuceno vyrobcem
• V ramci dennfho uklidu nebyl drive zapisovano doplnenf siranu/injekcni vody a mereno mnozstvi tekutiny v inkubatoru. Bylo zavedeno v prubehu reseni CAPA-SP-RA-0016.
• Uklid trfdy cistoty C o vikendu provadf vyrobni dvojice, nikoliv v celem predepsanem rozsahu

結果 (英文) 1:

Prevention of contamination of the HHP osetrenych nadorovych Nalezy zivymi nadorovymi bunkami cells, which led to the vyssimu the risk of contamination of the HHP osetrene bunecne supenze die Root causeinvestigation-CAPA-SP-PR-11/2014 Non released lots of apoptotic cells due to positive results in clonnogenic assay:• Clean the laboratory ukoncenf Nedostatecny after work with zivymi bunkami and zahajenfm work with the HHP osetrenymi bunkami• Use the same media CellGro on redeni zivych and HHP osetrenych cells• Use of pipettes and pipetmanu stejnych automatickych• Pracovnfci nemenf's gloves• In the laminarnfm boxing zustava bottle on the waste with obsahujfdm zive cells• Are not otreny dezinfekd AIDS pouzfvane to work with zivymi bunkami (stojanky, nuzky) the revision of the system uklidu• in a mesfcnfch uklidu, with bunkami, pestovanymi hyba coz nenf told vyrobcem• In dennfho uklidu zapisovano doplnenf siranu not drive/injekcni water and which shall be measured quantity of fluid in the inkubatoru. It was introduced in the solutions CAPA-SP-RA-0016.• Clean trfdy vikendu provadf (C) chastity production pairs, not in the whole predepsanem range

結果 (英文) 3:

prevention of contamination of hhp osetrenych nadorovych research zivymi nadorovymi bunkami nalezy, which led to the risk of contamination of vyssimu hhp osetrene bunecne suspension the root causeinvestigation - cap - sp - pr - 11 / 2014 non but lots of apoptotic cells due to positive results in clonnogenic assay:- nedostatecny clean lab after ukoncenf work with zivymi bunkami and zahajenfm work with hhp osetrenymi bunkami- to stejneho media cellgro on redeni living and hhp osetrenych research- use the same surplus machine pipettes and pipetmanu- you pracovnfci nemenf gloves- laminarnfm box for bottle waste with waste obsahujfdm live cells- not otreny dezinfekd pomucky pouzfvane to work with zivymi bunkami (stojanky, nuzky) uklidu revision system- ramci mesfcnfch uklidu is hyba with pestovanymi bunkami, which is doporuceno vyrobcem- ramci dennfho uklidu wasn't drive zapisovano doplnenf siranu / injekcni water and which shall be measured of fluid in the inkubatoru. it was introduced in the solution layer - sp - ra - 0016.- get trfdy cistoty c on the weekend provadf vyrobni pairs, rather than in the predepsanem scale