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Masirinji Anoraswa - Appendix 2

Masirinji Anoraswa - Appendix 2

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Majekiseni Anoraswa - Appendikisi II

1. Bacterial endotoxin bvunzo:

1.1 Kugadzirira bvunzo:

Midziyo inoshandiswa mukuedzwa inoda kurapwa.Nzira yakajairika ndeyekuomesa kubika pa180 ℃ kwemaawa maviri.Kusvibiswa kweMicrobial kuchadzivirirwa panguva yekuedzwa kushanda.

Mvura yebhakitiriya endotoxin bvunzo inoreva mvura yakasvava yejekiseni isingaburitse condensation reaction neLAL reagent ine sensitivity ye 0.03EU/ml kana kukwira pasi pe37 ℃± 1 ℃ kwemaawa makumi maviri nemana.

1.2 Nzira yekuedza:

Tora 8 maampoules epakutanga e0.1 ml/chidimbu che lysate lysate, 2 ayo anowedzerwa ne 0.1 ml yemhinduro yebvunzo sechubhu yekuyedza, uye maviri ayo anowedzerwa ne 0.1 ml ye2.0 yakagadzirwa nechiyero chekushanda chebhakitiriya endotoxin nemvura. yebhakitiriya endotoxin bvunzo λ Iyo yekumisikidza endotoxin mhinduro inoshandiswa seyakanaka yekudzora chubhu.Wedzera 0.1ml yebhakitiriya endotoxin yekuyedza mvura kune maviri machubhu seyakaipa yekudzora chubhu.Wedzera 0.1ml yechinyorwa chebvunzo chakanakira kudzora mhinduro kune maviri machubhu λ Concentration ye endotoxin mhinduro] seyakanaka yekudzora chubhu yechinyorwa chebvunzo.Zvinyoro sanganisa mhinduro muchubhu yekuyedza, vhara muromo, woiisa mubhokisi remvura yekugezera 37 ℃± 1 ℃, uye zvinyoro nyoro ibudise mushure me60 ± 2min yekuchengetedza kupisa.Dzivisa mhedzisiro yenhema inokonzerwa nekudengenyeka panguva yekuchengetedza kupisa uye kutora chubhu.

Mutongo wemhedzisiro:

Zvinyoro tora chubhu yekuedza uye zvishoma nezvishoma uitenderedze pasi kune 1800. Kana iyo gel muchubhu isina kuremara uye isingatsvedze kubva pamadziro echubhu, imhedzisiro yakanaka uye yakanyorwa se (+);Kana iyo gel isingagoni kuchengetwa yakasimba uye inotsvedza kubva pamadziro echubhu, mhedzisiro yakaipa inonyorwa se (-).

sirinji inoraswa-holesale-Smail

(1) Iwo maviri ebvunzo machubhu (-), ayo anofanirwa kutariswa sekuzadzisa zvinodiwa;Kana ari maviri ari (+), achatorwa seasina kukodzera.

(2) Kana imwe test chubhu iri (+) uye imwe iri (-), tora mamwe machubhu mana ebvunzo kuti uongororwe zvakare maererano nenzira iri pamusoro, uye imwe yemachubhu ina iri (+), inoonekwa seisina kukodzera.

(3) Kana iyo yakanaka yekudzora chubhu iri (-) kana bvunzo sampu iri (-) kana iyo yakaipa yekudzora chubhu iri (+), bvunzo yacho haishande.

Masirinji Anoraswa - Appendix III

1. Imwe nguva sampling plan inogamuchirwa kuti iongororwe nguva nenguva.Kurongeka kwezvigadzirwa zvisingaenderane, boka rekuyedza, zvinhu zvekuongorora, nhanho yerusarura, RQL (isingaenderane mhando nhanho) uye chirongwa chesampling zvinotsanangurwa mutafura inotevera.

Ongorora: Iyo cadmium yemukati mu5.14.1 yechiyero yakapihwa kuti iongororwe.

2. Imwe nguva sampling chirongwa chinogamuchirwa kuti chiongororwe batch.Kuomarara kunotanga kubva kune yakajairika yekuongorora sampling chirongwa.Kurongeka, zvinhu zvekuongorora, nhanho yekuongorora (IL) uye inokwanisa nhanho yemhando (AQL) yezvigadzirwa zvisingaite zvinotsanangurwa mutafura inotevera.

 

 

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Nguva yekutumira: Oct-06-2022