Njengohlobo olutsha lwekofu ekhawulezileyo, izinti zekofu zikwindawo ebalulekileyo kwimarike yabathengi behlabathi ngenxa yoncedo lwazo, incasa esemgangathweni, kunye nomgangatho ongaguqukiyo. Nangona kunjalo, ukutenxa komgangatho kulo naliphi na inqanaba kulo lonke ikhonkco lemveliso, ukusuka ekukhethweni kwezinto ezikrwada ukuya ekuthuthweni kwemveliso egqityiweyo, kunokuchaphazela ngokuthe ngqo ukuguquguquka kwencasa yemveliso, ukhuseleko, kunye namava omthengi. Ke ngoko, ukuseka inkqubo ecwangcisiweyo neyobunzululwazi yolawulo lomgangatho lolona khuphiswano lungundoqo lwabavelisi beentonga zekofu. Eli nqaku liza kuphonononga izinto eziphambili kunye nezicwangciso ezisebenzayo zolawulo lwekhwalithi yentonga yekofu kwiimbono ezine: ulawulo lwemathiriyeli ekrwada, ulawulo lwenkqubo yemveliso, ukusetyenziswa kobuchwepheshe bovavanyo, kunye-nenkqubo yokulandeleka ngokupheleleyo.
1. Ulawulo loMgangatho weMpahla ekrwada: ISiqinisekiso seSiseko seNcasa kunye noKhuseleko
Umgangatho wezinti zekofu uvela kwimathiriyeli yazo ekrwada, equka iimbotyi zekofu, umgubo wobisi (okanye isityalo{{0}ezezinye ezisekelwe kwisityalo), iswekile, kunye nezinye izongezo. Okokuqala, ukhetho lweembotyi zekofu kufuneka lubambelele ngokungqongqo kwimigangatho ehambelanayo yemvelaphi, iindidi, kunye neqondo lokutshisa. Umzekelo, iimbotyi zeArabica zihlala zisetyenziswa kwimveliso-ephezulu ngenxa yeasidi esezantsi kunye nevumba elimnandi, ngelixa iimbotyi zeRobusta zisoloko zisetyenziswa kwimigca yezoqoqosho ukongezelela incasa epholileyo. Idigri eqhotsiweyo (elula, ephakathi, okanye emnyama) ichaphazela ngqo iprofayili yencasa yemveliso yokugqibela. Kufuphi{6}}i-infrared spectroscopy (NIRS) okanye itekhnoloji yekomityi kufuneka isetyenziselwe ukulinganisa umthamo wokufuma (ixabiso elifanelekileyo 11% -12.5%), umlinganiselo wembotyi eneziphene (ibakala 1 Ngaphantsi okanye elilingana ne-3%), kunye nesiqulatho sencasa yesandulela sebhetshi nganye yeembotyi eziluhlaza.
Okwesibini, umgangatho we-excipients ubaluleke ngokulinganayo: Umgubo wobisi kufuneka uhlangabezane nemigangatho ye-microbiological (umzekelo, ukubala kwekholoni iyonke Ngaphantsi okanye ilingana ne-10⁴ CFU / g, akukho i-E. coli ebonakalayo), kunye neqondo le-fat oxidation kufuneka ilawulwe (ixabiso le-peroxide Ngaphantsi okanye lilingana ne-0.25g / 100g). Iiswekile (ezifana neswekile emhlophe kunye ne-erythritol) kufuneka zivavanyelwe iintsalela zetsimbi enzima (ikhokelela Ngaphantsi okanye ilingana ne-0.5mg / kg, i-arsenic Ngaphantsi okanye ilingana ne-0.5mg / kg) kunye nokusabalalisa ubungakanani bamasuntswana (ukuqinisekisa ukuchithwa okufanayo). Izongezo (ezifana ne-emulsifiers kunye ne-stabilizers) kufuneka zihlangabezane nemida ebekwe kwi-GB 2760, "iSigangatho soKhuseleko loKutya kweSizwe - uMgangatho wokuSetyenziswa kweZongezo zokutya," kunye nokuhambelana kwazo kunye ne-matrix yekhofi kufuneka kuqinisekiswe.
Phambi kokuba imathiriyeli ekrwada ingene kwindawo yokugcina, ibhetshi -nge{1}}inkqubo yokuhlola ibhetshi kufuneka iphunyezwe, kubandakanywa uphononongo lwesiqinisekiso somthengisi (umzekelo, isatifikethi se-ISO 22000), ujongo lwemeko yothutho (ubushushu obuNgaphantsi okanye bulingana nama-25 degrees , ukufuma Ngaphantsi okanye okulingana ne-60 yesampling ye-sampling yemveliso, kunye nokulinganisa i-sampling 5%) ukuqinisekisa ukuba imingcipheko kumthombo iyalawulwa.
2. Ulawulo lweNkqubo yeMveliso: Ulawulo oluchanekileyo lweeParameters eziphambili
Ukuveliswa kwentonga yekofu ngokuqhelekileyo kubandakanya amanyathelo amathathu angundoqo: ukuxuba, ukubumba kunye nokomisa. Ukuguquguquka kwiiparameters zenkqubo kulo naliphi na kwezi zigaba kunokukhokelela ngokuthe ngqo kwiziphene zemveliso (ezifana ne-clumping, i-dissolution ecothayo, kunye nokulahleka kwencasa).
Ngexesha lokuxuba, umxube ophezulu we-shear{0} usetyenziselwa ukusabalalisa ngokulinganayo umgubo wekofu kunye nezithako ezincedisayo ngokomlinganiselo osele ubekiwe (ngempazamo eNgaphantsi okanye elingana ne-±0.5%). Ulawulo oluphambili lukhona ngexesha lokuxuba (imizuzu eyi-15-20) kunye nesantya sokujikeleza (200-300 rpm) ukukhusela i-particle agglomeration ebangelwa ukugxininiswa okugqithiseleyo kwendawo. Ngaphezu koko, ukufana komxube kufuneka kubekwe esweni (kunye ne-coefficient of variation (CV) Ngaphantsi okanye ilingana ne-5%). Oku kunokuqinisekiswa ngesampulu kunye nokulinganisa ukuhanjiswa komxholo we-caffeine we powder phambi kwegranulation.
Ngexesha lenkqubo yokubumba, ukhetho phakathi kwegranulation emanzi (elungele ukwakheka kunye-nezithako ezincedisayo zokufuma eziphezulu) okanye ukucinezela okomileyo (okulungele iswekile -esimahla/ephantsi{2}}imveliso yeswekile) ixhomekeke kwindawo ekuyo imveliso. Ukuba usebenzisa indlela emanzi, i-dosage ye-binder (umzekelo, i-maltodextrin kwi-3% -5%) kunye noxinzelelo lwe-spray (0.3-0.5 MPa) kufuneka ilawulwe ngokuchanekileyo ukuze kuqinisekiswe ubungakanani be-particle (Inkulu okanye ilingana ne-90% ye-80-120 mesh). Ukucinezela okomileyo, i-tablet press pressure parameters (10-15 kN) kufuneka ilungelelaniswe ukukhusela ukuxinana okugqithisileyo ekuchaphazeleni izinga lokuchithwa okulandelayo.
Ukomisa linyathelo elibalulekileyo ekumiseleni umgangatho wokugqibela wentonga yekofu. Ukomisa umoya oshushu (ngokuqhelekileyo usebenzisa ibhedi edibeneyo okanye i-tunnel dryer) idinga i-gradient yeqondo lokushisa (i-50-60 yokuqala, i-degree yokugqibela ye-40-45) ngokusekelwe kwiimpawu zezinto eziphathekayo, ukugcina umswakama ngaphakathi kwe-3% -5%. (Amaqondo okushisa aphezulu angakhokelela ekubunjeni, ngelixa ubushushu obuphantsi bunokubangela ukuthungwa okunzima.) Nangona ukomisa ukukhenkceza kunokugcina incasa engcono, kubiza kakhulu kwaye kufuna ukulawulwa okungqongqo kwinqanaba le-vacuum (Ngaphantsi okanye elilingana ne-10 Pa) kunye nokushisa kweplate (-30℃ukuya kwi-20 degree) ngexesha le-sublimation. Ngexesha lemveliso, izinga lokumisa (ngempendulo yemitha yokufuma kwi-intanethi) kunye nokuhanjiswa kweqondo lokushisa kunye nokufuma ngaphakathi kwesixhobo kufuneka kubekwe iliso ngexesha lokwenyani ukuphepha ukufudumeza kwendawo kunye nevumba elivuthayo.
3. Uvavanyo lweTekhnoloji kunye neMigangatho: Izixhobo zeNzululwazi zokuHlola uMgangatho
Inkqubo ebanzi yolawulo lomgangatho ifuna iteknoloji yovavanyo oluchanekileyo. Uvavanyo lwesiqhelo lwezinti zekofu lunokwahlulwa lube ngamacandelo amathathu: i-sensory, ngokomzimba kunye neekhemikhali, kunye ne-microbiological.
• Uvandlakanyo loVavanyo: Igqiza labagwebi abaqeqeshiweyo (ubuncinci amalungu amahlanu aqeqeshwe kwi-ISO 13300) livavanya umbala wemveliso (umdaka oyunifomu, ongacimiyo-amabala ombala), ivumba (ivumba lekofu elahlukileyo, akukho vumba litshileyo okanye elirhangqweni), kunye nencasa (ixesha lokunyibilika Ngaphantsi okanye elilingana ne-30 ye-residualness kunye nesuntswana elimnandi) kwisikali se-10-point, kunye nenqaku lokupasa le-8 okanye ngaphezulu kwinto nganye.
• Izalathisi zePhysical and Chemical: Ezi ziquka ukufuma (i-GB 5009.3-2016 indlela yokomisa ngokuthe ngqo), umxholo we-caffeine (indlela ye-HPLC, ukutenxa kwixabiso elibhalwe Ngaphantsi okanye elilingana ne-±10%), ukunyibilika (intsalela emva kokulinganisa ukufunyaniswa kwamanzi ashushu Ngaphantsi okanye ilingana ne-2%), i-pH ye-5, i-residual 5, i-5. (umzekelo, i-sulphur dioxide Ngaphantsi okanye ilingana ne-0.05g/kg).
• Uvavanyo lweMicrobiological: Gxininisa ekubekeni iliso kwinani elipheleleyo lekholoni (GB 4789.2-2022, Ngaphantsi okanye elingana ne-1000 CFU/g), ibhaktheriya ye-coliform (Ngaphantsi okanye ilingana ne-3 MPN/g), kunye nokungunda kunye ne-yeast (Ngaphantsi okanye ilingana ne-50 CFU/g). Iibhaktheriya ze-Pathogenic (i-Salmonella kunye ne-Staphylococcus aureus) kufuneka "ingabonakali."
Ukongeza, kwiimveliso eziphezulu-, iimpumlo zombane (GC{1}}i-MS edityanisiweyo) zingasetyenziselwa ukuhlalutya iikhompawundi zencasa eziguquguqukayo (ezifana nepesenteji ye-furfural kunye ne-2-notywala obunobushushu), okanye i-spectroscopy ekufuphi ne-infrared ingasetyenziselwa ukukhangela ngokukhawuleza ukuhambelana kwemathiriyeli ekrwada kunye neemveliso ezigqityiweyo ukuphucula ukusebenza kakuhle kovavanyo.
3
Ukulawulwa komgangatho akusiyo isiphelo; ifuna uphuculo oluqhubekayo nge{0}}inkqubo yokulandeleka kunye nohlalutyo lwedatha. Iinkampani kufuneka ziseke inkqubo ebanzi yolawulo lwedijithali (njengeqonga elihlanganisiweyo le-ERP + MES) eligubungela yonke ikhonkco lokubonelela, ukusuka ekuthengeni izinto ezikrwada (inombolo yebhetshi, umthengisi, ingxelo yokuhlola) kwinkqubo yokuvelisa (iirekhodi eziphambili zeparamitha, umqhubi, imeko yesixhobo), kwaye ekugqibeleni ukugqiba ukuhanjiswa kwemveliso (ubushushu bokusebenza, impendulo yomthengi). Oku kuqinisekisa ukuba ulwazi olusemgangathweni kuyo nayiphi na imveliso inokulandelwa ngokukhawuleza kwikhonkco elithile.
Kwangaxeshanye, iinkampani kufuneka ziqhube uphicotho lwangaphakathi rhoqo (ngekota) kunye neziqinisekiso zangaphandle (ezifana nenkqubo yolawulo lwekhwalithi ye-ISO 9001 kunye neFSSC 22000 inkqubo yokhuseleko lokutya). Uhlalutyo lwengcambu (RCA) kufuneka luqhutyelwe kwizikhalazo zabathengi (ezifana ne "dissolution engaphelelanga" kunye "off-flavour"), kunye nenkqubo yeeparameters kufuneka ihlengahlengiswe okanye imigangatho yovavanyo iphuculwe ngeSicwangciso{4}}Yenza{5}}Jonga{6}}Umjikelo woMthetho (PDCA). Ngokomzekelo, ukuba i-batch yemveliso ibonisa imiba ye-clumping, iirekhodi zokulawula ukufuma ngexesha lokuxuba kunye neeprofayili zeqondo lokushisa ngexesha lokumisa kufuneka zilandelwe ukuze kulungiswe umlinganiselo we-binder okanye ixesha lokumisa.
Ukulawulwa komgangatho weentonga zekofu yinkqubo ecwangcisiweyo edibanisa yonke ikhonkco lokubonelela, efuna ukhetho olungqongqo lwemathiriyeli ekrwada kunye nolawulo lwepharamitha yenkqubo, kunye netekhnoloji yovavanyo oluphezulu kunye nenkqubo yokulandela umkhondo. Kuphela ngokudibanisa ngokunzulu "imveliso esemgangathweni" kunye "nolawulo olusulungekileyo kunye nolawulo" sinokuthi siqinisekise incasa ezinzileyo, ukhuseleko, kunye nokuthembeka kwebha yekofu nganye, ekugqibeleni sifumana ukuthenjwa kwexesha elide{1}}kwabathengi. Iqhutywa sisimo esibhekiselele ekusetyenzisweni okunempilo kunye nokwakho, ulawulo lomgangatho wekofu yexesha elizayo luya kunabela "kwisondlo esichanekileyo" (ezifana ne{3}}i-GI ephantsi, -iifomula zefayibha eziphezulu) kunye "nemveliso eluhlaza" (efana nokubhaka okuphantsi{5}}kwekhabhoni kunye nokupakishwa kwe-biodegradable). Oku kubeka iimfuno eziphezulu kwiinkqubo zolawulo lomgangatho weenkampani, kodwa umgaqo ongundoqo uhlala ungatshintshi: ukusebenzisa iindlela zenzululwazi ukukhusela isithembiso somgangatho wemveliso nganye.