I-Capsule Filling Difference Monitor Capsule Weight Variation Monitor Machine
Incazelo emfushane:
Ukugcwalisa Umehluko Wokugcwalisa I-Capsule Monitor I-Capsule Weight Variation Monitor Machine CVS ingaxhunywa kunoma yiluphi uhlobo lomshini wokugcwalisa i-capsule, isampula ngokuzenzakalelayo ngemvamisa ephezulu, iqapha usuku lonke!Uhlelo olusebenza kahle kakhulu lokulawula ikhwalithi ye-SPC ku-inthanethi!Indlela engcono kakhulu yokuqinisekisa ikhwalithi!Isingeniso Umshini Wokuqapha Weight Capsule we-CVS ungasetshenziswa esikhundleni se-inspe yezandla...
I-Capsule Filling Difference Monitor Capsule Weight Variation Monitor Machine
I-CVS ingaxhunywa kunoma yiluphi uhlobo lomshini wokugcwalisa i-capsule, isampula ngokuzenzakalelayo ngemvamisa ephezulu, iqapha usuku lonke!
Uhlelo olusebenza kahle kakhulu lokulawula ikhwalithi ye-SPC ku-inthanethi!Indlela engcono kakhulu yokuqinisekisa ikhwalithi!
Isingeniso
I-CVS Automatic Capsule Weight Monitoring Machine ingasetshenziswa esikhundleni sokuhlolwa okwenziwa ngesandla kokunemba kokugcwalisa, ngisho nanjengenguqulo ebuyekeziwe yokuhlola okwenziwa ngesandla.Umshini ugcina isampula ngokuzenzakalelayo usuka lapho uphuma khona umshini wokugcwalisa i-capsule ukuze uhlole izisindo, ngemonitha yesikhathi sangempela yokubonisa izisindo.Uma isisindo sidlula uhla lokumisa, luthusa opharetha futhi lukhiphe amasampula angafaneleki.Okwamanje, ihlukanisa ingxenye egcwele ingozi yamaphilisi futhi iqinisekisa ukuthi imikhiqizo eyahlulelwe igcwele kahle.
Izinzuzo:
◇ Xhuma emshinini wokugcwalisa ama-capsule, ukuthatha amasampula ngokuqhubekayo amahora angama-24 ngosuku, yingakho ukugcwalisa okudidayo akunalo ithuba lokuvela.Uma kwenzeka i-anomaly, kulula ukutholakala, ngaphezu kwalokho, imikhiqizo eyingozi kule nqubo izohlukaniswa ngokushesha.
◇ Yonke idatha yokuhlola ingokoqobo futhi iyasebenza, irekhodwa kahle futhi iphrintwe ngokuzenzakalelayo.Ingasetshenziswa njengerekhodi lokukhiqizwa kwenqwaba.Amadokhumenti e-elekthronikhi kulula ukuwagcina, ukucinga nokufaka isicelo sokubuyekezwa kwekhwalithi kanye nokuhlonza inkinga.
◇Umsebenzi wokuqapha werimothi we-CVS ukwenza kube lula futhi kusebenze kahle ukulawula ukukhiqizwa nekhwalithi.Futhi ngokuhlolwa kwe-single-orifice, i-CVS ithola futhi ixazulule ukugcwalisa okudidayo ngokushesha nangokuqondile.
◇ Kuphela ngaphansi kokubhekwa okuqinile kwe-CVS, ukunemba kokugcwalisa i-capsule kungalawulwa ngempumelelo futhi nekhwalithi yomkhiqizo iyaqinisekiswa.
◇ Ngemisebenzi enamandla ne-SPC ehlakaniphile, umshini uhlala ufeza umsebenzi wawo.Ukuphatha kwayo kulula kakhulu kunabantu futhi umphumela wayo wokusebenza ungcono kakhulu kunokuhlola ukuchezuka kokugcwalisa ngesandla.I-CVS iyindlela ephumelelayo yokuqinisekisa ikhwalithi yokukhiqiza.
Ifomu Lomsebenzi Nokukhethwa
| Into NO. | Incazelo Yemisebenzi Eyisisekelo | Ukunemba ±3mg | Ukunemba ±1.5mg | ||
| 2 iziteshi | 4 amashaneli | 2 iziteshi | 4 amashaneli | ||
| 1 | Isistimu yokubethela kathathu(ngena nge-ID nephasiwedi, izinga ngalinye linelungelo lokuqinisekisa ukuthi ukusebenza kuyalawulwa) | ||||
| 2 | Shayela imininingwane yomkhiqizo ngokuzenzakalela(gcina futhi ucele imininingwane yokukhiqiza, qinisekisa ulwazi ukuze ugcine amarekhodi okukhiqiza elungile) | ||||
| 3 3A | Isikhathi sokuthatha amasampula okwenziwa mathupha(ngesikhawu sesikhathi esimisiwe sokuhlaba umkhosi ngokungapheli ukuze ugcwalise isheke elifika ngesikhathi) | ||||
| Isampula ezenzakalelayo exhunyiwe(ngesikhathi esimisiwe sokusampula amahora angama-24 ngosuku ukuze kuqashelwe isikhathi esigcwele) | |||||
| 4 | Izimo Ezilungisekayo(izimo ezinengqondo ezilungisekayo zokugcwalisa ukuchezuka ngokubala okuzenzakalelayo nokusebenza) | ||||
| 5 | I-alamu yokudidayo(kala amaphilisi ngokunembile ngalinye ngalinye, bonisa idatha yesisindo, i-alamu yamaphilisi angafaneleki) | ||||
| 6 | Umlando we-alamu obuyisekayo(bonisa futhi urekhode isizathu, isikhathi, u-opharetha nolunye ulwazi lwayo yonke i-alamu ukuze uthuthukise ikhwalithi) | ||||
| 7 | Phrinta ithebula lokuhlukahluka kwesisindo(idatha yeqiniso nenemininingwane njengamarekhodi okukhiqiza amaqoqo e-GMP, amafayela e-e alondolozwe unomphela) | ||||
| 8 | 21CFR-11 ama-e-signatures(rekhoda amagama okusebenza, ukubuyekezwa kanye nokungena kwe-QA kumathebula, okuhambisana ne-21CFR ingxenye11 ku-FDA) | ||||
| 9 | Amajika ezisindo zesikhathi sangempela(ijika libonisa ukuhluka kwesisindo, lisiza ekutholeni nasekuxazululeni izinkinga ngokusekelwe kumikhuba yalo) | ||||
| 10 | Ijika leBell lokubala i-CPK(njengokubonakaliswa kwekhwalithi yeqoqo ukuze izimboni zilinganise yonke iqoqo lemikhiqizo) | ||||
| 11 | Ukuhlukaniswa kwamasampula(hlukanisa amaphilisi angafaneleki kwabanye ukuze ahlolwe kabusha futhi ahlaziywe, ukuze kutholwe okudidayo) | ||||
| 12 | Ukulinganiswa kwebhalansi enembile(imvamisa yokuzilinganisa okulungisekayo ukuze kuqinisekiswe ibhalansi ezinzile nedatha ethembekile) | ||||
| 13 | Isigaba samashadi nedatha(amafayela e-e alondolozwa futhi ahlukaniswa ukuze abuyekezwe, asekela imibuzo enemibandela eminingi nganoma yisiphi isikhathi) | ||||
| 14 | Finyelela amarekhodi okulungisa(abasebenzi abanelungelo eliphakeme bayakwazi ukushintsha amarekhodi ukuze balawule nezinjongo ze-GMP) | ||||
| Incazelo Yemisebenzi Eyengeziwe Yenani Eliphezulu | |||||
| (15) | Ukuqapha okukude kokukhiqiza(vumela abaphathi ukuthi bazi ngekhwalithi yomkhiqizo, ukusebenza kanye nabasebenzi ekukhiqizeni) | ||||
| (16) | Ukuhlukaniswa ukuze kuqukethe ubungozi(i-logic eqinile yokwahlulela nokuhlukanisa ama-capsules emshinini wokugcwalisa, okungcono kunokuhlola okuphelele) | ||||
| (17) | Ithola i-orifice engalungile(ngemuva kokuhlolwa, ikhomba imojuli ethile kanye ne-orifice yaleyo ebangela amaphilisi ayingozi) | ||||
| (18) | I-Statistical Process Diagnosis (SPD)(amajika esisindo orifice ngayinye, ukuthola nokuxazulula izinkinga ngokuqondile) | ||||
Qaphela: Umsebenzi “3A” wengezwe ukuze usebenze “(16)”.Ukuhlukaniswa kwezinto kungokuba sobala.“(16)” kufanele imakwe kanye no-“3A”, okuyinani eliyinhloko le-CVS.
