I-ZEOPHARM® 5170 iyimpuphu ye-silica precipitated egayiwe enobumsulwa obuphezulu, ethanda amanzi, eyakhelwe njengesithwali sokukhangisa esisebenza kahle sezicelo zemithi, zezokudla okunomsoco kanye nezokunakekelwa komuntu siqu okusezingeni eliphezulu. Ikhiqizwa yi-Evonik Operations GmbH ngaphansi kwezimo zokukhiqiza ezihambisana ne-GMP, le nto yakhelwe ngamabomu ukuguqula izithako zemithi ezisebenzayo eziwuketshezi (ama-API), izithako ezinamafutha, izicaphuno zezitshalo kanye noketshezi olusebenzayo kube yizimo zempuphu ezigeleza ngokukhululekile, ezikwazi ukulinganiswa ngokunembile, ngokuhambisana okuphelele kwezomthetho ezimakethe ezinkulu zomhlaba.

Njengomlingani wekhwalithi yezemithi we-Evonik's ZEOFREE® 5170 isithwali sekhwalithi yokudla, i-ZEOPHARM® 5170 inikeza ukusebenza kokumunca okuyisisekelo okulinganayo nokulawulwa kokuhlanzeka okuphezulu nokuhambisana ne-pharmacopoeia, okukwenza kufanelekele izinhlobo zomthamo oqinile womlomo, izinhlelo zokulethwa kwe-liquisolid kanye nokukhiqizwa kwamaphilisi okucindezela okuqondile.

Ucwaningo oluzimele lokwakhiwa kwemithi lukhombise i-ZEOPHARM® 5170 ekusetshenzisweni kwezinto eziqinile, okuqinisekisa ukuziphatha okukhethekile kokugeleza okusekela ukukhiqizwa okusheshayo:

· Ubukhulu obonakalayo (obungacindezelwanga): 0.32 g/cm³

· Ukuminyana okuthintiwe: 0.34 g/cm³

· Inkomba Yokucindezelwa ka-Carr: 6.2 % – ihlukaniswa njengokugeleza okuhle kakhulu

· Isilinganiso sika-Hausner: 1.07 – sikhombisa ukubumbana okuphansi kakhulu phakathi kwezinhlayiya kanye nengozi encane yokuhlukaniswa

· Ububanzi bomgodi wokugeleza (ukuhlolwa kwe-Copley): 4 mm – izinga lokugeleza eliphezulu kuma-carrier ayimpushana

· Ukuqina okuhlanganisiwe (ukuhlolwa kwe-Wells): 15–16 N ngamandla okuhlanganisa ajwayelekile

Lezi zici zisungula i-ZEOPHARM® 5170 njengesisekelo se-carrier yobuchwepheshe bamaphilisi e-liquisolid, lapho idlula khona ezinye izinto zokuthwala i-silicate ekufananeni kwengxube nasekuvumelaneni kokucubungula izidakamizwa ezingancibiliki kahle ze-BCS Class II.

I-ZEOPHARM® 5170 ikhiqizwa ukuze ihlangabezane namazinga omhlaba wonke ekhwalithi nokuphepha, isekela ukubhaliswa komkhiqizo eNyakatho Melika, eYurophu, e-Asia-Pacific nasezimakethe ezisafufusa:

· Izinhlelo Zekhwalithi: Ikhiqizwa ngaphansi kwezimo ze-GMP; izindawo zokukhiqiza eziqinisekisiwe nge-ISO 9001

· Ukuhambisana Ne-Pharmacopoeia: Ihambisana ne-USP/NF (United States Pharmacopeia / National Formulary) Silicon Dioxide monograph kanye ne-Ph. Eur. (European Pharmacopoeia) Silicon Dioxide monograph

· Izindinganiso Zokudla Nokuphakelayo: Kuhlangabezana ne-EU Regulation (EU) 231/2012 imigomo yokuhlanzeka ye-E 551 (i-silica edonsiwe); kuhambisana ne-FDA 21 CFR izinhlinzeko zezicelo zokuxhumana nokudla

· Ukuhambisana Kwezimonyo: Kuhlangabezana nezidingo zezinga le-COSMOS zezithako zezimonyo zemvelo neziphilayo

· Izitifiketi Zokudla Nezenkolo: Kuqinisekisiwe i-Kosher (Pareve), i-Kosher ye-Passover, ne-Halal

· Isitatimende Somdabu: I-silica amorphous yokwenziwa engu-100%; azikho izinto zokusetshenziswa ezivela ezilwaneni, ifanele ukwakheka kwe-vegan ne-vegetarian

1. Ukuguqulwa Okuthembekile Koketshezi Kube Uphawuda Ivolumu ephezulu yezimbobo namandla okumunca kuvumela ukulayishwa okulinganayo kwama-API awuketshezi, ama-oyili e-herbal, izicaphuno ze-herbal nama-excipients ane-viscous, kuwaguqulela kube uphawuda ogeleza ngokukhululeka ngokulingana kwedosi okunembile.

2. Ukusebenza Kahle Kwenqubo Okuphezulu Izici zokugeleza ezihamba phambili embonini zinciphisa ukuhlukaniswa kwengxube, zithuthukisa ukulingana kwesisindo sokugcwalisa, futhi zivumela umthamo ophezulu emisebenzini yokwenza amaphilisi, yokufaka emikhawulweni nokugcwalisa uphawuda, ngezikhathi zomjikelezo ezimfushane nokulahlekelwa okuncane kwezinto

3. Ukungasebenzi Kwamakhemikhali Nokungathinteki Kwezinzwa I-silica e-ayimofasi engasebenzi ngamakhemikhali ayisebenzisani nezakhi ezisebenzayo. Umkhiqizo awunambitheki futhi awunaphunga, ugcina ukunambitheka kwasekuqaleni, umsebenzi wokwelapha kanye nokuzinza kwezakhi ezisebenzayo ezilayishiwe.

4. Ukuthuthukiswa Kokuphepha Emsebenzini Kuguqula izingxenye eziwuketshezi ezilimazayo, ezine-asidi noma ezicasula isikhumba zibe yimpuphu eyomile, kunciphisa ingozi yokuchitheka, kunciphisa ukuchayeka kwabasebenzi futhi kwenza kube lula ukuphatha, ukugcina nokuthutha esitshalweni.

5. Ukuzinza Kwesikhathi Eside Kokwakheka Kokuzinza kwamakhemikhali okwemvelo kugcina ubuqotho bezakhi ezisebenzayo ezilayishiwe phakathi nesikhathi sokuphila kweshelufu; isakhiwo esinezimbobo ezilawulwayo sisekela ukusebenza okungaguquki kokukhishwa kwezinto ezisetshenziswayo emithini eqediwe.

· Izidakamizwa Zomlomo Eziqinile: Amaphilisi e-Liquisolid ezinto ezingancibiliki emanzini, izingxube zamaphilisi okucindezela okuqondile, amakhapsuli aqinile agcwele impushana, kanye nezinsiza zokucubungula i-granulation

· Izinhlelo Zokuthwala i-API Ne-Excipient: Ukumuncwa kwezinto eziwuketshezi zomuthi, ama-concentrate amafutha asebenzayo, izinto zokugcwalisa ama-softgel kanye nezinto zokugcoba eziwuketshezi ezimweni zempushana eyomile, ephethekayo

· Ama-Nutraceuticals Nokudla Okusebenzayo: Ukulayisha izikhuthazi zezitshalo, amafutha e-omega-3, ama-concentrate emakhambi, izinto ezisebenzayo ze-liposomal kanye noketshezi lwamavithamini kuma-premix empushana egeleza ngokukhululekile

· Ukunakekelwa Komuntu Okusezingeni Eliphezulu: Isithwali sokuhlanzeka okuphezulu sezinto ezisebenzayo zesikhumba esiyimpushana, izinhlanganisela ze-shampoo eyomile, kanye nezisekelo zezimonyo eziyimpushana

· Ukucubungula Kwezimboni Zemithi: Insiza yokugeleza, isinqandi-mhlangano kanye nensiza yokucubungula yokuhlanganisa impushana enqwaba, ukucubungula kwangemva kokomisa nge-spray kanye nemigqa yokukhiqiza eqhubekayo

Imininingwane ephelele yezingozi, ukuchayeka kanye nosizo lokuqala ibhalwe ku-Safety Data Sheet (SDS) esemthethweni, ehlinzekwa nokuthunyelwa kokuqala noma etholakala uma iceliwe ku-Evonik Product Safety.

· Sebenzisa ngokuphefumula okwanele kwendawo ukuze ulawule amazinga othuli oluphefumulwayo

· I-PPE ejwayelekile (izinto zokuvikela amehlo, imaskhi yothuli, amagilavu okuvikela) iyanconywa emisebenzini yokuphatha i-bulk

· Le nto ayisebenzi ngamakhemikhali futhi inobuthi obuncane kakhulu (i-oral LD₅₀ > 10,000 mg/kg kumagundane)

· Gwema ukukhiqizwa nokuqongelelwa kothuli olucolekile ezindaweni zokusebenza

· Ukupakisha: Kuhlinzekwa ngokupakisha kwe-bulk ejwayelekile yezimboni; osayizi namafomethi okupakisha ngokwezifiso ayatholakala ngeziteshi zokuthengisa zasekhaya ze-Evonik.

· Izimo Zokugcina: Gcina emaphaketheni okuqala, avaliwe ngokuphelele noma ezitsheni ezivaliwe ngokungangeni komoya endaweni epholile, eyomile. Gcina kude nezinto eziphilayo eziguquguqukayo, ngoba indawo ephezulu yokuxhumana ingaholela ekumuncweni kwemiphunga yendawo.

· Isikhathi Sokugcina: Izinyanga ezingama-36 kusukela nosuku lokukhiqizwa ngaphansi kwezimo zokugcina ezinconyiwe. Impahla egcinwe ngaphezu kwezinyanga ezingama-36 kufanele ihlolwe ngokuqukethwe komswakama ngaphambi kokusetshenziswa ukuze kuqinisekiswe ukuhambisana nezidingo zokusetshenziswa.

I-EMEA / i-Latin America Evonik Operations GmbH, Umkhakha Webhizinisi I-Silica Rodenbacher Chaussee 4, 63457 Hanau-Wolfgang, Germany Ucingo: +49 6181 59-3536 Ifeksi: +49 6181 59-4096 I-imeyili: ask-si@evonik.com

INyakatho Melika Evonik Corporation, Commercial Silica 299 Jefferson Road, Parsippany, NJ 07054-0677, USA Ucingo: +1 800 233-8052 Ifeksi: +1 973 929-8502 I-imeyili: ask-si@evonik.com

I-Asia Pacific Evonik (SEA) Pte Ltd, Commercial Silica 3 International Business Park, #07-18 Nordic European Centre Singapore 609927 Ucingo: +65 6 809 6877 Ifeksi: +65 6 809 6677 I-imeyili: ask-si-asia@evonik.com