Hōʻoia kēia palapala i ka huahana i hana ʻia e TS Filter e like me nā kūlana o Current Good Manufacturing Practice.
Ua hoʻomohala ʻia, hana ʻia a hāʻawi ʻia aku kēia huahana e like me ka ʻōnaehana hoʻokele i hōʻoia ʻia e ISO9001:2015.
Nā Kūlana Hōʻoiaʻiʻo Kūlana
Ka maʻemaʻe
Ua kūlike kēia huahana kānana me ke poʻo inoa 21 CFR, ʻāpana 210.3 (b)(5)(6) a me 211.72
❖ Papa Kuhikuhi a me ke Alakaʻi
Ma hope o ka holoi ʻana i ka wai i kāohi ʻia, ʻoi aku ka liʻiliʻi o ke kalapona ma mua o 0.5mg (500 ppb) o nā laʻana no ka lita, a ʻoi aku ka liʻiliʻi o ke conductivity ma mua o 5.1 S/cm @ 25°c.
❖ Nā Endotoxins bacteria
ʻO ka unuhi wai o kahi capsule aia ma lalo o 0.25EU/ml
❖ Palekana Olaola
Ua kūlike nā mea a pau o kēia ʻāpana kānana i nā koi o ka USP o kēia manawa no ka papa plastik VI-121°c.
❖ Mea Hoʻohui Meaʻai ʻAʻole Kūpono
Ua kūlike nā mea hana āpau i nā koi hoʻohui meaʻai ʻole pololei a ka FDA i ʻōlelo ʻia ma 21CFR. Ua kūlike nā mea hana āpau i nā koi o ke kānāwai EU 1935/2004/EC. E kelepona i nā mea hoʻolako no ka ʻike hou aku e pili ana i nā mea hana.
❖ Hōʻike Kumu Holoholona
Ma muli o ka ʻike o kēia manawa mai kā mākou mea hoʻolako, ʻaʻohe holoholona i nā ʻāpana a pau i hoʻohana ʻia ma kēia huahana.
❖ Paʻa ʻana o ka bacteria
Ua hoʻāʻo pono ʻia kēia huahana no ka mālama ʻana i kahi microorganism hoʻokūkū i ʻae ʻia, me ka hoʻohana ʻana i nā kaʻina hana i wehewehe ʻia ma TS Filter Validation Guides a ua pili pū me ASTM Standard Test Methos ASTM F838, e like me nā koi kūpono o ka FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Kepakemapa 2004).
❖ Nā Kūlana Hoʻokuʻu Lot
Ua laʻana ʻia kēia ʻāpana hana, hoʻāʻo ʻia a hoʻokuʻu ʻia e TS Filter Quality Assurance.
❖ Hoʻāʻo Kūpono
Ua hoʻāʻo ʻia kēlā me kēia ʻāpana kānana e ka hōʻoia maikaʻi o ka TS Filter e pili ana i nā kūlana ma lalo nei, a laila hoʻokuʻu.
Kūlana Hoʻāʻo Kūpaʻa (20°c):
Kiko Pehu (BP)
Kahe Hoʻolaha (DF)
A i ʻole ka komo ʻana o ka wai (WI)
Nānā: Pono e hoʻāʻo ʻia ʻo BP a me DF ma hope o ka hoʻomaʻū ʻia ʻana o ka ʻāpana kānana.
No kēia kānana, ua hoʻopili piha ʻia kēia mau kūlana hoʻāʻo kūpaʻa i ka hoʻāʻo bacteria ASTM F838, e like me nā koi kūpono o ka FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Iulai 2019).
❖ Hoʻāʻo Leaka
Ua hoʻāʻo ʻia kēlā me kēia ʻāpana kānana e ka hōʻoia maikaʻi o ka TS Filter e pili ana i nā Kūlana ma lalo nei, a laila hoʻokuʻu ʻia: