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Ntụkwasị obi ịdị mma

Asambodo mmesi obi ike

Akwụkwọ a na-akwado ngwaahịa nke TS Filter rụpụtara n'ìhè nke ụkpụrụ Omume nrụpụta ọma dị ugbu a. A na-emepụta ngwaahịa a, mepụta ma kesaa ya dịka usoro nlekọta nke ISO9001: 2018 kwadoro.

Usoro mmesi obi ike

Ịdị ọcha
Ngwa nzacha a na-akwado aha 21 CFR, ngalaba 210.3 (b)(5)(6) na 211.72

❖ TOC & Omume
Mgbe a na-achịkwa mmiri mmiri, ihe nlele nwere ihe na-erughị 0.5mg (500 ppb) nke carbon kwa lita, na conductivity bụ ihe na-erughị 5.1 S/cm @ 25°c.

❖ Nje bacteria Endotoxins
Mwepụta nke capsule nwere ihe na-erughị 0.25EU/ml

❖ Biosafety
Ihe niile nke ihe nzacha a na-emezu ihe achọrọ nke USP ugbu a <88> maka klas plastik VI-121°c.

❖ Ihe mgbakwunye nri na-apụtaghị ìhè
Ngwa niile mejupụtara ihe mgbakwunye nri na-apụtaghị ìhè nke FDA akpọrọ na 21CFR. Ngwa niile mejupụtara ihe achọrọ nke iwu EU 1935/2004/EC. Kpọtụrụ ndị na-eweta ngwaahịa maka ozi ndị ọzọ gbasara ihe eji arụ ụlọ.

❖ Okwu Mmalite anụmanụ
Dabere na ozi dị ugbu a sitere n'aka ndị na-ebubata anyị, ihe niile akụrụngwa na-eji na ngwaahịa a enweghị anụmanụ.

❖ Njide nje
A nwalere ngwaahịa a nke ọma maka njigide microorganism ihe ịma aka a na-anakwere, na-eji usoro akọwara na TS Filter Validation Guides yana jikọtara ya na ASTM Standard Test Methos ASTM F838, n'ikwekọ n'ihe achọrọ nke FDA Guideline Sterile Drug Ngwaahịa Mepụtara site na nhazi Aseptic- Omume nrụpụta ọma dị ugbu a (September 2004).

❖ Usoro ntọhapụ Lot
Emere ọtụtụ ihe nrụpụta a, nwalere ma wepụta ya site na TS Filter Quality Assurance.

❖ Nnwale iguzosi ike n'ezi ihe
A nwalela ihe nzacha ọ bụla site na mmesi obi ike ịdị mma TS Filter dabere na ụkpụrụ ndị dị n'okpuru, wee hapụ ya.

Ọkọlọtọ Nnwale Iguzosi ike n'ezi ihe (20°c):

Ihe ngosi Bubble (BP), Mgbasa Mgbasa (DF)

Cheta na: Ekwesịrị ịnwale BP na DF mgbe ihe nzacha wesara mmiri.
Maka nzacha a, ejikọtala ụkpụrụ ule iguzosi ike n'ezi ihe ndị a na nnwale ịma aka nje nje ASTM F838, n'ikwekọ n'iwu nke FDA Guideline Sterile Drug Product Processing by Aseptic Processing-Current Good Manufacturing Practice (July 2019).

❖ Nnwale ntapu
A nwalela ihe nzacha ọ bụla site na mmesi obi ike ịdị mma TS Filter dabere na ụkpụrụ ndị dị n'okpuru, wee wepụta: Ọ nweghị ntapu na 0.40MPa n'ime nkeji 5.