Akwụkwọ a na-akwado ngwaahịa nke TS Filter mepụtara dịka ụkpụrụ ọrụ mmepụta dị mma ugbu a si dị.
A na-emepụta, emepụta ma kesaa ngwaahịa a dịka sistemụ njikwa nke ISO9001: 2015 kwadoro.
Ụkpụrụ Nkwanyesi Ike Ogo
Ịdị ọcha
Ngwaahịa nzacha a kwekọrọ na aha 21 CFR, ngalaba 210.3 (b)(5)(6) na 211.72
❖ TOC na Conductivity
Mgbe a gwọchara mmiri a na-achịkwa, ihe nlele ahụ nwere ihe na-erughị 0.5mg (500 ppb) nke carbon kwa lita, ike conductivity ahụ erughịkwa 5.1 S/cm @ 25°c.
❖ Nje bacteria Endotoxins
Mwepụta mmiri kapsụl nwere ihe na-erughị 0.25EU/ml
Nchekwa ihe ndị dị ndụ
Ihe niile dị na ihe nzacha a na-emezu ihe USP dị ugbu a maka klas plastik VI-121°c.
❖ Ihe mgbakwunye nri na-apụtaghị ìhè
Ihe niile mejupụtara ya na-emezu ihe FDA chọrọ maka ihe mgbakwunye nri na-apụtaghị ìhè nke e depụtara na 21CFR. Ihe niile mejupụtara ya na-emezu ihe EU chọrọ na 1935/2004/EC. Kpọtụrụ ndị na-ebunye ya maka ozi ndị ọzọ gbasara ihe owuwu ahụ.
❖ Nkwupụta Ebe Anụmanụ Si Malite
Dabere na ozi dị ugbu a sitere n'aka ndị na-ebunye anyị ngwaahịa a, ihe niile ejiri mee ihe na ngwaahịa a enweghị anụmanụ.
❖ Nchekwa nje bacteria
A nwalela ngwaahịa a nke ọma maka ijigide obere nje a na-anabata, site na iji usoro akọwara na Ntuziaka Nyocha TS Filter ma jikọta ya na ASTM Standard Test Methos ASTM F838, dịka iwu FDA siri dị maka Ngwaahịa Ọgwụ Sterile nke Aseptic Products Production mepụtara (Septemba 2004).
❖ Usoro Mwepụta Nleta
E jiri TS Filter Quality Assurance wepụta ebe a na-emepụta ihe, nwalee ya ma wepụta ya.
❖ Nnwale Iguzosi Ike n'Ezi Ihe
A nwalela ihe nzacha ọ bụla site na nkwenye ịdị mma TS Filter dabere na ụkpụrụ ndị dị n'okpuru, wee hapụ ya.
Ụkpụrụ Ule Iguzosi Ike n'Ezi Ihe (20°c):
Ebe afụfụ (BP)
Mgbasa Mgbasa (DF)
Ma ọ bụ Mbibi Mmiri (WI)
Rịba ama: A ga-anwale BP na DF mgbe e tinyere mmiri n'ime ihe nzacha ahụ.
Maka nzacha a, ụkpụrụ ule iguzosi ike n'ezi ihe ndị a ejikọtara nke ọma na ule ASTM F838 bacteria Challenge, dịka iwu FDA siri dị maka ngwaahịa ọgwụ dị iche iche nke Aseptic Processing-Current Good Manufacturing Practice (Julaị 2019) mepụtara.
❖ Nnwale Ntapụ
A nwalela ihe nzacha ọ bụla site na nkwenye ịdị mma TS Filter dabere na Ụkpụrụ ndị dị n'okpuru, wee hapụ ya: