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Netefaletso ea boleng

Setifikeiti sa Tiisetso ea Boleng

Tokomane ena e fana ka setifikeiti sa sehlahisoa se entsoeng ke TS Filter ho latela maemo a hajoale a Ts'ebetso e Ntle ea Tlhahiso.Sehlahisoa sena se hlahisoa, se hlahisoa le ho ajoa ho latela tsamaiso ea tsamaiso e tiisitsoeng ke ISO9001:2018.

Litekanyetso tsa Tiiso ea Boleng

Bohloeki
Sehlahisoa sena sa sefe se lumellana le sehlooho sa 21 CFR, karolo ea 210.3 (b) (5) (6) le 211.72

OC OCD & Conductivity
Ka mor'a ho hlatsoa metsi a laoloang, lisampole li na le k'habone e ka tlase ho 0.5mg (500 ppb) ka litara, 'me conductivity e ka tlase ho 5.1 S/cm @ 25°c.

❖ Likokoana-hloko tsa Endotoxin
Ho ntšoa ha metsi ka capsule ho na le ka tlase ho 0.25EU/ml

❖ Tšireletso ea likokoana-hloko
Lisebelisoa tsohle tsa ntho ena ea filthara li fihlela litlhoko tsa USP ea hajoale <88> bakeng sa sehlopha sa polasetiki VI-121 ° c.

❖ Keketso ea Lijo e sa Tobang
Lisebelisoa tsohle tsa likarolo li kopana le litlhoko tsa kenyelletso ea lijo tse sa tobang tsa FDA tse boletsoeng ho 21CFR.Lisebelisoa tsohle tsa likarolo li kopana le tlhokahalo ea molao oa EU 1935/2004/EC.Ikopanye le bafani ba thepa bakeng sa lintlha tse ling mabapi le thepa ea kaho.

❖ Polelo ea Tšimoloho ea Liphoofolo
Ho ipapisitsoe le lintlha tsa hajoale tse tsoang ho barekisi ba rona, lisebelisoa tsohle tse sebelisoang sehlahisoa sena ha li na liphoofolo.

❖ Ho Boloka Libaktheria
Sehlahisoa sena se lekoa ka katleho bakeng sa ho bolokoa ha phephetso e amohelehang, ho sebelisoa mekhoa e hlalositsoeng ho TS Filter Validation Guides le e amanang le ASTM Standard Test Methos ASTM F838, tumellanong le litlhoko tse sebetsang tsa FDA Guideline Sterile Drug Products Produced by Aseptic Processing- Mekhoa e Metle ea Hajoale ea Tlhahiso (September 2004).

❖ Melao-motheo ea Tokollo ea Lotho
Sebaka sena sa tlhahiso se ile sa etsoa sampole, sa lekoa le ho lokolloa ke TS Filter Quality Assurance.

❖ Teko ea Botšepehi
Karolo e 'ngoe le e' ngoe ea sefe e lekoa ke netefatso ea boleng ba TS Filter ho latela litekanyetso tse ka tlase, ebe e lokolloa.

Maemo a Teko a Botšepehi (20°c):

Bubble Point (BP) , Phallo ea Phallo (DF)

Tlhokomeliso: BP le DF li lokela ho lekoa ka mor'a hore karolo ea sefe e kolobisoe.
Bakeng sa sefe sena, litekanyetso tsena tsa teko ea botšepehi li hokahane ka botlalo le teko ea ASTM F838 bacteria Challenge, ho ipapisitse le litlhoko tse sebetsang tsa FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Phupu 2019).

❖ Leak Test
Karolo e 'ngoe le e' ngoe ea sefe e lekiloe ke netefatso ea boleng ba TS Filter ho latela Melao-motheo e ka tlase, ebe e lokolloa: Ha ho na leakage ho 0.40MPa nakong ea 5 min.