Cell factorywani nau'in akwati ne na al'adun tantanin halitta wanda aka yi da albarkatun polystyrene.Don saduwa da buƙatun haɓakar ƙwayoyin sel, wannan albarkatun ƙasa dole ne ya cika buƙatun da suka dace na USP Class VI kuma tabbatar da cewa albarkatun ƙasa ba su ƙunshi abubuwan da ke shafar haɓakar tantanin halitta ba.Don haka, a cikin ma'aunin USP Class VI, waɗanne kayan gwaji ya kamata albarkatun ƙasa su bi?

Rarraba Pharmacopeia na Amurka na kayan aikin likita shine 6, kama daga USP ajin I zuwa USP aji VI, tare da USP aji VI shine mafi girma.Dangane da Dokokin Janar na USP-NF, robobin da aka yiwa gwajin amsawar halittu a cikin vivo za a sanya su zuwa rarrabuwar filastik na likita.Makasudin gwajin shine don tantance daidaituwar ƙwayoyin robobi don amfani da su a cikin na'urorin likitanci, dasawa, da sauran tsarin.

Babi na 88 na USP Class VI yayi magana game da gwajin bioreactivity na vivo, wanda ke da nufin tantance tasirin bioreactivity na kayan roba akan dabbobi masu rai.Kayan abinci na masana'antar tantanin halitta ya haɗa da buƙatun gwaji guda uku: 1. Gwajin allura na tsari: An shirya samfurin fili tare da takamaiman tsantsa (misali, man kayan lambu), kuma ana shafa polyethylene glycol akan fata, shaka, ko baki.Gwajin yana auna guba da haushi.2. Gwajin intradermal: Samfurin fili yana nunawa ga nama mai rai (nama wanda na'urar likita / na'urar ke shirin tuntuɓar).Gwajin yana auna guba da fushin gida.3. Shigarwa: An shigar da fili a cikin tsokar samfurin.Gwajin yana auna virulence, kamuwa da cuta da haushi.