Changshan Pharmaceutical
APIs 'Kugadzira Mitsetse
Iko kune yakatsaurirwa yekugadzira semusangano nenzira yeHeparin API, Enoxaparin Sodium API uye Dalteparin Sodium & Nadroparin Calcium API. Aya matatu eworkshop ari ese achangogadzwa uye ane avo akazvipira akapihwa zvigadzirwa zvekugadzira, HVAC system uye inochenesa mvura system.
| APIs 'Kukwanisa kwegore | |||
|---|---|---|---|
| Heparin Sodium API: mamirioni mashanu mega DMF Kwete: 24595 | |||
| Enoxaparin Sodium API: 5,000kg DMF Kwete: 26258 | |||
| Dalteparin Sodium API: 3,000 kg DMF No: 29154 | |||
| Nadroparin Calcium API: 3,000 kg | |||
| Hyaluronic Sodium API: 21,000 kg |
F5 B + S Syringe Kuzadza Mutsara
German B + S pre-kuzadza syringe yekuzadza mushini:
Yakazara servo tekinoroji, yekugadzirisa-isina dhizaini, uye kusanganisa neSwitzerland SKAN aseptic ari oga kuti uwane iyo yepamusoro sosi yemamiriro ezvinhu aseptic ekugadzirwa kwemagetsi, uye unosangana zvizere neFDA uye European GMP mazinga.
Switzerland SKAN:
Isolator, yekuparadzanisa zvigadzirwa zvekugadzira zvizere kubva munharaunda yemusangano kuitira kuti iwane zvakanakira kugadzirwa nharaunda. Kuparadzanisa chigadzirwa nemushandi. Rega chigadzirwa chengeteke, uye mushandi agadzikane.
| Mitsetse yezvigadzirwa | Kugona / gore (Mamirioni) | Batch nhamba | Batch kugadzirwa nguva (h) |
|---|---|---|---|
| F1, Terminal Sterilization-ampoule mutsara | 30 | 250 | ≤ 8 |
| F2, Aseptic -ampoule mutsara | 30 | 250 | ≤ 8 |
| F3, Aseptic -vial mutsara | 25 | 250 | ≤ 8 |
| F4, Aseptic -PFS mutsara | 40 | 250 | ≤ 8 |
| F5, Aseptic -PFS mutsetse (kuvakwa) | 60 | 250 | ≤ 8 |
| FDFs 'Kubata kwegore | |||
|---|---|---|---|
| Heparin Sodium Injection (vials): 20 miriyoni | |||
| Heparin Sodium Injection (ampoul): makumi masere emamirioni | |||
| LMWH Injection (PFS): zviuru makumi mana |
Kuvaka kwakatanga muna Chikunguru 2015, iri muZhengding yepamusoro-tech nzvimbo yedunhu, inosanganisira nzvimbo inosvika 198,000㎡, kusanganisira 66,700㎡ yeakakora heparin chirongwa.
Negore rinogadzirisa zviuru mazana manomwe nezviuru zvemazana emukati memukati, zviuru zviuru zvitatu zvevedumbu rakarongedzwa, uye rakapetana 500000 mega yeakasviba heparin.
Crude Base
