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## Skin ### Button Button_8D97CAB4_D9D1_A971_41E1_A14F44401ABF.label = EN Button_8D97CAB4_D9D1_A971_41E1_A14F44401ABF.pressedLabel = 中 ### Image Image_E45E51AD_D833_BB13_41DB_A791784DE214.url = skin/Image_E45E51AD_D833_BB13_41DB_A791784DE214_en.png Image_F9098D83_D8D1_6B17_41D3_DFF392120CC8.url = skin/Image_F9098D83_D8D1_6B17_41D3_DFF392120CC8_en.png ### Label Label_C485CAA6_E0C3_3FB2_4192_6F7B24B426A2.text = Drug Product (Fill & Finish) Suite Label_C4235E22_E0C1_16B2_41B3_C0AFA1406A67.text = Drug Substance Suite 2 Label_C55CFAB4_E0FF_1F96_41E4_9C12829312DF.text = Drug Substance Suite 1 Label_C308088A_E0C3_1A72_41C0_CDE4CAC762F1.text = Drug Substance Suite 3 Label_C8C8EAF6_E0C7_FF92_4187_611E600D722A.text = Inspection & Packaging Room Label_C6AE931A_E0C1_0E92_41EA_5CB8D3B2DCDD.text = Return Corridor Label_B0FA831D_D852_DF33_41E2_8458E3187589.text = Solution Preparation Room Label_C7C67FD2_E0C1_1592_41E9_43D8C3354EE5.text = Supply Corridor Label_C7FD153C_E0C7_0A96_41C2_4257445E65C2.text = Warehouse ### Multiline Text HTMLText_C4840AA7_E0C3_3FB2_41CE_728B83103D76.html =
A Grade C fill-finish suite features a Grade A isolator housing filling, capping & stoppering systems together alongside a lyophilizer for aseptic liquid and freeze-dried products. The isolator enables aseptic operations and transfers via glove and rapid transfer ports, supported by an integrated VHP decontamination system. It supports filling of 2R–25R vials, up to 10k vials/run (2R liquid) and ~5k vials/lyo cycle.
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A Grade D room with two downflow booths (Grade C) – one for dispensing and another for preparation of media and buffer using single-use 200L mixer equipped with process monitoring and automation capabilities. Meanwhile, an IPC bench supports rapid in-process release testing. Prepared solutions support both drug substance and drug product manufacturing.
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ACES dedicated supply and return corridor concept maintains unidirectional movement of personnel, materials, products and waste. Materials enter suites via a material airlock from warehouse, and finished goods is transported to warehouse via the supply corridor. Personnel enter via the gowning room, supply corridor to clean room suites and exit via the return corridor. The dedicated air handling unit reduces risk of cross-contamination and enables multiproduct manufacturing. The personnel will wear additional secondary gown before entering the higher-grade clean room.
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Filled vials are transferred via a dynamic pass-through box for manual visual inspection, where each vial is checked for particulates, container defects, and other quality issues. Accepted vials are then labelled, packaged, and prepared for storage or shipment.
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Materials from the warehouse enter manufacturing suites via a secure material airlock into the Grade D supply corridor in a unidirectional manner for contamination control. The warehouse is temperature-controlled and humidity-monitored, supporting storage at various temperatures. Raw material sampling capabilities ensures comprehensive quality control prior to manufacturing.
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Suite 1 is designed as a Grade C, platform-agnostic ballroom that supports flexible, plug-and-play operations. It is equipped with single-use upstream and downstream systems - 50L and 250L bioreactors, a 30L fermenter, and 50–500L jacketed mixers, all connected to centralized utility poles providing gases, chilled water, power, and data. A ceiling-mounted airflow system, together with BSCs, ensures contamination-controlled operations within a cleanroom environment.
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Suite 2 mirrors Suite 1, enabling parallel, independent manufacturing of different product/platform with dedicated air-handling to minimise cross-contamination, enhancing flexibility, throughput and efficient multi-product operations. Advanced on-the-floor testing supports real-time monitoring and rapid batch progression, in addition to a fully equipped IPC.
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Suite 3 is a compact Grade C cleanroom designed for viral inactivation for inactivated vaccines or post-viral processes as part of the downstream purification of biologics/monoclonal antibody manufacturing.
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The Grade D return corridor is the controlled exit route from cleanroom suites. QC samples is transported via dynamic pass-through boxes to QC labs outside the cleanroom. Bagged solid waste is segregated and discarded via pass-through boxes to the waste-treatment autoclave room for decontamination and disposal.
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