1. Company Profile Hubei Knowlux Biotechnology Co., Ltd. is located at No. 2 Chibi Avenue, Huangzhou District, Huanggang City, Hubei Province, covering a total area of 1,910 m2. It is a subsidiary of GL Biochem, a Shanghai-headquartered manufacturing company led by a team of PhD-level scientists from around the world. GL Biochem operates five production sites across China and overseas, together with two R&D centers. Backed by strong overall capabilities, extensive quality-management experience and significant economies of scale, the group supplies high-quality, cost-effective and technology-driven products to customers worldwide.

2. Injectable Products Workshop The injectable products workshop has a built-up area of 760 m2. Its overall layout complies with current GMP requirements and the production-process design. The cleanroom area consists of three cleanliness grades — A, B and C — and each functional zone satisfies the manufacturing-process requirements.

3. Main Production Equipment Rotary ultrasonic vial washer; hot-air depyrogenation (sterilization) tunnel oven; vial filling and stoppering machine; aluminum-cap capping machine; vacuum lyophilizer (freeze dryer); CIP cleaning station for the lyophilizer; automated fixed-position vial loading/unloading system; pulsating vacuum sterilizers (autoclaves) of 240 L and 350 L; aseptic transfer chamber; open restricted-access barrier system (oRABS); [negative-pressure weighing booth — confirm]; automatic visual (light) inspection machine; automatic labeling machine.

4. Main Utility Systems Combined air handling units (AHUs); ozone generator; vaporized hydrogen peroxide (VHP) sterilizer; two-stage reverse-osmosis (RO) purified-water (PW) system; tube-type multi-effect water distillation unit for water for injection (WFI); clean/pure steam generator; air compressor. The PW tank holds 2 m3 with a capacity of 1 m3/h, while the WFI tank holds 3 m3 with a capacity of 0.5 m3/h. The PW distribution loop is sanitized by pasteurization, and the WFI distribution loop by superheated water. The Grade B and Grade C cleanrooms are served by AHUs No. PS-A-001 and PS-A-002, respectively [confirm pairing]. The air compressor, installed on the first floor, delivers compressed air at 7 m3/min.

5. Quality Control Laboratory (380 m2 built-up area) Physicochemical testing room; [standard-solution/titration room — confirm]; drying room; precision instrument rooms 1–3; balance room; reagent storage room; stability testing room; general-purpose instruments room; laundry room; washing and disinfection equipment room; standard-sample storage room; sample receiving room; refrigerated sample room; room-temperature sample room; biochemical reagent preparation room; microbial strain storage room; microbial culture room; controlled/toxic reagent storage room [confirm]; sterility testing area; microbial positive-control area; and microbial-limit-testing (MLT) area.

6. Main QC Instruments HPLC (liquid chromatograph); UV-Vis spectrophotometer; FTIR infrared spectrometer; total organic carbon (TOC) analyzer; solution-clarity detector; [perpendicularity/vertical-axis deviation tester — confirm]; container-closure seal-integrity tester; polariscope (polarization-stress analyzer); mold/fungal incubator; bacterial-endotoxin tester; biological safety cabinet; laminar-flow clean bench. Key instruments such as the HPLC, UV-Vis spectrophotometer and FTIR spectrometer are equipped with data workstations and support an electronic audit-trail function.