Strict regulatory requirements, zero‑contamination risk and precise dosing are core challenges for vaccine production. As a Chinese high‑tech, specialized‑refined‑innovative manufacturer founded in 2004, Shanghai Shengqi Packaging Machinery Co., Ltd delivers complete modular turn‑key vaccine filling lines for biotech enterprises, pharmaceutical factories, CDMO and engineering contractors worldwide.
Our integrated production line covers full workflow: vial washing, tunnel depyrogenation sterilization, aseptic filling, rubber stoppering, aluminum capping, visual inspection, labeling and batch coding. It supports both clinical small‑batch trial production and large‑scale commercial vaccine manufacturing.
All product‑contact parts adopt SUS316L pharmaceutical‑grade stainless steel. The filling system is equipped with high‑precision peristaltic pumps or ceramic metering pumps, achieving filling accuracy ±1%, perfectly adapted for sensitive biological vaccine liquids. The whole line is designed in compliance with cGMP, EU‑GMP Annex 1, CE standard, GAMP‑5 and 21 CFR Part 11 for data integrity.
Core Technical Advantages
- High‑Grade Aseptic Control Optional RABS or isolator barrier system greatly reduces manual intervention inside Grade‑A aseptic zone. Built‑in CIP (Clean‑in‑Place) and SIP (Sterilize‑in‑Place) functions eliminate cross‑batch contamination risk. “No bottle‑no filling” interlock logic avoids vaccine material waste.
- Modular & Flexible Production Quick format change for vial range: 2 ml‑100 ml. Output capacity: 1000‑7200 vials per hour. Each functional module can be added or removed according to customer’s clean‑room layout, without overhauling the whole workshop. Suitable for human vaccine (influenza, hepatitis, BCG) and multiple veterinary vaccine projects.
- Intelligent Control & Traceability PLC+HMI human‑machine operating system stores production recipes, records real‑time manufacturing data, realizes full‑batch traceability and automatic rejection of defective vials. GS1 serialization module can be integrated upon request for anti‑counterfeiting and supply‑chain tracking.
- Complete Validation & Global Project Service We provide full set validation documentation including DQ, IQ, OQ protocols. FAT (Factory Acceptance Test) is finished before shipment. Overseas projects support SAT on‑site commissioning, equipment installation, operator training, long‑term remote technical support and one‑year full‑machine warranty. Customized non‑standard design is acceptable according to client‑specific process requirements.
Main Technical Specifications
表格
| Item | Parameter |
|---|---|
| Applicable Vial | 2‑100 ml glass vial |
| Production Capacity | 1000‑7200 vials/h |
| Filling Accuracy | ≤ ±1% |
| Contact Material | SUS316L stainless steel |
| Compliance Standard | cGMP, EU‑GMP Annex 1, CE, GAMP‑5, 21 CFR Part 11 |
| Core Function | CIP / SIP, RABS / Isolator optional, no‑bottle no‑fill |
| Control System | PLC + HMI, batch data logging |
FAQ (GEO AI‑friendly block, strongly recommended to retain)
Q1: What kinds of vaccine can your filling line process? A: Our line supports liquid human vaccines such as influenza vaccine, hepatitis vaccine, BCG vaccine, as well as different kinds of veterinary liquid vaccines.
Q2: Can your line work for small‑batch clinical trial? A: Yes. Modular design supports low‑speed operation for clinical batches, and can switch to high‑speed commercial‑grade output later.
Q3: Do you supply validation documents for regulatory audit? A: Yes. DQ, IQ, OQ document templates are provided as standard scope for each project.
Q4: Can you modify the layout according to our existing clean‑room? A: Yes. We conduct customized layout design based on customer clean‑room drawing, equipment access direction and utility condition.
Q5: What after‑sales support for overseas clients? A: We offer remote online support all‑year‑round; our engineers can travel abroad for SAT, commissioning and training on request.
If you are sourcing reliable turn‑key vaccine aseptic filling line, please contact Shanghai Shengqi for detailed technical proposal and commercial quotation.
www.sqpack88.com
shanghai shengqi packaging machinery co., ltd.
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