Profesionāls aseptiskās uzpildes līnijas ražotājs - "līdz atslēgai" risinājumi

Service

Full-Process Consulting

Whether you are building a new pharmaceutical plant, upgrading a GMP cleanroom or launching an aseptic filling line, our technical team provides one-on-one end-to-end consulting. We cover process layout, HVAC, clean piping, utility system and automation planning, balancing your layout, compliance target and project budget.

2D/3D Design & BIM Modeling

Our CAD & BIM engineers develop process drawings, 3D simulation models, HVAC construction drawings and equipment layout plans. All designs follow EU GMP Annex 1 and FDA guiding principles, to avoid on-site conflicts and shorten your whole project timeline.

Machine Customization

We customize aseptic filling lines for SVP, LVI, oral liquid and solid preparations. Our tailored configurations protect high-value, oxygen-sensitive and biological products, matching your unique filling, containment and output requirements.

Certification & Compliance Support

Our compliance specialists interpret GMP regulations and prepare regulatory alignment plans. We help your project meet requirements of Annex 1, EU GMP and FDA, and we support containment performance up to OEB 5 with independent test reports.

Validation Services (FAT / SAT)

A dedicated project manager tracks every step. We perform FAT together with your representatives at our factory. After shipment, our team supports on-site installation and SAT to confirm the whole line runs as designed.

Installation & Commissioning

Our skilled engineering team provides on-site or remote guidance for installation and commissioning. We have successfully handed over pharma projects for clients in over 70 countries, strictly following the agreed project schedule.

Documentation Services (DQ/IQ/OQ/PQ)

We offer 1-year warranty, spare parts supply, routine maintenance training and plant renovation consultation. Our remote & on-site technical support minimizes unexpected downtime of your production line.

After-Sales & Lifecycle Support

We offer 1-year warranty, spare parts supply, routine maintenance training and plant renovation consultation. Our remote & on-site technical support minimizes unexpected downtime of your production line.

FAQ

A: We are a manufacturer. Our factory is based in Changsha.

A: We have CE, ISO, RoHS, SGS and other relevant certifications. Our equipment complies with cGMP and EU GMP standards.

A: Lead time ranges from 25–60 days for standard equipment, and 60–150 days for customized machines, after receiving the deposit and confirming all technical documents. We can arrange priority shipment upon request.

A: Warranty is 12 months after installation & commissioning, or 18 months from the date the equipment arrives at your site, whichever comes first. Extended warranty service is available at an extra cost.

A: We support multiple international trade terms, including FOB, CIF, CFR, DAP, etc.

A: Yes. Our engineering team can develop equipment strictly based on your User Requirement Specification, and support full documentation delivery.

A: Yes. Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) are available. We will prepare the test protocol and witness the inspection together with your team.

A: We have relevant test reports for OEB 5 containment. Please contact us for detailed supporting documents.

A: We provide overseas remote technical support, on-site service, operator training and lifetime spare parts supply.

A: We supply a complete document package including IQ/OQ/PQ support files, operation manual, spare parts list, material certificates and material traceability records.

A: We adopt export-standard fumigation-free wooden cases, suitable for sea and air transportation.

Full Lifecycle Pharmaceutical Equipment Solutions for Your GMP Project

From URS design, manufacturing, validation to after-sales support. Get in touch to discuss your custom requirements.

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