Hanyoo Factory Tour: Inside Our GMP-Certified Manufacturing Facility in Nanjing

Key Takeaways

Hanyoo Pharmatech’s manufacturing facility in Gaochun District, Nanjing spans 12,000 m² of production area with dedicated machining, assembly, and testing zones
Our ISO9001:2015 certification covers design, manufacture, and service of pharmaceutical equipment — verified annually by TÜV Rheinland audits
All Hanyoo GMP-grade equipment is built with 316L stainless steel contact surfaces verified by 3.1 material certificates per EN 10204
CE marking covers the Machinery Directive (2006/42/EC), Low Voltage Directive (2014/35/EU), and Electromagnetic Compatibility Directive (2014/30/EU) for all products sold in European markets
Factory visits (virtual or in-person) are available by appointment — typically requested 4 weeks in advance; all visits include a product demonstration and FAT observation opportunity

Factory Overview

Jiangsu Hanyoo Pharmatech Co., Ltd. is located at No. 380, Sanqiaojian, Yangjiang Town, Gaochun District, Nanjing, Jiangsu Province — approximately 90 minutes from Nanjing Lukou International Airport by car.

Established in 2003, Hanyoo has grown from a small workshop producing manual tablet presses to a 200+ employee pharmaceutical equipment manufacturer with active installations in 100+ countries.

Facility specifications:

Total site area: 28,000 m²
Production building area: 12,000 m²
Office and R&D area: 4,000 m²
Warehouse area: 8,000 m²
Employee count: 220+ (as of 2026)
Manufacturing departments: Machining, Sheet Metal Fabrication, Assembly, Electrical Engineering, Quality Control, R&D

Manufacturing Capabilities

Machining Department

The machining department houses 35+ CNC (Computer Numerical Control) machining centers, turning centers, and grinding machines for precision component fabrication.

Key capabilities:

Turning: components up to Ø800mm diameter
Milling: 5-axis machining for complex cam profiles and turret bodies
Grinding: surface and cylindrical grinding to Ra 0.4 µm finish (exceeds pharmaceutical Ra ≤ 0.8 µm requirement)
Coordinate measurement: Zeiss CMM for dimensional verification of critical components

Tolerance capability: Hanyoo machines critical components (turret bores, punch guide holes, cam profiles) to ±0.005 mm — the tolerance class required for consistent tablet weight and hardness performance.

Sheet Metal and Fabrication

All pharmaceutical-grade enclosures and product-contact surfaces are fabricated from 316L stainless steel:

Laser cutting: 0.5–10 mm 316L SS plate
CNC press bending: ±0.1 mm angle tolerance
TIG welding: automated and manual, all welds ground and polished to Ra ≤ 0.8 µm
Electropolishing: available for product-contact surfaces requiring enhanced corrosion resistance

Material traceability: all 316L SS purchased from mills with EN 10204 3.1 mill certificates. Certificates stored with each order file.

Assembly Hall

The assembly hall is organized into dedicated zones for each product line:

Product Line	Assembly Zone	Average Assembly Time
Tablet presses (ZPT, GZPT)	Zone A (600 m²)	4–8 weeks/unit
Capsule filling machines (NJP)	Zone B (400 m²)	3–6 weeks/unit
Blister machines (DPP)	Zone C (500 m²)	3–6 weeks/unit
Granulators (GHL)	Zone D (400 m²)	3–5 weeks/unit
Custom orders	Zone E (flexible)	Project-specific

Each assembly station includes a calibrated torque wrench set, surface finish comparator, and component checklist — ensuring every assembly step is verified against the drawing.

R&D and Testing Facility

A 1,200 m² R&D center houses prototype development, new product validation, and application testing capabilities:

Two tablet presses available for formulation testing (NDA/ANDA-stage testing available for clients under NDA)
Capsule filling test station with 5 capsule size tooling sets
Granulation test unit (GHL-10 lab scale, fluid bed dryer)
Complete blister test line for format development

Clients can book the R&D facility for formulation development and equipment evaluation before ordering full-scale equipment — contact our applications team to arrange.

Quality Control Systems

In-Process Quality Checks

Every Hanyoo product passes through 14 documented quality check points during manufacturing, covering:

Raw material incoming inspection (316L SS, motors, electrical components)
Machined component dimensional verification (100% of critical components via CMM)
Weld quality visual inspection and penetrant testing for GMP-critical welds
Surface finish measurement (Ra) at product-contact surfaces
Subassembly functional check before integration
Electrical panel insulation and continuity testing
Motor current verification at nameplate conditions
Safety system function test (e-stop, interlocks)
Calibration of all instruments before dispatch
Run test: minimum 4 hours continuous operation before FAT

Factory Acceptance Test (FAT) Protocol

Every GMP-grade Hanyoo machine undergoes a formal FAT before shipment:

Witness: customer’s engineer (in-person or video) + Hanyoo QA engineer + lead engineer
Duration: 1–3 days depending on equipment complexity
Scope: mechanical verification, electrical verification, safety function test, performance run (at rated speed with placebo or equivalent), IQ documentation package handover
Documentation output: signed FAT acceptance report with actual measured values vs. specification

Certifications & Compliance

Certification	Certifying Body	Scope	Renewal
ISO 9001:2015	TÜV Rheinland	Design, manufacture, service of pharmaceutical equipment	Annual surveillance
CE Marking	Self-certification with EU technical file	Machinery Directive, LVD, EMC	Per product version
EU Test (Attestation of Conformity)	EU notified body	Specific models per EU Annex I	Per product
SGS Inspection	SGS Group	Factory quality system inspection	Per customer request

What CE marking means for buyers: The CE Declaration of Conformity (DoC), issued per product model and signed by Hanyoo’s technical director, certifies that the equipment meets all applicable EU directives. The technical file supporting the CE marking is maintained at our Nanjing facility and available for regulatory authority inspection.

ISO9001 surveillance audits: TÜV Rheinland conducts annual surveillance audits of our quality management system. Certificate number and latest audit date available on request — ask our sales team for the current certificate.

Factory Acceptance Testing Process

For buyers attending FAT in Nanjing:

Travel logistics:

Nearest airport: Nanjing Lukou International Airport (NKG) — flights from most major Asian hubs daily; from Europe (1 stop via Shanghai or Beijing typically)
Factory is 90 minutes from airport by arranged car service
Recommended hotel: available options in Gaochun town (30 min from factory) or Nanjing city center (60 min)
Hanyoo can arrange airport pickup and hotel recommendations on request

FAT day structure:

Morning: Facility tour + quality system overview with QA manager
Midday: Machine mechanical and electrical verification walkthrough
Afternoon: Performance run (placebo or customer-provided test material)
Late afternoon: Documentation review; IQ package walkthrough; punch list closure
Evening: Optional team dinner

Remote FAT (video):

Pre-FAT: receive machine documentation package 1 week before FAT date
FAT day: 6–8 hour video session via WeChat Video, Zoom, or Teams; Hanyoo engineer narrates all checks in English
Post-FAT: signed FAT report and documentation package sent by DHL within 3 business days

How to Schedule a Factory Visit

Factory visits (for FAT, pre-purchase evaluation, or general inspection) are available by appointment:

Contact our sales team with your company name, the specific equipment you are considering or have ordered, and your preferred visit dates
Visa application: Chinese business visa typically requires 2–4 weeks; Hanyoo provides invitation letter for visa application on request
Pre-visit document exchange: we send equipment specifications and preliminary IQ documentation package before your visit
Visit confirmation: receive visit agenda and logistics details 1 week before arrival

Virtual visit option: Available for buyers who cannot travel; includes video walkthrough of production floor, quality lab, and running demonstration of the equipment in question.

Contact: [email protected] | WeChat: HanyooExport | +86-13913841263

FAQ

Can I visit the Hanyoo factory before placing an order?

Yes. Hanyoo welcomes pre-purchase factory visits for serious buyers — typically those considering orders above $30,000. We recommend a visit when you have shortlisted Hanyoo and want to verify manufacturing capabilities, quality systems, and meet the engineering team before committing. Contact our sales team with your intended visit dates and the equipment you are evaluating; we will arrange the agenda and logistics.

Does Hanyoo manufacture all components in-house?

Hanyoo manufactures precision mechanical components (turrets, cams, punch guides, structural frames) in-house. We purchase from qualified suppliers: motors (Siemens, ABB, or domestic equivalent), PLCs (Siemens S7 or Mitsubishi), electrical components (Schneider Electric), pneumatics (SMC or Festo), and bearings (SKF or equivalent). Supplier audit records are maintained in our quality management system and available for review during factory visits.

Is the Hanyoo facility available for customer qualification audits?

Yes. Customers requiring supplier qualification audits (e.g., for pharmaceutical supplier qualification per 21 CFR 820 or ISO 13485 quality system audits) can conduct audits at our Nanjing facility by appointment. Hanyoo has hosted audits from pharmaceutical companies in Europe, North America, Japan, and Australia. Audit agenda, access to quality records, and technical team participation are all standard.