A pharmaceutical production equipment specialist built around GMP

SHINWONGPharmaceutical Manufacturing
PHARMACEUTICAL MANUFACTURING EQUIPMENT

Every step of drug production,
built to one design standard

Shinwong designs and builds equipment for solid dosage, sterile filling, packaging, inspection and plant utilities. The same team is responsible for installation, qualification and the maintenance that follows.

01 / 05
WHY SHINWONG

Four things decide whether a machine is the right one

A design that satisfies the regulations, clear responsibility, verification before purchase and support afterwards. We have built the company around those four.

01

Designed around GMP from the start

Cleanability, contact materials and record keeping are decided at the start. Regulatory requirements are built into the drawings instead of being added later.

02

One team from design to qualification

Mechanical, control and validation engineers work in the same project team. Responsibility is not split, so problems get resolved quickly.

03

Trials before manufacture

We run trial batches with your own product at the R&D centre before the specification is fixed. It is the surest way to shorten commissioning.

04

Support that continues after handover

Preventive maintenance, spare parts, remote diagnostics and operator training continue through the service agreement. Cost is managed over the life of the machine.

The head office and the production plant
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COMPANY

Since 1996 we have worked on one thing only

We began with machined parts, moved on to complete machines and then to whole lines. Instead of spreading into other industries we went deeper into pharmaceutical equipment.

  • One site in Hwaseong, holding the offices, production and the test bays
  • An R&D centre with a process trial suite
  • A supply record with Korean pharmaceutical companies and overseas partners
  • ISO 9001, ISO 14001 and ISO 45001 certified, with CE conformity

More in the company overview

Thirty years, one trade
  • 1996Year founded
  • 28Standard equipment models
  • 5Equipment families
  • 2Production sites
The process trial suite
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R&D AND QUALITY

We trial the machine with your product first

Trial batches run with the real formulation at our R&D centre, and the results go straight into the specification and the qualification documents.

  • Design qualification through to IQ, OQ and PQ documents, supplied together
  • Material certificates and weld records traced per machine
  • Factory acceptance testing before shipment, witnessed by the customer
  • Electronic records and audit trail aligned with 21 CFR Part 11

More on quality management

CERTIFICATION

Certifications and conformity

  • KGMPGMP compliant design
  • EU GMPAnnex 1 ready
  • ISO 9001Quality management
  • ISO 14001Environmental management
  • ISO 45001Safety and health
  • CEMachinery directive

Planning a new line or a replacement machine?

Tell us the process conditions and the output you need, and we will propose a configuration and an outline schedule.

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