Ompi of China:
Top Notch Quality Glass
Pharmaceutical Packaging
CFDA License
Approved
Ompi continues its expansion towards globalization and
internationalization. With the purpose to be closed to its final
customers, it has established a brand new manufacturing unit
in China, further strengthening its position in the market.
The Ompi Plant in China is Now CFDA Certified
The Ompi plant in China is now CFDA certified. From this
moment we can supply both foreign and Chinese
customers. Ompi has also achieved US and Canada FDA to
Ompi has created in China a center of excellence for vials and
be the best partner of the pharmaceutical company who
cartridges, to be the reference point of the pharmaceutical
exports the product.
industry for high quality primary packaging.
For this purpose the Group has invested a lot in the
Ompi China is a greenfield project, accurately prepared to
engineering and construction of this facility, which produces
win the challenges of the future in a market requiring more
according to the highest international standards (GMP, FDA,
and more Quality.
ISO, etc).
Ompi of China means now best in class Packaging Quality.
Only brand new machines of latest generation are installed
in this plant, and therefore Ompi of China meets the
requirements of the most demanding customers.
Ompi of China
Main Products:
• 1-100ml Vials
• Insulin and Dental
Cartridges
Zhangjiagang
Plant
Ompi worldwide
OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
N. 1 Xinfeng East Road, Zhangjiagang
Economic and Technological Development
Jiangsu Province, China - P.C. 215600
www.ompiofchina.com.cn
ompiofchina@stevanatogroup.com
tel. +86 512 80153007
Production Area
The plant has been designed for an optimal flow of material, from
the raw material until the finish goods.
The clean room is classified ISO 8, with an optimized distance
between the production lines.
Production Standards
CFDA Certifications
Vials & Cartridges
• GMP (ISO 15378)
ISO 9001
ISO 15378
• ISO 9001
• CFDA
(Vial: GuoYaoBaoZi 20140901; Cartridge: GuoYaoBaoZi 20140924)
• US and Canada FDA (Corporate DMF 11321)
• EP, USP, JP requirements
Equipment
With the purpose of guaranteeing the same production process of
the other Ompi plants, and high quality performances, only brand
new machines of the latest generation are installed in the plant.
The production process is free of glass to glass contact for high
quality level. The process is a replica of the one present in the other
facilities of the Group: completely automatic from the tube loader
until the automatic packing of the containers inside the boxes.
Controls
All equipment include the 100% automatic inspection systems
for both dimensional and cosmetic parameters.
The laboratories are high class equipped for the physical and
chemical tests before the release of the batches.
Quality System
Complete alignment to Ompi procedures and job instructions.
Training of selected local personnel has been performed in
Europe according to the highest requirements of pharmaceutical
market. The International Quality Standards are applied in the
production and quality control operations.
OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
N. 1 Xinfeng East Road, Zhangjiagang
Economic and Technological Development
Jiangsu Province, China - P.C. 215600
www.ompiofchina.com.cn
ompiofchina@stevanatogroup.com
tel. +86 512 80153007