Building 5-6, Zone No. 4
Zhong Han Qiao Industrial Park
Wang Niu Dun Town
523200 Dongguan City, Guangdong Province
P.R. of China
Phone: + 86 769 8851-7100
Fax: + 86 769 8851-7101
Email: click here
Our production site in Dongguan City (near Hong Kong) covers the entire production chain from ISO class 8 clean room injection molding, assembly and post-finishing right through to packaging. Services also include project management, validation of customer molds as well as mold repair and maintenance.
This production site covers all processes for the production of inhaler – injection molding, assembly, post-finishing as well as testing and packaging. Injection molding and assembly take place in an ISO class 8 clean room. Dongguan also caters to the diagnostics segment, specializing in the production and assembly of lancing devices for diabetes patients, single-use tests and laboratory disposables like collection container and much more.
Dongguan has a total area of 10,700 sqm and 1,800 sqm (20,000 sqft) of production area, 600 sqm (6,500 sqft) of which are designated for clean room production to ISO class 8 (100,000) and 1,100 sqm (12,000 sqft) are controlled areas. The site is equipped with 14 injection molding machines (with clamping forces of between 40 – 200 t) and 6 assembly lines including welding stations and Kent pad printing machines.
The production site is certified to ISO 13485 and ISO 9001. The clean room is certified to ISO 14644-1 (class 8) and is subjected to regular microbiological inspection for re-certification at annual intervals. Production complies with GMP and FDA guidelines including 21 CFR Part 11 P. Dongguan City also has an AFM Japan certificate (accreditation certificate of foreign medical device manufacturer) according 13-3 Pharmaceutical affairs law.
Gerresheimer Medical Plastic Systems Dongguan Co. is a FDA-inspected Medical Device Manufacturer. Pre-Approval inspection (PAI) included inspection of the management system and of the entire production from goods in to goods out.