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Hangzhou Bocon

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Hangzhou Bocon Hangzhou Bocon Hangzhou Bocon Hangzhou Bocon Hangzhou Bocon Hangzhou Bocon
Company Details:
Business Type : Manufacturer
Main Market : North America
South America
Worldwide
Western Europe
Eastern Europe
Eastern Asia
Southeast Asia
Middle East
Africa
Oceania
Brands : hzbocon
No. of Employees : 50~100
Export p.c : 90% - 100%
HIGH QUALITY: We can provide the necessary documentation to meet stringent requirements including the ISO 11135, ISO 13485, ISO 9001, EN 1422 and adherence to GMP guidelines.
DEVELOPMENT: This future plan aims to drive the ETO sterilizer factory(hzbocon) towards enhanced operational efficiency, environmental responsibility, and technological advancement while prioritizing safety and quality assurance.
MANUFACTURING: Hangzhou Bocon Mechanical And Electrical Equipments Co., Ltd, was established in 2006. Our company is a high-tech enterprise that multifunctionally and comprehensively comprises research, development, production, sales, and international patent certification. Our company insists on innovation, emphasis on service, and concentrates on quality.
SERVICE: ▪ Supply installation drawings. ▪ Equipped installation and testing service. ▪ Supply technical support all time. ▪ Training how to operate the machine. ▪ Engineers available to service machinery overseas. ▪ Upgrades to improve the performance of equipment. ▪ Process optimization for current and future customer's product.

URS (User Requirement Specifications)



Definition of requirements to fulfill the demands of the process. Generally, URS is required for eto sterilizer machine before making the design.
In order to meet the user requirement, we pay special attention to the URS (User Requirement Specifications) (such as chamber size, product, package, EO percentage, etc.)
Issued by: User


FDS (Functional Design Specifications)



Specification in which the demands of the buyer are transferred into a technical solution (from the manufacturer's point of view)
Issued by: Manufacturer


DESIGN SPECIFICATION (DS)



Specification of the technical basis and specification of the limiting factors that are to be considered during development, construction and assembly. DS ensures that all customer requirements and current valid standards from CGMP, EU, EN ISO and the FDA are satisfied.


FAT / SAT (Factory Acceptance Test /Site Acceptance Test)



Documented acceptance tests at the supplier/customer with test log, test summary, list of open issues, and release certificates.
In BOCON, before the sale, the factory provides customers with the design and consultation on the overall equipment and facilities of the ETO workshop and assists in the formulation of the overall planning and layout of the ETO workshop. According to the characteristics of the customer site and product, material, packaging, transportation, and future development, we choose the material, configuration, control mode, volume, and quantity for the sterilizer. To assist in the preparation of the ethylene oxide sterilization process, verification scheme, ETO workshop management rules and regulations, equipment use and maintenance, etc. At the same time to provides relevant standards, preheating, residual analysis, processing technology consultation, and cooperation.


DQ, IQ, OQ, PQ



DQ(Design Qualification)
IQ (Installation Qualification)
OQ(Operational Qualification)
PQ(Performance Qualification)
From product and requirements specifications, to risk analyses, to planning and execution of the individual qualification steps, we takes care of everything implementation requires.


Validation: BOCON would provide software validation. IQ, OQ report, and support of PQ after installation.









Contact Details
Hangzhou Bocon

Contact Person: Mrs. nancy

Tel: 86-18158114897

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