Comprehensive Bioprocessing Solutions - Services

SmithBio Range of Services - Process Analytical and QC Testing Services

SmithBio is an ISO9001:2015 accredited company and operates manufacturing sites (10,000 ㎡), cell culture research and QC laboratories located in Huangshan, Anhui province, as well as in Suzhou and Shanghai.

Upon request we can support you with your needs for process analytical and QC related testing.

SmithBio applies a rigorous quality program throughout the design, engineering, manufacturing and supply of its products and services.

Our cross-disciplinary Quality Management System adheres to various standards and regulations:

SmithBio is certified for ISO 9001:2015 which guarantees that it’s quality management system

a) demonstrates its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) is aiming to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

ASME BPE

Equipment manufactured by SmithBio have been created in adherence to the relevant ASME BPE standard, "Bioprocessing Equipment". This standard provides the requirements applicable for the design of equipment used in the bioprocessing, pharmaceutical, and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements.

cGMP
SmithBio designs and manufactures automated bioprocessing systems for the biopharmaceutical Industry that follow the industry guidance for cGMP manufacturing. These systems have been successfully validated and are being used every day in the cGMP production of regulatory approved biopharmaceutical products.

GAMP®5

SmithBio’s automation engineering complies with GAMP®5, the industry guidance for computerized systems, for good automation manufacturing practice. These guidelines to provide a framework for the risk-based approach to computer system validation where a system is evaluated and assigned to a predefined category based on its intended use and complexity. Categorizing the system helps guide the writing of system documentation, including specifications and test scripts and everything in between.

Contact us to find out what we can do for you.

• Range of Services - Overview

• Technical Service and After Sales Support

• Equipment Remediation and Upgrade Services

• Process Development Services

• Process Analytical and QC Testing Services

• OEM Equipment Manufacturing

Providing Comprehensive Services For Bioprocessing Solutions

Comprehensive services for biopharmaceutical, cell therapy, and biotechnology applications from design to installation.

Quality Assurance

Ensuring compliance with European quality standards and ISO9001 through rigorous design and manufacturing oversight.

Process Design

Tailored bioprocessing solutions from initial design through to final installation and qualification at customer sites.

Expertise in lab, pilot, and industrial scale bioreactors, fermentation, and cell culture equipment.

Complete Solutions

Global Reach

Smithbio provides bioprocessing solutions worldwide, enhancing efficiency in various industries.

SmithBio's solutions transformed our bioprocessing efficiency; their expertise is unmatched in the industry.

Dr. Doe

Exceptional service and quality equipment; SmithBio exceeded our expectations in every aspect of the project.

Dr. Jin

★★★★★

★★★★★

Contact SmithBio for Equipment of Bioprocessing Solutions

Reach out to us for inquiries about bioprocessing solutions, bioreactors, and compliance with European quality standards. We're here to help!

Connect

+44 1223 981791

Support

support@smithbio.co.uk