MANUFACTURING & QUALITY

Manufacturing and Quality

From raw material to finished kit, quality is controlled at every step under an ISO 13485 quality management system and validated in our in-house laboratories.

Facility R&D Quality Certifications Factory Tour
ISO Class 8 cleanroom at PRISES Biotechnology IVD manufacturing facility in China

Quality at Every Step

Every rapid test is produced in a controlled, contamination-free environment. Our ISO Class 8 cleanroom handles primary production, while critical microbiological work is carried out in a separate ISO Class 7 area.

Air cleanliness, temperature and humidity are continuously monitored, and zoned workflows separate processes to prevent cross-contamination, protecting the sensitivity and stability of every diagnostic kit.

Manufacturing Facility

Our IVD manufacturing facility in Gaobeidian, China operates under strict environmental controls to ensure the quality and reliability of every rapid test kit we produce.

Total Facility Area

3,000 m²

Cleanroom Area

1,000 m²

Annual Production Capacity

High-volume production capacity

Production Lines

Multiple dedicated production lines

Cleanroom Classifications

ISO Class 8 Cleanroom

Primary production area for rapid test assembly and packaging. Continuous environmental monitoring ensures consistent conditions.

ISO Class 7 Area

Dedicated space for critical microbiological work and sensitive reagent handling requiring stricter particle control.

R&D Capabilities

Our research and development team drives innovation in IVD rapid test technology, supporting custom product development and continuous improvement of existing assays.

Microbiology Laboratory

500 m² dedicated to microbiological testing and reagent development.

Immunoassay Development

Specialized facilities for developing and optimizing lateral flow immunoassays.

Analytical Testing

Equipment for sensitivity, specificity, and stability testing of diagnostic products.

Raw Material Testing

Quality control laboratory for incoming material verification.

Development Capabilities

Custom Assay Development

Development of new rapid test assays based on customer requirements and market needs.

Product Optimization

Continuous improvement of existing products for better sensitivity, stability, and user experience.

Format Adaptation

Adaptation of assays to different formats including strips, cassettes, midstream devices, and cups.

Technical Documentation

Preparation of technical files, validation reports, and regulatory documentation.

Quality Management

Our ISO 13485 certified quality management system ensures consistent product quality through comprehensive controls at every stage of production.

ISO 13485 Quality Management System

PRISES Biotechnology operates under an ISO 13485 certified quality management system specifically designed for medical device manufacturing. This international standard ensures that our processes consistently meet regulatory requirements and customer expectations for IVD products.

Our QMS covers the full product lifecycle from design and development through production, storage, distribution, and post-market surveillance.

QMS Scope

  • ✓ Design and development controls
  • ✓ Supplier qualification and management
  • ✓ Production process controls
  • ✓ Quality inspection and testing
  • ✓ Corrective and preventive actions
  • ✓ Document and record management

Quality Control at Every Stage

Incoming Material Inspection

All raw materials and components are verified against specifications before entering production. Supplier certificates of analysis are reviewed and materials are tested as required.

In-Process Controls

Continuous monitoring during manufacturing ensures process parameters remain within validated limits. Critical process steps include verification checkpoints.

Microbiological & Performance Testing

Products undergo rigorous testing in dedicated laboratories to verify sensitivity, specificity, and stability meet specifications.

Finished Product Release

Final release includes review of all batch records, test results, and quality documentation. Full traceability is maintained for every batch.

Certifications

PRISES Biotechnology maintains certifications and approvals that demonstrate our commitment to quality and regulatory compliance for IVD manufacturing.

ISO 13485

Quality management system certification for medical device manufacturing, demonstrating consistent processes and controls.

CE Marked

Products bearing CE marking meet applicable European requirements for safety and performance.

Medical Device Manufacturing License

Manufacturing license for IVD products issued by China's National Medical Products Administration (NMPA).

Medical Device Trading License

Trading license for IVD products issued by China's National Medical Products Administration (NMPA).

Certificate Copies

Certificate copies are available on request. Please contact us from a company email address.

Request Certificates

Factory Tour

See our IVD manufacturing facility firsthand. We welcome visits from distributors and OEM partners to tour our production lines and quality laboratories.

Cleanroom Production

Tour our ISO Class 8 and ISO Class 7 cleanroom areas where rapid tests are manufactured under controlled conditions.

Production Lines

Multiple dedicated production lines for various rapid test formats including strips, cassettes, and midstream devices.

Quality Control Labs

Visit our quality control laboratories where incoming materials and finished products are tested.

Packaging Area

See our packaging operations including labeling, kitting, and final product inspection.

Schedule a Visit

Our facility is located in Gaobeidian City, Hebei Province, approximately 100 km south of Beijing.

Address:
No.136, Shiji West Road
Gaobeidian City, 074000
Hebei Province, P.R. China

Quality You Can Document and Trust

Request our certificates and technical files.

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