Production Facilities

Our GMP-compliant production site is equipped with Class-100,000 cleanroom laboratories and supports an annual capacity of up to 10 million test units.

Important note

Our production site is GMP-compliant and includes Class-100,000 cleanroom laboratory areas, supporting an annual capacity of up to 10 million test units. Product quality is controlled under ISO 13485 and ISO 9001 quality management systems.

Documentary evidence (certificates, capacity statements, audit reports and facility references) is available to qualified partners on request and is released through our quality and regulatory contact route.

Facility features

GMP-compliant reagent manufacturing environment
Class-100,000 cleanroom laboratory areas
Annual capacity of up to 10 million test units
Quality management under ISO 13485 and ISO 9001 systems
In-process and finished-product quality control before release

Production & laboratory gallery

Multichannel pipetting into a 96-well microplate (illustrative stock photograph) — Laboratory bench work (illustrative stock image)

Molecular diagnostics laboratory with real-time PCR instruments and a laboratory technician (illustrative stock photograph) — Molecular diagnostics laboratory (illustrative stock image)

Illustration of a cleanroom layout with airlock, filling area and quality control bench — Cleanroom layout (illustration)

Illustration of an IVD laboratory workflow: sample reception, nucleic acid extraction and result reporting — IVD laboratory workflow (illustration)

Illustration of a lateral flow immunoassay test strip with sample pad, conjugate, membrane and absorbent pad — Lateral flow immunoassay strip (illustration)

Illustration of a nucleic acid detection workflow: sample lysis, isothermal amplification, specific detection and read-out — Nucleic acid detection workflow (illustration)

Photographs on this page are royalty-free stock images used for general illustration; diagrams are schematic illustrations. They are not photographs of the production site described above.

Quality documentation and audits

For specific quality documentation, certificate references or audit arrangements, please contact our quality and regulatory team through the inquiry form. Requests are reviewed before release, and documentation is provided under the applicable confidentiality arrangements.

This website is for informational purposes. Products are for professional in-vitro diagnostic use only. Facility and capacity information describes our current production arrangements; supporting documentation is released through the quality and regulatory contact route.

The content of this website is provided for corporate and product information purposes only. It does not constitute an offer, quotation, warranty or medical advice. The terms of the executed sales contract shall prevail.