MicroDome Labs: Science-driven microbial control
Founded in 2016 — Global expertise, local support
MicroDome Labs is a science-driven manufacturer dedicated to microbial control solutions for the pharmaceutical, biotechnology, and medical device sectors. Headquartered in China with an expert R&D team in Australia, MicroDome combines global technical capability with agile manufacturing to help clients meet the highest sterility assurance standards.
LotusTech is the co-founder and authorised Australian representative of MicroDome Labs, providing local technical support, regulatory guidance, and supply chain management for customers in Australia and internationally.
All MicroDome products are manufactured to ISO 9001:2015 quality standards and comply with ISO 11135 and ISO 11138 sterilisation validation requirements.
Explore the full MicroDome catalogue
Visit the MicroDome Labs website for comprehensive product specifications, technical data sheets, and ordering information.
Visit www.microdome.com.auSpecialist laboratory services
Third Party Laboratory Testing
Independent microbiological testing services to support your quality assurance and regulatory submissions.
Strain Customisation
Custom reference strain preparation to meet specific compendial or in-house testing requirements.
Microbial Identification
Isolation, purification, and identification of microorganisms, including establishment of microbial spectrum libraries.
Technical Consulting
Expert guidance from design to deployment — sterilisation validation, QC programme development, and regulatory compliance.
Certifications, Accreditations & Regulatory Registrations
TGA — ARTG Entry 455431
VHP (Vaporized Hydrogen Peroxide) Biological Indicator. LotusTech Pty Ltd registered as Australian sponsor. Medical Device Class 1 — Active since 16 July 2024.
↓ ARTG Registration Document — Entry 455431TGA — ARTG Entry 465729
Steam & Dry Heat Biological Indicator. LotusTech Pty Ltd registered as Australian sponsor. Medical Device Class 1 — Active since 24 October 2024.
↓ ARTG Registration Document — Entry 465729ISO 9001
Quality Management Systems — Requirements
Quality management system certification ensuring consistent manufacturing processes and supply chain integrity.
↓ DownloadISO 17025
General Requirements for the Competence of Testing and Calibration Laboratories
General requirements for the competence of testing and calibration laboratories, underpinning the reliability of MicroDome's laboratory testing services.
↓ DownloadISO 13485
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
Medical device quality management system certification, demonstrating compliance with regulatory requirements for the design and manufacture of medical devices.
↓ Download