About Us-MicroDome Labs，Biological Indicator

MicroDome Labs

About Us

MicroDome Labs

Overview
Founded in 2016, 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, we combine global technical expertise with agile manufacturing to help clients meet the highest sterility-assurance standards.

Core Offerings

· Reference Cultures (qualitative & quantitative)

· Biological Indicators – moist heat, dry heat, EtO, VPHP (ISO 11138-certified)

· High-Performance Disinfectants – quaternary ammonium, alcohol, peroxide blends

· Technical Services – D-value testing, sterilization-cycle validation, on-site training

Why Choose Us

· Regulatory Assurance – ISO 9001 QMS; every BI lot accompanied by a full Certificate of Analysis, CNAS Accreditation (Pending).

· Scientific Rigor – Optimised sporulation media and statistical tools (Stumbo‑Murphy‑Cochran) for lot‑to‑lot consistency

· Dual‑Site Expertise – Australian oversight plus Chinese manufacturing efficiency

· Customer‑Centric Support – 48‑hour technical response and custom product configurations

Mission & Vision

· Mission: Simplify sterility validation and environmental control, safeguarding patient safety worldwide.

· Vision: To be the industry benchmark for dependable, science‑driven microbial control technologies.

History

2025

November, Certified to GB/T 42061-2022 / ISO 13485:2026 Medical Devices Quality Management System
December, Granted CNAS (China National Accreditation Service for Conformity Assessment) Laboratory Accreditation
December, Certified to ISO 9001:2015 International Quality Management System
December, Registered as a Zhejiang Provincial High-Tech Enterprise

2024

January, Launched the CNAS Accreditation Program
May, Upgraded the Automated Production Line for Stainless Steel Carrier-based BI

2023

September, MD Pro Strain Process Development
December, Launched the Renovation of the Quaternary Ammonium Salt Disinfectant Production Line

2022

April, the expansion of Microdome Laboratory was completed.
May, the upgrading of sporicidal agent production line in disinfectant workshop was completed.
November, MK-VI concentrated sterilizer and MC-I cleaner were listed.

2020

January, became the key enterprise of Wenzhou emergency prevention and control material production, and fight against the epidemic together.
May, cooperated with Shandong Pharmaceutical Inspection Institute to provide standard samples PT

2019

May, quality control strains cooperative units - pharmaceutical enterprises, drug testing laboratories
July, cooperation unit of sporicidal agent-pharmaceutical enterprises and many institutes
August, cooperated with China Academy of Inspection and Quarantine to provide standard samples for pharmaceutical enterprises and drug testing laboratories.
September, bio-indicator was successfully developed and officially put into the market.

2018

May, obtained the patent certificate of biological indicator (Patent No.: ZL 2021 2 3152996.2)
September, obtained the certificate of Zhejiang Science and Technology-based Small and Medium-sized Enterprises.

2017

February, passed ISO9001:2015 international quality management system certification.
June, the sporicidal agent was successfully developed.

2016

March, Wenzhou Microvault Microbial Technology Co.
August, the quality control strains GP/TK/HK/WC series were successfully developed and officially put into the market.
November, passed ISO9001:2008 international quality management system certification.

Certification