MEDIVEN, a trusted name in medical diagnostics and manufacturing, has strengthened its high-quality Real-Time PCR kit production line with the integration of automated platforms—enhancing throughput, precision, and contamination control. The company, already certified under ISO 13485, now leverages automated liquid handling systems and automated labelling machines to further streamline operations and scale production.
As part of its commitment to innovation and efficiency, MEDIVEN has implemented a fully integrated manufacturing workflow that includes advanced automated liquid handling platforms and automated tube and box labelling systems. These systems operate within controlled environments specifically designated as DNA-free and PCR processing rooms, effectively minimizing cross-contamination risks and ensuring the integrity of every batch.
With these upgrades, MEDIVEN now has the capability to produce up to 1 million Real-Time PCR kits per month, addressing rising demand across Malaysia and international markets.
“We’ve long operated under ISO 13485 standards, but the addition of automation elevates our manufacturing precision to new heights,” said Dr. Lim, Operations Director of MEDIVEN. “By minimizing manual handling, we not only reduce the risk of human error and contamination, but also ensure every kit is produced with consistent accuracy and traceability.”
Key Advancements in MEDIVEN’s PCR Kit Production:
- Automated Liquid Handling: Streamlines reagent preparation and aliquoting with minimal human intervention, significantly reducing error rates and improving consistency.
- Zoned Contamination Control: Production areas are compartmentalized into DNA-Free and QC zones to prevent cross-contamination.
- Automated Labelling Systems: Integration of high-speed tube and box labellers ensures traceability, accuracy, and compliance with medical device labelling regulations.
- Scalable Throughput: Enhanced infrastructure supports large-scale production of up to one million kits monthly, suitable for national screening efforts and export demands.
- ISO 13485 Compliance: All processes are governed under an internationally recognized quality management system, ensuring product safety, traceability, and adherence to regulatory standards.
This advancement aligns with MEDIVEN’s ongoing mission to support healthcare providers, researchers, and diagnostic developers with high-quality, scalable, and regulation-ready molecular testing solutions.
