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Ensuring ultra-pure air in a Mobidiag molecular diagnostics laboratory

 

  • Developing and manufacturing molecular diagnostics platforms and test kits for detecting human pathogens.
  • Specializing in Antimicrobial Resistance Management and Hospital Associated Infections (HAIs), by reliable, cost-effective molecular diagnostic solutions for detecting Gastrointestinal Infections including most clinically relevant bacteria, parasites, viruses and antibiotic resistances.
  • Established in 2000
  • Finnish-based multi-national company with Headquarters in Finland, offices in France, Sweden and UK.
  • Worldwide distribution network.

 

 

CHALLENGE

 

The products for detecting human pathogens, utilize PCR technology, where target DNA segments are amplified, generating thousands to millions of copies of a particular DNA sequence. Due to this, the purity of the laboratory environment is extremely important.

 

”The challenge in air decontamination is not only the traditional particle purification, but for us the most critical part is the purification of the amplification product that we are making ourselves in the laboratory”, describes CEO Tuomas Tenkanen. A contamination of our samples or products with amplification products could cause wrong positive results in our diagnostics tests. The PCR amplification products (amplicons) are very difficult targets for air purification, since their size is small. The size of these is from 100 to 500 base pairs which equals 30–200 nanometers. Traditional HEPA filters have insufficient capability to filter those amplicons”, he adds.

 

The aim is to have the air purified in both R&D and production laboratories, where the assay contamination is minimized. The most important target for purification is to eliminate PCR amplicons, bacteria and viruses.

 

SOLUTION

 

In order to achieve the targets described above, which could be considered as risks, Genano Air Decontamination Units were placed in the working rooms that have the greatest influence on the purity of the products or have a risk of cross contamination between laboratory rooms, carried by airborne particles.

 

Three different air purification solutions with a positive pressure kit, were installed to laboratory premises depending what was the desired cleanliness level. In two rooms the supply air passed through Genano 4500 Air Decontamination Unit before let to the room.

 

In addition to decontaminated supply air, stand-alone Genano 4500 units are used to circulate and purify the air in critical areas within the premises.

Ventilation was adjusted to achieve the optimal pressure differentials between laboratory rooms, in order to prevent airborne particles and contaminants to transfer towards clean areas.

 

RESULTS

 

The airborne particle measurements have been conducted in the laboratory, according to ISO 14464-1.

  • The laboratory has now two clean areas where the particle count is ISO 6 compliant
  • The air in these laboratories is 96 % cleaner compared to the central area (sampling of 0.3 μm particles with 10 sampling locations).

 

Genano Air Decontamination Solution ensures constantly high-quality standards, eliminating the risk of defective products, which is of utmost importance for this type of business. Reliability is the core in molecular diagnostics solutions, and Genano devices with a capability to eliminate airborne microbes is a feasible solution.

 

Clients expect to have 100% reliable and safe molecular diagnostics platforms and test kits, and therefore failure in this matter damages company’s reputation on the market. “We are regularly audited against ISO 9001 and ISO 13485 standards. Our quality management systems ensure that we adhere to the highest quality principles and procedures to develop and deliver safe, high-quality products to our customers, therefore Genano system is a perfect solution for our needs, as it does not only purify the amplicons, but it also destroys them”, summarizes Mr. Tenkanen.

 

Mobidiag Case