Heracell VIOS CR the only cleanroom-compatible CO2 incubators

Thermo Fisher Scientific
Tuesday, 01 June, 2021

Microbial contamination and particulates are primary concerns for biological drug manufacturers. Microbial contamination poses a constant risk for cultured cells and is the leading cause for sterility assurance recalls. Airborne particles can be detrimental to cells and dangerous to patients, from an unintended immune response to a pulmonary embolism. Hence the need for cleanrooms — highly controlled spaces that allow science to be the only variable.

The purpose of every cleanroom is to control an environment by limiting the presence of sub-micron particulates and modifying inadequate environmental conditions. The ISO cleanroom classification rates the level to which an environment is controlled and how much particulate of specific sizes exist per cubic metre. For example, an ISO Class 5 cleanroom is ten thousand times cleaner than normal indoor room air at ISO Class 9.

While most cleanroom particulates come from the staff working there, an estimated 15% are due to equipment. Particulates sourced from equipment can be due to construction materials, including painted surfaces, plastics, insulation and packaging materials, glass, metal parts with sharp edges, or crevices that could harbour microorganisms. It is difficult to estimate the number of particulates that could come from a given instrument; the only way to know for sure is by testing. Such tests are performed according to ISO 14644-14, and for unbiased data, that testing should be performed by an experienced and independent third party, not by the manufacturer.

The Thermo Scientific™ Heracell™ VIOS™ CR CO2 incubator is the first of its kind — a third party-certified, cleanroom-compatible CO2 incubator, suitable for use in ISO Class 5 and GMP Grade A/B environments. This new cleanroom-compatible design has been fully and independently evaluated according to DIN EN ISO 14644-1 and VDI 2083 Part 9.1. These CO2 incubators are designed to meet the needs of today’s labs generating rapid-fire discoveries. Known for optimal cell growth conditions and minimal contamination risk, they keep your projects moving. Manufactured with the same quality you’ve come to depend on from Thermo Scientific laboratory equipment, Heracell VIOS CR incubators represent the ultimate contamination control design and the next wave of industry-leading innovation for your cleanroom.

From the in-chamber ISO Class 5 HEPA filtration system, to the covered, protected humidity reservoir, and the electropolished interior to the automated on-demand 180°C sterilization cycle with efficacy proven according to international pharmacopeias, your precious cultures are protected from every direction.

Heracell VIOS CR CO2 incubators are available in 165 L and 255 L in a compact footprint, readily stackable with a choice of electropolished stainless steel or 100% copper interior. The brushed 304-grade stainless steel exterior is robust enough to withstand the demanding cleaning procedures typical of cleanroom and GMP settings while continuing to operate with precision to keep precious contents healthy and safe.

For more information, visit thermofisher.com/cleanroomco2.

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