Japanese industrial manufacturer giant Kawasaki chose Vaisala Humidity and Temperature Transmitter HMD110 for its automatic cell culturing process.
Following the revision of the Pharmaceutical Affairs Act in 2014, regenerative medicine using stem cells and induced pluripotent stem cells (iPSC) has become an increasingly promising field. However, there are still some challenges in terms of regulation, quality control, and upscaling.
Cell culture and quality tests often require complicated manual work. In culture processes and quality tests, the reduction of human error, streamlined processes and high reproducibility without dependence on human intervention are basic requirements.
To overcome these challenges, Japanese industrial manufacturing giant Kawasaki Heavy Industries Ltd. initiated a development project for an automated cell culture system to be used in the drug discovery and regenerative medicine field. The system was named AUTO CULTURE™, and it aimed to enable safe and efficient cell culture process, which contributes to efficient practices in regenerative medicine.
Automating Manual Work
In the delicate cell culture process, the development is usually advanced manually at the initial clinical stage. However, as the phase progresses, production needs to be scaled up in a cost-effective manner. If the chosen manual method is changed at the early clinical stage, challenges with approvals in end-product quality could arise. Kawasaki’s AUTO CULTURE™ was developed based on an automation concept that resembles the manual cell culture process as accurately as possible. As a result, the cell culture process, that used to be manual, can now be automated, leading to high reproducibility and increased convenience for staff.
Firstly, Kawasaki’s automated innovation was adopted in their Research and Cell Quality Testing units. The next stage is to facilitate the clinical use of cultured cells. In order to do that, compliance with GCTP (Good Gene, Cellular and Tissue Based Products Manufacturing Practice) and GMP (Good Manufacturing Practice) is needed. The prevention of both contamination and errors is an essential element of compliance.
Bio-Decontamination with Vaporized Hydrogen Peroxide
AUTO CULTURE™ cell culture systems were equipped with an automatic vaporized hydrogen peroxide bio-decontamination function to prevent cross-contamination during the treatment of multiple specimens as well as contamination when inserting samples. To guard the bio-decontamination process with hydrogen peroxide, Kawasaki tested the Vaisala Humidity and Temperature Transmitter HMD110, fitted with a catalytic HUMICAP 180V sensor.
Hydrogen peroxide bio-decontamination can be divided into three phases: spraying, retention, and aeration. The Vaisala HUMICAP 180V Humidity and Temperature Transmitter HMD110 is used for humidity measurement in these processes. In many types of bio-decontamination equipment, humidity measurement before spraying is an important parameter to ensure even spraying of hydrogen peroxide. Hydrogen peroxide cannot be sprayed evenly in a high-humidity environment because it condenses immediately.
In the spraying phase, vaporized hydrogen peroxide is injected into the chamber to achieve correct conditions for decontamination. During the transition from the spraying phase to the retention phase, Kawasaki measures humidity in order to determine the amount of hydrogen peroxide present in the chamber after spraying.
In the aeration phase, the hydrogen peroxide is removed and humidity decreases. At this stage, the concentration of residual hydrogen peroxide is measured using a hydrogen peroxide measurement sensor. In the automatic bio-decontamination process, the sterilization status is validated using a biological indicator. Humidity measurement acts as an important parameter in the process.
Humidity measurement using vaporized hydrogen peroxide is essential in the automatic bio-decontamination process. However, humidity sensors have traditionally faced challenges such as drift caused by corrosion that occurs as a result of repeated long-term exposure to hydrogen peroxide. Kawasaki searched for a reliable hygrometer with high resistance to vaporized hydrogen peroxide. Another important requirement for the humidity sensor was system maintenance frequency, as the humidity sensor needed to be used continuously at least for a year.
Kawasaki chose the Vaisala HUMICAP 180V Humidity and Temperature Transmitter HMD110 to be incorporated to their AUTO CULTURE™ systems due to its unparalleled qualities. The HMD110 did not only perform excellently in the testing phase, convincing with its durability and reliability, but it also had additional benefits such as being easy to replace and good availability of spare units for periodic maintenance.
Vaisala’s HMD110 is a durable solution for automated bio-decontamination using vaporized hydrogen peroxide in this Kawasaki’s automated cell culture application. Vaisala’s broad product portfolio continues to cater for versatile customer needs that vary case-by-case. Several factors can influence the choice of the best method for bio-decontamination: for example, material compatibility, efficacy of the process, desired level of bio-burden reduction and health and safety concerns. Vaporized hydrogen peroxide is used extensively in the bio-decontamination processes, as it destroys even the most resistant micro-organisms yet readily breaks down in water vapor and oxygen.
The need for bio-decontamination and sterilization increases all over the world. To respond to the growing need, Vaisala launched recently its new HPP272 probe to measure humidity, temperature and hydrogen peroxide accurately and consistently. Regarding humidity measurements, HPP272 measures both relative saturation and relative humidity, which indicates the humidity percentage derived from water vapor and H2O2 vapor together. Thus it reliably reveals when bio-decontaminated air starts to condense. The probe is suitable for several types of bio-decontamination processes where it is necessary to measure other parameters in addition to humidity. The new 3-in-1 measurement probe uses the new Vaisala PEROXCAP® sensor and is based on the company’s HUMICAP® sensor technology for the measurement of relative humidity.
Kawasaki Heavy Industries Ltd. is a Japanese industrial manufacturer giant. Together with about 100 group companies in Japan and overseas, it oversees the formation of a “technology corporate group”. The technological capabilities, polished over a one hundred year old history, send diverse products forth into wide-ranging fields that go beyond land, sea, and air, extending from the ocean depths to space. Kawasaki manufactures motorcycles, aerospace equipment, rolling stock, ships and a range of industrial products, among others.
Measuring humidity is important in automatic bio-decontamination processes that use vaporized hydrogen peroxide. The hygrometer has to have high resistance to vaporized hydrogen peroxide due to its corrosive nature. Vaisala HUMICAP 180V Humidity and Temperature Transmitter HMD110 was the ideal solution for Kawasaki Heavy Industries in this specific application.