On March 15th, 2018, Jordi Net and Cristian Hernández from Netsteril, S.L. (picture below) attended an intensive training course at the Berthold house, located in Bad Wildbad, nearby Stuttgart. The course was organized by Protak Scientific, pioneer in the introduction of Enzyme Indicators for the monitoring and validation of decontamination processes with vaporized hydrogen peroxide (VH2O2 or VHP). Berthold is the manufacturer of the Luminometer Lumat used to read the degree of decontamination by means of Enzyme Indicators with the application developed by Protak.
The first part of the session was led by Phillip Godden, CEO of Protak, who explained how the enzymatic indicators are correlated with the biological indicators. The discussion went through how the manufacturing process involving the inoculation of spores onto the carrier discs can influence the D-Value, the variability of spore populations, etc. This fact implies that indicators may have different results, from batch to batch, for the same decontamination process or cycle. As a result, it is always needed to refer to a specific batch of indicators and/or to perform some adjustments in order to have equivalent results cycle after cycle. In order to establish a correlation, the standard Enzyme Indicators are also referenced to a manufacturer, at a given D-Value and to a certain population. Therefore, every time a validation is carried out, a correlation study should be made in order to establish reference of RLU readings to a specific threshold value, for example, 6-log, 5-log, et. The advantage of the Enzyme Indicators is that their variability, on each manufacturing batch, is much lower than in Biological Indicators (6% versus 20%), giving a much higher confidence in the results.
Once this talk was made, Berthold’s Technical Support Officer, Mr. Hans-Dieter Waidelich, presented us the maintenance manual and we proceeded to the practical workshop, disassembling the main parts of the Luminometer and addressing step by step the main problems that can arise in the daily use of this device. It was noted the need to keep the device clean, especially the injection tubes and reflective lenses as well as the protective filters of each tube, etc. He also presented the most common spare parts and the recommended replacement frequency according to usage, although in principle, preventive maintenance would be advisable once a year. Then we performed a sensor calibration simulation with a pattern light bulb, using a specific software for this purpose. In short, it was seen that in order to have correct readings, it is very important to keep the device in good conditions of cleanliness and, obviously, properly calibrated.
The last part of the training was to carry out an IQ / OQ / PQ qualification of the reader. Basically, it consisted of verifying, by means of a protocol, that the equipment was supplied in good conditions and had the labels correctly referenced in the manual and also that critical functions like reading of the RLU as well as the operation of dispensers and injectors is correct and within the established range.
At the end of the training, we joined a farewell dinner with the attendees coming from different countries such as France, Japan, Korea, United Kingdom, Germany and Italy. We all commented that there is a great interest in enzyme indicators and they undoubtedly have a great future. There are already leading companies in the pharmaceutical sector that are currently doing their correlation studies to carry out validations with the Enzymatic Indicators. When these companies have validated it in their internal processes, there will be little for regulatory entities to include it in their guides of recommendation and best practices.
It was really and intensive and profitable day. We’d really like to thank Berthold and Protak for giving us the opportunity to learn so many things. We really believe that with the knowledge acquired, we will be able to contribute to support better our customers and contribute to the development of the industry in our country.