BIOtAK Ltd - Proof of Concept of PEROXItAK and STEAMtAK

在医院，手术仪器会在无菌服务部处理后再用，经清洗和消毒后，会在过氧化氢等离子体或蒸汽装置内消毒。能够检查消毒过程是否正常运行，确保病原体水平已降至足够的水平，以便不会将疾病传播给后续患者。BIOtAK正在开发两种设备，PEROXItAK和STEAMtAK，以监测分别使用过氧化氢和蒸汽作为灭菌剂的消毒过程。该项目的主要目标是对这些产品进行专家测试，以获得概念验证。这些产品使用创新的基于酶的技术，提供了客观、明确、快速和可量化的结果，这在该领域是第一次。现有的测试一次最多只能实现这些功能中的一到两种。PEROXItAK和STEAMTAK将组成两个不同的工作包。这些项目的目的是使用测试台来评估PEROXItAK监督过氧化氢灭菌过程的潜力。此外，该包还将涉及测试设备的配方，以确保它们适合用于此应用。对于STEAMtAK，目的是评估可以监控蒸汽灭菌过程的可能的酶配方。测试将确定在140°C干热30分钟后是否仍有化学指示标准所要求的酶活性，并在饱和蒸汽存在的情况下进行评估。健康保护局(HPA)一直在研究称为耐热激酶的酶，这是一种非常健壮的酶。耐热腺苷酸激酶(Tak)是由BIOtAK开发的一种医院手术器械洗涤过程指示剂。现在，BIOtAK希望评估这项酶技术在监测灭菌过程中的应用。

In hospitals, surgical instruments are processed for reuse in the Sterile Services Dept (SSD).After being washed and disinfected, the instruments are sterilised in a hydrogen peroxideplasma or steam device. The ability to check that the sterilisation process is functioningproperly ensures that pathogen levels have been reduced to a sufficient level so as not totransmit disease to the following patient.BIOtAK is developing two devices, PEROXItAK and STEAMtAK, to monitor sterilisationprocesses which use hydrogen peroxide and steam respectively as the sterilant. The keyobjective of this project is to perform specialist testing of these products to obtain proof ofconcept. These products use innovative enzyme based technology that provides an objective,unambiguous, rapid and quantifiable result which is a first in this sector. Existing tests canachieve at best only one or two of these capabilities at a time. PEROXItAK and STEAMtAKwould make up 2 distinct work packages.The aims of these projects are to use a test rig to evaluate the potential of PEROXItAK tomonitor hydrogen peroxide based sterilisation processes. In addition this package will involvethe formulation of test devices to ensure they are suitable for use for this application. ForSTEAMtAK the aim is to evaluate possible enzyme formulations that can monitor the steamsterilisation process. Testing will determine if there is remaining enzyme activity at 140°C dryheat after 30 minutes as required by the chemical indicator standards, and also assess in thepresence of saturated steam.The Health Protection Agency (HPA) has been carrying out research on enzymes calledthermostable Kinases which are very robust enzymes. Thermostable Adenylate Kinase (tAK)has been developed by BIOtAK as a wash process indicator in hospitals for surgicalinstruments. Now BIOtAK wishes to assess the application of this enzyme technology tomonitor sterilisation processes.