合并介绍了有史以来的首先远程验证服务
如果您是实验室或医疗高压灭菌者的所有者或运营商，则确保您的单位始终以最佳性能水平运行符合您的最大利益。为此，重要的是在初始安装和常规的基础上验证高压釜。
在这篇博客文章中，我们将解释什么是高压釜验证，并引入合并灭菌系统的新远程高压釜验证服务。
什么是高压釜验证？
在高水平上，验证是指技术人员验证高压灭菌器的安装，操作和性能的过程，满足用户的要求和制造商的规格。
为了被视为“经过验证”，并遵守ISO 17665年确定的当前美国和国际蒸汽灭菌标准 - 高压釜必须进行三项资格测试。每个资格测试旨在评估高压釜功能的不同方面：
- 安装资格（IQ）：IQ provides documentary evidence that the unit has been built and installed to your specifications, and that all supporting devices — utilities, specifically — are available and properly connected. The IQ process methodically documents all aspects of the installation, the machine’s components, and any testing equipment used to provide a complete, closed-loop assessment. In addition, IQ includes NIST-traceable calibration verification of the unit’s critical components.
- Operation Qualification (OQ):OQ provides documentary evidence that the sterilizer operates in accordance with design specifications. The OQ test examines the autoclave’s ability to run the sterilization process correctly and to respond appropriately to error conditions, assuring that the unit operates as intended.
- Performance Qualification (PQ):高压釜的abilit PQ文档y to achieve the desired outcome — that is, to sterilize specific loads when operated in accordance with predefined operating procedures.
尽管可以请求单独的资格测试（例如，没有OQ或PQ的智商），但在单个验证中执行所有三个是标准的。作为我们的一部分Iteril-Q™验证计划，Consolidated为针对经过验证的特定单元量身定制的每个资格测试开发了一个自定义协议。
验证过程通常如何工作？
The validation process typically begins with a consultative interview, during which the Consolidated team will work with you to understand your sterilization needs, including your usual process and the different materials you need to sterilize. Using this information, as well as supplementary materials, such as autoclave manuals, we’ll create customized protocols for each of our three qualification tests.
建立这些协议后，我们将发送一个经过培训的合格代表现场来管理每个资格测试。有关在每次测试中发生的情况的全面细分，我们建议阅读完整的验证系列，我们在下面链接：
- How to Validate an Autoclave: Installation Qualification (IQ)
- How to Validate an Autoclave: Operational Qualification (OQ)
- How to Validate an Autoclave: Performance Qualification (PQ)
完成所有三个资格测试后，我们将编译最终报告，其中包括所有附件文件，包括：
- Pre-testing sensor calibration accuracy verification
- 打印数据以进行审查和签名
- 负载项目和传感器放置的照片
- Photos of incubated biological indicators (including positive and negative controls)
- Post-testing sensor calibration accuracy verification
- Test equipment calibration certificates
- 作者/执行人凭据
所有附件的最终报告通常为数百页。除最终报告外，我们还提供了一份摘要报告，这是我们发现的执行摘要。
合并化如何适应验证过程到远程体验？
两年前，合并的灭菌器系统开始探索提供远程验证服务的可能性，以简化流程并向更大的受众提供服务。迄今为止，我们是我们行业中唯一提供此服务的组织，无论品牌或模型如何，我们都可以对市场上的任何高压釜进行远程验证。
立即安排您的远程验证约会>>
Remote validation works like this: Similar to our in-person validation service, we begin by conducting a consultative interview, which we use to develop our custom qualification test protocols. During this initial step, we’ll also work with you to designate a qualified individual from your team to perform the remote validation.
建立必要的协议后，我们将把所有必要的设备运送到您的设施。这款高精度，易于使用的设备包括预校准的传感器，视频耳机和无线调制解调器，为我们所有设备创建一个远程接入点，以便我们可以远程控制设备而无需连接到您的Wi-wi-FI网络。为了使Covid安全起见，我们在将所有设备发送给您之前，然后在返回后再次消毒。
在您指定的个人完成包装和设置所有硬件之后，合并验证专家将与设备建立联系，并通过每个资格测试远程指定您的指定个人。远程验证的隐藏好处之一是负责代表您完成工作的人获得了新的技能。
验证完成后，合并的团队将通过我们的个人Wi-Fi链接下载整个过程中生成的所有数据，对所有数据和下载进行彻底分析，并签署结果。然后，我们将在最终和摘要报告中编译我们的发现，我们将运送给您以进行审查和签名。
就这样，您的验证已完成。
There are a few major benefits to this service: First and foremost, it’s safe. In light of COVID-19, remote validation enables our clients to receive the same level of service they’re accustomed to, without the risk of exposure. Second, it’s more efficient. As mentioned above, in-person validation requires a representative to travel to your location, which could sometimes lead to delays and even repeat trips. Third, it’s cost-effective. Without the representative’s travel costs — hotel, airfare, car rental, and so on — factored into the cost of service, you save money.
立即安排您的远程验证约会>>
“ [合并]提供了卓越的客户服务，并且知识渊博且易于使用。我强烈推荐他们。”
- 来自国际生物技术公司的快乐远程验证客户
您准备好验证高压灭菌器了吗？使用合并的灭菌系统安全有效地做到这一点 -联系我们今天安排您的远程验证约会。
