如何验证AutoClave：性能资格（PQ）
An autoclave undergoes qualification testing in order to validate and verify that it’s performing consistently and properly. In previous posts, we outlined the first two qualification tests known asInstallation Qualification（智商）和Operation Qualification(OQ). In this post we will review Performance Qualification (PQ) as a final critical step invalidating your autoclave。
什么是性能资格（PQ）？
PQ demonstrates that the autoclave not only runs the required cycles, but provides the required result: sterility. The PQ process involves testing the loads that must be successfully sterilized in the autoclave. The prerequisites for PQ are successful IQ and OQ.
Performance Qualification (PQ) –A process which obtains and documents evidence that the autoclave, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby meets its specification.[ISO TS 11139:2006, definition 2.30]
样本测试协议
PQ is comprised of at least three repeated tests for each defined load. The critical aspect of the tests is to validate sterility in each of the loads. Each load type will have its own challenges so it’s important that each is specified with information such as: number and type of objects being sterilized, sterile barrier material used, and in certain cases, orientation of the objects being sterilized in the autoclave.
Here is a sample PQ test protocol:
目标是
The Objective is to prove sterilization of the specified load. The sterility assurance level may derive from a standard, from a client SOP or specification, or from a manufacturer’s specification. Specific citations to any of these should be made in this section.
2.程序或设置
The Procedure or Setup explains how to setup and execute the test. The following specifications should be noted here:
- 包括所有关键参数的循环类型（动态空气去除，重力，液体，空气过压，空气过压支持，水级联等）
- 测试所需的任何设备
- 负载中每个项目的数量和位置
- If a mixed load is to be run, the number of each item and the items’ locations should be specified.
- 指标和数据记录探针的位置 - 这些应放置在负载中的“最坏情况”位置，以提供保证整个负载被消毒
- Sterile barrier materials or vessel covers (like aluminum foil for flasks), as well as their application to the items closed by them
- 如何执行测试的逐步列表
3.验收标准
验收标准部分列出了所需的结果或结果范围。性能资格认证的验收标准的例子涉及无菌和温度。例如，如果在灭菌期间的腔室内的温度范围的“可接受标准”是相对于实际设定点的-0 / + 3°C，则所有测量点的腔室温度必须在该范围内进行成功的结果被记录。
Another example of a critical “Acceptance Criteria” is sterility, which is proven through the use of biological indicators (BIs). The obvious result is that there should be no surviving spores on the BI. If there are survivors, an examination of the BIs should be undertaken to ensure that the resistance (i.e. D-value) of the BIs is not greater than those of the BIs used in the original cycle development.
4. Result Record
结果记录是记录所有测试数据的位置。至少三个迭代通常运行用于过程测试。任何未能遵守验收标准会使“迭代”进行失败的测试。必须连续运行所需的迭代次数，以便将测试成功的结果被视为通行证。记录必须包括：
- 灭菌循环胶带或电子记录
- Biological (and chemical, if used) indicator results
- Datalogger结果及其遵守验收标准
- Analysis of the datalogger (thermocouple) records for accumulated lethality (Fo) and compliance with allowable load temperature ranges in the exposure phase
5. Verification
测试完成后，通常审查结果遵守验收标准。该审查在本节中最终确定，其中来自测试的人员的签名，最好是第二个人或经理的计数器。
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无菌测试和记录保存
顺序运行一个灭菌周期d the load setup should follow the Procedure or Setup section of the test. Indicators and data logger probes are to be placed as specified. Sterile barrier or closure materials are to be applied as specified. If sample loads are to be reused, they should be allowed to cool to a specified temperature (optimally room temperature) between cycles to provide a real-world thermal load for the sterilizer and a real-world exposure for the indicators.
在所有测试中，记录保持对测试的完整性至关重要。记录可以包括来自消毒器，数据记录器数据文件，照片，速写图等的循环磁带打印输出。这些必须附加或提供报告，每个都通过它适用的PQ协议部分标识。任何电子数据记录应以非易失性形式提供，其中最终报告，即作为CDROM或DVDROM，或通过云存储。
此处列出了更广泛的所需记录列表：
- A catalog of who carried out the testing, the verification of results, and approvals with initials and signatures.
- A listing of reference or other test equipment, manufacturer, model, serial number, and calibration due date, if applicable.
- A listing of biological indicators and chemical indicators (if used), including manufacturer, model number, lot number, D-value, and nominal population.
- 如果使用培养液,复苏研究应当堂e to ascertain the actual recoverable population of the indicators; also, a growth promotion study shall be done to ensure that the item upon which the inoculum is deposited does not have a negative effect on outgrowth of the indicator organism
- A calibration record for test equipment (e.g. thermocouples) if done at the work-site, both before and after a series of tests and/or after the entire test protocol is performed.
执行良好的PQ将使您能够演示和记录AutoClave可以执行所需的流程并提供应用程序所需的无菌保证水平。PQ通常是资格的最后一步。此测试创建了自动灭菌能力执行指定作业的能力的不可用的基线级别，并且是定期间隔的保存的基础。
如果您有其他验证问题或与高压灭菌器有关的任何问题，请contact us了解更多信息。
（由Jonathan A. Wilder，Ph.D.，Stericert.div。H＆W技术）
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