GxP 合规认证服务 - 合规其实很简单!

认证服务

安装验证

安装验证通过规定的测试方法,确认设备按照 Eppendorf 规格安装。

操作验证

操作验证通过规定的测试方法,确认设备按照 Eppendorf 规格运行。

  • 确保高质量的结果和设备的安全性
  • 满足复杂的 GxP 标准和法规要求

New: Multi-Temperature Mapping for Ultra-Low Temperature Upright Freezer

Regular verification with the help of an external, calibrated multi-channel temperature verification system inside your ULT freezer provides you with security of reliable long-term sample storage.

Our factory-trained and certified service technician will perform an on-site temperature mapping study including a full report stating:

  • Minimum, maximum and average temperature of each location
  • Full log of raw data of each measurement
  • Temperature profile graphic for duration of measuring period
  • All relevant calibration certificates

Norms, standards and best practices such as ISPE-Controlled Temperature Chamber Mapping and Monitoring, IEC 60068 - Environmental testing, or Vaisala – 5 Rules of Sensor Placement in Validation/Mapping Applications recommend a temperature mapping of 9 or 15 probes after installation, and subsequently every two years, or when changes are made to the system.

A probe holder system (9 and 15 probes) is used to ensure comparable results between different measurements and units
Example of a Multi-Temperature Mapping with 9 probes inside an ULT upright freezer

Your advantages

  • 24 hours, 365 days a year reliable storage for temperature-sensitive samples
  • Comparable annual temperature distribution results in one or multiple freezers
  • Audit proof documentation

This service is only available in selected countries. Please contact your local Eppendorf serviceorganization for further information.

FAQ

Why do I need a temperature mapping for an Eppendorf upright ULT freezer?

Regardless how well a freezer is designed, it will have temperature fluctuation which will have an impact on the stored samples.

When should I have a temperature mapping performed on my upright ULT freezer?

We recommend a temperature mapping directly after installation to ensure the quality of your samples during storage. Afterwards the mapping should be performed every 2 years, or after major changes to the system (e.g. repair).

How many measuring positions are tested during an Eppendorf temperature mapping study of an upright ULT freezer?

Eppendorf offers ULT freezer temperature mapping at 9 and 15 measuring positions. We recommend temperature mapping at 15 positions for a more comprehensive sturdy, but this will depend on your risk assessment requirements.

Over what duration should the temperature mapping of an upright ULT freezer be performed?

For best practice, we recommend conducting a temperature mapping study for at least 48 hours.

Why should I perform a temperature mapping on an empty upright ULT freezer?

Air temperature in an empty freezer will always fluctuate more than any product inside. If a ULT freezer demonstrates its effectiveness at successfully controlling air temperature, then it is more than capable of effectively also controlling the temperature of the product contained.

Does Eppendorf offer a temperature mapping service for ULT freezers from other manufacturers?

Yes, Eppendorf can perform temperature mapping on ULT freezers from other manufacturers.

Do you also offer a temperature mapping for chest ULT freezer?

No, due to the positioning of temperature probes, currently we can only perform temperature mapping on upright ULT freezers.


超低温冰箱安装验证和操作验证服务

安装验证和操作验证
订购信息
IQ/OQ OQ
超低温冰箱 0082 070 009 0082 070 008
包含项目:    
交付状态和安装环境检查  
设备安装,包括配置和功能检查  
基本安装验证报告  
警报功能测试
设备参数验证(如温度)
基本操作验证报告

注意:此表仅列出各服务项目中最重要的服务内容。您的服务报告中将列出所执行的完整服务项目。

备注:我们提供的服务可能因国家/地区而异。如需了解更多信息,请联系您当地的服务代表。