GxP対応適格性確認サービス – 適格性確認がより簡単に!

適格性確認サービス

設置時適格性認定 

設置時適格性認定は機器がエッペンドルフ社が定めている機器の仕様に沿って設置されていることを保証します。

性能適格性認定 

稼働性能適格性確認は機器がエッペンドルフの定めている機器の仕様に沿って稼働していることを保証します。

お客にとってのメリット

  • 結果の品質と機器の安全性の信頼性を確保
  • 複雑なGxP標準と法規定への準拠をサポート

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.


ULTフリーザー設置時適格性確認および稼働性能適格性確認サービス

設置時適格性確認および稼働性能適格性確認
注文情報
IQ/OQ OQ
ULTフリーザー 0082 070 009 0082 070 008
内容:    
納品状態と設置環境のチェック  
システム構成組み上げを含む機器の設置と機能のチェック  
基本IQレポート  
アラーム機能のテスト
機器パラメータの検証(温度等)
基本OQレポート

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