Q&A討論區
本交流園地目的是開放工業界同仁技術分享交流
歡迎大家踴躍回應分享經驗
請注意下列事項:
互動回應資料僅供參考並非標準答案
提問時請註明產業類別或性質,以便問題交流
禁止任何廣告

 

 

冰箱及冷凍櫃溫度分佈測點數量決定原則

#1
chen 發表於 2019 / 06 / 05
關於溫度設備之驗證其中溫度分佈測點數量之原則及佈點位置是否有相關指導文件或是法規可參考?目前僅找到WHO Technical supplement to WHO Technical Report Series No 961 2011 但內文提到不包含小型溫度設備如冷凍櫃及冰箱, 因此請教關於溫度設備之溫度分佈可參閱何標準?
管理員回覆
您所引用的是 WHO TRS 961 Annex 9 Supplement 8:  Temperature mapping
of storage areas 的導論(Introduction)內容,雖然說該指導手冊不含括小型的冰箱
或冷凍櫃,但這些設備使用前還是要個別試驗,通過驗證(包括溫度分布)。其原文為:

This document describes how to carry out a systematic mapping procedure in
any cold room, freezer rooms or other temperature-controlled store. It does
not cover mapping of small scale cold chain equipment such as refrigerators
of freezers. Generally speaking, these products are independently tested and
prequalified for the storage of TTSPPs, although it is still important that
the equipment is correctly installed and operated.

建議參考 WHO TRS 961 Annex 9 Supplement 7:Qualification of temperature
controlled storage areas,其內容就要求如何驗證冰箱與冷凍櫃(包括溫度分布,部
分會參考Supplement 8)。其中章節2.7還說明對小型設備的特定要求:2.7 Specific
requirements for small-scale equipment。

 

另外可參考下列資料:

ISPE Good Practice Guide :Controlled Temperature Chamber Mapping and
Monitoring. Appendix 2- Sample Document: Number and Location of Mapping
sensors

PDA TR64 :Active Temperature-Controlled Systems: Qualification Guidance
Vaisala:GMP Warehouse Mapping
(網址:
https://www.vaisala.com/sites/default/files/documents/CEN-LSC-AMER-GMP-Warehouse-Mapping-White-Paper-B211170EN-A_0.pdf )

Vaisala :8 Steps to Validating/Mapping a Chamber

(網址:
https://www.vaisala.com/sites/default/files/documents/LSH-8-Steps-to-Mapping-Validation-Project.pdf)

MHRA Inspectorate Blog:Temperature Mapping – An Introduction
(網址:https://mhrainspectorate.blog.gov.uk/2016/07/14/temperature-mapping-an-introduction/

From TPDA
2018/06/25

 

 

暱稱
回覆內容
姓名
公司名稱
部門
聯絡電話+分機
Email
驗證碼