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洗瓶機洗淨能力驗證

#1
mf 發表於 2014 / 08 / 07
請問Amp及Vial洗瓶機如何執行洗淨能力驗證?除了檢測氯化鈉滲透壓,異物,Liquid particle是否有其他驗證項目能有效評估洗淨效能?
TPDA 發表於 2014 / 08 / 08
建議:
1.先考慮購買容器的潔淨度,檢測其外觀與可目視粒子或不可目視微粒子

2.接著考慮洗瓶機的清潔方法,參數包括清潔液(只使用純水/注射用水或使用清潔劑),清潔液溫度,噴洗壓力,噴洗時間等

3.最後檢視清潔過後的容器的外觀與可目視粒子或不可目視微粒子是否符合既定規格(例如,優於USP訂定的注射液的 異物規格)

通常Type 1 的玻璃瓶子都很乾淨,多以製藥用水清洗,也較少有萃出物(extractables)與滲出物(leachables)的問題,但不甚了解所提問題中檢測氯化鈉滲透壓的原因為何?請提出進一步的說明與探討。

CCPC 發表於 2014 / 08 / 22
"Performance Qualification of Ampoule/Vial Washing Machine"
The ampoule/ vial washer is used to clean the drug container to eliminate the contamination (endotoxin, chemical substance, particles etc.) from the container itself to ensure that the products produced meet expectations for purity, identity, safety, and quality.
Performance of the ampoule/ vial washer should be qualified at regular intervals. Even though depyrogenation may be achieved using a heating tunnel or oven, if the washing process cannot remove chemical contaminants or particles, they will produce a pyretic response in humans or animals, although there are no pyrogens present.
Thus decontamination studies for endotoxin, chemical contaminants, and particles should be performed. Each study to be challenged three times to verify the reproducibility of the machine’s performance.
【Endotoxin Decontamination Study】
Inoculate endotoxin suspension in each testing ampoule/vial ( 10 Numbers) calculated to obtain 100EU/ml. Dry in a oven at 450C - 600C and 30 mmHg about one hour until no visual water present. After drying send the spiked ampoule/vials for washing. After washing send the ampoule/vials to Microbiology lab for testing
Acceptance Criteria: at minimum, a three-log reduction in endotoxin.
【Chemical Decontamination Study (Sodium Chloride Challenge Test – [Soluble])】
Prepare 30% Sodium chloride solution & spike it in 10 ampoules/vials. Dry the ampoules/vials under LAF for 8-10 hours, after drying send the spiked ampoule/vials for washing. After washing send the vials to Quality control lab for testing.
Acceptance Criteria: Precipitation & chloride content should be absent in the ampoules/vials after washing.
【Particulate Decontamination Study (White Powder Talc Solution Challenge Test – [In soluble])】
Prepare white powder talc solution & spike it in 10 ampoules/vials. Dry the ampoules/vials under LAF for 8-10 hours, after drying send the spiked ampoule/vials for washing. After washing send the vials to Quality control lab for testing.
Acceptance Criteria: 10 µ particles NMT 25 & 25 µ particles NMT 3
【Glass Particle Challenge Test】
Take glass particles and put it in 10 ampoules/vials. After washing check visually for any glass particles.
Acceptance Criteria: No particles shall be observed in the ampoules/Vials after washing.
Note: For each study, the quantity of ampoules/vials to be washed is the same as normal production size to demonstrate the performance of the normal process.
The above information is for your reference. My E-mail: 1b4149@ccpc.com.tw

 

 

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