Flame Sealing Temperature Test:A-10 Sealer
2℃-8℃熔封溫度挑戰：A-10 熔封機

Background 背景

One of the largest international pharmaceutical companies is packaging a product in glass ampules, to be kept at a temperature between 2° C and 8° C.
國際上最大的制藥公司之一正想要包裝一個產品在玻璃安瓿瓶里，并且熔封后保持一個在2℃-8℃的溫度。
The purpose of this project was to measure the rise in temperature of the liquid after being flame sealed by the Ampulmatic-10 Ampule Sealer.
這個項目的目的是想在被A-10熔封機密封后，測量液體溫度的上升。

Procedure 處理

We filled 1 mL Wheaton ampules with 1 mL of water and 5 mL Wheaton ampules with 5 mL of water.  Everything was cooled to 5° C or less and placed inside a cooler with ice packs.
我們灌裝1mL水在1mL美標安瓿瓶，5mL水在5mL安瓿瓶中。每樣東西都在制冷器里被制冷到5℃左右。

The Ampulmatic-10 Sealer was used to flame seal each ampule.  The Ampulmatic-10 System utilizes the tip seal method for sealing glass ampules.  The flame melts the glass at the top of the ampule while the Sealer spins the ampule, creating a strong hemispherical seal.
A-10熔封機被用于每個安瓿瓶密封。A-10使用半球密封法用于密封玻璃安瓿瓶。火焰融化在安瓿瓶頂端的玻璃，同時熔封機旋轉安瓿瓶，制造一個強半球密封。

Each ampule was placed in the carousel one space before the flame sealing position. Immediately after sealing, we broke open the ampule, placed it in a refrigerated environment, and used a digital thermometer to measure the temperature of the liquid. The thermometer probe was kept at ~4° C between measurements to minimize equilibration time.
每個安瓿被放在在載具盤火焰熔封位置前一個的位置。在熔封后，我們快速打開安瓿瓶，把它放在一個冰箱環境里，使用數字的溫度計測量液體的溫度。兩次測量之間溫度計探頭保持在~4°C，以盡量縮短平衡時間。

Results 結果

In the 1 mL ampules, temperature rise ranged from 3.0° C to 3.7° C.
在1mL安瓿瓶中，溫度上升范圍從3.0° C to 3.7° C。

1 mL ampule Temperature Sealing Test   7/25/18
Starting Temperature (°C)	Temperature After Sealing (°C)	Temperature Rise (°C)
1.7	5.4	3.7
2.6	6.9	4.3
4.0	7.0	3.0

 
In the 5 mL ampules, temperature rise ranged from 1.8° C to 2.1° C.
在5mL安瓿瓶中，溫度上升范圍從1.8° C to 2.1° C。

5 mL ampule Temperature Sealing Test   7/26/18
Starting Temperature (°C)	Temperature After Sealing (°C)	Temperature Rise (°C)
3.5	5.4	1.9
2.5	4.3	1.8
1.9	4.0	2.1
1.9	4.0	2.1

 

Recommendations 推薦

·Ampules should be pre-filled and kept refrigerated until ready to seal.
安瓿應預先裝好并冷藏，直到準備好密封。

·The pre-filled ampules should be kept at the lowest possible temperate before sealing.
預灌裝的安瓿在密封前應保持在最低溫度。

·The operator should use Kevlar insulated gloves (Bioscience PCN 270 114) to reduce heat transfer. 
操作員應使用Kevlar絕緣手套（Bioscience PCN 270 114）以減少熱傳遞。

· Immediately after sealing, the ampule should be returned to refrigerated conditions.
密封后，應立即將安瓿放回冷藏狀態。

· It’s our opinion that the smaller ampules will have the greatest variability in temperature, so care should be taken to keep the liquid chilled during the sealing process.
我們認為較小的安瓿溫度變化最大，因此在密封過程中應注意保持液體冷卻。

本文章總結的知識來自于美國BIOSCIENCE及其母公司Monera Technologies Corporation。如需轉載，請注明出處。侵權必究。