Flame Sealing Temperature Test:A-10 Sealer
2℃-8℃熔封温度挑战：A-10 熔封机

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.
国际上最大的制药公司之一正想要包装一个产品在玻璃安瓿瓶里，并且熔封后保持一个在2℃-8℃的温度。
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.
这个项目的目的是想在被A-10熔封机密封后，测量液体温度的上升。

Procedure 处理

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.
我们灌装1mL水在1mL美标安瓿瓶，5mL水在5mL安瓿瓶中。每样东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熔封机被用于每个安瓿瓶密封。A-10使用半球密封法用于密封玻璃安瓿瓶。火焰融化在安瓿瓶顶端的玻璃，同时熔封机旋转安瓿瓶，制造一个强半球密封。

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.
每个安瓿被放在在载具盘火焰熔封位置前一个的位置。在熔封后，我们快速打开安瓿瓶，把它放在一个冰箱环境里，使用数字的温度计测量液体的温度。两次测量之间温度计探头保持在~4°C，以尽量缩短平衡时间。

Results 结果

In the 1 mL ampules, temperature rise ranged from 3.0° C to 3.7° C.
在1mL安瓿瓶中，温度上升范围从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，温度上升范围从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 推荐

·Ampules should be pre-filled and kept refrigerated until ready to seal.
安瓿应预先装好并冷藏，直到准备好密封。

·The pre-filled ampules should be kept at the lowest possible temperate before sealing.
预灌装的安瓿在密封前应保持在最低温度。

·The operator should use Kevlar insulated gloves (Bioscience PCN 270 114) to reduce heat transfer. 
操作员应使用Kevlar绝缘手套（Bioscience PCN 270 114）以减少热传递。

· Immediately after sealing, the ampule should be returned to refrigerated conditions.
密封后，应立即将安瓿放回冷藏状态。

· 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.
我们认为较小的安瓿温度变化最大，因此在密封过程中应注意保持液体冷却。

本文章总结的知识来自于美国BIOSCIENCE及其母公司Monera Technologies Corporation。如需转载，请注明出处。侵权必究。