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[物料管理] 【包装100问】---怎样测试泡罩包装的密封性?

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发表于 2014-9-12 15:53:57 | 显示全部楼层 |阅读模式

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泡罩包装以其阻隔性高,各药品间的独立性好,已经取食的药品不会对剩余药品包装的阻隔性、密封性产生影响而被广泛采用。由于泡罩包装的阻隔性较高,故其密封性能的优劣则成为影响药品保质期的一个重要因素。
泡罩包装的密封性能可通过密封试验仪进行测试。测试过程为:将泡罩包装浸没在密封试验仪密封罐的水中,盖好密封盖,打开真空泵,对密封罐内进行抽真空,这样就在泡罩包装的内、外形成了一定的压力差,若泡罩包装的密封性较差,包装内部的气体则在压力差的作用下,从包装表面密封薄弱的部位向外溢出,表现为包装表面有连续不断的气泡冒出。


搜索【包装100问】,获取更多包装知识......

本帖被以下淘专辑推荐:

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药师
发表于 2018-8-29 15:54:00 | 显示全部楼层
INNOVATIVE LEAK TESTING OF PHARMACEUTICAL BLISTER PACKAGES
https://www.pfeiffer-vacuum.com/ ... equest_locale=en_US

补充内容 (2018-10-19 10:08):
LEAK TESTING
https://www.pfeiffer-vacuum.com/ ... sting-PL0016PEN.pdf

补充内容 (2018-10-19 10:34):
https://www.pfeiffer-vacuum.com/ ... ethod-PI0457PZH.pdf
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药生
发表于 2014-9-12 16:06:33 | 显示全部楼层
连续不断应该不至于
泡罩眼就这么大 里面的空气没多少  
实际检查时 不好判断
还不如检查泡罩眼内部有没有进水方便
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药徒
发表于 2014-9-12 18:21:20 | 显示全部楼层
广告贴。。鉴定完毕。
现场的话,我拿沸水冲泡一下板子就行了。。。好的板子:铝箔鼓起,pvc收缩,内部没水气,就这样简单,要啥设备呀。

点评

www.kkquanben.com看看全本小说  发表于 2020-1-5 12:50
这个方法能写到文件里面吗  详情 回复 发表于 2014-9-17 20:57
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大师
发表于 2014-9-12 19:25:42 | 显示全部楼层
连个参数都没有。
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药徒
发表于 2014-9-12 21:17:19 | 显示全部楼层
这是包材检测方法。
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 楼主| 发表于 2014-9-15 16:59:55 | 显示全部楼层
幻影 发表于 2014-9-12 19:25
连个参数都没有。

您好,您可以参考 GBT 15171-1994 软包装件密封性能试验方法,进行生产过程实际运用。
感谢您的关注,更多药品包装问题可以下载【包装100问】App了解
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 楼主| 发表于 2014-9-15 17:06:12 | 显示全部楼层
河西智叟 发表于 2014-9-12 18:21
广告贴。。鉴定完毕。
现场的话,我拿沸水冲泡一下板子就行了。。。好的板子:铝箔鼓起,pvc收缩,内部没水 ...

这个方法是有标准可循的,而且可以确定具体的发生漏气的位置,帮助企业进行量化生产线;
检测仪器可以测得产品在多大压强下会出现破损,这样可以使企业在生产线上随时调整产品的参数,减少出现问题的几率,防范于未然。

感谢您的参与讨论,您可以下载【包装100问】App,了解更多药品包材知识
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 楼主| 发表于 2014-9-16 16:31:32 | 显示全部楼层
更多包装知识,请下载【包装100问】应用了解
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药生
发表于 2014-9-17 20:57:21 | 显示全部楼层
河西智叟 发表于 2014-9-12 18:21
广告贴。。鉴定完毕。
现场的话,我拿沸水冲泡一下板子就行了。。。好的板子:铝箔鼓起,pvc收缩,内部没水 ...

这个方法能写到文件里面吗  

点评

为啥不能?简单易用的方法,只要能判断出好坏。。。实际操作中还有这个比用机器花时间检测好吗?  详情 回复 发表于 2014-9-18 11:45
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 楼主| 发表于 2014-9-18 09:26:29 | 显示全部楼层
【包装100问】是Labthink兰光面向食品企业全球首发的一款针对包装疑难问题汇总与答疑的手机软件。基于Labthink兰光十余年的包装研究与测试经验,为用户精心打造了两大实用栏目“我要问”和“我要测”,具有案例丰富、提问免费、反馈及时、解答专业、提单便捷、下载流畅等特点,目前覆盖iOS和Android两大主流平台。
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药徒
发表于 2014-9-18 11:45:24 | 显示全部楼层
t9t1 发表于 2014-9-17 20:57
这个方法能写到文件里面吗

为啥不能?简单易用的方法,只要能判断出好坏。。。实际操作中还有这个比用机器花时间检测好吗?
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 楼主| 发表于 2014-9-23 09:58:35 | 显示全部楼层
想要了解更多包装知识,敬请搜索搜索【包装100问】~
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药徒
发表于 2016-7-10 12:13:30 | 显示全部楼层
楼主,你家的密封性测试仪大概什么价位啊,可以私信回一下吗?
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药徒
发表于 2018-8-29 16:06:11 | 显示全部楼层
谢谢分享


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药师
发表于 2018-10-19 10:58:40 | 显示全部楼层
本帖最后由 roadman 于 2018-10-19 10:59 编辑

In-Process Checks During Blister PackagingBy Pharma Editor -
June 10, 2017

During Blister packing of solid oral dosage followings are the In-process checkpoints:

  • After running the machine in initial, a piece of blister foil to be collected for inspection, the piece of length should covering two impression of total number of mats mounted on the roller with overprinting instruction printed on it.
  • Correct positioning of the overprinted matter and proper sealing of Aluminum foil with PVC shall check. The knurling impressions should  specifically checked.
  • overprinted matter with the over printing instructions should check as in-process check, as per quality system, collected and inspected piece of blister foil should signed by IPQA, counter sign by Packing section in-charge and finally this signed foil is a specimen and should affixed in BMR.
  • When the specimen of foil checked, packing shall start and initially packed medicine shall be checked for leak test.
  • Leak test shall be done to check integrity of sealing of Blister Pack, after checking it shall be recorded in BMR.
  • Total no. of sample to be tested for leak test shall calculate as follows:

Total number of packs to be tested =  Number of cavities per track on the roller (for pack with 2 rows)

         (OR)

Number of packs from each side = Total number/2 single row)

Total number of packs to be tested = 2xNumber of cavities per track roller (for pack with 2 rows)

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药师
发表于 2018-10-19 11:19:28 | 显示全部楼层
本帖最后由 roadman 于 2018-10-19 11:30 编辑

SOP On In-process Control of Packing Line
Posted By: PharmaceuticalGuidanace on: April11, 2016 In: QA & QC, Quality Assurance, SOP

INPROCESS CHECKS DURING STRIP/BLISTER PACKAGING OPERATIONS:

  •   Ensure the overprinted batch details of the strips, cartons and shippers. Ensure that they match with the details given in the BPR.
  •   Ensure that leak test is passed or not. If passed allow to continuing the packing. If fail re-set the machine until the leak test will pass.
  •   Ensure that RH, temperature and pressure differential of strip/blister packing room is within specified limit.
  •   Inspect the in-process packing parameters on few initial packs ,if satisfactory, allow further online packing.
  •   Inspect the in-process packing parameters at frequency specified on BPR for –
  •   Coding details on strips/blisters, unit cartons/catch cover and shipper.
  •   Quantity of tablets in strips/blisters; strips/blisters in cartons and cartons in shippers
  •   Pack inserts like literature etc. and their arrangement.
  •   Sealing of strip/blister’s corners and cutting.
  •   Visible defects in strips like cut pockets, missing pockets in strips and smudging of overprinting on carton / shippers/ strips etc.
  •   Leak test of strips / blisters produced in one complete rotation of forming roller at the start of batch.(taken from one cut at the machine).
  •   Ensure that all the parameters checked are found within specified limit. Record the observation in BPR at specified table.
  •   Ensure that the set temperature of both sealing forming rollers is maintained during strip packing and observations of the temperature are recorded by operator in BPR in respective table.
  •   Ensure that a length of printed foil from each joint in a roll is kept as specimen and evidence along with approved specimen in BPR. In case, the packaging material like cartons, leaflets and printed / plain aluminum foil are more than one A.R.No., attach a representative sample of each to the BPR.
  •   If any pocket fails in leak test, hold the strip packing operation immediately.
  •   Withdraw sample from the cartons, packed in between the duration of present and previous leak test and perform leak test again on double of the quantity of the strips. None of the pocket should fail in leak test.
  •   If repeat leak test fails reject the strips packed in duration under question and ask production executive / officer to keep these strips for recovery of the tablets with proper identification.
  •   Withdraw control sample so as to represent start, middle and end of the strip packing from the running line and keep in cartons before transferring them in control sample room.
  •   After completion of the packing ensure that stereos of the batch are destroyed and  details of destruction are recorded in BPR.
  •   After completion of the packing operation ensure that extra packing material is returned after being recorded on sheet of Excess Return Note.
  •   Verify the quantity and the A.R. No. of the material remained unused for packing before signing of clearance for return of extra packaging material back to stores.
  •   Check and verify the reconciliation of the packaging material and ensure that variance is within limit as specified in BPR.
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药师
发表于 2018-10-19 15:46:17 | 显示全部楼层
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药圣
发表于 2022-7-12 20:41:12 | 显示全部楼层
谢谢分享,下载学习
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