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      樓主: 藥窕淑女
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      [驗證管理] 有獎討論:工藝驗證需要做壓片機速度的確認嗎?

        [複制鏈接]
      药徒
      21#
      发表于 2015-2-11 09:29:40 | 只看該作者
      飄過,不想多說,看了上面的,國內制藥還是參差不齊。
      药徒
      22#
      发表于 2015-2-11 09:39:50 | 只看該作者
      驗證轉速的範圍。
      药徒
      23#
      发表于 2015-2-11 10:16:09 | 只看該作者
      如果不做,那壓片的速度怎麽來定,工藝難道不需要定壓片速度嗎?那員工怎麽操作
      药徒
      24#
      发表于 2015-2-11 10:20:56 | 只看該作者
      再說就是工藝再驗證也要做,因爲設備通過多年的磨損是否能達到現在的要求
      药生
      25#
       樓主| 发表于 2015-2-11 11:22:42 | 只看該作者
      河西智叟 发表于 2015-2-10 19:50
      難道就沒人知道轉速和片子的硬度、外觀有直接的關系嗎???
      难道就没人知道压片开始、中段、结束由于料斗 ...

      壓片開始、中段、結束由于料鬥內顆粒重量的不同,這個應該不屬于混合物料的分層吧,只是一種物理現象,導致調整壓片速度。
      药生
      26#
       樓主| 发表于 2015-2-11 11:23:29 | 只看該作者
      道路漫长黑暗 发表于 2015-2-10 20:21
      很重要,不同速度下片的受压时间不同,硬度脆碎重量差异等均有影响,最典型的例子,你把速度不断往上加最后 ...

      速度越大,硬度越低,脆碎度越大嗎?
      药生
      27#
       樓主| 发表于 2015-2-11 11:23:59 | 只看該作者
      紅茶. 发表于 2015-2-11 08:09
      當然要,這麽關鍵的工藝參數竟然不做?

      做了,想了解一下爲什麽要去做的。

      點評

      片重,片重差異,硬度,脆碎度,崩解時限,溶出度,含量均勻度,每一項都與機速有莫大關系。  詳情 回複 发表于 2015-2-11 11:51
      药士
      28#
      发表于 2015-2-11 11:51:03 | 只看該作者
      藥窕淑女 发表于 2015-2-11 11:23
      做了,想了解一下爲什麽要去做的。

      片重,片重差異,硬度,脆碎度,崩解時限,溶出度,含量均勻度,每一項都與機速有莫大關系。
      药徒
      29#
      发表于 2015-2-11 13:09:07 | 只看該作者
      這個跟你的工藝有關,你的工藝裏有轉速參數的要求那就必須得做,因爲要保證在合理的範圍內壓出的片子符合要要求
      30#
      发表于 2015-3-20 14:18:14 | 只看該作者
      不需要,閑的沒事也可以做
      药徒
      31#
      发表于 2015-6-23 10:35:10 | 只看該作者
      老实的做吧  关键参数呀 不然你正常生产时怎么要求员工控制机器呢
      药徒
      32#
      发表于 2015-6-23 10:49:45 | 只看該作者
      不同速度都去驗證不現實,國産設備我個人認爲設定其最大産能的八成運轉左右進行驗證,最大速度運行估計用不了三天就拜拜了。
      药徒
      33#
      发表于 2015-6-23 11:10:06 | 只看該作者
      個人認爲,壓片機種類與壓片速度範有關,如果壓片機是高速壓片機,可以正常開到30萬左右/小時的如果範爲正負2萬/小時,對片重差異,硬度,脆碎度,崩解時限,溶出度,含量均勻度影不大,不可能一影響也沒有,但是不容易發現差異。如果正負5萬/小時,最大與最小有所差異,但可壓性特別好的品種,也有可能差異也不大。
      药徒
      34#
      发表于 2015-6-23 11:47:43 | 只看該作者
      一般得做壓片速度上下限和一個工藝設定速度的片重差異、脆碎度,硬度,溶出度等吧?外觀嘛,一定檢查的咯,最基本檢查項之一。
      35#
      发表于 2015-6-23 12:53:29 | 只看該作者
      不需要。。你工藝驗證是對已確定的工藝參數看其是否能滿足産品生産要求
      药徒
      36#
      发表于 2015-6-23 12:57:35 | 只看該作者
      需要做,片重差異、崩解時限、脆碎度都與速度有較大關系。
      药徒
      37#
      发表于 2015-6-23 13:13:24 | 只看該作者
      河西智叟 发表于 2015-2-10 19:50
      難道就沒人知道轉速和片子的硬度、外觀有直接的關系嗎???
      难道就没人知道压片开始、中段、结束由于料斗 ...

      是有一定的道理,同意楼上的观点,转速和压力有一定的关系,还和填充量有一定的关系,是一系列的联系,比如~~在料斗满的情况下,物料填充好,速度控制在20转,压力调试,在料斗一半时,还按20转的话,会出现装量不稳,,一般轻了,  不稳之后会出现硬度不够...............实际干过的人应该明白~~~不过现在都是机械上料,验证得出片差、压力改变的临界点,可以机械控制  当料斗物料不足时会自动上料~~保证质量。。所以现在基本不存在那个问题,以前的设备 验证速度 还是很有必要的
      38#
      发表于 2015-7-17 10:57:02 | 只看該作者
      壓片機速度對片子的影響比較大,我覺得還是要做一下
      39#
      发表于 2015-7-20 08:50:46 | 只看該作者
      学习学习                 
      40#
      发表于 2025-12-5 17:29:50 | 只看該作者
      可以做,如果中試做過了的話可以不做
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