【有奖翻译】国外工业药剂跟踪——胶囊充填技术分析

欢迎大家踊跃参与，除上述奖励之外，对于积极参与者本版将会给予额外的奖励，赶快行动吧！

大家不喜欢这种方式吗？有什么好的意见建议欢迎站短反馈给我！

先把第一部分贴出来方便大家参与，选取其中的一段、一句或一个短语均可，只要您参与，我们都会给予积分奖励：

How do I determine the appropriate capsule size for my formulation?

You need to determine the density of the formulation to answer this question. For powder formulations, use the tapped density
value. For pellets or granules, use the bulk density. Once you have this information and you know the target fill weight, ask a
capsule supplier for a capacity chart, such as the one shown in Table 1. Using this chart as an example, encapsulation 500
milligrams of a powder with a tapped density of 0.8 gram per milliliter would require a size 0 capsule.

第二部分，有点长：

You can accomplish this with statistical process control (SPC) techniques. SPC establishes the process capability for a specific formulation being encapsulated on a designated filling machine. Most statistical textbooks and publications on “lean sigma” provide the procedures and formulas for establishing process control limits. I’ve also found a website that is particularly helpful [1], and a variety of SPC software is available.

I’ve had excellent results monitoring capsule filling runs by charting the average weights and range of weights of the samples. Figure 1 provides an example of a control chart (UCL stands for upper control limit. LCL stands for lower control limit). Making a chart like this requires using SPC procedures to determine the upper and lower control weight limits and the upper and lower control limits for the average weight and weight range. Then follow these steps:

• Take a sample of 10 capsules at regular intervals (every 15 to 30 minutes), calculate the average and range of their weights, and plot the results on the control chart. These plots provide a simple graphical technique for determining if the average or range val ues are outside the control limits. See Figure 2.

• If the data points are within the acceptable limits, don’t adjust the weight settings unless there is a trend where the previous six average weight checks were consistently above or below the centerline.

• If either the average or range of weights falls outside the control limits, stop the filling run and investigate to determine the cause(s).

• Isolate all the production collected from the previous satisfactory weight check and evaluate it to determine the disposition for this segment of production. In most cases, this segment of production is either discarded or weight-sorted.

• Resume processing only when you have ascertained the causes of the change and taken the required corrective action to bring the average and range back within control limits. We would usually perform two weight checks a minute apart to verify this.

In summary, the upper and lower control limits for both the average weight and range of weights are used to identify conditions where the process weight variation has changed due to an assignable cause. Such changes indicate that the capsule filling machine is no longer in a state of statistical control.

对于我的的药剂，如何选择合适的胶囊型号？
要回答这个问题，你需要先确定药剂的密度。对于粉末状药剂，使用堆积密度值。对于丸状或是颗粒状药剂，使用体积密度值。一旦确定密度信息，并且确定填充质量，就要求胶囊供应商提供一张胶囊容积表，如表1 所示的表。以此表为例，500mg的堆积密度为0.8g/ml 的粉末需要用一个0号胶囊来填充。

怎么参与的只有一位呢？是不是还要做一下广告？

第三部分：

How do I ensure capsule filling quality?

The traditional approach is to perform a quality check on a small sample (usually 10 capsules) every 30 or 60 minutes when you take a weight-check sample. While this is certainly a good procedure and one that my capsule filling department followed for many years, we still visually inspected the batches to remove defects that were not always found in the routine quality checks. Every time we analyzed a quality problem, we discovered a high correlation between the setup of the capsule filling machine and the incidence rate of defects. Based on this, we began to check a large sample for acceptable quality level (AQL) after every machine setup and after every major repair. After adjusting the machine to hit the target fill weight, we would perform a sustained run for 5 to 10 minutes, stop, and then carefully inspect every capsule for defects. Using such a large sample highlighted specific defects that, in most cases, we could attribute to machine setup.

For example, a high incidence rate of “telescoped” or split capsules indicates either a misalignment of the upper and lower capsule segments (or bushings) or an incorrect setting of the cap hold-down pin (or plate) in the joining station. Dents in the capsule body indicate either an incorrect setting of the body joining pins or an incorrect pin size or pin configuration. Most manufacturers of capsule filling machines supply a troubleshooting guide to assist with this kind of analysis.

Based on the information obtained from these procedures, we developed a detailed checklist for machine setup, which required operators to measure components and settings precisely at each critical step. The operator or mechanic then had to sign off that everything on the checklist was indeed checked. These procedures allowed us to build quality into the process and to reduce by 85 percent the time we spent visually inspecting for defects. That represented a significant labor savings.

给个建议：下次不要弄附件了，而且不要这么长篇大论了，真的头疼。可以少一点，慢慢来嘛。这样大家的参与度不就高了！
另外你们网站老是送积分，可是积分有什么用呢？奖品不给力，文章还这么长，大家自然就没兴趣了。

有时候太少了大家又会说没有上下文不好理解，其实也可以选取其中的一句或一段来参与的，形式很自由也很方便。

另外积分可以用来下载论坛的资料，也可以当作虚拟货币在积分商城换实物的啊

气死了，我的翻译没有了，还说我发广告，到底是什么情况！！！！