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​Checking Your Tooling

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It is time consuming and expensive for tablet manufacturers to inspect tooling equipment. That said, changes and advancement in technology makes it easier to do in-processinspections. Below is a brief on the improvement in technology to improve in-processinspection.

Inspecting tablet-tooling equipment has several challenges; it can also be time consuming as well as expensive for manufacturers. Due to its prohibitive cost, some manufacturers cut back on the number of inspection or eliminate the process to minimize cost. That said, it is a problem waiting to happen as the tablet’s quality relies on the quality of the tooling equipment. Although the equipment might run smoothly, if the tooling has wear on it, it will affect the quality of the tablet produced. The only way to ensure overall quality of the tablet is to inspect the equipment for wear and defects. Another problem would be in keeping inspection records. Once the data is recorded, it will be filed and never be seen again. Recent advancement however allows companies to file their data in their computer making it easier, efficient and more conducive for tablet manufacturers.

Tooling Inspections

A common misconception among tablet manufacturers is that the former would need to inspect the equipment in the same way that tooling manufacturers would. A tooling manufacturer would need to inspect the overall specification of the equipment to ensure that it conforms to the industry’s standard. This is not the case with tablet manufacturers. The tablet manufacturer would only need to inspect a few essential parts such as key wear areas.In-process inspection by tablet manufacturers would usually involve the working length of the punch as well as the cup depth as the two areas are prone to wear. Other areas such as the barrel diameter, overall length and tip dimension are not crucial as they do not change or are impossible to inspect accurately.

Punch Working Length Dimension

In measuring, the working length of the new punch is different compared with measuring a worn punch. Unlike other areas, the working length tolerance applies to the punch only when it comes together with the other tools in the equipment. The working length is graded on a curve. An example would be if a new one is designed with 5.230 inch working length with 0002 in tolerance range with each punch having the working length of at least 5.299 inch but not more than 5.231 in. Worn out tools can wear out to less than 5.229 in but are still within the 0.002 in range. The key area is the total range of 0.002 in which has a working length tolerance of +/- 0.001 in.

Another example is tooling equipment with working lengths of 5.228, 5.227 and 5.226 in which all are below the lower limit of 5.229in for a new tool. The dimensions are however within the limit of 0.002 in. Calculating manually the working length and the tolerance can be time- consuming and difficult for many. Using a computer however would make the process faster, accurate and much easier. It is not recommended though to use the first punch as basis for measurement as the condition of the first punch is not determined and may vary from one punch to another. It is a waste of time to find out later on that the first punch is not at par with the rest of the punches and would require a re-work.

Entering data also presents several problems and one way of overcoming these is to capture the information and process it directly in the computer’s database. The most common way to do

so is to use a USB that is activated through a foot pedal or button. One can transfer the data directly to the computer and step on the foot pedal to stop. This eliminates the possibility of typographical errors, which is quite common especially when dealing with measurements. Some systems can also communicate and synchronize with other software making it easier to input data without the use of foot pedals or press a button to capture the details needed.

Inspection of data stored electronically will allow easier retrieval of information for a review or further analysis. Results that have different tolerances can be reviewed, compared with other reports making it easier to check and identify any inconsistencies. This automated approach makes it easier to review data compared to viewing the reports manually. Information such as the average, minimum and maximum as well as range differences can be added as well. The automated system can compare reports between several inspections.

Another use for the automated system is during tool matching. Here one can utilize the data already collected to generate reports that are otherwise hard to provide when conducting a manual inspection. Matching is important as it allows the tablet manufacturer to lower any deviation of the tablet’s thickness as well as hardness. Matching occurs by sorting the upper and lower punches based on the longest to shortest sequence. If the previous data is already stored electronically, it is easier to provide the result in a matter of seconds. This is not the case when done manually as it would take longer to process the data and uniformity may not be established.

An inventory of the company’s entire tooling equipment is another advantage with using technology, as the database can be an excellent source of information. Data can be easily shared among tool manufacturers and tablet manufacturer and vice versa. One no longer needs to do a manual entry as the database already has the information of each tooling equipment as well as inspection data. This also eliminates the need to re-enter any previous information.

Laser Technology

The advent of laser technology allows inspection without any intervention of the inspector. Low cost laser devices can be integrated allowing for non-contact inspection. This is beneficial as inspection can be done without any direct contact with the tooling equipment, some of which have sensitive tips that can easily have scratches or marks on it. Measuring the cup’s depth is done easily as one uses the laser to measure the depth without the possibility of damaging the tip-face of the equipment. A simple button would activate the laser and the value collected is recorded instantly. Some lasers are powered electronically and as such can reduce operating expenses such as the need for supporting equipment (ex. Compressed air).

Unconventional Ways To Monitor Tools

There are different ways to monitor wearing of tools aside from inspecting the tool itself. One way to do so is to track the number of tablets manufactured within a set of tools and use the historical data for comparison. An example would be when the historical data states that the tools have a record of producing 1M tablets on average; therefore, if the tool is producing 800,000 tablets, the tool wear is at 80%.

A database that has the capability to record the tool use and compare it with the total estimated yield makes it easier to monitor the tool wear. The information can also help the manufacturer have a backup of the tools or be warned when the tool needs to be replaced. Correct

forecasting allows tablet manufacturers to contact the tool vendor and request for the needed equipment with plenty of lead times.

Other tool control information obtained from the inspection would also be useful. Entering data such as drawings makes it easier to track and maintain tool specifications and provides a visual for any changes in the care procedures.

Multi-tip Tooling Inspections

The multi-tip tooling is relatively new in the market and as such presents new challenges especially when it comes to the inspection guidelines. As the equipment has several tips, punches and working length as well as overall length, the software to be used must differentiate each tip’s information. The ideal method in tool matching for multi-tip is to measure the working length for each tip and average the values of the combined working length for the punch assembly. The average of each upper length working length is then matched with the corresponding average length of the lower punch during the tool matching process. Although it is possible to match one tip to another individually, it is time consuming to do so.

Digital Technology

The advent of digital technology enables taking pictures of the equipment during the inspection process. The pictures taken are then uploaded to the database for reference and can be linked to previous records, attached to email and even sent to the tool vendor for analysis. The process enables other individuals to check and have access to the information provided by the inspector.

Inspection of the Die Punches

To date, there is no cost effective way to do an inspection of die punches. During inspection, one would focus mainly on the wear points on the die, which is the inner diameter, and the die bore. Measuring the inner diameter of round shape dies is easy; that said, measuring non- circular objects is the problem. Measuring an oblong shaped die bore would require one to measure the minor and major axes. It is difficult to measure the centre line of both the major and minor axes accurately and failure to measure the axis correctly would lead to incorrect measurement.

Another wear point area is the place inside the die where the compression takes place, also called as the “wear ring”. Any problem in this area would mean that the die is no longer acceptable for use. One method that inspectors used is called “bore sight” where any visual ring would suggest a dimensional wear. One would also use a sensitive deviation indicator, which would help determine the die’s functionality. One can use a bore gauge to measure the wear ring; however, it may depend on the depth and variation of the die bore. One can also do a visual inspection and look for damages such as cracks, nicks, wear rings as well as abrasions.

How to Measure the Tip Diameter

It is difficult to measure the tip diameter of a worn punch and as such, one does not normally make an in-process inspection. As wear only happens on the edge of the leading tip, a conventional contact measure equipment is ineffective. Using a micrometer to measure the tip straight is often a failure as the wear is usually difficult to see with the naked eye. This is not the case when measuring a new tip, as they are still new and not worn. The tip diameter dimension is another type of measurement often used by tooling manufacturers but not forin-process

inspections of tablet manufacturers. To measure the tip, digital measuring equipment and optical comparators are available.

Security Features

To prevent the corruption of data, it is important to include security features to protect the database. An electronic audit can be used to record previous data before new data or information is added or deleted. Referring to previous data would help check if there is a modification or alteration of previous data.

Summary

Changes in the inspection process have long been overdue and thanks to the advent of technology, the tooling industry is now ahead. What was once a costly process has now evolved enabling one to collect data and help improve the quality of tablets. A database of tooling data makes it easier to provide information, forecast and even provide historical analysis. The automation of many processes allows non-contact inspection, which reduces the risk of damages to sensitive tooling equipment. The use of technology enables tool manufacturers to produce high quality tablets more efficiently.

The pressure that the industry faces helps promote changes. The changes in terms of monitoring, manufacturing and consistent quality is an evidence that the sector realizes the need for the industry to work more efficiently. The success and failure of the approaches depends on the understanding and knowledge of each one involved.

Although there is still a challenge when it comes to powders, modern techniques help in alleviating this problem. Understanding the different dynamics of the process allows one to understand the properties that are essential to the said process. This approach allows one to quantify and measure the terms of parameters. The approach is still in some extent empirical; however, it is more superior than relying on manual methods or through experience. Current technology allows one to test different methods with the use of a single instrument providing ease of access to data. The information opens up a world of accessibility and transferability of the knowledge allowing many in the industry to study the complexities of the process and develop new ideas and products.