Developments in Tooling Inspections and Technology

Transcription

1 Developments in Tooling Inspections and Technology Robert Caruso Inspecting punches and dies can be timeconsuming and costly for tablet manufacturers. Advances in technology, however, have greatly improved in-process inspections. The author examines improvements in equipment and computer software for in-process tool inspections. Punch Working of a punch The distance from the head flat to the the lowest measurable area of the punch cup Considered the most important dimension in a tool-inspection program Working Figure 1: The working of a punch. Robert Caruso is the software support manager at Natoli Engineering, 28 Research Park Circle, St. Charles, MO 63304, tel , fax , rcaruso@natoli.com. Tablet-tooling inspections present many challenges. Inspecting punches and dies can be time-consuming and costly for tablet manufacturers. Sometimes the cost is prohibitive and leads to cutbacks in the frequency of inspections or even eliminates them entirely. This situation is unfortunate because the quality of the tablet is determined in large part by the quality of the tooling. Every aspect of tablet production may be set up and run perfectly, yet if the tooling is of poor quality, the tablet quality will suffer. The only way to truly determine that tooling conforms to allowable specifications is to inspect the tooling for defects and excessive wear. Inspection data represent an additional challenge of the tool-inspection process. Often, inspection results are recorded on paper stored in a file and never seen again. Improvements in equipment and computer-software technology, however, have helped to make in-process tooling inspections more efficient and productive for tablet manufacturers (1, 2). Tooling inspections by tablet manufacturers A misconception is that the tablet manufacturer needs to conduct in-process tooling inspections in the same manner that a tool manufacturer conducts them. The tooling manufacturer must inspect all dimensions to ensure that the tools were manufactured to industry standards. The tablet manufacturer, however, does not need to inspect all punch dimensions and can concentrate on a few critical dimensions. Once dimensions have been confirmed during the tool-manufacturing process, only a few key wear points are of concern. For the most part, in-process inspections performed by the tablet manufacturer should be limited to the working of the punch and cup depth as these two dimensions have the greatest impact on tablet quality (see Figures 1 3). The remaining dimensions, such as barrel diameter, tip dimensions, and overall, are not critical because they do not change often or are difficult, if not impossible, to inspect accurately and consistently. Punch working- dimension. Measuring the working of a new punch is different than measuring the same dimension of a worn punch during an in-process inspection. Unlike other dimensions, the working- tolerance applies ALL FIGURES ARE COURTESY OF THE AUTHOR s30 Pharmaceutical Technology TABLETING 2008 pharmtech.com

2 Working Variation within complete set should not exceed range of in. (0.50 mm). Equals reference in. ( mm) after application of a land. Cup depth Cup depth Land Working Upper punch.002 in. (.05 mm) T.I.R in. Ref. ( mm) tablet thickness Tablet Sidewall thickness Figure 2: The working of a punch compared with the overall. T.I.R. is total indicator reading. Working Lower punch to each punch only in relation to the other tools within the set. Working is graded on a curve. For example, if new tools are designed to have a working of in. with a tolerance range of in. (i.e in.), the analysis of new tools simply requires that each punch have a working of at least in. but not greater than in. Worn tools, however, can wear to a that is less than in. as long as they all are within the in. range. The key point to consider is the total range of in. provided by a working- tolerance of in. Continuing the example, although working s of 5.228, 5.227, and in. are below the lower limit of in. for a new tool, these dimensions are still within the in. range of each other. Manually calculating which tools are within each other s specific tolerance range and at what working can be difficult and time-consuming. Using a computer with the proper software, however, can make the process much easier. Moreover, using the first punch as the basis for comparison and simply comparing the measurements of the remaining punches with the first is not recommended as the condition of the first punch is not always certain. After completing an entire inspection, it would be unfortunate for the tablet manufacturer to discover that the first punch was the most severely worn, but was used as the comparative basis for the entire tool set. Data entry. Data entry presents various obstacles during the inspection process. Overcoming these obstacles requires that the process be as efficient as possible. Several methods for capturing inspection data directly into a personal computer s database or spreadsheet may be used rather than typing or writing the measurements by hand. The most basic approach is to connect the measuring gauge to a USBconnection tool activated by a button or foot pedal. With this approach, the inspector transfers the value (i.e., the reading) on the gauge directly to the computer database or spreadsheet whenever he or she pushes the button or steps on the foot pedal. The inspector no longer needs to take the time to s32 Pharmaceutical Technology TABELETING 2008 Figure 3: In tool matching, the longest upper punch is matched with the shortest lower punch based on their working s. write or type the inspection measurements. This approach eliminates the potential for typographical errors, which are common when dealing with measurements that have threeor four-place decimal-point accuracy. Some inspection systems provide greater convenience and efficiency by enabling communication between the measuring devices and the software through a serial cable or USB connection. Usually, systems with sophisticated communication can eliminate the need for the technician to step on a foot pedal or press a button to capture data. Data storage.storing inspection data electronically facilitates easy data retrieval for review or analysis. Inspection results with allowable tolerances can be readily compared by clicking a mouse to produce a report that lists each tool and identifies any measurements that exceed allowable tolerances. This automated approach is much better than visually reviewing a printed document for such occurrences. Summary information such as average, minimum, and maximum dimensions and range can be included in the automated report. An automated system can easily issue a report that compares each dimension and calculates the difference between two inspections. Tool matching. Tool matching is an excellent example of how an automated system can utilize inspection data that have already been collected to generate reports which are difficult to produce in a manual system. The purpose of matching the longest upper punch with the shortest lower punch based on their working s is to allow the tablet manufacturer to minimize deviations in tablet thickness and hardness (see Figure 3). The process consists of sorting the upper punches in sequence from longest to shortest and sorting the lower punches in opposite order (i.e., from shortest to longest). If pharmtech.com

3 More difficult to measure punches with embossing or a bisect at lowest area of the punch cup Measure from the deepest area of the cup accessible with the point of the indicator Be sure to measure consistently punch-to-punch Figure 5: The working of the punch is obtained using the deepest point of the cup. Figure 4: An example of tool-matching report. the working- measurements collected during the last inspection are stored electronically, producing this report takes only a matter of seconds (see Figure 4). Completing the process manually would take much longer and possibly prevent a tablet manufacturer from improving consistency in tablet thickness and hardness. Databasing tooling inventory. Establishing a comprehensive database of a tablet manufacturer s entire tooling inventory creates a great source of information. By transferring electronic files between computer systems, data can be passed from the tool manufacturer to the tablet manufacturer, downloaded, and integrated directly into a tooling database. No manual data entry is required. An electronic tooling database can include information such as size, shape, steel type, purchase order number, tolerances, cup configuration, embossing, and inspection data. An additional benefit of using a database to store tooling information is that it eliminates the need to retype the same information every time that it is needed for a report or an inspection. Laser technology in tooling inspections Laser technology allows tooling to be inspected without the inspector touching the tip of the punch. Relatively low-cost laser measurement devices may be incorporated for a noncontact inspection. In a noncontact inspection, various tool dimensions are measured without a gauge probe ever physically touching the surface of the punch tip. This technique eliminates the potential for scratching the sensitive tip face of the punch. Typically, a punch tip with a deep cup, bisect, or embossing requires a relatively sharp gauge tip to access the deepest point of the cup. Measuring the deepest point of the cup is necessary to obtain the working of the punch accurately (see Figure 5). Unfortunately, the sharper gauge tip has a greater risk of scratching the face of the punch tip. Noncontact laser measurements eliminate the risk of tip-face damage and will speed up the process because this method typically requires few moving parts. A button is pressed to activate the laser for a measurement, and the value is collected and recorded instantly. Electrically powered laser measuring devices further reduce overall maintenance costs and the requirement for supporting systems such as compressed air. Alternative methods for monitoring tool wear There are other ways to monitor tool wear besides tool inspections. One method is to track the number of tablets produced with a set of tools and to use the historical data for forecasting. For example, if history indicates that a set of tools has typically produced 1 million tablets on average per tool and 800,000 tablets were produced, the tool wear is 80%. A database designed to record tool use and compare it with an estimated total yield makes monitoring tool wear relatively easy. This information can also provide a notice to prepare a backup set of tooling or signal a warning that the tooling should be monitored more closely. Properly forecasting toolreplacement needs allows tablet manufacturers to contact tool suppliers in a timely manner to improve lead times for procuring needed equipment. Other tool control-related information is useful to maintain in a tooling database. For example, storing drawing files electronically is much more efficient than keeping track of Pharmaceutical Technology TABLETING 2008 s33

4 Extreme tip wear Detail A Worn area Figure 6: Typical wear of a punch tip occurs at the leading edge of the tip. hardcopy drawings. Using a database to track tool-related activities such as maintenance or issues found during visual inspection provides many opportunities for trend analysis to justify changes in approach to tool-care procedures. Inspections of multi-tip tooling Multi-tip tooling is a relatively new phenomenon in the tablet industry and presents its own set of challenges to the inspection process. With multi-tip punches, a tool has a separate cup, working, and overall for each tip on a single punch. The software that tracks this information must differentiate between each tip on a punch. For example, a punch with three tips will typically be numbered as Tool Number 1 with Tips A, B, and C, then Tool Number 2 with Tips A, B, and C, and so forth. The preferred method for toolmatching with multi-tip punches is to measure the working of each tip, then average the values for the combined working for the punch assembly. The average working of each upper punch then is matched with the corresponding average working of the lower punches during the tool-matching process. Although it is still possible to match each tip of an upper punch with each tip of a lower punch according to individual working s, this approach would be very time-consuming. Vision-system and digital technology Vision-system technology and digital photography make the practice of taking pictures of punches during inspection more common. A digital photo of a suspected issue with a particular punch can be saved as an electronic file. The electronic file can be linked to inspection records, attached to an , or forwarded to the tablet manufacturer s management team or to the tool supplier for analysis. This process allows other interested parties access to the same view of the punch as the tooling technician has. Die inspections Technology has yet to provide a cost-effective solution for die inspections. As with punches, the tablet manufacturer does s34 Pharmaceutical Technology TABELETING 2008 Figure 7: Contact measurement of a typically worn punch. not need to focus on every dimension of a die in the same manner as the tool manufacturer. The crucial wear points on a die are the inner diameter (I.D.) and the inner surface area of the die wall (known as the die bore). Measuring the I.D. of a round die is relatively easy; it is the nonround or oblongshaped die bore that presents a problem. Measuring an oblong die bore requires the measurement of both the minor and major axis. Determining the center line of each of the minor and major axis is difficult to do accurately and consistently. Failure to correctly measure each axis could result in an incorrect measurement. Another key wear point of a die is the location inside the die bore where tablet compression takes place. This location is often referred to as the wear ring. Any occurrence of a wear ring may indicate that the die is unacceptable for continued use. The most common inspection method is to bore sight through the die bore with a bright light on the far side. Any visual ring indicates dimensional wear. Further inspection of a wear ring using a sensitive deviation indicator may help determine the functionality of the die. Although inspecting a wear ring can require a certain amount of equipment setup, depending on the extent of variation of each die bore, the depth within the wear ring can be measured with a bore gauge. The primary method for inspecting dies, however, is to conduct a visual inspection that diligently looks for damage in the form of nicks, cracks, and abrasions on the outer walls and wear rings within the die bore. pharmtech.com

5 Measuring tip diameters Because measuring the tip diameter of a worn punch can be difficult, this dimension is not recommended for inprocess inspections. Measuring the tip diameter of new punches is relatively easy, but the tip diameter of a worn punch is difficult to measure accurately and consistently. Typical punch tip wear occurs only at the leading edge of the tip (see Figure 6), so conventional contact-measuring devices are ineffective. Using a micrometer on the tip straight will often fail to capture the diameter of the outermost edge of the tip (see Figure 7). Because the amount of wear can be difficult to see with the naked eye, an inspector may be left with a false sense of accuracy. This situation is typically not a problem for new tools because they are not worn. The tip-diameter dimension is another example of a measurement that is included in the inspection by a tool manufacturer but excluded from the in-process inspection by a tablet manufacturer. Various imaging equipment such as optical comparators and digital-measuring systems are available to assist with viewing and measuring this dimension. Electronic audit and security Electronic-audit and security features should be built into any tool-management database to prevent the loss or corruption of data. An electronic audit is the function of recording data as they existed prior to any modification or deletion. Referring to previous audit data records can be helpful if any data are modified inadvertently or otherwise altered. Conclusion Improvements in tooling management and inspection have been long overdue, and advances in technology bring the tool room into the 21st century. What was once a costly and timeconsuming process that often involved storing paper in a file has become an efficient procedure for capturing valuable tooling data that can be used to improve tablet quality. The oncedifficult task of analyzing working s, the most critical punch dimension, is now incorporated into the inspection process. An entire database of tooling data can be created and maintained with little effort and used to provide information, tool forecasting, and historical analysis. Automated and noncontact inspection systems reduce the risk of punch-tip damage from handling or scratches during the inspection process. Magnified images that highlight tool conditions can be circulated for improved troubleshooting. At last, tool-control functions are using technology to help the tablet manufacturer produce better quality tablets more efficiently. References 1. Tableting Specification Manual, L. Young Ed. (American Pharmacists Association, Washington, DC, 7th edition, 2006). 2. Encyclopedia of Pharmaceutical Technology, Thermal Analysis of Drugs and Drug Products to Unit Processes in Pharmacy: Fundamentals (Vol. 15), J. Swarbrick and J. Boylan, Eds. (Marcel Dekker, New York, 1997). PT Powder Characterization Continued from page s11 The way forward The pressures on the pharmaceutical industry are catalyzing change. Designing quality into the product and manufacturing process (quality by design), monitoring and controlling processes to consistently produce the correct material (process analytical technology), and the long-term trend toward continuous processing are all evidence that the sector recognizes the need to work more efficiently. The success of such approaches ultimately rests on the development of better understanding. Although powders present a challenge to the formulator and processor, modern powder-characterization techniques have much to contribute. Correlating various powder properties shear, bulk, and dynamic with product performance or processing behavior develops understanding of the properties that are critical for a given application. This approach allows experience to be quantified in terms of parameters that can be measured reproducibly. The experience that A processes well while B is much worse can be converted into knowledge that A processes better than B because it has a BFE in the range x to y, a compressive strength of z, and deaerates after only two deaeration cycles. The approach remains to some extent empirical, but it is vastly superior to development and operation that depend solely on experience. State-of-the-art powder testers offer a suite of testing methodologies in a single instrument, thus providing access to the necessary data. The information opens up a route to better understanding and the development of transferable knowledge. These systems have an important role to play in helping the pharmaceutical industry conquer the complexities of powder processing and more effectively develop new products. Reference 1. R. Freeman, Measuring the Flow Properties of Consolidated, Conditioned, and Aerated Powders A Comparative Study Using a Powder Rheometer and a Rotational Shear Cell, Powder Technol. 174, 25 33, (2007). PT Pharmaceutical Technology TABLETING 2008 s35