Issue link: https://www.e-digitaleditions.com/i/1331851
22 January/February 2021 Tablets & Capsules Ensuring adequate vacuum Filling capsules efficiently is difficult if they don't open easily. Effective capsule separation is critical, so pay careful attention to the machine supplier's recom- mendations for vacuum pump settings and maintenance of all related system components, including filters, seals, and vacuum lines. Cleaning Simply keeping a capsule filler clean at all times will improve its performance. And other than in contained applications, where it may not be possible to open a machine mid-campaign, cleaning doesn't need to be limited to between batches. Periodically wiping interior components and surfaces, vacuuming excess formulation, and maintaining optimal dust extraction can help ensure the free movement of all parts and sub-assemblies. Training While comprehensive operator training is important for any type of capital manufacturing equipment, it is critical for capsule-filling machines because they are so complex and contain so many moving parts. Still, drug product manufacturers often overlook this essential com- ponent of a successful capsule-filling operation. Many equipment suppliers offer training programs that can be tailored to a company's specific needs, but all such pro- grams should at least cover machine setup, operation, and maintenance. The most reputable suppliers retrain their own technicians regularly, and end users should capital- ize on that progressive expertise. At a minimum, a good operator training program should cover the following: • A basic overview of encapsulation processes; • Capsule sizes and specifications; • An introduction to major sub-assemblies and their functions; • How to develop effective, comprehensive standard operating procedures for such tasks as machine use, cleaning, and tamping-pin station removal/installa- tion (for machines that offer such capability); • The user interface and how to make machine adjustments; • Best practices for handling empty capsules; • Format parts and wear patterns; • How to create product recipes (for machines that offer such capability); • Capsule separation and vacuum requirements; • Dosing and how to use a slug tester; • Key methods for alignment operations; • How to troubleshoot process-related issues; • Calibration methods; and • Preventive maintenance procedures (see below). It is impossible to overstate the importance of sound training; after the equipment investment itself, training should receive the highest priority in an encapsulation process. facturers, approximately 400 to 450 billion hard capsules are produced per year, with an upward trend. Each dosage form brings its own challenges for drug product manufacturers, but capsule filling is generally more complex than tableting because the formulation— typically in powder, pellet, or liquid form—must be inserted into the empty capsules. This involves feeding and opening the empty capsules, compressing (in the case of powders) and inserting the formulation into the shells, then closing and ejecting the filled capsules, all at high speeds, which is inherently more challenging and mechanically complex than tableting. While the latest capsule fillers offer a suite of novel approaches, the overwhelming majority of capsule fill- ers currently installed and in operation are cam-driven machines that rely heavily on high degrees of synchro- nization. Each step in the process is inextricably linked to every other step, and any change to a particular move- ment can impact all the other movements. As complex as the encapsulation process is, paying close attention to a few key factors and machine attributes can effectively minimize the number of headaches that may otherwise arise. The following are just a few factors that can help you optimize your capsule filling operation and avoid undesirable occurrences, such as machine crashes. Storing and handling empty capsules Empty capsules are fragile, precise, and tempera- ture-sensitive, and you must give careful consideration to their storage and handling. Each manufacturer of empty capsules offers its own guidelines on the temperature and relative humidity (RH) ranges most suitable for storage (generally between approximately 59°F and 77°F and 40 to 60 percent RH). Following these recommendations is imperative, as failure to do so can create unnecessary problems with capsule separation and closing. Careful handling is equally important, as seemingly small capsule defects, such as dings or dents can also create problems. The simple practice of treating empty capsules with the utmost care can pay big dividends. Handling format parts On a tablet press, product-specific change parts are generally limited to fill cams and tooling, whereas a cap- sule filler has a significantly larger number of change parts. These typically include: • Sorting blocks; • Push forks; • Magazines and segments; • Tamping pins; and • Dosing discs. Operators should handle all of these components care- fully at all times to ensure that they retain their factory tolerances and to minimize the risk of damage—primarily due to impact—that can, and often does, prevent good capsule movement and accurate weight control. Care- lessly tossing components onto a table during changeouts is a recipe for headaches down the road.