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Operators. Even if it's not recorded, the information that long-term employees can provide is nearly unlimited and is crucial for understanding how legacy products are made. These people could be the only ones who remem- ber how things were done before the facility was extended or reorganized. Some might even recall the ini- tial product and process transfer from R&D. Sugar coating is a good example. It was once preva- lent, and required operators to master the art of a confec- tionery process instead of how to click through drop- down menus on a human-machine interface of a film coater as they do today. In North America, sugar coating has all but disappeared, but in Europe it and other old techniques are still used. They're difficult to validate but these practices continue nonetheless thanks to the exper- tise of the operators. Ask them how they make these processes successful. The tooling room is one of my favorite places to explore, and if you're involved in technology transfer, take the time to speak to the employee in charge of the punches, dies, and other change parts. This person can inform you how frequently tooling is ordered and tell you about the specific features of the tooling design, including the addition of special treatments, such as a chrome coating. Whoever is in charge of the tooling room will also know about the tablet presses and the change parts they use, including the force feeders and turrets, and how to set up the press. Ask how the staff conducted troubleshooting of the tablet presses and cap- sule fillers. What worked? What didn't? I've helped transfer multiple products from mature facilities, and in this article I share some of what I've learned. The focus is on how to collect the information you need to gain enough process and product under- standing to facilitate a successful site change without dis- rupting supply. The article doesn't discuss how to handle shutdowns of new facilities when volume falls short of expectations or corporate strategy changes. Old facilities One cause of obsolete production environments is a management decision to save money by not investing in new equipment, even though it would increase efficiency and improve operator safety. Of course, that decision only hardens once managers learn that a divestiture is looming, and instead of being upgraded, such facilities may become donor sites. These facilities—working time capsules many of them—often use manufacturing processes that were adapted to suit the site's physical limitations. At some facilities, for example, the clearance between the ports of the V-type blenders and the ceiling is so tight that they must be loaded by an operator with acrobatic skill. In other cases, workers must scoop the compression blends into the tablet press hopper because it's impossible to dis- charge them from a lifted container or from an upper floor. I've seen a few cases where workers were allowed to charge the V-type blenders indiscriminately via the two ports. In short, there are almost as many different setups as there are companies when it comes to loading mixers and blenders, holding or storing powders, and feeding tablet presses and capsule fillers. Today, companies transfer products into manufactur- ing environments that have a smaller process footprint and require fewer workers. And the high ceilings popular in facilities built after World War II, which allowed pow- der blends to free-fall into the press hopper, are disap- pearing because process engineers recognize that long chutes can cause powders to segregate. Bin blenders are the modern approach. How and where to recover information The black notebook. FDA-approved processes must be run by the book, but if you want to know how things really work at legacy sites, ask long-term employees about their "black notebook." It's usually concealed in their back pocket or locker. While the practices it describes may not meet GMP, the notebook is a valuable source of information because it reveals key process para- meters and/or specific product handling methods that are sometimes decisive in whether a legacy product passes or fails. I remember asking one senior operator whether he had kept notes or drawings from the time when the prod- uct ran well. He had indeed, and that information helped me set up a roller compactor properly. I also recall a note- book that reported that the operators intentionally left compressed cores to "relax" for a few minutes before they were measured for hardness. Good to know! Courtesy of DJS Enterprises, Markham, ON Canada Manesty's DryCota tablet press, a machine used to develop and manufacture many tablet-in-tablet products. Most are now manufactured on more modern equipment. 12 October 2016 Tablets & Capsules