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was a lot to ask, but ACG's sales manager said his company could do it and offered a plan to complete the job. "He came to the rescue," the R&D head stated. "Nobody else could commit to bringing this equip- ment this quickly to the site and make it happen. "For my management, it was like 'Wow, can they really do it in that time?' I was skeptical from my end as well because it was really a tight timeline. This was a full machine—entirely brand new with cus- tomization and every- thing—to fill micro- tablets into capsules of three different sizes. This is a huge under- taking." But according to ACG's timetable—which spelled out what had to be done each day—it was doable. Work the plan On February 1, 2015, ACG received the purchase order for the machine, an AF90T tamping-style automatic capsule filler, which was to be built at ACG's facility in India. By 42 April 2016 Tablets & Capsules Speedy delivery: Manufacturer gets specialized capsule filler in record time " W e knew a few people and companies that could do the work," he said. But none of them could furnish the new change parts quickly enough to meet the company's ambitious schedule. It called for filing an abbreviated new drug application (ANDA) before the end of 2015. For that to happen, the company needed to launch 6-month stability tests by late June 2015. Waiting months for change parts wasn't an option. "So we asked, 'Is there anybody else who has this equipment available and can deliver on time?' It was very tight, 3 to 4 months." That's when the R&D head contacted ACG. Plan the work At the December meeting, the manufacturer described the product and explained to ACG what it required. "They would have to trans- fer the equipment from wherever it was, customize it to manufacture the product, plus perform the trials and qualification and everything else." It ACG customized its AF90T capsule filler to manufacture a challenging new product. The machine underwent FAT in India 6 weeks after the purchase order was received. Three months later, it was manufacturing the product at a facility on the East Coast. I N D U S T R Y In December 2014, the head of R&D process engineering at a major pharmaceutical manufacturer was pre- siding over a meeting with representa- tives from ACG North America, a South Plainfield, NJ, supplier of empty capsules, capsule fillers, tablet presses, and other solid dosage equipment. "The executive committee had decided to take on a challenging product," said the R&D head, who asked that neither he nor his company be identified. "It was a very smart decision, because this is a niche prod- uct where we can go in and stay with- out competition for a long time." But the executive committee was with- holding its full approval until the R&D staff developed the process and located all the m a c h i n e r y needed to make the product. The first part of that challenge— process development—was met quickly, and most of the equipment was already on site. Just one critical component was missing: a capsule filler to dose the product's micro- tablets. So the R&D head expanded the search and learned that his com- pany had manufactured similar prod- ucts at a European site. Could those machines be modified to handle the new product? a p p l i c a t i o n The team beat the deadline by 10 days and all three dosage strengths were ready for stability testing.