Tablets Capsules

TC0317

Issue link: http://www.e-digitaleditions.com/i/793410

Contents of this Issue

Navigation

Page 33 of 55

32 March 2017 Tablets & Capsules Patheon, based in Durham, NC, is a leading CDMO that operates worldwide and provides a full menu of services to the pharmaceutical industry, including formulation, API supply, finished dosage manufactur- ing, and packaging. Its site in Mississauga, ON, Canada, has long been a repository of the company's solid dosage expertise, particularly for high-potency products. For nearly 30 years, the site relied on a GKF 1200 tamping-style encap- sulator to manufacture clients' capsule products. "There were no major issues with the operation of that machine," said Michael Murray, the manager of process pharmacy. "It's a tank and ran well, but it wasn't too sensitive to deli- cate operations and it wasn't con- tained." But that didn't pose a prob- lem, Murray said. "We were managing without it by using pneumatic con- trols, gravity feed, and other devices to contain the products." Nonetheless, when a client asked whether Patheon would consider upgrading the capsule filling opera- tion, the company reassessed. "The client was satisfied with what we were doing but was concerned with the long-term containment of the product if we grew into volume with it," Muarry said. "This is a client that does very well with containing their products that are high potency. They're class-leading. So it was per- haps a reflection of themselves that they wanted to assist us in acquiring a machine that could better contain this particular product for the safety of our operators." Because the GKF 1200 was reliable and because of SUPAC requirements, Patheon sought to replace it with a similar tamping-style machine. To evaluate the options, the company sent user-requirement specifications (URS) to three vendors, including Bosch Packaging Technology, Minneapolis, MN, which won the business. "Not many companies do tamping-style encapsulators, and Bosch is probably the premier supplier so the selection was easy," Murray said. Tight fit Patheon chose Bosch's GKF HiProTect 1700 encapsulator for use in commercial production and a Bosch GKF Protect 702 encapsulator for use by colleagues in its Product Development Services (PDS) group. The GKF 1700, designed and built for containment, keeps operators iso- lated from the product while it oper- ates and during maintenance and cleaning. It fills as many as 100,000 capsules per hour with powders or pellets and can be equipped to han- dle micro-tablets, liquids, and combi- nation fills. The machine's check- weigher adjusts capsule fill weights as it works to keep products on-spec. After Bosch built the larger machine, Murray and his colleague Nick Walsh spent a week in Stuttgart, Germany, to attend factory-accep- tance tests. The equipment was then shipped to Mississauga, where the smaller machine had arrived 8 months earlier and was in use by PDS. But the larger machine couldn't be installed until Patheon made some upgrades to overcome severe space constraints. "Our site in Mississauga is at its limit in terms of building out- ward, and that presented some chal- lenges in designing the room and then getting all the accessories and auxiliaries that are required for this machine into the appropriate areas," Murray said, including a dust collec- tor and a wash-in-place (WIP) sys- tem. Those and other auxiliary equip- ment were installed on an upper level, with the Bosch machine below. "The dust collector is designed to be on an outside wall, but because we couldn't go out any further on Patheon's property, we had to build within," Walsh said. That meant changing four different design features of the dust collectors to make it explo- Patheon's Bosch's GKF HiProTect 1700 encapsulator will begin commercial pro- duction this summer. The company's Mississauga site also installed a Bosch GKF Protect 702 encapsulator for use by its PDS group. Patheon installs Bosch contained capsule filler, first in North America I N D U S T R Y a p p l i c a t i o n

Articles in this issue

Archives of this issue

view archives of Tablets Capsules - TC0317