Good Manufacturing Practice
NCK has its own multi-purpose pilot plant facilities operated under Good Manufacturing Practice (GMP). They consists of a large and a small pilot plant, a final handling room with two drying cabins and several storage areas and utility rooms.
“The old pilot plant 24” (108 m2) is housed in a single story concrete building and was build up over the yars 1980 – 1990 and from the beginning of the nineties operated under GMP. It contains five production lines equipped with glass or glass-lined reactors, ranging from 40-250 L (-20°C to +150°C) plus one 150 L steel reactor used for cryogenic reactions (-80°C).
“The new pilot plant 69” (1,154 m2) is housed in a large, two story concrete building and was constructed in 2020. It contains five separate production suites and two auxiliary suites for isolation and discharging of solid materials. Two of the production suites are equipped with three 250 L glass lined reactors operating from -25°C to +120°C. The remaining suites are not yet in use. The plant also has dedicated storages for chemicals, solvents, packaging materials, equipment and waste.
In addition to traditional chemistry manufacturing, NCK has a vast experience with downstream purification using both normal phase chromatography (flash) and low pressure, reverse phase chromatography (LPLC).
Our new state of the art pilot plant
The building of the “the new pilot plant 69” was finished and inspected by the Danish Medicine Agency in the spring of 2020. The plant contains five separate production suites, each suite designed for installation of two separate reactors. Currently two suites are taken into use with three 280 L glass lined reactors, and additional suites will be included over the cause of 2021.
The facilities are staffed with a highly experienced team.
When a project is transferred from the laboratory to the pilot plant, the responsible project manager actively participates in the transfer and production and has the overall responsibility.
The pilot plant work is performed under our SOP system, e.g. controlled production documentation and Quality Assurance involvement, including equipment cleaning verification, training, auditing, release/approval decisions and investigations.
