{"id":35291,"date":"2022-07-26T15:55:00","date_gmt":"2022-07-26T13:55:00","guid":{"rendered":"https:\/\/fhi.nl\/nieuws\/zeer-nauwkeurig-doseren-conform-gmp\/"},"modified":"2024-07-10T13:23:58","modified_gmt":"2024-07-10T11:23:58","slug":"zeer-nauwkeurig-doseren-conform-gmp","status":"publish","type":"news","link":"https:\/\/fhi.nl\/en\/news\/zeer-nauwkeurig-doseren-conform-gmp\/","title":{"rendered":"Very accurate dosing in accordance with GMP"},"content":{"rendered":"
\n\n\t\n\t\t\t
<\/div>\n\t\n\t
\n\t\t
\n\t\t\t
\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t

\n\t\t\t\t\tVery accurate dosing in accordance with GMP\t\t\t\t<\/h1>\n\n\t\t\t\t
\n\t\t\t\t\t<\/svg>\t\t\t\t<\/div>\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\n\t\t\t\n\t\t<\/div>\n\t<\/div>\n<\/header>\n\n\n\n
\n\t
\n\t\t\t\t\t\t\t\t\t\t\t
\n\t\t\t

Preventing API waste with a GMP-adapted micro dosing system. It worked with combined forces. An economical and safe solution, also for your process! Completely validated according to GMP.<\/em><\/p>\r\n

A major player in the pharmaceutical industry had long been familiar with the application of the highly accurate and pulsation-free micropumps of HNP Mikrosysteme on a laboratory scale. Over time, increasingly more far-reaching questions and requirements were asked. For the very accurate dosing of 2 products, 2 microdosing systems were ultimately requested in accordance with GMP. However, the systems of HNPM are not standardized on GMP.<\/strong><\/p>\r\n\"\"\r\nHNPM MoDos micro dosing system. GMP compliant.\r\n\r\n

GMP (Good Manufacturing Practices)<\/h3>\r\n

In order to comply with\u00a0GMP<\/a>\u00a0quite a few demands are made. Both on the materials used and the roughness of the surface and with regard to the cleanability of the dosing system. Because contamination is undesirable and even not allowed. The ultimate goal of GMP is to always guarantee the same high quality product, without the risk of cross-contamination by residual product in one of the components of the process equipment.<\/p>\r\n

GMP provides a number of procedures and guidelines. The purpose of the procedures is to make each component traceable. All batches must be validated. This means that they are recorded with certificates. For laboratories, this means that DIN is used as a guideline. This is a European guideline. This also immediately complies with CE.
Only a carefully recorded and controlled production process ensures the quality of a medicine.<\/p>\r\n

The standard microdosing systems of HNPM do not meet GMP. To achieve this, adjustments had to be made.<\/p>\r\n

Our solution<\/h2>\r\n

To prevent material from remaining in the dosing system and unnecessary API usage, the standard system has been modified on several fronts. A special flow meter that meets GMP was also selected.<\/p>\r\n