After the recent inauguration of the GMP laboratory in Chile, we presented the new INVIMA authorized conditioning area in Colombia.
The GMP certification was granted by the Colombian regulatory agency INVIMA in July, which allows BOMI to perform manual conditioning processes for room temperature and cold chain pharmaceutical products in the SIBERIA facility in Bogotá. In the case of medical devices, we have a Regional certification granted by the same agency, which also enables warehousing and conditioning in this area.
It has a temperature control system which ensures it will not go above 25°C which is backed by thermal mapping data collected in the beginning of summer.
We currently display 8 conditioning GMP certified lines: 5 labeling lines, 2 inkjet lines and 1heat shrink line. The processes carried out are kit Assembly, simple and double labeling (regulatory labels or product identification labels), sealing, heat shrinking, inkjet printing, insert changes, regulatory labeling and damaged good inspection.
There is enough inkjet printing output to support the 9000m2 Siberia III operation, and it can be increased with an additional certified line at headquarters, depending on customer demand and product packaging.
“The challenge is to offer our pharmaceutical and medical devices customers faster processes and the best quality solutions in all activities. Siberia III is undoubtedly a site with excellent infrastructure conditions so the labeling and kitting area has to be top quality class too.” Says Juan Sebastián Esguerra, Sales Head of BOMI GROUP in Colombia.