SternMaid Achieves GMP Certificate
SternMaid processes active pharmaceutical ingredients and excipients and manufactures nutrient premixes in a modern Bohle container blending unit.
Dec 7 2011 --- After successful qualification of the counter-current container blending line and validation of the relevant cleaning process in accordance with Part II of the EU GMP Guide, SternMaid has now been awarded the official GMP certificate by the competent drug inspectorate. This step enables the outsourcing specialist to manufacture pharmaceutical blends of active chemical ingredients and excipients with GMP certification. Frank Hellerung from Business Development Pharmaceuticals and Food: “The certificate is an important requirement for cooperation with companies in the pharmaceutical industry. We had been working to GMP standards already, but we lacked the official audit. We passed the audit with no trouble at all, and are now looking forward to new challenges.” And these new challenges are already in sight: at CPhI Worldwide in Frankfurt, numerous visitors to the exhibition stand showed great interest in SternMaid’s services. “We had numerous meetings that led to concrete inquiries”, Hellerung explains. “The biggest response was to our new fluid bed processor, but there was a great demand for blending pharmaceutical substances too.”
SternMaid processes active pharmaceutical ingredients and excipients and manufactures nutrient premixes in a modern Bohle container blending unit. The unit is made entirely of stainless steel, installed in a completely independent part of the factory and meets the strictest hygiene requirements. With the aid of the production plant the outsourcing specialist also carries out repacking orders. “We have a fairly large mixer for the pharmaceutical sector”, Frank Hellerung says. “That means customers can have large batches made up and save on analysis costs.” Analysis is a major cost factor in the manufacture of products for the pharmaceutical industry. Each batch has to be subjected to thorough tests. But many manufacturers can only produce batches of 300 kg at most on their blending equipment, whereas SternMaid can process three times this amount in one batch. As far as packaging materials are concerned, practically any requirements can be met: drums, sacks, fibreboard boxes or big bags, but also individual packs. And on request, SternMaid can also carry out special tasks such as control sifting and metal detection besides contract repacking from industrial containers.
Most important: the new Glatt fluid bed processor will widen the range of services to include coating, agglomerating, granulating and drying. The new unit is in two parts: it consists of a smaller plant for pilot runs and a large industrial-scale plant. The smaller pilot plant is already available for testing in the technical trials department, and the large plant is due to be commissioned in May 2012. This new production unit will also be built to pharmaceutical standards and designed to meet the requirements of the EU GMP Guide. It will subsequently be GMP-certified.
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