Similasan AG develops and manufactures homeopathic medicines. The company, based in Jonen in the canton of Aargau, employs around 100 people in Switzerland. Its product range includes more than 110 homeopathic preparations approved by Swissmedic. Similasan is the world's largest manufacturer of natu…
Die Hygieneanforderungen an die industrielle Herstellung von Pharma, Lebensmittel- und Kosmetikprodukten nehmen kontinuierlich zu. Die Globalisierung und die weite Verbreitung von Produkten für Menschen und Tiere können im Ernstfall weltweite Auswirkungen haben. Obwohl alle drei Branchen unterschi…
The month of March was particularly busy for AM, with a strong presence at international trade shows and events. These included the Lounges 2025 stood out as a valuable opportunity to present innovative solutions in the pharmaceutical secondary packaging sector. Elena Mantegazza, Product Specialist…
With the implementation of the EU GMP Annex 1 ("Manufacture of Sterile Medicinal Products"), pharmaceutical companies are facing new challenges, particularly in the fill-and-finish processes—the filling and final processing of medicinal products. Annex 1 introduces expanded requirements for the op…
The implementation of EU GMP Annex 1, which sets strict requirements for the production of sterile medicines, presents new challenges for pharmaceutical companies. In the foreseeable future, Ralf Wagner, Sales Director for the DACH region, Portugal and Spain at Optima Pharma, believes that glove int…
With the implementation of the EU GMP Annex 1 ("Manufacture of Sterile Medicinal Products"), pharmaceutical companies are facing new challenges, particularly in the fill-and-finish processes—the filling and final processing of medicinal products. Annex 1 introduces expanded requirements for both e…
How Isolators, RABS, Laminar Flow Hoods, and Biosafety Cabinets Compare
During sterile manufacturing, human operators pose the greatest risk for product contamination. To reduce microbiological and particulate contamination risks, aseptic techniques typically rely on either laminar flow equipment use…
In light of the new version of Annex 1, which came into force in August 2023, many pharmaceutical manufacturers are facing the question whether they must invest in new equipment. However, in many cases upgrades are a good alternative, as the Danish company AJ Vaccines showed. Together with this cust…
A fundamental consideration in Annex 1 is the risk posed by people and the necessity to exclude people from Grade A environments. Any personnel interaction with Grade A poses a risk. The primary means to address this is trough the use of separative devices – isolators and forms of RABS.
Once again, we…
“For disinfection to be effective, prior cleaning to remove surface contamination should be performed. Cleaning programmes should effectively remove disinfectant residues. More than one type of disinfecting agent should be employed to ensure that where they have different modes of action, their co…
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