New injection-delivery systems have introduced new challenges to package validation and product development, particularly for container closures. Each component coming in contact with the critical product path must be validated to provide a reliable sterile barrier. Planning for container-closure integrity testing of the delivery system is crucial.
Shelf life is the length of time that foods, beverages, pharmaceutical drugs, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption.
Shelf life studies are used to determine how long a product can reasonably be expected to maintain its quality, safety, and character. These studies take into account not only products’ functional qualities such as safety and effectiveness, but also cosmetic qualities such as color and texture that make them appealing to customers.
Which parameters must pharmaceutical manufacturers take into account for scale-up? How can Quality by Design be introduced in the development phase?
Compact and flexible – these are the dominating keywords when it comes to machines for producing and developing parenterals in small batches. If the machine is also supposed to fill pharmaceuticals into different types of packaging, the market does not have that much to offer. This is why the Fraunhofer ITEM and Bosch Packaging Technology developed the filling and closing machine ARF 1010, which is now in operation at Fraunhofer ITEM’s Pharmaceutical Biotechnology Division in Braunschweig, Germany.
Diabetes mellitus is the first non-infectious disease that has taken on the magnitude of a pandemic. For diabetes patients, the independent administration of insulin is now a lot easier. Due to their shape, the pens can not only be transported more conveniently, they can also be applied “en route” without attracting attention.
Robots can carry out pharmaceutical manufacturing tasks faster, more consistently and more cost-effectively than manual labor.