Maximum product quality and operator protection ideally combined: Optima Group Pharma implemented a KUGLER Linoline with a special containment concept for Rottendorf Pharma GmbH. The new machine allows Rottendorf the filling of dry granular materials and powders in bottles.
Rottendorf is an FDA-certified contract manufacturer and packager and manufactures exclusively oral drugs. Hence, sterile conditions in the filling and packaging zone are not needed. Even if the new Linoline is presently not intended for filling highly active ingredients, the line-s barrier concept works in two directions – not only to the product side. It also provides operator protection within the production environment.
The premises and the machine design form a coherent technical concept. In an internal process Rottendorf developed the basic ideas for the environment zones already in the preparatory phase. Then, Optima Group Pharma took up and drove these ideas proactively. The matter of interface between the technical room and the actual filling area, for example, was solved with much professional expertise.
To contract packagers, a particularly important criterion is flexibility, i.e. the capability to respond to continuously changing market and customer requirements at short notice. The Linoline allows, for example, separate dosing of excipients and active ingredients. Dr. Thomas Rohn, Head of Packaging Department at Rottendorf Pharma GmbH: “If we are confronted with this task by the market later on, only minor modifications will become necessary. From the beginning, we set a course ensuring that no option is excluded.”
Rottendorf Pharma is one of the leading pharmaceutical contract manufacturers for development, production and packaging of solid dosage forms in Europe. Besides the two sites in Germany the company is also represented by a subsidiary, Rottendorf Pharma S.A.S., in Valenciennes/France.
Rottendorf Pharma belongs to a nonprofit foundation and focuses not only on market success but also on social engagement.
For its 150 customers, among them a lot of the biggest Big Pharma companies, Rottendorf is an exclusive service provider who offers a maximum of production reliability and investment security in addition to modern production facilities and high potency technologies. Audited and approved by the internationally recognized FDA, the company is not only qualified for the European but also for the US market. Moreover, Rottendorf is optimally positioned for future challenges due to annual investments of several million Euros in the modernization and expansion of the facilities and technologies. In addition to contract manufacturing and contract packaging, the development of processes and formulations plays a decisive role in the future company strategy.
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