Greifensee, Switzerland based Mettler claims that version 5.2 of its system provides drugmakers with a complete set of in-process and pre-packaging quality control solutions, covering -dose drug preparations, individual blister filling, and retail pack checking.
In addition traceability, which is a topic always high on drugmakers’ list of priorities, is another key component of the system. According to Mettler, the software features an optional audit trail module capable of tracking all changes that occur during a production process.
Mettler also stressed that the software’s adaptability allows it to be integrated directly into a wide range of production devices without any additional programming. As a result it can be used to check tablet characteristics such as weight, diameter, thickness, or hardness and as a metal detection unit in a rapid continuous process.
FreeWeigh supports regulations of both the United States Pharmacopeia (USP) and the European Pharmacopeia (PhEur) and is compliant with all good automated manufacturing practice requirements in place in the US and Europe.
The system is also fully compliant with the US Food and Drug Administration’s 21 CFR Part 11 quality documentation requirements, providing an automated and accredited way of recording all key information associated with production runs.
Additionally, the software system provides an unlimited number of user groups and over 50 individual, centrally managed authorisation options allowing considerable workforce flexibility.