The requirements for quality and efficiency in the manufacturing of sterile products are steadily becoming more stringent. Haupt Pharma meets these demands by continuously investing in modern technologies. The performance of Haupt Pharma has been optimised further by a new filling system from Inova for the sterile production department at the Wolfratshausen site.

With this new filling system, installed in a conventional cleanroom, Haupt Pharma is able to fill vials with a capacity of 2ml to 250ml under aseptic conditions.
The new system is equipped with restricted access barrier system (RABS) technology. RABS systems feature securely mounted gloves integrated into the doors that allow manipulation in cleanroom zone A without having to open the door.

During aseptic filling, the highest risk of microbial contamination comes from the operating staff. RABS minimises this risk. The new system is also used for the corresponding US products. The filling line, including qualification and documentation, thus fulfils FDA requirements.

In addition to aseptic filling of conventional vials with solutions or suspensions, Haupt Pharma can also use the new system for aseptic filling of nasal sprays. A growing demand is expected in this market segment, in particular, because the use of preservatives in nasal sprays is becoming increasingly controversial. The Wolfratshausen site is now well-prepared for this trend.

The entire upgrading of the sterile department commenced at the end of November 2008 and was finished by the beginning of April 2009, with the completion of the last media fills. The new equipment has been successfully integrated into routine production since the middle of April.

This greater capacity raises the competitiveness of Haupt Pharma in sterile production at the highest technical level.