Ensuring sterility in the aseptic filling of parenterals

GMP-compliant qualification

In addition to the GMP-compliant calibration and qualification of entire aseptic filling lines, from cleaning machines and sterilizers to the sterile filling area, Valicare's service includes the development and validation of biodecontamination processes in isolators. Our experts also qualify isolators (filling and compounding) from other manufacturers, provided they use hydrogen peroxide for sterilization.

Worldwide activities

The Valicare teams operate worldwide. In India, they cooperate successfully with Klenzaids, a joint venture member of Syntegon Technology GmbH and a leading manufacturer of aseptic, bioclean and containment equipment placed in Mumbai since 1969.

Global laboratory services

Valicare identifies and quantifies the batches of biological indicators (BIs) to be used for the validation of a successful sterilization process and determines the D-value in it's own test laboratory using pharmaceutical scale isolators. BIs characterized in this way ensure controllable and effective use in process development and validation in the isolators of customers.

Extensive approach

Our support can even start before sterilization processes and accompany you throughout the entire life cycle of your plant. Our life cycle management brings your idea on the road to success. If required, our experts take over the entire project management from pharmaceutical procurement to risk-based qualification of the plant and processes. In addition, they carry out maintenance and requalification after conversion or system updates and accompany you in every critical step.

Workshops

During professional workshops, our experts explain the isolator functions and jointly develop a suitable risk-based qualification and validation strategy. You can implement this strategy yourself or in collaboration with the Valicare engineers. The focus is on isolators (filling and compounding) that use hydrogen peroxide for sterilization.

Our isolator experts have the experience and technical understanding to successfully advance your isolator project.