Sterility is an absolute necessity in the aseptic filling of parenterals
Valicare experts have the technical and practical experience to establish the sterilization processes in isolators.
Valicare GmbH is a subsidiary of Syntegon Technology GmbH, a leading supplier of process technology and packaging solutions for the pharmaceutical industry for decades. With a portfolio that ranges from individual machines to complete lines and integrated solutions with a particular focus on aseptic filling lines.
Through many years of support in the qualification and validation of the Syntegon machines, our engineers developed a high level of expertise in this technology.
In addition to the GMP-compliant calibration and the qualification of entire aseptic filling lines, from washing machine and sterilizer to the sterile filling area, their special service includes the development and validation of biodecontamination processes in isolators. Our experts qualify also isolators from other manufacturers provided they use hydrogen peroxide for sterilization.
The european 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.
The batches of biological indicators (BIs) to be used for the validation of a successful sterilization process are identified, quantified and the D-value is determined in Valicare's own test laboratory using pharmaceutical scale isolator. BIs characterized in this way ensure controllable and effective use in process development and validation in the isolators at customer side.
If desired, our support can start much earlier and accompany you throughout the entire life cycle of your plant. With life cycle management our experts bring your idea purposefully on the road to success and, if required, 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 update as well as accompany and support you at every critical step.
During professional workshops, our experts explain the function of isolators and develop a suitable risk-based qualification & validation strategy in cooperation with you.
The implementation can be done by yourself or in collaboration with the Valicare engineers. The focus here is also on isolators (fill and compounding) that use hydrogen peroxide for sterilization.
Our isolator experts are professional. Use their long-term experience and technical understanding to successfully advance your isolator project.