Pharmaceutical Industry cGMP and EHEDG guidelines are an integral part of PVA SYSTEMS’ compliance with the highest of the world’s regulatory standards. Complete safety to ensure low-risk product manufacturing in sterile environments as well, is part of PVA SYSTEMS’s long-lasting experience in supplying specialized solutions to our customers.

ADVANTAGES

• Exceptional reproducibility of results, ensuring an extremely narrow particle size distribution that meets the most stringent specifications outlined in the URS
• Complete control over the homogenization process with highest shear rates, ensuring uniform distribution of active pharmaceutical ingredients (APIs) throughout the product
• Full compliance with CIP (Cleaning-in-Place) and SIP (Sterilization-in-Place) protocols, along with comprehensive certification adhering to the most widely recognized standards. This includes the integration of the highest-class cleanroom environments, ensuring complete sterility and zero-contamination

In accordance with customer User Requirement Specification (URS), We provide expert consulting services across all phases of the project, starting from the creation of the Functional and Execution Specifications. Our support extends to the production, installation, and commissioning of the plant, including the required qualification processes, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

APPLICATION EXAMPLES