The DPTE® Transfer Leak Testers (TLT) support a preventive maintenance program. Check the leak tightness of your transfer system before and after production batches to ensure that your processes are compliant with international standards and regulations.
Support requalification of your installed base – DPTE® Alpha and Beta, guaranteeing product and patient safety. The TLT solution is aligned with recommendations to perform integrity testing regularly as stated by the following guidelines:
- Annex 1 to EU GMP: Manufacture of Sterile Medicinal Products
- FDA Aseptic Processing Guidance: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
- PIC/S Pharma Inspection Convention Cooperation Scheme