Description
In pharmaceutical production, it is crucial to ensure the quality and safety. Therefore, regulatory agencies in various countries have established strict regulations and guidelines for sterile pharmaceutical production.
PUPSIT (Pre-Use/Post-Sterilization Integrity Testing) is one of the key regulations and practices. It refers to the integrity test of the sterile filter after sterilization and before production to ensure that the sterile filter maintains its integrity and filtration capacity throughout the production process, thus ensuring the sterility of final drug product.
Cobetter’s designed PUPSIT Semi-Automatic System is based on relevative engineering requirements and practical experience. The system enables pre-use/ post-sterilization integrity testing of sterile filters to be carried out efficiently and simply.
Features
- Set the operation parameters and methods in advance to reduce manual operation steps
- Equipped with Cobetter self-produced Certitest 20 Filter Integrity Tester and Bag Integrity Tester, flexible customization of integrity test schemes
- Customised programme design based on actual customer process requirements
- Pumps and weighing modules can be customized according to different liquid properties or production levels
- Real-time monitoring and alarm to reduce the probability of risk occurrence
- Data integrity records and management, and audit trail is allowed
- Self-produced single-use consumables to ensure a stable supply chain
- PUPSIT assemilies are manufactured in the ISO 4.8 clean area to strictly control the cleanliness of the single-use consumables.