Lifecube™ SAP PUPSIT Semi-Automatic System
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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.
Function
| Functional Module | Test Step |
| Leak Test | Leaking test of the tubing assembly |
| Bag Integrity Test | Pre-filtration integrity test of top wash bags and waste liquid bags |
| Sterile Filter Wetting | Wetting the sterile filters in preparation for pre-filtration integrity testing (diffusion flow) |
| Sterile Filter Integrity Test Before Filtration | Diffusion flow testing for sterile filter integrity |
|
Gas Filter Integrity Test
|
Pre-filtration gas filter integrity test (water intrusion) |
|
Liquid Top Washing
|
Cleaning the tubing and draining WFI |
|
Liquid Filtration
|
Sterility filtration the product solution
|
|
Final Integrity Test
|
Perform integrity test after final sterile filtration |
Software Function Module
| Manual Mode | All components can be operated individually, and a single process step can be operated manually |
| Single Module Formula | All process modules can be run individually, each process module can set parameters individually |
| Semi-automatic Formula | The formulas runs in sequence, with parameters and steps that can be set according to actual needs |
| Authority Management | Custom permissions, user management, password management, audit trail, electronic signature |
| Other Functions | Flow calibration, weight calibration, data backup, data recovery |
|
Regularoty Compliance
|
Complies with FDA 21 CFR part11 |
Product List
Lifecube™ SAP Single-use PUPSIT Assembly
| Item | Specifications |
| Gas Filter | Cobetter Bricap C01, C02, C03 capsule filter |
| Sterile Filter | Cobetter Bricap L02 - L10 capsule filter |
| Single-use 2D Bag | Cobetter Lifecube Single-use 2D Storage Bag (100 mL-50 L) |
| Single-use Pressure Sensor | Cobetter Lifemeta SPC single-use pressure sensor Body Material: PSF Pressure Range: 0-30 PSI Accuracy: 0-6 psi ±2% | 6-30 psi ±3% |
|
Reinforced Silicone Tubing
|
Cobetter Lifemeta ST9B reinforced silicone tubing, with max. pressure 5 bar |
|
Silicone Tubing
|
Lifemeta STT platinum-cured silicone tubing, with max. pressure 2 bar |
|
Tube Fitting
|
Straight tube fitting, Cross fitting, Tee Fitting, Y-Fitting |
Hardware Configuration List
| Main Pump | Speed range: 0-650 rpm; Accuracy: ± 0.1% Flow range: ≤13 L/min; Accuracy: < 3% FS Suitable for 73# and 82# tubing |
| Auxiliary Pump | Speed range: 0-600 rpm; Accuracy: ± 0.1% Flow range: ≤13 L/min; Accuracy: < 5% FS Suitable for 73# and 82# tubing |
| Electrically Controlled Pinch Valves | Suitable for reinforced silicone tubing, with maximum pressure 5 bar |
| Weighing Module | Max. weighing: 60 kg; Accuracy: ≤ 5 g Max. weighing: 11 kg; Accuracy: ≤ 1 g |
| Filter Integrity Tester | Cobetter Certitest 20 Plus Filter Integrity Tester Pressure range: 100-8000 mbar; diffusion accuracy: 4% or 2 mL/min whichever is greater |
|
Bag Integrity Tester
|
Cobetter Certitest Bag Integrity Tester Pressure range: 0-300 mbar; Accuracy: Max±0.3 mbar |
|
Control Cabinet
|
Siemens PLC control system |
|
HMI
|
Siemens SIMATIC IPC477E 15" touchscreen Windows 10 IoT Enterprise 2019 LTSC, 64-bit |
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.
PUPSIT Scheme Example
