Cobetter, PUPSIT-SAC0, Lifecube™ SAP PUPSIT Semi-Automatic System

Check this product with a package size of SAP PUPSIT Semi-Automatic System on Iright. 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-filtrationintegrity 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 sensorBody Material: PSFPressure Range: 0-30 PSIAccuracy: 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% FSSuitable for 73# and 82# tubing
Auxiliary Pump
Speed range: 0-600 rpm; Accuracy: ± 0.1%Flow range: ≤13 L/min; Accuracy: < 5% FSSuitable 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 gMax. weighing: 11 kg; Accuracy: ≤ 1 g
Filter Integrity Tester
Cobetter Certitest 20 Plus Filter Integrity TesterPressure range: 100-8000 mbar; diffusion accuracy: 4% or 2 mL/min whichever is greater
Bag Integrity Tester
Cobetter Certitest Bag Integrity TesterPressure range: 0-300 mbar; Accuracy: Max±0.3 mbar
Control Cabinet
Siemens PLC control system
HMI
Siemens SIMATIC IPC477E 15" touchscreenWindows 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