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Lifecube™ SAP PUPSIT Semi-Automatic System

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Part No. PUPSIT-SAC0
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*Not for medical use

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 assemblies are manufactured in the ISO 4.8 clean area to strictly control the cleanliness of the single-use consumables.

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

 

PUPSIT Scheme Example
    • Cobetter_Lifecube_SAP_PUPSIT_Semi-Automatic_System_20250523 Download
    Why the PUPSIT (Pre-Use/Post-Sterilization Integrity Testing) is necessary?

    PUPSIT is the requirement of the EU GMP Annex 1 for confirming the integrity of sterilizing-grade filters before use and after sterilization. The use of PUPSIT is necessary because there are concerns that a sterilizing filter may develop flaws that could allow microbiological contamination to pass through during filtration. These flaws may be blocked or clogged by fluid contaminants or components during the filtration process and remain undetected during post-use integrity testing. This is known as "filter flaw masking." In order to prevent this, it is necessary to test the filter before use in order to detect and address any flaws, which would ultimately reduce the risk of product contamination.

    What filtration categories are included in PUPSIT?

    1. Single filtration: A single terminal sterilizing-grade filter.
    2. Serial filtration: A bioburden-reducing filter followed by a sterilizing-grade filter.
    3. Redundant filtration: A redundant filter and a primary filter, where both filters must pass Pre-Use/Post-Sterilization Integrity Testing (PUPSIT) prior to use.

    What methods are there for the integrity testing of the sterilizing-grade filters in PUPSIT?

    Bubble point test / diffusion flow test. To avoid leakage risks caused by excessive pressure in the PUPSIT system, the diffusion flow test is recommended.

    What are the advantages and disadvantages of choosing WFI as a wetting liquid?

    Advantages:
    1. Cost efficiency: WFI is less expensive than the process liquid.
    2. Reduced extractables: WFI can be used for flushing during filter wetting, minimizing leachables.
    3. No masking effect: WFI does not mask filter defects or cause clogging, ensuring reliable integrity test results (avoiding false-negative integrity test results).

    Disadvantages:
    1. Potential product dilution: After PUPSIT, the filter remains wet, which may dilute the process liquid.
    2. Extended drying time: Removing water via air blow-through may take hours, delaying process readiness.
    3. Integrity risks: Prolonged purging may challenge filter integrity.

    What are the advantages and disadvantages of choosing process liquid as a wetting liquid?

    Advantages:
    1. Simplified operation: Using process liquid as wetting liquid streamlines the filtration procedure;
    2. No dilution risk: Maintains product concentration after PUPSIT.

    Disadvantages:
    1. Process liquid consumption: Requires valuable process liquid;
    2. Validation requirements: Necessitates additional validation to establish acceptance criteria for integrity testing;
    3. Formula sensitivity: Any changes in process liquid formulation require reevaluation of integrity test parameters.

    What components are included in PUPSIT assemblies? Can customized solutions be provided?

    Standard configurations include: capsule filters, single-use storage bags, tubing, aseptic connectors, easy connectors, instrumentation tees, pressure sensors, monitoring equipment and so on. These components provide comprehensive solutions for nearly all terminal sterilization filtration requirements. We offer fully customized solutions tailored to specific client needs in component selection and configuration design.

    What is the ISO class level of Cobetter PUPSIT manufacturing cleanroom?

    The production and assembly are in ISO class 4.8 workshop (equivalent to GMP Class A). And the accessories will be pre-washed, ensuring a high level of cleanliness.