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Lifecube™ Single-Use PUPSIT Assembly

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Part No. SAT6XY40AC3E1AS01
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*Not for medical use

PUPSIT determines the integrity of the sterilizing-grade filter and assembly. PUPSIT is performed to help ensure that the filter has not been damaged during shipping, installation, and sterilization prior to use. A damaged filter could result in a non-sterile product, which can ultimately affect drug safety. Cobetter offer a range of pre-designed and pre-sterile PUPSIT assemblies which are available in a wide variety of configurations. Looking for a complete solution? Explore our Single-Use Assemblies, with custom configurations available to match your process requirements.

Regulatory Compliance: EU GMP Annex 1

The Integrity of the sterilized filter should be verified before use and should be confirmed immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test. PUPSIT can verify the integrity of a sterilizing grade filter before use and after sterilization.

GMP Guidelines: Integrity testing of finished sterilization grade filters before and after use is a critical element of sterility assurance.

Cobetter PUPSIT Assemblies Advantages

  • Full line of single-use products including sterilizing-grade filters, storage bags, tubing, aseptic connectors, fittings, pressure gauge, in-line pressure sensors and monitor, etc. Meet almost all need for sterile filtration in final filling.
  • Pre-designed and self-produced assemblies, save at least 50% waiting times.  
  • A complete listing of supporting documents, including validation guide, extractable data, system design guide, user manual, application data, etc

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • ISO 4.8 / ISO 7 / ISO 8 cleanroom production
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • COA/COQ provided with shipment
  • Validation documents are available upon request
  • TSE/BSE certificate available

Learn more about how to perform PUPSIT testing and risk assessment, read this article PUPSIT Risk Assessment (6 attention points).
Physical Properties Product Name Lifecube™ PUPSIT
Sterilizing-grade Filter Bricap™ C03 Capsule Filter 0.2 μm PES membrane, EFA 660cm²
Gas Filter Bricap™ C02 Capsule Filter 0.2μm PTFE membrane, EFA 640cm²
Tubing Pt-Cured Silicone
Volume of Single-Use Bag 500 mL/ 5L
Applications Typical Application Terminal Sterilization Filtration (EU GMP requirements)
Customized Solutions Configuration-to-Order (CTO): Short delivery time
Engineer-To-Order (ETO) : Flexible design
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Sterility Delivery Condition Sterile
Sterilization Method Gamma irradiation at 25–45 kGy
Package Pack Size Pack of 1
Packaging Individually packed in double PE bag


  • 10_Cobetter_Lifecube_SA_PUPSIT_Assemblies_-_Standard_Configuration_I Download
  • Cobetter_Lifecube_SAP_PUPSIT_Assemblies_Catalog_250708 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.