Lifecube™ Single-Use PUPSIT Assemblies
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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.
Specifications
| Sterilizing-grade Filter | Bricap™ C03 Capsule Filter with SLE 0.2μm membrane. Filtration Area: 660cm² |
| Gas Filter | Bricap™ C02 Capsule Filter with APB 0.2μm membrane. Filtration Area: 640cm² |
| Tubing | Platinum Cured Silicone Tubing |
| Single-Use Bag | 500 mL, 5L Single-Use Bag |
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 Assurance
- ISO Class 4.8 clean area assemble (equivalent to GMP Class A cleanliness)
- ISO 9001:2015 Quality Management System
- USP<87> Biological Reactivity Test, In Vitro
- USP<88> Class VI plastics Biological Reactivity Test, In Vivo
- Bacterial endotoxin meets WFI requirements (< 0.25 EU/mL)
- Particles matter meet the requirements in CP and USP<788> for large-volume parenterals
- Gamma radiation dose validation according to ISO11137, sterile packaging
Learn more about how to perform PUPSIT testing and risk assessment, read this article Six Attention Points When Performing PUPSIT.