PureTain® PUPSIT Single-Use Assemblies
Product Description
The PureTain® PUPSIT single-use assemblies provide a fully enclosed, pre-sterilized solution for implementing pre-use post-sterilization integrity testing in final fill and critical downstream sterile filtration steps. These plug-and-play manifolds are engineered for bioprocessing applications where the product cannot be terminally sterilized in its final container and must instead rely on validated sterile filtration.
Each PureTain PUPSIT assembly combines sterile-grade filtration with single-use tubing sets in a controlled, closed fluid pathway. This design enables full integrity testing of the sterile filters without exposing the process stream to contamination risk, helping manufacturers align with current EU GMP Annex 1 expectations for PUPSIT while maintaining robust product protection and process control.
Parker’s PUPSIT assemblies are built within ISO Class 7 cleanrooms under ISO 9001 and ISO 14001 quality and environmental systems, and are available non-irradiated, gamma-irradiated (low bioburden), or gamma-irradiated with validated sterility to ISO 11137-2. They can be customized with a wide range of tubing, filtration, sampling, and connection options to fit your specific process requirements and integrity test methods.
Supported by CLEAR Solutions’ filtration specialists and Parker’s global single-use team, PureTain PUPSIT assemblies can be integrated as standalone manifolds or as part of a broader automated single-use solution. This allows life sciences and medical device manufacturers to de-risk implementation of PUPSIT, streamline validation, and meet regulatory expectations without overburdening routine manufacturing operations.
Key Features
- Pre-sterilized, ready-to-use PUPSIT single-use assemblies
- Fully enclosed fluid pathway to minimize contamination risk
- Enables full pre-use post-sterilization integrity testing of sterile filters
- Designed to support compliance with EU GMP Annex 1 final sterilizing filtration requirements
- Customizable tubing, filter, sampling, and connection configurations
- Available as standalone manifolds or integrated into automated single-use systems
- Manufactured in ISO Class 7 cleanrooms under ISO 9001 and ISO 14001
- Supplied in non-irradiated, gamma (low bioburden), or gamma (validated sterile) formats
Typical Applications
PureTain PUPSIT assemblies are designed for critical bioprocessing steps where terminal sterilization is not possible and sterile filtration with integrity testing is required, including:
- Downstream sterile filtration prior to final filling
- Final fill solutions for biologics and other sterile injectables
- Drug substance and drug product formulation steps
- Vaccine production and sterile bulk filling operations
- Single-use biopharmaceutical processes requiring PUPSIT capability
Specifications
| Product Type | Single-use PUPSIT manifold / assembly |
|---|---|
| Intended Use | Pre-use post-sterilization integrity testing for final sterile filtration |
| Assembly Configuration | Custom to process (tubing, filtration, sampling, connectors) |
| Sterilization Formats | Non-irradiated (RTS), Gamma-irradiated (low bioburden), Gamma-irradiated (validated sterile per ISO 11137-2) |
| Fluid Path | Fully enclosed, single-use, pre-assembled |
| Manufacturing Environment | ISO Class 7 cleanroom |
| Quality Systems | ISO 9001, ISO 14001 |