The Kleenpak™ sterile connector represents the latest in connection technology, allowing for the dry connection of two separate fluid pathways while maintaining the sterile integrity of both. Much of the validation of the Kleenpak sterile connector can be applied generically and is provided in the product Validation Guide. Users often supplement this data with application and product-specific validation studies and training. Pall's Sterile Connector Validation Services aim to ensure a smooth implementation without delay.
The Kleenpak Sterile Connector Validation Services are an extension of the established Pall Validation Services and are an integral part of the user's validation of Pall single-use systems. The services are always backed by Pall's expertise and scientific resources.
Pall's close links with the industry and the regulatory agencies ensure that your protocols and documentation can adhere to current good manufacturing processes and respond to the most recent regulatory guidelines.
Connector Validation ObjectivesThe objective is to prove the suitability of the Kleenpak sterile connector for the selected fluid transfer process by answering the following questions:
- Does the product affect the Kleenpak sterile connector?
- Does the Kleenpak sterile connector affect the product?
- Does the product affect the sterile connection?
Pall leverages its design knowledge of the Kleenpak sterile connector to ensure that these validation objectives are met by taking into account all critical product attributes and process parameters.
Connector Validation PackageThe validation package will be tailored to meet your specific needs and will include some or all of the following:
- Compatability Assessment
- Extractables Analysis
- Soiling Test
Prior to the start of any test, a protocol detailing the test methodology and acceptance criteria will be submitted for approval. Upon completion of testing, a comprehensive report including all experimental data will be provided.
Ordering InformationNote: To ensure timely and accurate analytical work, Pall laboratories require complete information on product specification and process conditions such as pressure, temperature and duration before commencing analysis. Each of the validation projects also requires approximately 2000 - 3000 mL of product.
Compatibility AssessmentThe Kleenpak sterile connector is considered compatible with a product if exposure under process conditions does not alter its ability to perform intended functions. Tests that evaluate the physical integrity of the Kleenpak sterile connector, such as the pressure exposure test can be used to establish compatibility with specific product or process conditions. During the pressure exposure test, the connector is exposed to process pressure conditions for a suitable duration at process temperature. Dimensions are measured to verify conformance to specifications under process conditions.
Soiling TestsThe soiling test was developed to evaluate the ability of the Kleenpak sterile connector to produce a sterile fluid path after the protective peel-away strips of the male and female connectors have been intentionally contaminated with a Geobacillus stearothermophilius spore suspension. After the deliberate contamination, the connection is made and sterile trypticase soy broth (TSB) is passed through the connector to a collection container. The container is incubated and analyzed for contamination. The results of this soiling test are reported in the Validation Guide of the Kleenpak sterile connector. Process-specific soiling tests can be developed and performed as below:
- Fluid specific soiling test: standard organism (Geobacillus stearothermophilius), product specific fluid
- Organism specific soiling test: process specific organism, standard fluid (TSB)
- Full process specific: process specific organism and fluid