The Kleenpak aseptic 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 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 Aseptic Connector Validation Services aim to ensure a smooth implementation without delay.
The Kleenpak Connector Validation Services are an extension of the established Pall Validation Services and are an integral part of the user’s validation of Pall disposable 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.
Validation Objectives
The objective is to prove the suitability of the Kleenpak connector for the selected
fluid transfer process by answering the following questions:
- Does the product affect the Kleenpak connector?
- Does the Kleenpak connector affect the product?
- Does the product affect the aseptic connection connector?
Pall leverages its design knowledge of the Kleenpak connector to ensure that these validation objectives are met by taking into account all critical product attributes and process parameters.
The Validation Package
The validation package will be tailored to meet your specific needs and will include some or all of the following:
- Compatibility 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.
Male and Female Connector Assemblies prior to Connection
