Extractables and leachables
Extractables ecosystem​
Suppliers, integrators and users are now starting to gain the full benefits of the standardized extractables testing established as the industry practice in the last few years. Critical to this has been the implementation by key suppliers and integrators of a system of extractables information exchange that enables the rapid assessment of planned systems by end users. While this ecosystem is now well established, it is not complete and there is room for more companies to join and share their information using the same model to create the seamless global system the industry needs.Â
There are three main actions that a company supplying single use systems needs to take to fully implement the BioPhorum extractables ecosystem:
Generate high quality extractables data and make it READILY AVAILABLE
As data is shared within the ecosystem, the quality of that data becomes very important. With that in mind the team has generated a short document downloadable here intended as a primer to help you in generating high quality extractables data either internally or via a contract service. We would also encourage you to seek advice from your customers who have experience of, or have requested extractables testing if this type of study is new to your organization
Develop an extractables landing page including prioritization information
It’s easy for extractables data to become lost, especially in large companies where websites are covering multiple divisions and product lines. We are proposing an extractables landing page that details:
- Your prioritization/availability of extractables data using the prioritization template
- How your customers can access detailed extractables information
Information on the prioritization template is available by clicking here.
In addition, BioPhorum are providing an Extractables Data Portal here, which gives direct access to the landing pages of the BioPhorum member companies who have created this facility.
Agreeing to and implementing standardized rules for data sharing
We recommend that wherever possible, component manufacturers own the extractables information for their products and that this information is passed up the supply chain to the end user. In the past this has caused challenges with the need for non disclosure agreements (NDA)/confidential disclosure agreements (CDA) between multiple parties. To allow this ecosystem to function effectively we promote a standard set of rules (rules of the road) to facilitate integrators collating and relaying relevant extractables information directly to their customers.
Information reporting​
There are two critical elements to hosting extractables information that add value for biomanufacturers and allow the rapid assessment of risk. These bring benefit to the whole biomanufacturing and single-use system industry by supporting more rapid and flexible adoption of single use technologies.
1. Extractables Data
Firstly it is critical that high quality extractables data, meeting the requirements specified by the end user in the BioPhorum protocol, is generated. Typically, this information is generated on one component that may represent a family of components with the same material and manufacturing characteristics but perhaps with a different physical format or size (e.g. Polypropylene T-Connector vs. Polypropylene Y-Connector). The recommendation for the BioPhorum Extractables ecosystem is that information be provided in two formats. Firstly information must be provided in a controlled document approved by the vendors quality assurance (QA). Typically this will take the form of a written document provided in a pdf format that cannot be edited by recipients.
Secondly, information should also be made available in excel format using the standardized data template available here. The information is provided in this standardized format to:
- facilitate the use of the data by end users
- save time
- reduce the risk of incorrectly transcribing data.
For this to work, the supplier must warrant that the information is correct at point of download, and the biomanufacturer must acknowledge that the controlled report is the verified document and accept that they are accountable for any errors introduced during manipulation of the excel data.
2. Component Information
In order to make the extractables data valuable it is essential that end users can link the information to the relevant component and physical characteristics of that component. There are two situations in which an end user needs to know which extractables data is relevant to the component in use:
Component Families
This relates primarily to components which are manufactured from the same material using the same process. Suppliers are asked to generate data on one size of component and define which components the testing covers along with physical characteristics (component mass and fluid contact area) of the components. Physical characteristics of the test article must also be provided.
The component family template is the recommended format for providing this information.
Assembly families
In cases where an integrator is providing single use assemblies, possibly of different sizes, it is important that a biomanufacturer can identify which components are used in the assembly and which extractables study is relevant for that component. This information should be provided in the assembly family template.
Data Pass through
In order to make the system as efficient as possible integrators should not need to retest components that have been already tested by component manufacturers. This is achieved by component suppliers allowing integrators to pass on data to the customers. This is made frictionless by the removal of 3 way confidentiality agreements (CDA / NDA) between supplier integrator and end user. This approach is described in more details in guidelines or ‘Rules of the Road’ available here.
Data reporting guidelines
There are two critical elements to hosting extractables information that add value for biomanufacturers and allow the rapid assessment of risk. These bring benefit to the whole biomanufacturing and single-use system industry by supporting more rapid and flexible adoption of single use technologies.
To facilitate exchange of information between companies The BioPhorum team has identified a two document reporting format. This consists of:
- A controlled report approved by the SUS equipment vendors QA function
- A verified excel copy of the data to allow ready use of the data by biomanufacturers.
The way these two documents are used differs, there are cases where the format and content must be followed in order for the data to have most value, in other cases the information must be provided, but the format may alter, and in some cases provision of the information is recommended best practice. The table below shows what data should be provided in each document.
