Extractables and leachables
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.
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.
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.