Extractables Information

To strive to be the premiere supplier of choice and fully satisfy the needs of the market, Saint-Gobain has provided herein our revised approach to performing a comprehensive extractables analysis.  The Saint-Gobain approach described in the Extractable Test Strategy includes:

• grouping products into the product families,
• solvent selection using the Biophorum protocol and USP <665> as a guide,
• timelines for publication of each product family’s extractable report, and
• change control commitment as it relates to extractable testing

Saint-Gobain will publish its extractable data using the Biophorum Extractable Report template.  Once published, the data will be available as an Excel spreadsheet and PDF document in alignment with the recommendations from the Biophorum Supplier Partner Phorum to facilitate end user safety assessments.  By logging into the Technical Information and agreeing to the confidentiality statements, end users can gain access to the raw data in Excel spreadsheets and the approved PDF version of the Extractables Report. NOTE: The supplier warrants that the information is correct at point of download, but the end user must acknowledge that the controlled report is the verified document and is accountable for any errors introduced during manipulation of the excel data.

Saint-Gobain tests new products and any required changes using the Saint-Gobain Extractables protocol. The historical products already on the market will be tested using a campaign approach as outlined in the Saint-Gobain Extractable Test Strategy.