Extractables Information

Extractables Information

Extractables Information
Extractables and Single-Use Products:

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
Comprehensive Extractable Information:

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.

Status Update for Extractables Data Generation

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Extractables Information

Product type Formulation Representative Part Numbers Material of Construction Post Treatment Report ID
Extruded Tubing, Overmolding, Diptube C-Flex® 376 and C-Flex® 377

R70-376-000
376-XXX-X
Tubing used in Flexjoints

TPE Gamma and X-Ray
Disposable Parts for Flowmeter, Connect with Tubing Equflow® Disposable PVDF Flow Tube

0045 (low flow)
0045 (standard)
0085
0250

PVDF Autoclave
Disposable Parts for Flowmeter, Connect with Tubing Equflow® Disposable PVDF Flow Tube

0045 (low flow)
0045 (standard)
0085
0250

PVDF Gamma
Tubing PharmaFluor® FEP

PCAMGXXXXX
PH100XXXXXX
PHFE6XXXXXX
PH6303XXXXX
PCFE6XXXXXX

X = numeric character
7 to 13 characters in length

FEP Autoclave
Tubing PharmaPure®

AL2XXXXX

X = numeric character

TPE Gamma
Tubing PharmaPure®

AL2XXXXX

X = numeric character

TPE Autoclave
Tubing PharMed® BPT

AY2XXXXX

X = numeric character

TPE Autoclave
Tubing PharMed® BPT

AY2XXXXX

X = numeric character

TPE Gamma and X-Ray
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