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 BPOG 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 BPOG Extractable Report template. Once published, the data will be available as an Excel spreadsheet and PDF document in alignment with the recommendations from the BPOG 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 Extractable Protocol
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.
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Product Type | Formulation | Representative Part Numbers | Status | Target Date | Material of Construction | Post Treatment | Report ID | Doc Access |
---|---|---|---|---|---|---|---|---|
Single-Use Bioprocess Bag | Bioprocess Bags (All sizes) |
K(a)(a)XXXXX K = chamber |
Complete | October, 2020 | LDPE/EVOH/Tie/LDPE | Gamma | 12 mil Bioprocess Bag_Gamma | Request Access |
Extruded Tubing, Overmolding | C-Flex® 001 |
R70-001-000 X = numeric character |
In Progress | March, 2021 | TPE | Gamma | C-Flex® 072_Gamma | Request Access |
Extruded Tubing, Overmolding | C-Flex® 001 |
R70-001-000 X = numeric character |
In Progress | March, 2021 | TPE | Autoclave | C-Flex® 072_Autoclave | Request Access |
Extruded Tubing, Overmolding | C-Flex® 003 |
R70-003-000 X = numeric character |
In Progress | March, 2021 | TPE | Gamma | C-Flex® 072_Gamma | Request Access |
Extruded Tubing, Overmolding | C-Flex® 003 |
R70-003-000 X = numeric character |
In Progress | March, 2021 | TPE | Autoclave | C-Flex® 072_Autoclave | Request Access |
Extruded Tubing | C-Flex® 050 |
R70-050-000 X = numeric character |
Complete | December, 2020 | TPE | Gamma | C-Flex® 082_Gamma | Request Access |
Extruded Tubing | C-Flex® 050 |
R70-050-000 X = numeric character |
Complete | December, 2020 | TPE | Autoclave | C-Flex® 082_Autoclave | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 072 |
R70-072-000 X = numeric character |
In Progress | March, 2021 | TPE | Autoclave | C-Flex® 072_Autoclave | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 072 |
R70-072-000
|
In Progress | March, 2021 | TPE | Gamma | C-Flex® 072_Gamma | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 082 |
R70-082-000 |
Complete | December, 2020 | TPE | Gamma | C-Flex® 082_Gamma | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 082 |
R70-082-000 |
Complete | December, 2020 | TPE | Autoclave | C-Flex® 082_Autoclave | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 374 |
R70-374-000 |
Complete | December, 2020 | TPE | Gamma | C-Flex® 374_Gamma | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 374 |
R70-374-000 |
Complete | December, 2020 | TPE | Autoclave | C-Flex® 374_Autoclave | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 376 and C-Flex® 377 |
R70-376-000 |
In Progress | March, 2021 | TPE | Gamma | C-Flex® 072_Gamma | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 376 and C-Flex® 377 |
R70-376-000 |
In Progress | March, 2021 | TPE | Autoclave | C-Flex® 072_Autoclave | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 376 and C-Flex® 377 |
R70-376-000 |
Complete | December, 2020 | TPE | Autoclave | C-Flex® 374_Autoclave | Request Access |
Extruded Tubing, Overmolding, Diptube | C-Flex® 376 and C-Flex® 377 |
R70-376-000 |
Complete | December, 2020 | TPE | Gamma | C-Flex® 374_Gamma | Request Access |
Tubing | PharmaFluor® FEP |
PCAMGXXXXX X = numeric character |
In Progress | May, 2021 | FEP | Autoclave | PharmaFluor® FEP_Autoclave | Request Access |
Tubing | PharmaPure® |
AL2XXXXX X = numeric character |
In Progress | January, 2021 | TPE | Gamma | PharmaPure®_Gamma | Request Access |
Tubing | PharmaPure® |
AL2XXXXX X = numeric character |
In Progress | January, 2021 | TPE | Autoclave | PharmaPure®_Autoclave | Request Access |
Tubing | PharMed® BPT |
AY2XXXXX X = numeric character |
Complete | January, 2021 | TPE | Gamma | PharMed® BPT_Gamma | Request Access |
Tubing | PharMed® BPT |
AY2XXXXX X = numeric character |
Complete | January, 2021 | TPE | Autoclave | PharMed® BPT_Autoclave | Request Access |
Overmolding, Tubing, Diptube | Polypropylene |
R80-106-000, 30-10008, 30-10013, 30-10014, 30-10115, 30-10175, 30-10482, 30-10488, 30- 10519 and 30-10709 |
In Progress | PP | Gamma | PP-SUS Components_Gamma | Request Access | |
Overmolding, Tubing, Diptube | Polypropylene |
R80-106-000, 30-10008, 30-10013, 30-10014, 30-10115, 30-10175, 30-10482, 30-10488, 30- 10519 and 30-10709 |
In Progress | PP | Autoclave | PP-SUS Components_Autoclave | Request Access | |
Tubing Connector | Pure-Fit® Smooth Inner Bore (SIB) Connectors |
PF(A)XXXPVDFAF |
In Progress | PVDF | Gamma | PVDF-SUS Components_Gamma | Request Access | |
Tubing Connector | Pure-Fit® Smooth Inner Bore (SIB) Connectors |
PF(A)XXXPVDFAF |
In Progress | PVDF | Autoclave | PVDF-SUS Components_Autoclave | Request Access | |
Tubing Connector | Pure-Fit® Smooth Inner Bore (SIB) Connectors |
PF(A)XXXPPAF |
In Progress | PP | Gamma | PP-SUS Components_Gamma | Request Access | |
Tubing Connector | Pure-Fit® Smooth Inner Bore (SIB) Connectors |
PF(A)XXXPPAF |
In Progress | PP | Autoclave | PP-SUS Components_Autoclave | Request Access | |
Tubing | Pure-Fit® SPT-50 (manufactured in Bangalore, India) |
Refer to product code/description on drawing for SPT-50 |
Complete | January, 2020 | Silicone | Gamma | India Pure-Fit® SPT-50_Gamma | Request Access |
Tubing | Pure-Fit® SPT-50 (manufactured in Bangalore, India) |
Refer to product code/description on drawing for SPT-50 |
Complete | January, 2020 | Silicone | Autoclave | India Pure-Fit® SPT-50_Autoclave | Request Access |
Tubing | Pure-Fit® SPT-60 |
Refer to product code/description on drawing for SPT-60 |
Complete | January, 2020 | Silicone | Gamma | India Pure-Fit® SPT-50_Gamma | Request Access |
Tubing | Pure-Fit® SPT-60 |
Refer to product code/description on drawing for SPT-60 |
Complete | January, 2020 | Silicone | Autoclave | India Pure-Fit® SPT-50_Autoclave | Request Access |
Sterile Connector | Pure-Fit® Sterile Connector |
PFSC250-XXX |
In Progress | PVDF | Gamma | PVDF-SUS Components_Gamma | Request Access | |
Sterile Connector | Pure-Fit® Sterile Connector |
PFSC250-XXX |
In Progress | PVDF | Autoclave | PVDF-SUS Components_Autoclave | Request Access | |
Tubing Connector | Sani-Tech® Rigid Connector |
KXXXXX-XXX “K” |
In Progress | PVDF | Gamma | PVDF-SUS Components_Gamma | Request Access | |
Tubing Connector | Sani-Tech® Rigid Connector |
KXXXXX-XXX “K” |
In Progress | PVDF | Autoclave | PVDF-SUS Components_Autoclave | Request Access | |
Sani-Tech® Rigid Connectors | Sani-Tech® Rigid Connectors |
KXXXXX-XXX “K” or “T” followed by 5 to 6 alpha or numeric characters then a dash followed by 3 to 4 alpha or numeric characters. KXXXXX “K” or “T” followed by 5 to 7 alpha or numeric characters. |
In Progress | PP | Gamma | PP-SUS Components_Gamma | Request Access | |
Sani-Tech® Rigid Connectors | Sani-Tech® Rigid Connectors |
KXXXXX-XXX “K” or “T” followed by 5 to 6 alpha or numeric characters then a dash followed by 3 to 4 alpha or numeric characters. KXXXXX “K” or “T” followed by 5 to 7 alpha or numeric characters. |
In Progress | PP | Autoclave | PP-SUS Components_Autoclave | Request Access | |
Tubing | Sani-Tech® SPT-60L |
Refer to product code/description on drawing for Sani-Tech® SPT-60L |
Not Started | July, 2021 | Silicone | Gamma | Sani-Tech® SPT-60L_Gamma | |
Tubing | Sani-Tech® SPT-60L |
Refer to product code/description on drawing for Sani-Tech® SPT-60L |
Not Started | July, 2021 | Silicone | Autoclave | Sani-Tech® SPT-60L_Autoclave | |
Tubing | Sani-Tech® STHT-65 |
Refer to product code/description on drawing for Ultra-65 reference |
Complete | November, 2020 | Silicone | Gamma | Sani-Tech® STHT-C_Gamma | Request Access |
Tubing | Sani-Tech® STHT-65 |
Refer to product code/description on drawing for STHT-65 reference |
Complete | November, 2020 | Silicone | Autoclave | Sani-Tech® STHT-C_Autoclave | Request Access |
Tubing, Diptube | Sani-Tech® STHT-C |
Refer to product code/description on drawing for STHT-C or STHT-65 reference |
Complete | November, 2020 | Silicone | Gamma | Sani-Tech® STHT-C_Gamma | Request Access |
Tubing, Diptube | Sani-Tech® STHT-C |
Refer to product code/description on drawing for STHT-C or STHT-65 reference |
Complete | November, 2020 | Silicone | Autoclave | Sani-Tech® STHT-C_Autoclave | Request Access |
Tubing | Sani-Tech® STHT-R |
Refer to product code/description on drawing for STHT-R reference |
Complete | January, 2021 | Silicone | Gamma | Sani-Tech® STHT-R_Gamma | Request Access |
Tubing | Sani-Tech® STHT-R |
Refer to product code/description on drawing for STHT-R reference |
Complete | January, 2021 | Silicone | Autoclave | Sani-Tech® STHT-R_Autoclave | Request Access |
Tubing | Sani-Tech® Ultra 65 |
Refer to product code/description on drawing for Ultra-65 reference |
In Progress | March, 2021 | Silicone | Gamma | Sani-Tech® Ultra-C_Gamma | Request Access |
Tubing | Sani-Tech® Ultra 65 |
Refer to product code/description on drawing for Ultra-65 reference |
In Progress | March, 2021 | Silicone | Autoclave | Sani-Tech® Ultra-C_Autoclave | Request Access |
Tubing, Diptube | Sani-Tech® Ultra-C |
Refer to product code/description on drawing for Ultra-C reference |
In Progress | March, 2021 | Silicone | Autoclave | Sani-Tech® Ultra-C_Autoclave | Request Access |
Tubing, Diptube | Sani-Tech® Ultra-C |
Refer to product code/description on drawing for Ultra-C reference |
In Progress | March, 2021 | Silicone | Gamma | Sani-Tech® Ultra-C_Gamma | Request Access |
Overmolding | Silicone Overmolding |
Refer to product description: |
In Progress | Silicone | Gamma | LIMs_Gamma | Request Access | |
Overmolding | Silicone Overmolding |
Refer to product description: |
In Progress | Silicone | Autoclave | LIMs_Autoclave | Request Access | |
Tubing, Diptube | Tygon® 3350 |
ABWXXXXXX X = numeric character |
In Progress | January, 2021 | Silicone | Gamma | Tygon® 3350_Gamma | Request Access |
Tubing, Diptube | Tygon® 3350 |
ABWXXXXXX X = numeric character |
In Progress | January, 2021 | Silicone | Autoclave | Tygon® 3350_Autoclave | Request Access |
Tubing | Tygon® 3370IB |
AHJXXXXXXX X = numeric character |
In Progress | January, 2021 | Silicone | Gamma | Tygon® 3350_Gamma | Request Access |
Tubing | Tygon® 3370IB |
AHJXXXXXXX X = numeric character |
In Progress | January, 2021 | Silicone | Autoclave | Tygon® 3350_Autoclave | Request Access |
Tubing | Tygon® 3370IB |
AHJXXXXXXX X = numeric character |
Complete | January, 2021 | Silicone | Autoclave | Sani-Tech® STHT-R_Autoclave | Request Access |
Tubing | Tygon® 3370IB |
AHJXXXXXXX X = numeric character |
Complete | January, 2021 | Silicone | Gamma | Sani-Tech® STHT-R_Gamma | Request Access |
Tubing | Tygon® ND-100-65 |
AADXXXXX – ND-100- 80 series ADFXXXXX- ND-100- 65 series |
In Progress | May, 2021 | PVC | Autoclave | VueLife® AC Bag w/ND-100-65 Tube Set_Autoclave | |
Tubing | Tygon® ND-100-80 |
AADXXXXX – ND-100- 80 series ADFXXXXX- ND-100- 65 series |
Complete | September, 2020 | PVC | Autoclave | VueLife® Bag w/ND-100-80 Tube Set_Autoclave | Request Access |
FEP Bag, Tubing | VueLife® AC Bag w/ND-100-65 Tube Set |
VueLife® AC Bag w/ND-100-65 Tube Set |
In Progress | May, 2021 | FEP, PVC | Autoclave | VueLife® AC Bag w/ND-100-65 Tube Set_Autoclave | |
FEP Bag, Tubing | VueLife® Bag w/ND-100-80 Tube Set |
VueLife® Bag w/ND-100-80 Tube Set |
Complete | September, 2020 | FEP, PVC | Autoclave | VueLife® Bag w/ND-100-80 Tube Set_Autoclave | Request Access |
Sterile Filter | Z Series Filters w/ PES membrane |
To be provided in future update |
Complete | November, 2019 | PES/PE/PP/Nylon/Silicone | Gamma | Zero® Filter_Gamma | Request Access |
Sterile Filter | Zero® Filter w/ PES membrane |
To be provided in future update |
Complete | November, 2019 | PES/PE/PP/Nylon/Silicone | Gamma | Zero® Filter_Gamma | Request Access |
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