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  3. 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 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. 

Status Update for Extractables Data Generation

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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
(a) = alpha character
X = numeric character

Complete October, 2020 LDPE/EVOH/Tie/LDPE Gamma 12 mil Bioprocess Bag_Gamma Request Access
Extruded Tubing, Overmolding C-Flex® 001

R70-001-000
001-XXX-X
001-XXX-XS
001-XXX-XM

X = numeric character
S= spool
M = mini-spool

In Progress March, 2021 TPE Gamma C-Flex® 072_Gamma Request Access
Extruded Tubing, Overmolding C-Flex® 001

R70-001-000
001-XXX-X
001-XXX-XS
001-XXX-XM

X = numeric character
S= spool
M = mini-spool

In Progress March, 2021 TPE Autoclave C-Flex® 072_Autoclave Request Access
Extruded Tubing, Overmolding C-Flex® 003

R70-003-000
003-XXX-X
003-XXX-XS
003-XXX-XM

X = numeric character
S= spool
M = mini-spool

In Progress March, 2021 TPE Gamma C-Flex® 072_Gamma Request Access
Extruded Tubing, Overmolding C-Flex® 003

R70-003-000
003-XXX-X
003-XXX-XS
003-XXX-XM

X = numeric character
S= spool
M = mini-spool

In Progress March, 2021 TPE Autoclave C-Flex® 072_Autoclave Request Access
Extruded Tubing C-Flex® 050

R70-050-000
050-XXX-X
050-XXX-XS
050-XXX-XM

X = numeric character
S= spool
M = mini-spool

Complete December, 2020 TPE Gamma C-Flex® 082_Gamma Request Access
Extruded Tubing C-Flex® 050

R70-050-000
050-XXX-X
050-XXX-XS
050-XXX-XM

X = numeric character
S= spool
M = mini-spool

Complete December, 2020 TPE Autoclave C-Flex® 082_Autoclave Request Access
Extruded Tubing, Overmolding, Diptube C-Flex® 072

R70-072-000
072-XXX-X
072-XXX-XS
072-XXX-XM

X = numeric character
S= spool
M = mini-spool

In Progress March, 2021 TPE Autoclave C-Flex® 072_Autoclave Request Access
Extruded Tubing, Overmolding, Diptube C-Flex® 072

R70-072-000
072-XXX-X
072-XXX-XS
072-XXX-XM


X = numeric character
S= spool
M = mini-spool

In Progress March, 2021 TPE Gamma C-Flex® 072_Gamma Request Access
Extruded Tubing, Overmolding, Diptube C-Flex® 082

R70-082-000
082-XXX-X
082-XXX-XS
082-XXX-XM

Complete December, 2020 TPE Gamma C-Flex® 082_Gamma Request Access
Extruded Tubing, Overmolding, Diptube C-Flex® 082

R70-082-000
082-XXX-X
082-XXX-XS
082-XXX-XM

Complete December, 2020 TPE Autoclave C-Flex® 082_Autoclave Request Access
Extruded Tubing, Overmolding, Diptube C-Flex® 374

R70-374-000
374-XXX-X
374-XXX-XS

Complete December, 2020 TPE Gamma C-Flex® 374_Gamma Request Access
Extruded Tubing, Overmolding, Diptube C-Flex® 374

R70-374-000
374-XXX-X
374-XXX-XS

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
376-XXX-X
Tubing used in Flexjoints

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
376-XXX-X
Tubing used in Flexjoints

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
376-XXX-X
Tubing used in Flexjoints

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
376-XXX-X
Tubing used in Flexjoints

Complete December, 2020 TPE Gamma C-Flex® 374_Gamma Request Access
Tubing PharmaFluor® FEP

PCAMGXXXXX
PH100XXXXXX
PHFE6XXXXXX
PH6303XXXXX
PCFE6XXXXXX

X = numeric character
7 to 13 characters in length

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
(A) = style (e.g. T, cross, etc.)
XXX = Size in inches

In Progress PVDF Gamma PVDF-SUS Components_Gamma Request Access
Tubing Connector Pure-Fit® Smooth Inner Bore (SIB) Connectors

PF(A)XXXPVDFAF
(A) = style (e.g. T, cross, etc.)
XXX = Size in inches 

In Progress PVDF Autoclave PVDF-SUS Components_Autoclave Request Access
Tubing Connector Pure-Fit® Smooth Inner Bore (SIB) Connectors

PF(A)XXXPPAF
(A) = style (e.g. T, cross, etc.)
XXX = Size in inches 

In Progress PP Gamma PP-SUS Components_Gamma Request Access
Tubing Connector Pure-Fit® Smooth Inner Bore (SIB) Connectors

PF(A)XXXPPAF
(A) = style (e.g. T, cross, etc.)
XXX = Size in inches 

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
PFSC375-XXX
PFSC500-XXX
PFSC750-XXX
PFSC1000-XXX
Where XXX = IHM,
OHM or CAM

In Progress PVDF Gamma PVDF-SUS Components_Gamma Request Access
Sterile Connector Pure-Fit® Sterile Connector

PFSC250-XXX
PFSC375-XXX
PFSC500-XXX
PFSC750-XXX
PFSC1000-XXX
Where XXX = IHM,
OHM or CAM

In Progress PVDF Autoclave PVDF-SUS Components_Autoclave Request Access
Tubing Connector Sani-Tech® Rigid Connector

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 PVDF Gamma PVDF-SUS Components_Gamma Request Access
Tubing Connector Sani-Tech® Rigid Connector

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 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:
Sani-Tech® LIM
Sani-Tech® 65 LIM
Tygon® 3350 LIM
Tygon® 3370 LIM
Ultra LIM
Ultra 65 LIM
PC Silicone ST50 LSR
PC Silicone ST65 LSR
PC Silicone
TYG50 LSR
PC Silcone ULT50 LSR
PC Silicone
ULT65 LSR
PC Silicone
TYG70 LSR

In Progress Silicone Gamma LIMs_Gamma Request Access
Overmolding Silicone Overmolding

Refer to product description:
Sani-Tech® LIM
Sani-Tech® 65 LIM
Tygon® 3350 LIM
Tygon® 3370 LIM
Ultra LIM
Ultra 65 LIM
PC Silicone ST50 LSR
PC Silicone ST65 LSR
PC Silicone
TYG50 LSR
PC Silcone ULT50 LSR
PC Silicone
ULT65 LSR
PC Silicone
TYG70 LSR

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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