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Emprove® Extractables Data for Filters and Single-use Systems

Enabling a More Robust Extractables and Leachables Risk Assessment

 

Enabling a More Robust Extractables and Leachables Risk Assessment

extractables and potential leachables

All polymeric components such as the filters and single-use systems used in biopharmaceutical manufacturing must be assessed for safety through an evaluation of extractables and potential leachables.

Extractables are compounds that can be extracted from these materials while leachables are compounds that leach from the materials into the process stream. An understanding of extractables is essential as it can help identify the leachables that may enter a process stream.

Fast-track your Extractables Risk Assessment

With our Emprove® Program, developing an extractables profile for filters and single-use systems used in biopharmaceutical manufacturing no longer requires a time- and resource-intensive compilation of a vast amount of data.

Our Emprove® Operational Excellence Dossiers will enable you to fast-track extractables risk assessment by providing reliable extractables data, based on industry standards and guidelines established by the BioPhorum standardized testing protocol and USP <665> draft chapters. Our focus has been on consistency in quality, test methodology and reporting across the portfolio of products in scope.

The datasets generated facilitate your safety risk assessment by accelerating your ability to identify potential leachables and patient exposure which can be calculated based on process conditions, total surface area in contact with the product, batch size and final drug product maximum daily dose.

BioPhorum Requirements USP <665> (Nov, 2021) Emprove® Program Approach
Scope Single-use components in contact with fluid path (for biopharmaceutical manufacturing) Single-use and multi-use components and devices with fluid path contact (for pharmaceutical drug product and biopharmaceutical drug substance and drug product manufacturing) Single-use and multi-use components and devices with fluid path contact, all relevant existing and new products
Solvents
  1. 50% Ethanol
  2. 0.5N NaOH
  3. 0.1M Phosphoric Acid
  4. WFI
  1. 0.2M KCl, pH 3 (C1)
  2. 0.1M Phosphate buffer, pH 10 (C2)
  3. 50% Ethanol (C3)
  1. 50% Ethanol
  2. 0.1M Phosphate buffer, pH 10
  3. 0.1M Phosphoric Acid
  4. WFI
  5. 0.5N NaOH (when compatible)
Analytical methods HPLC-PDA/MS (APCI, ESI, +/-) ICP/MS, GCMS-DI, GCMS-HS
(TOC, pH, NVR) 		Described in USP <1663>. Broader scope in method selection. BioPhorum, additionally Ion Chromatography.
Time Points 1-3, dependent on component Described in USP <1663>.
Broader scope in methods selection 		BioPhorum + USP <665>
Pre-treatment …‘should be pre-treated the same way before … extractables testing…‘ “…tested when they have been conditioned or processed in a manner consistent with their intended use and as specified in the manufacturer's instructions for use.”
  • Separate tests and reports for gamma irradiation or autoclave pre-treatment
  • No pre-flush unless required (worst case)

A full spectrum of services that caters to your specific needs for Extractables and Leachables risk assessment

A thorough interpretation of the extractables datasets from the operational excellence dossiers to your specific product and process can further be supported through consultation and services from Bioreliance® Validation Services.
Together with our BioReliance® Validation Services Experts, we provide a higher level of confidence in safety risk assessment through careful selection of well-characterized materials, experience in identifying and analyzing potential leachables (or process-specific extractables) data and expertise in the design and execution of need-based leachables studies. Because every product and process are unique, we tailor our approach to deliver best-in-class services and robust results that meet global industry standards, even as the standards continue to evolve:
Emprove and BioReliance

Emprove® Operational Excellence Dossiers Availability for Filtration and Single Use Systems

Product Family
Dossiers and Availability		 Test approach Materials of construction/ Resin Pre-Treatment Accessibility to Operational Excellence Dossier Representative P/N**
Lynx® CDR Connectors
Lynx® CDR Connectors
 Full BPOG PS, Silicone, Stainless Steel, Glass-filled PS Gamma Emprove® Suite CDRXXXN05
Lynx® S2S Connectors
Lynx® S2S Connectors
 Full BPOG PS, Silicone Gamma Emprove® Suite SSCXHBXAXX
Lynx® ST Connectors
Lynx® ST Connectors
 Full BPOG PEI, Silicone Gamma Emprove® Suite STCXXXXXXX
Millistak+®HC Pro Process Scale Pod Depth Filters (C0SP and D0SP)
Millistak+® HC Pro Process Scale and Lab Scale Pods with C0SP and D0SP Media Grades
Full BPOG, USP <665> PP, Silica NA* Emprove® Suite MC0SPXXXXX, MD0SPXXXXX
Millistak+®HC Pro Process Scale Pod Depth Filters (X0SP)
Full BPOG, USP <665> PP, Silica NA* Emprove® Suite MX0SPXXXXX
PureFlex™ Plus Single-Use Process Container Films
PureFlex™ Plus Single-Use Process Container Film
 Full BPOG ULDPE, EVOH, EVA Gamma Request Dossier NA*
PureFlex™ Single-Use Process Container Films
PureFlex™ Single-Use Process Container Film
 Full BPOG ULDPE, EVOH, EVA Gamma Request Dossier NA*
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.22µm Durapore® Membrane
Autoclavable 0.22 μm Hydrophilic Durapore® Cartridge Filters and Opticap® XL and XLT Capsule Filters with 0.22 μm Hydrophilic Durapore® Membrane
Full BPOG PVDF, PP, Silicone Autoclave Emprove® Suite KVGLAXXXXX
Gamma Compatible and Sterile Opticap® XLT Capsule Filters with Millipore Express® SHC Membrane - high Area
Gamma Compatible and Sterile Opticap® XLT Capsule Filters with Millipore Express® SHC Membrane - high Area
Full BPOG, USP <665> PES,PP,Silicone Gamma Emprove® Suite KHGEGXXXXXX, KHGESXXXXXX
Gamma Compatible and Sterile Opticap® XL and XLT Capsule Filters with Hydrophilic 0.22µm Durapore® Membrane
Gamma Compatible and Sterile Opticap® XL and XLT Capsule Filters with 0.22 μm Hydrophilic Durapore® Membrane
Full BPOG PVDF, PP, Silicone Gamma Emprove® Suite KVGLGXXXXX, KVGLSXXXXX
Gamma Compatible and Sterile Opticap® XL and XLT Capsule Filters with Millipore Express® SHC Membrane - Standard Area
Gamma Compatible and Sterile Millipore Express® SHC and Millipore Express® SHF Capsule Filter
Full BPOG PES,PP,Silicone Gamma Emprove® Suite KHGEGXXXXX, KHGESXXXXX
Gamma Compatible and Sterile Opticap® XL and XLT Capsule Filters with Millipore Express® SHF Membrane
Gamma Compatible and Sterile Millipore Express® SHC and Millipore Express® SHF Capsule Filter
Full BPOG PES,PP,Silicone Gamma Emprove® Suite KGEPGXXXXX, KGEPSXXXXX
Gamma Compatible and Sterile Opticap® XL and XLT Capsule Filters with Millipore Express® SHR Membrane - Standard Area
Gamma Compatible and Sterile Opticap® XL and XLT Capsule Filters with Millipore Express® SHR Membrane - Standard Area
Full BPOG PES,PP,Silicone Gamma Emprove® Suite KHVEGXXXXX, KHVESXXXXX, KVEPGXXXXX, KVEPSXXXXX
Gamma Compatible and Sterile Opticap® XLT Capsule Filters with Millipore Express® SHR Membrane - High Area
Gamma Compatible and Sterile Opticap® XLT Capsule Filters with Millipore Express® SHR Membrane - High Area
Full BPOG, USP <665> PES,PP,Silicone Gamma Emprove® Suite KHVEGXXXXXH
Hydrophilic 0.22 μm Durapore® Cartridge Filters
Autoclavable 0.22 μm Hydrophilic Durapore® Cartridge Filters and Opticap® XL and XLT Capsule Filters with 0.22 μm Hydrophilic Durapore® Membrane
Full BPOG PVDF, PP, Silicone Autoclave Emprove® Suite MSP000XXX, CVGLXXXXXX
Milligard® PES Capsule Filters
Milligard® PES Capsule Filters
Full BPOG, USP <665> PES, PP Gamma Emprove® Suite KWXXXXXXXX
Milligard® PES Cartridge Filters
Availability to be determined.
Full BPOG, USP <665> PES, PP Gamma Emprove® Suite CWXXXXXXXX
Millipak® Final Fill 0.1 µm Filter
Available Now
Full BPOG, USP <665> PVDF, PS Gamma Emprove® Suite MFVLXXXXX
Millipak® Final Fill 0.22 µm with Hydrophobic Durapore® Membrane
Availability Now
Full BPOG, USP <665> PVDF, PS Gamma Emprove® Suite MFGBXXXXX
Millipak® Final Fill 0.45 µm Filter
Millipak® Final Fill 0.45 µm Filter
Full BPOG, USP <665> PVDF, PS Gamma Emprove® Suite MFHLXXXXX
Millipak® Final Fill 5.0 µm with Hydrophilic Durapore® Membrane
Millipak® Final Fill 5.0 µm with Hydrophilic Durapore® Membrane
Full BPOG, USP <665> PVDF, PS Gamma Emprove® Suite MFSLXXXXX
Millipore Express® SHC 0.5/0.2 μm Cartridge Filters - High Area
Millipore Express® SHC 0.5/0.2 μm Cartridge Filters - High Area
Full BPOG, USP <665> PES, PP, Silicone, EPDM/ Fluoroelastomer Autoclave Emprove® Suite CHGEXXHXX
Millipore Express® SHC 0.5/0.2 μm Cartridge Filters - Standard Area
Autoclavable Millipore Express® SHC and Millipore Express® SHF Cartridge and Capsule Filters
Full BPOG PES, PP, Silicone, EPDM/ Fluoroelastomer Autoclave Emprove® Suite CHGEXXTXX
Millipore Express® SHC Autoclavable Opticap® XL and XLT Capsule Filters
Autoclavable Millipore Express® SHC and Millipore Express® SHF Cartridge and Capsule Filters
Full BPOG PES,PP,Silicone, EPDM/ Fluoroelastomer Autoclave Emprove® Suite KGEAXXXXX
Millipore Express® SHF Autoclavable Opticap® XL and XLT Capsule Filters
Autoclavable Millipore Express® SHC and Millipore Express® SHF Cartridge and Capsule Filters
Full BPOG PES, PP, Silicone, EPDM/ Fluoroelastomer Autoclave Emprove® Suite KGEPAXXXXX
Millipore Express® SHF Cartridge Filters
Autoclavable Millipore Express® SHC and Millipore Express® SHF Cartridge and Capsule Filters
Full BPOG PES,PP,Silicone, EPDM/ Fluoroelastomer Autoclave Emprove® Suite CGEPXXTXX
Millipore Express® SHR Autoclavable Opticap® XL and XLT Capsule Filters
Autoclavable Millipore Express® SHC and Millipore Express® SHF Cartridge and Capsule Filters
Full BPOG PES, PP, Silicone, EPDM/ Fluoroelastomer Autoclave Emprove® Suite KHVEAXXXXX
Millipore Express® SHR with Prefilter Cartridge Filters - High Area
Available July 2020
Full BPOG, USP <665> PES, PP, Silicone, EPDM/ Fluoroelastomer Autoclave Emprove® Suite CHVEXXHXX
Pellicon® 3 cassettes with Biomax® membranes
Availability to be determined.
Full BPOG, USP <665> PES, PP, PE NA Emprove® Suite P3B0XXXXX
Pellicon® 3 cassettes with Ultracel® membranes
Availability to be determined.
Full BPOG, USP <665> Composite Regenerated Cellulose, PP, PE NA Emprove® Suite P3C0XXXXX
Pellicon® Capsules with Ultracel® Membrane
Pellicon® Capsules with Ultracel® Membrane
Full BPOG, USP <665> Composite Regenerated Cellulose, PP, PE Gamma Emprove® Suite PCC030CXX, PCC030CXXX
Viresolve® Barrier Capsule Filters
Availability to be determined.
Full BPOG, USP <665> PP, PES, PE, Silicone, EPDM Gamma Emprove® Suite VBKGXXXXXX
Viresolve® Pro Modus and Magnus Devices
Viresolve® Pro Devices
Full BPOG, USP <665> PES, PVDF, Silicone NA* Emprove® Suite VPMDXXXXXX, VPMGXXXXXX
Viresolve® Pro Modus and Magnus Shield
Available Now
Full BPOG, USP <665> PES, PVDF, Silicone NA* Emprove® Suite VPPSXXXXXX
Viresolve® Pro Modus and Magnus Shield H
Available Now
Full BPOG, USP <665> PES, PVDF, Silicone NA* Emprove® Suite VPPHXXXXXX
Mobius® Library components
BPOG, USP <665> Component Specific Gamma Emprove® Reports NA
** P/N stands for part number. The indicated part numbers are generic for the family. Please replace your specific part numbers as applicable.

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