Emprove^® Filters and Single-Use Components

Information is crucial for drug manufacturers selecting filtration and single-use technologies. Answering the industry-wide demand for increasing levels of transparency, our expanded Emprove^® Filter and Single-use Components portfolio now covers all the major steps of the biopharmaceutical process. So you can move forward in your product development with confidence.

If you are interested in Extractables data or other premium content, Demo dossiers are available to download including data for custom assemblies, chemicals and consumables.

New Advanced Qualification Dossier

Your Fluid Management Closed & Single-Use 

Emprove^® Dossier documentation addresses current and anticipated regulatory requirements to help speed up internal qualification procedures and accelerate your preparation of the drug approval process. While Emprove^® Dossiers address families of components, Single-Use assemblies are composed of multiple components requiring extensive qualification. The Emprove^® Advanced Qualification Dossier combines all component information into one comprehensive dossier to further Expedite Approval Preparation and Extend Compliance.

Content:

• General information: Assembly item number, description, certification level & revision
• Materials of Construction: Included in assembly drawing, component part numbers & descriptions
• Specifications: Specific certification level specifications
• Test Summaries and Results: General explanation of validation and testing, same for all assemblies
• Regulatory Statements: Custom Regulatory Statement for entire assembly based on the assembly components
• Extractables Data for Product Contact Components (when available): Surface areas, USP <665> Extractables Data including organic extractables and elemental impurities data

Read our Data Sheet to Learn More

Emprove^® Dossiers for Filters and Single-use Components

All our high-quality portfolio products feature Emprove^® Dossiers, providing the optimized information you need to fast track your drug to market. These include:

Material Qualification Dossier

Supports product qualification and speeds up regulatory filing preparation. Includes content on the manufacturing process, product specifications and various qualification criteria (product validation data), regulatory statements, and more.	General information Manufacturing flow chart Product validation and qualification Specifications (design and release criteria) Materials of construction Extractables summary** Regulatory statements (Animal Origin, BPA, etc.)	Free of charge*
** Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing, BioPhorum, published April 2020 & USP <665> draft, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, published Sep 2020.​

Quality Management Dossier

Answers questions during quality risk assessment. Provides valuable information on how quality variability attributes are controlled.

Quality Self-assessments Chain of custody Supplier and CMO management Shelf life testing and results Packaging and Sterilization Validation

Free of charge

Operational Excellence Dossier

Supports process optimization and safety risk assessment with detailed extractables profile (BPOG extractables protocol and USP <665> chapters and information on elemental impurities (ICH Q3D).	Extractables Report** Elemental impurities summary Analytical procedures
** Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing, BioPhorum, published April 2020 & USP <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, finalized November 2021 and effective May 2026.

Emprove^® Single-Use Specific Reports 

Advanced Qualification Dossier (For Mobius Custom Assemblies)

The Advanced Qualification Dossier is customized with specific information for your assembly. The dossier can be purchase individually or subscribe to the Emprove^® Suite

Supports product qualification and speeds up regulatory filing preparation. Includes content on the manufacturing process, product specifications and various qualification criteria.	General information Manufacturing flow chart Product validation and qualification Specifications (design and release criteria) Materials of construction Regulatory statements (Animal Origin, BPA, etc.)
Supports process optimization and safety risk assessment with detailed extractables profile (BPOG extractables protocol and USP <665> chapters and information on elemental impurities (ICH Q3D).**	Surface Area for product contact components Extractables Data for product contact components (when available) Elemental impurities summary

**Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing, BioPhorum, published April 2020 & USP <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, finalized Nov 2021, effective May 2026.

Single-Use Particulate Library

Support end-user risk assessment activities when particulates (particles) are found in/on Mobius® Single-Use Assemblies

Identified Particulates Characteristics FTIR Spectrum

Irradiation Information

Support end-user risk assessment for demonstration of sterility.

Component Extractable Reports

Supports process optimization and safety risk assessment with detailed extractables profile (USP <665> chapter and information on elemental impurities (ICH Q3D).	Extractables Report** Elemental impurities summary Analytical procedures
** USP <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, finalized November 2021 and effective May 2026.

Emprove^® Filtration and Single-use Component Product Groups*

For an overview of our portfolio products and dossier availability, select any product family below. 

*Status as per Q1 2023, constantly updated.

TFF Filters

Filter	Material Qualification Dossier	Quality Management Dossier	Operational Excellence Dossier
Pellicon® 3 Cassettes with Biomax® Membranes	✓	✓	✓
Pellicon® 3 Cassettes with Ultracel® Membranes	✓	✓	✓
Pellicon® Capsules with Ultracel® Membrane	✓	✓	✓
Cellicon® Perfusion Filter	✓	✓	✓

Virus Filters

Filter	Material Qualification Dossier	Quality Management Dossier	Operational Excellence Dossier
Viresolve® Pro Modus and Magnus Devices	✓	✓	✓
Viresolve® Pro Magnus Devices	✓	✓	✓
Viresolve® Pro Modus and Magnus Shield	✓	✓	✓
Viresolve® Pro Modus and Magnus Shield H	✓	✓	✓

Filters

Filter	Material Qualification Dossier	Quality Management Dossier	Operational Excellence Dossier
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.1 µm Durapore® Membrane			✓
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.22 µm Durapore® Membrane	✓	✓	✓
Hydrophilic 0.1 µm Durapore®  Cartridge			✓
Hydrophilic 0.22 µm Durapore®  Cartridge	✓	✓	✓
Millipak® Final Fill Filter	✓	✓	✓
Millidisk 0.1 µm Filter			✓
Millidisk 0.22 µm Filter	✓	✓	✓
Gamma Compatible and Sterile Opticap® XL Capsule Filters with  Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Membranes	✓	✓	✓
Gamma Compatible and Sterile Opticap® XLT Capsule Filters with Millipore Express® SHC and SHR Membrane – High Area	✓		✓
Gamma Compatible and Sterile Opticap® Small Scale Capsule Filters with  Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Membranes	✓	✓	✓
Autoclavable Opticap® XL and XLT Capsule Filters with Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Membranes	✓	✓	✓
Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Cartridges	✓	✓	✓

Process Container Films

* Available through subscription

PureFlex™ Film	Material Qualification Dossier	Quality Management Dossier	*Operational Excellence Dossier
PureFlex™ Single-use Process Container Films	✓		✓
PureFlex™ Plus Single-use Process Container Films	✓		✓
Ultimus® Single-Use Process Container Film	✓		✓

Assemblies

Assembly	Materials Qualification Dossier	Quality Management Dossier	*Operational Excellence Dossier	*Advanced Qualification Dossier
Single-use Assemblies with Mobius® Technology	✓	✓		✓
Mobius® Select Single-use Assemblies	✓	✓		✓
Mobius® Custom Assemblies  Order Advanced Qualification Dossier		✓		✓
Mobius® Bioreactors	✓	✓		✓
Mobius® Mixers and Power Mixers	✓	✓		✓
Flexware® Assemblies for Mobius® TFF 80 and Chrom Systems	✓	✓		✓
NovaSeptum® GO Sterile Sampling	✓	✓
Mobius® ADC Reactor Assemblies	✓	✓		✓
Mobius® iFlex Bioreactors	✓	✓		✓
High Cell Density Cryopreservation Mobius® Assemblies	✓	✓		✓
NovaSeptum® SURe Single-use Sterile Sampling Assemblies	✓	✓

Lynx^® Connectors

Lynx® Connector	Material Qualification Dossier	Quality Management Dossier	Operational Excellence Dossier
Lynx® S2S Connectors	✓	✓	✓
Lynx® CDR Connectors	✓	✓	✓
Lynx® ST Connectors	✓	✓	✓

PROCESS/DEPTH FILTERS

Filter	Material Qualification Dossier	Quality Management Dossier	Operational Excellence Dossier
Milligard® PES Opticap® XLT Filters	✓	✓	✓
Milligard® PES Cartridge Filters	✓	✓	✓
Milligard® PES Small Scale and T-Line Capsules	✓	✓	✓
Millistak+® HC Pro Process Scale Pod Depth Filters	✓	✓	✓
Clarisolv® Depth Filters	✓	✓

Fast track your extractables risk assessment

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.

With our Emprove^® Program, developing an extractables profile for filters and single-use systems no longer requires a time- and resource-intensive compilation of a vast amount of data. Instead, our Emprove^® Operational Excellence Dossiers provide you with reliable extractables data based on industry standards and guidelines established by the BioPhorum Operations Group's (BPOG) standardized testing protocol and USP <665> chapters. The datasets generated facilitate your safety risk assessment, accelerating your ability to identify potential leachables and calculate patient exposure based on process conditions, total surface area in contact with the product, batch size and final drug product maximum daily dose.

	BPOG Requirements	USP <665> (Finalized November, 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)	= BPOG + USP <665>
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	BPOG, additionally Ion Chromatography
Time Points	1-3, dependent on component	Described in USP <1663> Broader scope in method selection	= BPOG + 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 for extractables and leachables risk assessment

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 is 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^® Advanced Qualification Dossier and Component Extractables Reports

For Mobius Assemblies that contain multiple components, the Advanced Qualification Dossier includes assembly and component information to support the qualification and patient safety.  Included are the extractable datasets that are individually available through the Operational Excellence Dossiers (film, connectors, and filters) and Third-Party component Extractables Reports.  To evaluate your specific product and process, further support through consultation and services from  Validation Services are available. The Advanced Qualification Dossier or individual component Extractable reports can be obtained from the links below. 

Assemblies

Assembly	Test Approach	Materials of Construction / Resin	Pre-treatment	Access to Extractables Data
Mobius® Single-Use Assemblies (Full Component Evaluation)	BPOG, USP <665>	Multiple Components based on Assembly	Gamma	Advanced Qualification Dossier
Individual Third-Party Components	BPOG, USP <665>	Component Specific	Gamma	Emprove® Component Extractables Reports

Emprove^® Operational Excellence Dossiers by Product Family

A thorough interpretation of the extractables datasets from our Operational Excellence Dossiers to your specific product and process can further be supported through consultation and services from Bioreliance^® Validation Services. For an overview of available Operational Excellence Dossiers, select any product family below.

* P/N stands for part number. The indicated part numbers are generic for the family. Please replace your specific part numbers as applicable.

Lynx^® Connectors

Connector	Test Approach	Materials of Construction / Resin	Pre-treatment	Representative P/N**
Lynx® CDR Connectors	BPOG / USP Medium Risk	PS, Silicone, Stainless Steel, Glass-filled PS	Gamma	CDRXXXN05
Lynx® S2S Connectors	BPOG / USP Medium Risk	PS, Silicone	Gamma	SSCXHBXAXX
Lynx® ST Connectors	BPOG / USP Medium Risk	PS, Silicone	Gamma	STCXXXXXXX

PROCESS/DEPTH FILTERS

Filter	Test Approach	Materials of Construction / Resin	Pre-treatment	Representative P/N**
Milligard® PES Capsule Filters	BPOG / USP High Risk	PES, PP	Autoclave	KMXXXXXXXX
Milligard® PES Cartridge Filters	BPOG / USP High Risk	PES, PP	Gamma	CMXXXXXXXX
Millistak+®  HC Pro Process Scale Pod Depth Filters (C0SP and D0SP)	BPOG / USP High Risk	PP, Silica	NA*	MC0SPXXXXX, MD0SPXXXXX
Millistak+® HC Pro Process Scale Pod Depth Filters (X0SP)	BPOG / USP High Risk	PP, Silica	NA*	MX0SPXXXXX

Process Container Film

Process Container Film	Test Approach	Materials of Construction / Resin	Pre-treatment	Representative P/N**
PureFlex™ Plus Single-use Process Container Film	BPOG / USP Medium Risk	ULDPE, EVOH, EVA	Gamma	NA*
PureFlex™ Single-use Process Container Film	BPOG / USP Medium Risk	ULDPE, EVOH, EVA	Gamma	NA*
Ultimus® Single-Use Process Container Film	BPOG / USP High Risk	ULDPE, EVOH, EVA	Gamma	NA*

Sterile Filters

Sterile Filter	Test Approach	Materials of Construction / Resin	Pre-treatment	Representative P/N**
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.1 µm Durapore® Membrane	BPOG / USP Medium Risk	PVDF, PP, Silicone	Autoclave	KVVLAXXXXX
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.22 µm Durapore® Membrane	BPOG / USP Medium Risk	PVDF, PP, Silicone	Autoclave	KVGLAXXXXX
Hydrophilic 0.1 µm Durapore® Cartridge	BPOG / USP Medium Risk	PVDF, PP, Silicone	Autoclave	CVVLXXXXX
Hydrophilic 0.22 µm Durapore® Cartridge	BPOG / USP Medium Risk	PVDF, PP, Silicone	Autoclave	CVGLXXXXX
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.45/0.22 µm Durapore® Membrane	BPOG / USP Medium Risk	PVDF, PP, Silicone	Autoclave	KHGLAXXXXX
Millipak® Final Fill 0.22 µm and 0.1 µm Filters	BPOG / USP High Risk	PVDF, PS	Gamma	MFVLXXXXX, MFGLXXXXX
Millipak® Final Fill 0.45 µm Filter	BPOG / USP High Risk	PVDF, PS	Gamma	MFHLXXXXX
Millipak® Final Fill 5.0 µm Filter	BPOG / USP High Risk	PVDF, PS	Gamma	MFSLXXXXX
Millidisk 0.1 µm Filter	BPOG / USP Medium Risk	PVDF, PS	Autoclave	MCHLXXXXX
Millidisk 0.22 µm Filter	BPOG / USP Medium Risk	PVDF, PS	Autoclave	MCGLXXXXX
Milligard® PES Capsule Filters	/ USP High Risk	PES, PP	Autoclave	KMXXXXXXXX
Milligard® PES Cartridge Filters	BPOG / USP High Risk	PES, PP	Gamma	CMXXXXXXXX
Gamma Compatible and Sterile Opticap® XL Capsule Filters with  Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Membranes	BPOG / USP Medium Risk	PES,PET, PP, Silicone	Gamma	KHVEGXXXXX, KHVESXXXXX, KVEPGXXXXX, KVEPSXXXXX, KHGEGXXXXX, KHGESXXXXX, KGEPGXXXXX, KGEPSXXXXX
Gamma Compatible and Sterile Opticap® XLT Capsule Filters with Millipore Express® SHC and SHR Membrane – High Area	BPOG / USP High Risk	PES,PET, PP, Silicone	Gamma	KHVEGXXXXX, HKHGEGXXXXXX, KHGESXXXXXX,
Gamma Compatible and Sterile Opticap® Small Scale Capsule Filters with  Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Membranes	BPOG / USP Medium Risk	PES,PE, PP, Silicone	Gamma	KHVEG0XXXXX, KHVES0XXXXX, KVEPG0XXXXX, KVEPS0XXXXX, KHGEG0XXXXX, KHGES0XXXXX, KGEPG0XXXXX, KGEPS0XXXXX
Autoclavable Opticap® XL and XLT Capsule Filters with Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Membranes		PES,, PP, Silicone		KHVEAXXXXX, KVEPAXXXXX, KHGEAXXXXX, KGEPAXXXXX
Millipore Express® SHC, SHF, SHR, and SHR with Prefilter Cartridges		PES,, PP, Silicone		CHVEXXXXX, CVEPXXXXX, CHGEXXXXX, CGEPXXXXX

TFF Filters

TFF Filter	Test Approach	Materials of Construction / Resin	Pre-treatment	Representative P/N**
Pellicon® 3 Cassettes with Biomax® Membranes	BPOG / USP High Risk	PES, PP, PE	NA	P3B0XXXXX
Pellicon® 3 Cassettes with Ultracel® Membranes	BPOG / USP High Risk	Composite Regenerated Cellulose, PP, PE	NA	P3C0XXXXX
Pellicon® Capsules with Ultracel® Membrane	BPOG / USP High Risk	Composite Regenerated Cellulose, PP, PE	Gamma	PCC030CXX, PCC030CXXX

Virus Filters

Virus Filter	Test Approach	Materials of Construction / Resin	Pre-treatment	Representative P/N**
Viresolve® Pro Modus and Magnus Devices	BPOG / USP High Risk	PES, PVDF, Silicone	N/A	VPMDXXXXXX,
Viresolve® Pro Magnus Devices	BPOG / USP High Risk	PES, PVDF, Silicone	N/A	VPMGXXXXXX
Viresolve® Pro Modus and Magnus Shield	BPOG / USP High Risk	PES, PVDF, Silicone	N/A	VPPSXXXXXX
Viresolve® Pro Modus and Magnus Shield H	BPOG / USP High Risk	PES, PVDF, Silicone	N/A	VPPHXXXXXX

THE NEW EMPROVE^® SUITE: SPEED THROUGH COMPLEXITY WITH CONFIDENCE

Compliance with current Good Manufacturing Practices is a continuum. Changes are inevitable. Audits and periodic reviews are necessary.

Take a seat: The Emprove^® Suite is here to improve your risk assessment journey. This  Information-as-a-Service digital platform is your co-pilot to support your need for convenient access to reliable information – anywhere, anytime. A subscription helps you stay current:  You can  not only easily find, view and download Emprove^® Dossiers, but also to “opt-in” to notification updates to be informed of changes to documents. You can also generate Emprove^® Dossier download metrics and reports, and so much more.

Ultimately, a subscription to the Emprove^® Suite empowers you to:

• take advantage of everything the Emprove^® Program has to offer
• collaborate and share information globally
• speed your way through the complexity of compliance with confidence

Related Product Resources

• White Paper: The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

  Discover the advantages and potential risks of single-use systems in biomanufacturing, including the importance of assessing and mitigating extractables and leachables.

• Article: Reducing the Need for Animal Testing for Biological Reactivity in Polymer Characterization

  Get an overview of USP <87>, <88>, and <1031>, bioreactivity testing, and our organization's in vitro test methods.

• Article: Aiding Material Qualification and Risk Assessment for Single-use Biomanufacturing

  Learn how single-use technologies offer advantages while requiring preparative work, including managing extractables and leachables.

• Brochure: Enabling a More Robust Risk Assessment

  Discover How the Emprove^® Programs Simplify Qualification, Risk Assessment, and Process Optimization.

• Article: Successfully Navigate the Regulatory Landscape for Chemicals and Single-Use Consumables

  Get an overview of terminology and key considerations related to regulatory expectations for chemical raw materials and qualification of components and single-use assemblies including extractable and leachable testing.

• Article: Extractables and Leachables Risk Assessment for Single-Use Systems

  Discover different approaches to assess the risks associated with E&L from single-use systems.

• Article: Best Practices for Qualifying Single-Use Assemblies

  Get an overview on key aspects of single-use assembly qualification including quality by design (QbD), quality risk management (QRM) and operator handling and training.

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Emprove^® Dossiers Filters

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