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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.

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


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:

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.​
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
Supports process optimization and safety risk assessment with detailed extractables profile (BPOG extractables protocol and USP <665> draft 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> draft, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, published Sep 2020.

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.

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  
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 

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 
Lynx® ConnectorMaterial Qualification DossierQuality Management DossierOperational Excellence Dossier
Lynx® S2S Connectors
Lynx® CDR Connectors
Lynx® ST Connectors
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. 

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 AssemblyGammaAdvanced 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.

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

Filter

Test Approach

Materials of Construction / Resin

Pre-treatment

Representative P/N**

Milligard® PES Capsule FiltersBPOG / USP High RiskPES, PPAutoclaveKMXXXXXXXX
Milligard® PES Cartridge Filters BPOG / USP High RiskPES, PP

GammaCMXXXXXXXX

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

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 RiskULDPE, EVOH, EVA GammaNA*
Sterile FilterTest ApproachMaterials of Construction / ResinPre-treatmentRepresentative P/N**
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.1 µm Durapore® MembraneBPOG / USP Medium RiskPVDF, PP, SiliconeAutoclaveKVVLAXXXXX
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.22 µm Durapore® MembraneBPOG / USP Medium RiskPVDF, PP, SiliconeAutoclaveKVGLAXXXXX
Hydrophilic 0.1 µm Durapore® CartridgeBPOG / USP Medium RiskPVDF, PP, SiliconeAutoclaveCVVLXXXXX
Hydrophilic 0.22 µm Durapore® CartridgeBPOG / USP Medium RiskPVDF, PP, SiliconeAutoclaveCVGLXXXXX
Autoclavable Opticap® XL and XLT Capsule Filters with Hydrophilic 0.45/0.22 µm Durapore® MembraneBPOG / USP Medium RiskPVDF, PP, SiliconeAutoclaveKHGLAXXXXX
Millipak® Final Fill 0.22 µm and 0.1 µm FiltersBPOG / USP High RiskPVDF, PSGammaMFVLXXXXX, MFGLXXXXX
Millipak® Final Fill 0.45 µm FilterBPOG / USP High RiskPVDF, PSGammaMFHLXXXXX
Millipak® Final Fill 5.0 µm FilterBPOG / USP High RiskPVDF, PSGammaMFSLXXXXX
Millidisk 0.1 µm FilterBPOG / USP Medium RiskPVDF, PSAutoclaveMCHLXXXXX
Millidisk 0.22 µm FilterBPOG / USP Medium RiskPVDF, PSAutoclaveMCGLXXXXX
Milligard® PES Capsule Filters / USP High RiskPES, PPAutoclaveKMXXXXXXXX
Milligard® PES Cartridge FiltersBPOG / USP High RiskPES, PPGammaCMXXXXXXXX
Gamma Compatible and Sterile Opticap® XL Capsule Filters with  Millipore Express® SHC, SHF, SHR, and SHR with Prefilter MembranesBPOG / USP Medium RiskPES,PET, PP, SiliconeGammaKHVEGXXXXX, KHVESXXXXX, KVEPGXXXXX, KVEPSXXXXX, KHGEGXXXXX, KHGESXXXXX, KGEPGXXXXX, KGEPSXXXXX
Gamma Compatible and Sterile Opticap® XLT Capsule Filters with Millipore Express® SHC and SHR Membrane – High AreaBPOG / USP High RiskPES,PET, PP, SiliconeGammaKHVEGXXXXX, HKHGEGXXXXXX, KHGESXXXXXX,
Gamma Compatible and Sterile Opticap® Small Scale Capsule Filters with  Millipore Express® SHC, SHF, SHR, and SHR with Prefilter MembranesBPOG / USP Medium RiskPES,PE, PP, SiliconeGammaKHVEG0XXXXX, 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 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 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 RiskPES, PVDF, SiliconeN/AVPMGXXXXXX
Viresolve® Pro Modus and Magnus Shield BPOG / USP High RiskPES, PVDF, SiliconeN/AVPPSXXXXXX
Viresolve® Pro Modus and Magnus Shield H BPOG / USP High RiskPES, PVDF, SiliconeN/AVPPHXXXXXX
The new Emprove<sup>®</sup> Suite

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

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