Millipore Aervent® Sterilizing-Grade Hydrophobic Filter
| Brand | Millipore |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Imported |
| Model | Aervent® |
| Pricing | Upon Request |
Overview
The Millipore Aervent® Sterilizing-Grade Hydrophobic Filter is an engineered solution for the reliable, validated removal of microorganisms from gases and non-aqueous liquids in critical biopharmaceutical and life science applications. Based on a 0.2 µm polytetrafluoroethylene (PTFE) membrane, the filter operates via size-exclusion and surface retention mechanisms—principally leveraging the hydrophobic nature and uniform pore structure of PTFE to prevent microbial penetration while permitting high gas flow rates. Unlike hydrophilic membranes, Aervent® filters resist wetting by water or aqueous solutions, making them inherently suitable for venting, tank blanketing, sterilizing-grade air supply, and vacuum line protection where moisture ingress must be avoided. The device is manufactured under strict quality control aligned with ISO 13485 and conforms to ASTM F838-22 for bacterial retention validation using Brevundimonas diminuta (ATCC 19146), ensuring consistent log reduction values (LRV) ≥ 7 under defined test conditions.
Key Features
- Validated 0.2 µm sterilizing-grade retention performance per ISO 13485 and ASTM F838-22
- Hydrophobic PTFE membrane offering broad chemical compatibility—including resistance to alcohols, ketones, esters, hydrocarbons, and halogenated solvents
- Thermal stability up to 135°C for repeated autoclave cycles (e.g., 30 min at 121°C or 15 min at 135°C)
- No fiber shedding or extractables under validated operating conditions; low particle generation verified per USP
- High gas permeability and low ΔP across operational flow ranges, minimizing pressure drop in ventilation and sparging lines
- Robust polypropylene housing (in disc and cartridge formats) providing mechanical integrity during SIP (steam-in-place) and CIP (clean-in-place) procedures
Sample Compatibility & Compliance
Aervent® filters are compatible with compressed air, nitrogen, oxygen, CO₂, and other process gases used in bioreactor headspace control, fermenter aeration, WFI (Water-for-Injection) tank venting, and lyophilizer vacuum break systems. They are routinely deployed as sterile air breathers for glass carboys, stainless-steel vessels, and single-use bioreactors. All configurations undergo pre-sterilization integrity testing (bubble point or diffusion test) and post-manufacturing validation per FDA guidance on sterility assurance. The filters support compliance with cGMP, EU Annex 1 (2022), and USP , and documentation packages include Certificate of Conformance, Certificate of Validation Support, and batch-specific integrity test records.
Software & Data Management
While Aervent® filters are passive hardware components, their integration into automated process environments is supported through compatibility with industry-standard monitoring platforms. When used with digital pressure transducers or flow meters, real-time differential pressure trends can be logged into SCADA or MES systems for predictive maintenance and change-out scheduling. Integrity test data (e.g., bubble point values) may be recorded manually or via electronic test instruments compliant with 21 CFR Part 11 requirements—including audit trail, electronic signature, and data archiving capabilities. Millipore provides traceable lot documentation and supports GxP-aligned record retention strategies for regulatory submissions.
Applications
- Sterile air filtration for bioreactor inlet/outlet gas streams
- Venting of WFI and purified water storage tanks
- Steam sterilizer vacuum line protection and condensate trap venting
- Aseptic filling line environmental monitoring air sampling
- Single-use system (SUS) bag headspace filtration and pressure equalization
- Pharmaceutical cleanroom HVAC make-up air pre-filtration (as secondary barrier)
FAQ
What is the maximum recommended service life for Aervent® filters under continuous operation?
Service life depends on particulate load, gas composition, and sterilization frequency; typical validated lifespan is 10–20 SIP cycles when operated within specified temperature and pressure limits.
Can Aervent® filters be used for aqueous liquid filtration?
No—Aervent® is hydrophobic and not intended for liquid sterilization; use Millipore Express® or Durapore® hydrophilic filters for aqueous applications.
Is pre-wetting required before integrity testing?
Yes—hydrophobic PTFE membranes require wetting with 95% isopropyl alcohol (IPA) or 100% ethanol prior to bubble point or diffusion testing.
Do Opticap™ XL filters include pre-attached connectors?
Yes—Opticap™ XL configurations ship with standardized hygienic fittings (e.g., Tri-Clamp®, SMS, or hose barb) selected per order specification; no additional assembly is required.
How are Aervent® filters qualified for use in GMP manufacturing?
Qualification includes vendor qualification (Millipore Sigma QbD documentation), filter selection rationale, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) with microbial challenge studies and routine integrity testing protocols.
