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Versapor® RC Membranes

Hydrophobic/Oleophobic Membranes

The Versapor RC range of hydrophobic and oleophobic membranes are used where particle, bacterial and viral retention is required in venting applications. Versapor RC membranes represent the next generation of venting materials, having been designed to specifically address changing market requirements driven by environmental legislation and regulations. These filter membrane grades offer the physical integrity and ability to reduce the risk of aerosol particulate contamination, while demonstrating consistent performance over a broad range of operating conditions and sterilization methods, as well as meeting or exceeding typical industry requirements.

Applications 

 

  • Venting/hydrophobic barrier
  • Equipment protection 
  • Air and gas filtration
  • Medical bag/device vents

Sterilization Compatibility

 

  • Gamma
  • Ethylene Oxide (ETO)
  • Autoclave

Sealing

 

  • Ultrasonic
  • Mechanical
  • Adhesive
  • RF Welding
  • Heat

Versapor® RC Membranes

 

 

Users should verify chemical compatibility with a specific membrane under actual use conditions because chemical compatibility is affected by multiple variables including temperature, pressure, concentration, and purity. The possibility of various chemical combinations and conditions of use available prevent complete accuracy.

 

Specifications
Versapor RC
Acrylic Copolymer membrane on non-woven nylon support 
Membrane Grade Nominal Pore Size (μm) Water Breakthrough (psi) Air Flow (SLPM) Thickness (mils)
Versapor 200RC  0.2 ≥ 26.0 ≥ 4.2*  
Versapor 450RC 0.45 ≥ 16.0 ≥ 15.0*  
Versapor 800RC 0.8 ≥ 8.0 ≥ 39.0*  
Versapor 1200RC 1.2 ≥ 6.0 ≥ 34.0**  
Versapor 3000RC 3.0 ≥ 3.0 ≥ 60.0**  
Versapor 5000RC 5.0 ≥ 2.0 ≥ 88.0**  
* 3.7 sq.cm area @ 13.5 psi
** 3.7 sq.cm area @ 5.0 psi

 

 

Ordering Information 
Membrane Grade Dimensions Pkg Part Number
Versapor 200RC Membrane 7” X 10” 1 sheet ≥ 4.2*
Versapor 450RC Membrane 7” X 10”  1 sheet ≥ 15.0*
Versapor 800RC Membrane7” X 10”  7” X 10”  1 sheet ≥ 39.0*
Versapor 1200RC Membrane 7” X 10”  1 sheet ≥ 34.0**
Versapor 3000RC Membrane 7” X 10” 1 sheet 1 sheet ≥ 60.0**
Versapor 5000RC Membrane 7” X 10”  1 sheet ≥ 88.0**
Custom roll, sheet, and disc sizes available upon request.  

 

 

Chemical Compatibility

 

The following data was compiled by Pall Corporation, and provides data based on exposure of membrane materials to specified chemicals under static conditions for 48 hours at 25 ˚C (77 ˚F). Representative samples taken from nominal lots of Versapor 200RC membrane were selected for the study to represent the product family. Following chemical exposure at the prescribed conditions, the samples were evaluated to confirm they met the functional specifications as listed below.

 

 

Membrane Grade Nominal Pore Size (μm) Water Breakthrough (psi) Air Flow (L/min/3.7 cm² @ 13.5 psi) Thickness (mils) n-Nonane Resistance (30 seconds)
Versapor 200RC 0.2 ≥ 26.0 ≥ 4.2 ≥ 4.2 Pass

 

If test results from a membrane property after exposure were outside of the product specification, the membrane was considered not resistant (non-compatible) with the specific chemical. The following table lists the chemicals and concentrations used for the study and the test results.

 

Outcome of compatibility studies for Versapor-200RC

 

Chemical Group Chemical Concentration or Purity Results
Acids Acetic acid Glacia R
Acetic acid 30 % R
Hydrochloric Acid 1 M R
Nitric Acid 6 M N
Alcohols Benzyl Alcohol Analytical grade N
Ethanol 200 proof SDA R
Isopropyl alcohol Analytical grade R
Aromatic Hydrocarbons Toluene Analytical grade R

R = Resistant No signi cant change observed in the membrane properties tested, nor visible indication of chemical attack.

N = Not Resistant The membrane is unstable and is not recommended for use in these conditions

 

Chemical Group Chemical Concentration or Purity Results
Bases Ammonium hydroxide 6 M R
Sodium hydroxide 6 M N
Glycols Propylene glycol Analytical grade R
Halogenated Hydrocarbons Tetrachloroethylene Analytical grade N
Miscellaneous Acetonitrile Analytical grade N
Formaldehyde 37 % in Methanol R
Hexane Analytical grade R
Kerosene CAS# 64742-17-9 R
Cyclohexanone Analytical grade N
Oils Castor Analytical grade, CAS# 8001-79-4 R
Cottonseed Analytical grade, CAS# 8001-29-4 R
FishLaboratory grade, CAS# 8002-50-4 Laboratory grade, CAS# 8002-50-4 R
Olive Laboratory grade, CAS# 8001-25-0 R
Safflower Analytical grade, CAS# 8001-23-8  R
Sesame Laboratory grade, CAS# 8008-74-0  R
Soybean Analytical grade, CAS# 8001-22-7  R

 

 

Sterilization Compatibility

 

Versapor RC membranes were developed to withstand a variety of sterilization methods, ensuring compatibility with most sterilization requirements applied for medical applications. Representative samples taken from nominal lots of Versapor 200RC membrane were selected for the study to represent the product family. Sterilization conditions are listed opposite

 

Sterilization Method Tested Processing Conditions
Gamma 40 – 50 kGy
Ethylene Oxide (EtO) – 100 % 3 cycles at typical exposure time
Autoclave 2 cycles at 121 oC, 1 hour

 

Following sterilization conditions, the samples were evaluated to confirm they met the functional specifications as listed below. If test results from one of the membrane properties was not comparable to test results from control samples, the membrane was considered not compatible with the specific method. The physical properties evaluated were air flow rate, water breakthrough, and wetting resistance to n-Nonane.

 

Functional Specifications for Versapor-200RC

 

Membrane Grade Nominal Pore Size (μm)  Water Breakthrough (psi)  Air Flow (L/min/3.7 cm² @ 13.5 psi) n-Nonane Resistance (30 seconds)
Versapor 200RC 0.2 ≥ 26.0 ≥ 4.2 ≥ 4.2

 

Using one-way analysis of variance (ANOVA), no significant differences in any of the membrane properties were detected between controls (unsterilized) and sterilized samples. All samples tested passed test criteria and were determined to be stable to the sterilization conditions.

 

Testing Results

 

 

Specification Units Test Acceptance Criteria Sterilization Method Samples Tested Samples Passed
Air Flow Liters/minute/ 3.7 cm² @ 13.5 psi  ≥ 4.2 N/A (Control 5 5
Gamma 5 5
EtO 5 5
Autoclave 5 5
Water Breakthrough psi

bar
≥ 26.0

≥ 1.79
N/A (Control) 5 5
Gamma 5 5
EtO 5 5
Autoclave 5 5
n-Nonane Wetting Resistance - Pass @ 60 seconds exposure N/A (Control) 6 6
Gamma 6 6
EtO 6 6
EtO 6 6

 

Compliance

 

Biological Safety Data

 

Biocompatibility testing results for Pall’s Versapor RC membrane demonstrate that this material meets the requirements of the USP Biological Reactivity Testing <88> (USP Class VI Plastics Tests). The testing was conducted on gamma irradiated samples of the 0.2 μm grade as the representative for all grades within this family of microporous membranes.

 

Test Description External Lab Test Report No. External Lab Test Report No. Reference Standard Result
L929 MEM Elution Cytotoxicity Test - ISO 19-02421-G2 Cytotoxicity ISO 10993-5: 2009
ISO 10993-12, 2012
ISO/IEC 17025, 2017
Pass
Rabbit Hemolysis Test (Complete) – Saline Extract Method 19-02421-G3 Hemocompatibility ASTM F756-17
ASTM F619-14
ISO 10993-4, 2017
ISO 10993-12, 2012
ISO/IEC 17025, 2017
Pass
Kligman Maximization Test – ISO 19-02421-G4 Skin sensitization ISO 10993-10: 2010
United States
Pharmacopeia 42,
 National Formulary
37, 2019. <1184>
Sensitization Testing
ISO 10993-12, 2012
ISO/IEC 17025, 2017
Pass
Reverse Mutation Assay – with Con rmation – ISO 19-02421-G1 Mutagenicity ISO 10993-3, 2014
ISO/TR 10993-33, 2015
OECD 471
ISO 10993-12, 2012
ISO/IEC 17025, 2017
Pass
Systemic Injection Test – ISO 19-02421-G5 Toxicity after
systemic injection
  Pass
Intracutaneous Injection Test – ISO 19-02421-G5 Irritation
after intracutaneous
injection
  Pass
7 Day Muscle Implantation with Histopathology Evaluation – USP Method  19-02421-G5 Pathology after
implantation
  Pass
USP Physicochemical Test for Plastics 1201931-S01 Characterization
of physical and
chemical properties
  Pass

 

Regulatory Statements

 

The use of perfluoroalkyl and polyfluoroalkyl substances has a global environmental focus. This emphasis can be appreciated through the adoption of the voluntary 2010/2015 PFOA Stewardship Program in the US, aimed at facility emissions and product content, as well as in the implementation of European Commission Regulation (EU) number 2017/1000 of 13 June 2017, which amends Annex XVII to Regulation (EC) No 1907/2006 – setting new limits under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) for perfluorooctanoic acid (PFOA), its salts, and PFOA-related substances, coming into effect on July 4th, 2020. 

 

Versapor RC membrane grades have been designed to meet the requirements of Regulation 2017/1000. For additional details on this and other regulations, please visit the ‘Quality at Pall’ web page: 

https://www.pall.com/en/about-pall/quality.html 

 

By visiting this site, users have immediate access to the most up to date information from Pall on these topics.