Texwipe TX3213 Sterile PolySat® 9" x 11" Polypropylene Cleanroom Wipers - Pre-Wetted 70% IPA / 30% DIW - 1,000 Wipers/Case
Texwipe TX3213 Sterile PolySat® is a gamma-irradiated, pre-wetted cleanroom wiper manufactured from 100% melt-blown polypropylene. Designed for controlled cleaning applications requiring sterile consumables, TX3213 combines a soft, low-linting nonwoven substrate with a ready-to-use solution of 70% USP-grade isopropyl alcohol (IPA) and 30% deionized water (DIW).
Each 9" x 11" wiper features cut-edge construction and is pre-wetted with an IPA/DIW solution filtered to 0.2 µm. The factory-prepared format reduces the need for manual solvent mixing, dilution, and wetting of dry wipers at the point of use, helping operators maintain consistent cleaning practices while reducing unnecessary handling of free liquid.
TX3213 is gamma irradiated and sterile validated to a Sterility Assurance Level (SAL) of 10-6 according to AAMI guidelines. Texwipe also tests the product for endotoxin and provides manufacturer lot-specific Certificates of Compliance, Analysis, and Irradiation. These documents support material qualification, traceability, and quality review in pharmaceutical, biotechnology, and other controlled manufacturing environments.
The sterile wipers are supplied in peel-and-reseal flexpacks containing 50 wipers each. One manufacturer case contains 20 flexpacks, totaling 1,000 individual sterile wipers. This packaging supports convenient dispensing, controlled material transfer, and reduced evaporation between uses when the package is handled and resealed appropriately.
Texwipe identifies TX3213 for ISO Classes 5 through 8 and EU GMP Grades B through D. The manufacturer's product positioning also references applicable USP <797> and USP <800> wiping requirements. Facilities must independently determine suitability for their specific processes, contamination-control strategies, and cleaning or disinfection procedures.
Sterile Cleaning Advantage: TX3213 combines a soft polypropylene substrate, factory-prepared 70% IPA / 30% DIW, gamma irradiation validated to SAL 10-6, and manufacturer lot-specific documentation. Its 50-count resealable flexpacks help support controlled dispensing and consistent wiping in qualified sterile and aseptic environments.
Specifications:
- Manufacturer: Texwipe, an ITW company
- Manufacturer Part Number: TX3213
- SOSCleanroom SKU: TX3213 CASE
- Brand: Sterile PolySat®
- Product Type: Sterile Pre-Wetted Cleanroom Wiper
- Wiper Material: 100% melt-blown polypropylene
- Wiper Construction: Soft nonwoven
- Edge Treatment: Cut edge
- Wiper Color: White
- Nominal Size: 9" x 11" (23 cm x 28 cm)
- Wetting Chemistry: 70% isopropyl alcohol / 30% deionized water
- Alcohol Grade: USP-grade IPA
- Solution Filtration: 0.2 µm
- Presentation: Factory pre-wetted, ready to use
- Sterility: Sterile
- Sterilization Method: Gamma irradiation
- Sterility Assurance Level: 10-6
- Sterilization Validation: According to AAMI guidelines
- Irradiation Dose: Refer to applicable lot-specific Certificate of Irradiation
- Endotoxin: Manufacturer tested; numerical acceptance requirements must be confirmed in applicable quality documentation
- Cleanroom Environment: ISO Classes 5-8
- Traditional Cleanroom Classes: Class 100-100,000
- EU GMP Environment: Grades B-D, subject to facility requirements
- Packaging Format: Peel-and-reseal sterile flexpack
- Wipers per Flexpack: 50
- Flexpacks per Manufacturer Case: 20
- Total Wipers per Case: 1,000
- Manufacturer Lot Identification: Lot coded
- Quality Documentation: Certificates of Compliance, Analysis, and Irradiation
- Validation Documentation: Sterile validation documentation available from the manufacturer upon request
- Published Shelf Life: 3 years from date of manufacture
- Country of Manufacture: USA
- Manufacturer Quality Registration: ISO 9001
- Product Use: Single-use disposable wiping
- Primary Application: Sterile surface cleaning and wiping
- Product Limitation: Not independently established as a registered disinfectant or sporicide
- Manufacturer Technical Reference: TEX-LIT-TDS-013 Rev. 00-05/18
- SOSCleanroom Purchasing Configuration: Case quantity only
Sterile Packaging and Manufacturer Case Configuration:
TX3213 is supplied in convenient peel-and-reseal sterile flexpacks. The packaging helps reduce evaporation of the IPA/DIW solution and allows operators to dispense the required number of wipers while minimizing unnecessary exposure of the remaining contents.
| Packaging Level |
Quantity |
Description |
| Sterile Flexpack |
50 wipers |
Peel-and-reseal package for controlled dispensing |
| Manufacturer Case |
20 flexpacks |
Standard manufacturer case configuration |
| Total Case Quantity |
1,000 wipers |
20 flexpacks of 50 sterile wipers |
Each case is accompanied by applicable manufacturer quality documentation. Individual flexpacks must be inspected for damage, expiration, and package integrity before introduction into controlled environments.
Case Quantity Confirmation: TX3213 is packaged 50 sterile wipers per flexpack and 20 flexpacks per manufacturer case, totaling 1,000 wipers. Do not confuse this configuration with TX1051 non-sterile PolySat®, which contains 24 flexpacks per case, or TX3216 Sterile PolySat®, which contains 20 wipers per flexpack.
About the Manufacturer:
Texwipe, an ITW company, manufactures cleanroom wipers, swabs, pre-wetted cleaning products, and contamination-control supplies for pharmaceutical manufacturing, biotechnology, semiconductor processing, medical devices, and other critical industries.
The Sterile PolySat® product family combines melt-blown polypropylene substrates with controlled IPA/DIW pre-wetting, validated gamma irradiation, and manufacturer lot documentation. These features are intended to support consistent cleaning and traceable use of sterile wiping consumables in regulated operations.
SOSCleanroom is an authorized Texwipe distributor, providing manufacturer product information, cleaning-supply selection assistance, case-quantity verification, and procurement support for contamination-controlled environments.
TX3213 Features:
- Gamma-irradiated sterile cleanroom wiper
- Validated Sterility Assurance Level of 10-6
- 100% melt-blown polypropylene substrate
- Soft nonwoven construction with cut edges
- 9" x 11" nominal wiping dimensions
- Pre-wetted with USP-grade 70% IPA / 30% DIW
- 0.2 µm filtered wetting solution
- Ready-to-use sterile wiping presentation
- Low particle and extractables design
- Suitable for general wiping of compatible surfaces
- ISO Class 5-8 manufacturer positioning
- EU GMP Grades B-D environmental positioning
- Manufacturer endotoxin testing
- Certificates of Compliance, Analysis, and Irradiation
- Lot coding and manufacturer expiration dating
- Peel-and-reseal sterile flexpack
- Controlled dispensing and reduced evaporation
- 50 wipers per flexpack
- 20 flexpacks per manufacturer case
- 1,000 sterile wipers per case
- Three-year published shelf life
TX3213 Benefits:
- Validated Sterile Presentation: Gamma irradiation to SAL 10-6 supports procedures requiring sterile wiping materials.
- Lot-Specific Quality Documentation: Manufacturer certificates provide traceability for quality review and receiving requirements.
- Reduced Solvent Preparation: Factory pre-wetting eliminates routine manual mixing and filtration of the IPA/DIW formulation.
- Controlled Cleaning Chemistry: A defined 70% IPA / 30% DIW mixture helps standardize the cleaning consumable.
- Soft Polypropylene Contact: The nonwoven substrate supports wiping of compatible equipment and sensitive surfaces.
- Low Particle and Extractables Design: Texwipe manufactures PolySat® to minimize contamination contribution during appropriate use.
- Reduced Free-Liquid Handling: Pre-wetted wipes reduce the need for separate spray bottles and direct solvent application.
- Consistent Dispensing: Resealable packaging supports controlled removal of wipes at the point of use.
- Evaporation Management: Prompt closure helps preserve the wetness of remaining wipes.
- Material Traceability: Lot coding and expiration labeling support inventory and qualification procedures.
- Case-Level Supply: A 1,000-wiper case supports recurring cleaning schedules and controlled material distribution.
- Process Flexibility: Suitable for a range of qualified wiping operations involving compatible surfaces and residues.
Common Applications:
- Sterile wiping of compatible pharmaceutical manufacturing equipment
- Cleaning equipment and work surfaces in qualified aseptic environments
- Biotechnology production support
- Microbiological laboratory cleaning
- Wiping stainless steel equipment exteriors and fixtures
- Cleaning tools and accessories before controlled-area introduction
- Removal of compatible lubricants, adhesives, and processing aids
- Wiping cleanroom carts and material-handling accessories
- Approved cleaning of gloves and items entering controlled environments
- Routine cleaning within qualified ISO Class 5-8 areas
- Pharmaceutical compounding environments under applicable procedures
- Material-transfer and equipment-preparation activities
- Controlled production and maintenance cleaning
- Cleaning procedures that require sterile, pre-wetted consumables
Sterilization, Irradiation and Lot Documentation:
TX3213 is gamma irradiated and validated to SAL 10-6 in accordance with AAMI guidelines. Texwipe provides lot-associated documentation that supports the identification and qualification of sterile material received for controlled manufacturing operations.
- Certificate of Irradiation: Documents the applicable irradiation information associated with the manufactured lot.
- Certificate of Compliance: Supports confirmation that supplied products meet the manufacturer's applicable requirements.
- Certificate of Analysis: Provides manufacturer quality information for the applicable product or lot.
- Sterility Assurance Level: Validated SAL 10-6 describes the sterilization assurance target.
- Endotoxin Testing: Manufacturer testing is reported; where a numerical endotoxin limit is required, review the applicable documentation.
- Lot Coding: Supports tracking from receipt through controlled use.
- Expiration Dating: Use the labeled expiration date when releasing material for use.
- Package Integrity: Inspect packaging for damage or evidence of compromised closure.
- Manufacturer Validation: Sterile validation documentation may be requested where needed for material qualification.
- Quality Records: Retain certificates and lot information according to facility procedures.
The Sterility Assurance Level does not identify a universal irradiation dose for every production lot. The actual dose information should be obtained from the applicable Certificate of Irradiation.
Sterile Documentation Guidance: Texwipe identifies TX3213 as gamma irradiated to a validated SAL 10-6 and supplies Certificates of Compliance, Analysis, and Irradiation with each case. Use the manufacturer lot documents for release decisions, irradiation records, and any applicable endotoxin requirements. Sterile assurance also depends on maintaining package integrity and proper handling.
Sterile Material Transfer and Dispensing:
The peel-and-reseal packaging is suitable for controlled dispensing and permits exterior wipe-down as part of a facility-approved material-transfer procedure. Sterile product status does not eliminate the need for proper transfer, gowning, dispensing, or environmental controls.
- Verify Material: Confirm TX3213 identification and the correct manufacturer lot.
- Inspect Packaging: Check for leaks, damage, and compromised closures.
- Check Expiration: Use only material within its assigned expiration and approved in-use period.
- Prepare for Transfer: Remove unnecessary shipping materials before entering controlled areas.
- Follow Exterior Cleaning Requirements: Use the approved product and procedure for package wipe-down.
- Protect Package Openings: Prevent unqualified surface or glove contact with unused wipes.
- Dispense at the Approved Location: Open only when the controlled procedure permits.
- Minimize Open Time: Remove the required wiper without leaving the entire package unnecessarily exposed.
- Reseal Promptly: Help maintain wetness and protect remaining contents.
- Control In-Use Life: Follow the facility's approved opened-pack handling limits.
- Document Use: Record manufacturer lot and cleaning activity when required.
Handling Guidance: A sterile wipe can become contaminated through improper material transfer, packaging contact, or dispensing. Follow the site's approved transfer process and do not assume that wiping the exterior of a package makes that exterior sterile.
Best-Practice Wiping Procedure:
The effectiveness of a pre-wetted cleanroom wiper depends on more than its substrate and chemistry. Wiping direction, surface coverage, change-out frequency, package handling, and contamination-control practices all affect the outcome.
- Confirm the Approved Application: Verify that TX3213 is suitable for the surface and room classification.
- Inspect the Flexpack: Check package integrity, lot identification, and expiration.
- Complete the Material Transfer: Follow applicable exterior cleaning and controlled-area entry procedures.
- Prepare Personnel: Use approved cleanroom gloves and required protective clothing.
- Open the Flexpack: Peel back the closure only as far as needed to dispense a wipe.
- Remove One Wiper: Avoid contact with the remaining wipes.
- Reseal the Package: Close promptly to reduce solvent evaporation and unnecessary exposure.
- Fold the Wiper: Create manageable clean wiping faces where permitted by the approved SOP.
- Apply Controlled Strokes: Use overlapping strokes in the prescribed cleaning direction.
- Maintain Appropriate Contact: Apply sufficient pressure without unnecessary abrasion.
- Change Wiping Faces: Avoid redepositing collected residues on cleaned areas.
- Replace When Necessary: Discard wipes that are soiled, damaged, dry, or otherwise unsuitable.
- Do Not Reuse: Never return a used wipe to the original package.
- Complete Cleaning Records: Document the activity as required by the approved procedure.
Wiping Guidance: Pre-wetted sterile wipes reduce solvent-preparation steps but do not eliminate the need for controlled wiping. Follow the facility's established cleaning pattern, wipe-change criteria, surface compatibility requirements, and documentation procedures.
Polypropylene Substrate and Edge Construction:
TX3213 uses a soft 100% melt-blown polypropylene substrate with cut edges. This construction provides different wiping and contamination-control characteristics from cellulose/polyester blends and sealed-border polyester fabrics.
- 100% Polypropylene: Synthetic nonwoven material designed for general cleanroom wiping.
- Cut Edge: Does not offer the same edge containment as a sealed-border polyester wiper.
- Soft Surface Contact: Suitable for compatible sensitive and equipment surfaces.
- Low Particle Design: Manufactured to control particle and extractables contributions.
- Abrasion Resistance: Texwipe identifies the substrate as suitable for wiping abrasive surfaces without easily snagging.
- Fiber Considerations: Select a qualified sealed-edge alternative where process specifications require tighter edge-related fiber control.
- Chemical Compatibility: Evaluate compatibility with the cleaning chemistry and equipment material.
- Application Qualification: Use facility limits to establish suitability for particularly critical product-contact surfaces.
Material Selection Guidance: TX3213 is a sterile, cut-edge polypropylene wiper. Sterile presentation does not automatically make its fiber-release or residue performance equivalent to that of a sealed-edge polyester wipe. Choose the substrate based on the cleaning surface and the process's particle, fiber, ionic, and residue requirements.
70% IPA / 30% DIW Chemistry and Limitations:
TX3213 is pre-wetted with USP-grade 70% IPA and 30% DIW. The manufacturer identifies 0.2 µm filtration of the wetting solution and subsequent validated gamma irradiation of the sterile product.
- Ready-to-Use Formula: Reduces operator mixing and dilution steps.
- Cleaning Performance: IPA helps remove compatible processing residues, lubricants, and soils.
- Controlled Solution: Manufacturer preparation supports consistent chemistry and wetness.
- Solution Filtration: The IPA/DIW mixture is filtered to 0.2 µm.
- Finished Product Sterility: Supported by validated gamma irradiation, not filtration alone.
- Surface Compatibility: Evaluate plastics, coatings, adhesives, labels, and other sensitive finishes.
- IPA Evaporation: Wipes can become less wet when exposed to air or stored in poorly resealed packaging.
- Disinfection: Do not assume that the product has independently validated efficacy against every microorganism.
- Sporicidal Activity: Not a substitute for a qualified sporicidal product.
- Contact Time: Follow the applicable facility-approved disinfectant instructions where disinfection is required.
- Hazardous Drug Residues: Do not assume IPA wiping provides validated hazardous-drug deactivation or decontamination.
Chemistry Guidance: Sterility, cleaning, and disinfection are different product characteristics. TX3213 is sterile and pre-wetted with 70% IPA, but this does not independently establish registered disinfectant efficacy, sporicidal activity, or a universal contact time for every process.
Typical Particle, Fiber and Extractables Performance:
Texwipe's PolySat® technical data sheet provides typical substrate-family measurements for particle contribution, fiber release, nonvolatile residue, and absorbency. These values can assist product selection but are not lot-specific TX3213 acceptance limits.
| Typical Manufacturer Characteristic |
Reported Value |
| Particles ≥0.5 µm |
13 x 106 particles/m² |
| Fibers >100 µm |
4,500 fibers/m² |
| Nonvolatile Residue - IPA Extractant |
0.001 g/m² |
| Nonvolatile Residue - DIW Extractant |
0.005 g/m² |
| Typical Sodium |
0.3 ppm |
| Typical Potassium |
0.2 ppm |
| Typical Chloride |
0.15 ppm |
| Sorptive Capacity |
360 mL/m² |
| Sorptive Rate |
Less than 0.3 seconds |
| Basis Weight |
34 g/m² |
The manufacturer identifies these measurements as typical analyses under referenced testing methods. Actual performance depends on substrate handling, cleaning chemistry, equipment surfaces, and the specific operating procedure.
Performance Data Guidance: The reported values describe typical PolySat® material characteristics. They should not be represented as certified lot-specific particle or residue limits, or as proof that a particular cleaning operation meets its acceptance criteria.
Flexpack Handling and Evaporation Control:
The resealable flexpack helps preserve the pre-wetted condition of unused TX3213 wipers. Correct package handling is important for maintaining wetness and protecting sterile consumables from unnecessary exposure.
- Open Only When Needed: Avoid exposing the full package unnecessarily.
- Dispense Carefully: Do not touch remaining wipes with uncontrolled gloves or equipment.
- Reseal After Each Use: Reduce IPA evaporation and exposure of unused material.
- Avoid Excessive Heat: Do not stage packs near heat sources or ignition hazards.
- Inspect Wetness: Do not continue using compromised, dried, or inadequately wetted wipes.
- Follow Open-Pack Limits: Apply approved in-use time and environmental controls.
- Maintain Cleanliness: Keep the package opening protected from uncontrolled contact.
- Dispose of Used Material: Follow facility procedures for alcohol-containing waste.
Packaging Guidance: The peel-and-reseal closure helps preserve wipe wetness but does not guarantee sterility or solvent content indefinitely after opening. The facility should establish appropriate dispensing, open-pack time, and replacement requirements.
Selection Notes: TX3213 vs. Other PolySat® Wipers:
Texwipe offers sterile and non-sterile PolySat® formats using the same general polypropylene substrate and IPA/DIW wetting chemistry. Differences in sterility and packaging are important when selecting the correct manufacturer part number.
| Product |
Sterility |
Size |
Manufacturer Packaging |
| TX3213 |
Sterile |
9" x 11" |
50/flexpack; 20 packs/case; 1,000 wipes |
| TX3216 |
Sterile |
9" x 11" |
20/flexpack; 24 packs/case; 480 wipes |
| TX1051 |
Non-sterile |
9" x 11" |
50/flexpack; 24 packs/case; 1,200 wipes |
| TX1040 |
Non-sterile |
7" x 11" |
200/bag; 4 bags/case; 800 wipes |
| TX8723 |
Non-sterile |
6" x 11" |
75/bag; 24 bags/case; 1,800 wipes |
- Choose TX3213: For sterile polypropylene wiping with 50 wipes per flexpack.
- Choose TX3216: For sterile polypropylene wiping with smaller 20-count flexpacks.
- Choose TX1051: When non-sterile polypropylene wiping is appropriate.
- Choose TX1040: For a smaller, high-count non-sterile polypropylene format.
- Choose TX8723: For narrower non-sterile wiping applications.
- Check Sterility Requirements: A non-sterile product should not replace a sterile product without an approved qualification or change-control process.
- Verify Purchasing Quantity: Case counts differ significantly between these products.
Selection Guidance: TX3213 and TX1051 share a similar polypropylene substrate and 70% IPA formulation, but TX3213 is sterile and has a different case count. TX3216 is also sterile but uses smaller flexpacks. Select according to sterility requirements, dispensing preferences, and the approved cleaning procedure.
Safety, Storage and Chemical Compatibility:
TX3213 contains isopropyl alcohol, a flammable solvent. Its sterile pre-wetted format reduces separate liquid handling but does not eliminate chemical safety or surface-compatibility requirements.
- Flammability: Keep away from heat, sparks, open flames, and ignition sources.
- Ventilation: Follow workplace controls for IPA vapor exposure.
- Personal Protective Equipment: Wear gloves, eye protection, and other task-specific PPE required by the facility and SDS.
- Surface Compatibility: Evaluate sensitive plastics, adhesives, coatings, painted finishes, and markings.
- Electrical Equipment: Follow manufacturer-approved cleaning requirements before wiping energized equipment.
- Disinfection: Use separately qualified procedures when microbial efficacy or specified wet contact times are required.
- Sporicidal Requirements: Do not substitute TX3213 for an approved sporicidal treatment.
- Sterile Packaging: Protect sealed packages from damage, uncontrolled handling, and contamination.
- Storage: Follow the current manufacturer SDS and applicable flammable-material storage requirements.
- Shipping: Subject to current applicable dangerous-goods classification, package quantity, transport mode, and carrier rules.
- Waste Disposal: Follow approved procedures for used alcohol-containing wipes.
Safety Guidance: IPA is flammable and is not compatible with every surface. Follow the current product Safety Data Sheet, equipment cleaning instructions, and applicable workplace requirements. Do not rely on outdated ORM-D shipping classifications or assume the same transportation restrictions apply to every package and shipment.
Shelf Life and Storage Recommendations:
- Manufacturer SKU: TX3213
- Published Shelf Life: 3 years from manufacture
- Sterility: Gamma irradiated to validated SAL 10-6
- Flexpack Quantity: 50 sterile wipers
- Manufacturer Case Quantity: 20 flexpacks / 1,000 wipers
- Lot Coding: Manufacturer lot identification
- Quality Records: Certificates of Compliance, Analysis, and Irradiation
- Expiration Control: Follow labeled expiration dating
- Package Integrity: Inspect before transfer and use
- Storage Environment: Clean, protected conditions consistent with the applicable SDS
- Heat and Ignition: Keep away from excessive heat and ignition sources
- Material Transfer: Follow the approved controlled-area introduction procedure
- Opened-Pack Control: Apply approved in-use limits
- Evaporation Control: Reseal promptly after dispensing
- Wiper Condition: Discard dry, damaged, soiled, or compromised material
- Reuse: Single use only
- Disposal: Follow alcohol-containing waste requirements
Manufacturer Technical Documents:
Other Similar Products Available From SOSCleanroom.com
Sterile and Non-Sterile PolySat® Wiper Alternatives
Notes: Need assistance selecting sterile pre-wetted cleanroom wipers, comparing TX3213 with TX3216 or TX1051, or obtaining manufacturer sterility and irradiation documentation? SOSCleanroom can help with product selection, manufacturer technical information, packaging configurations, and procurement requirements.
SOSCleanroom.com supports pharmaceutical, biotechnology, medical device, laboratory, semiconductor, and other controlled environments with sterile and non-sterile wipers, pre-wetted cleaning products, protective apparel, and contamination-control supplies.
Product description updated: October 28, 2026 (SOS Technical Staff)
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