Texwipe TX3214 Sterile TechniSat® 9" x 11" Polyester/Cellulose Cleanroom Wipers - Pre-Wetted 70% IPA / 30% DIW - 1,000 Wipers/Case
Texwipe TX3214 Sterile TechniSat® is a gamma-irradiated, pre-wetted cleanroom wiper manufactured from 45% polyester and 55% cellulose nonwoven material. Designed for controlled cleaning in environments requiring sterile wiping consumables, TX3214 combines a durable hydroentangled polyester/cellulose substrate with a factory-prepared 70% isopropyl alcohol (IPA) and 30% deionized water (DIW) solution.
Each nominal 9" x 11" wiper features a cleanroom-manufactured nonwoven substrate with cut edges. The hydroentangled construction uses mechanically interlocked polyester and cellulose fibers to provide liquid sorption and a flexible wiping surface without relying on added chemical binders.
TX3214 is pre-wetted with 70% USP-grade IPA / 30% DIW, with the solution filtered to 0.2 µm. Factory preparation helps reduce variability associated with manually mixing alcohol and wetting dry wiping materials at the point of use.
Texwipe identifies TX3214 as gamma irradiated and sterility validated to a Sterility Assurance Level (SAL) of 10-6 according to AAMI guidance. The manufacturer provides lot-related Certificates of Compliance, Analysis, and Processing/Irradiation upon request. These documents support quality review and traceability for regulated cleaning programs.
Texwipe positions the product for ISO Classes 5 through 8 and EU GMP Grades B through D. These are manufacturer-identified environmental application ranges. They do not certify the cleanroom itself, authorize every aseptic operation, or independently demonstrate that a particular cleaning procedure is effective.
TX3214 is supplied in peel-and-reseal sterile flexpacks containing 50 pre-wetted wipers. One manufacturer case contains 20 flexpacks, totaling 1,000 wipers. SOSCleanroom offers TX3214 by the complete manufacturer case.
The manufacturer specifies a three-year shelf life from manufacture. Follow the labeled expiration date, verify package integrity before use, and apply facility-approved material-transfer and opened-pack handling procedures.
Sterile Cleaning Advantage: TX3214 combines gamma-irradiated sterile wiping material, controlled 70% IPA / 30% DIW pre-wetting, and lot-related manufacturer documentation. Its 50-count peel-and-reseal flexpacks support controlled dispensing and repeatable cleaning within approved sterile-material handling procedures.
Specifications:
- Manufacturer: Texwipe, an ITW company
- Manufacturer Part Number: TX3214
- SOSCleanroom SKU: TX3214 CASE
- Product Family: Sterile TechniSat®
- Substrate Family: TechniCloth®
- Product Type: Sterile Pre-Wetted Cleanroom Wiper
- Material: 45% polyester / 55% cellulose
- Fabric Construction: Hydroentangled nonwoven
- Binder Construction: Mechanically entangled without added chemical binders
- Edge Construction: Cut edge
- Sealed Border: No
- Color: White
- Nominal Dimensions: 9" x 11" (23 cm x 28 cm)
- Wetting Chemistry: 70% IPA / 30% DIW
- IPA Grade: USP grade
- Solution Filtration: 0.2 µm
- Presentation: Factory pre-wetted, ready to use
- Quantitative Pre-Wet Loading: No TX3214-specific mL-per-wiper value published in the reviewed TDS
- Sterility: Sterile
- Sterilization Method: Gamma irradiation
- Validated Sterility Assurance Level: 10-6
- Sterile Validation: According to manufacturer AAMI-based qualification program
- Lot Documentation: Certificates of Compliance, Analysis, and Processing/Irradiation available upon request
- Individual Lot Irradiation Dose: Refer to the applicable manufacturer processing certificate
- Manufacturer Cleanroom Application Range: ISO Classes 5-8
- EU GMP Application Range: Grades B-D, subject to site qualification
- Traditional Cleanroom Classes: Class 100-100,000
- Typical LPC Particles ≥0.5 µm: 72 x 106 particles/m²
- Typical Fibers >100 µm: 55,000 fibers/m²
- Typical Sorptive Capacity: 360 mL/m²
- Typical Sorptive Rate: Less than 0.3 seconds
- Typical Basis Weight: 69 g/m²
- Packaging Format: Peel-and-reseal flexpack
- Wipers per Flexpack: 50
- Flexpacks per Manufacturer Case: 20
- Total Wipers per Case: 1,000
- SOSCleanroom Selling Unit: Complete manufacturer case
- Manufacturer Traceability: Lot coded
- Published Shelf Life: 3 years from manufacture
- Country of Manufacture: USA
- Use Classification: Disposable, single-use wiper
- Primary Application: Qualified sterile wiping and controlled surface cleaning
- Disinfectant Status: No independently established TX3214-specific registered disinfectant or sporicidal efficacy
- SDS Occupational Hazards: Flammable Liquid Category 2; Eye Irritation Category 2A; STOT Single Exposure Category 3
- Transport Reference: UN3175, Class 4.1, Packing Group II, subject to shipment-specific rules
- Manufacturer TDS: US-TDS-003 Rev. 4/23
- Manufacturer SDS: Version 3.1, July 2, 2025
Packaging and Case-Only Ordering:
TX3214 is supplied in peel-and-reseal flexpacks designed for controlled dispensing of sterile, pre-wetted material. The current manufacturer configuration contains 50 wipes per flexpack and 20 flexpacks per case.
| Packaging Level |
Quantity |
Description |
| Sterile Flexpack |
50 wipers |
Peel-and-reseal dispensing package |
| Manufacturer Case |
20 flexpacks |
Current manufacturer configuration |
| Total Case Contents |
1,000 wipers |
20 flexpacks x 50 wipers |
| SOSCleanroom Order Unit |
1 case |
Complete 1,000-wiper manufacturer case |
Inspect every sterile flexpack before use. Damaged, leaking, compromised, or expired packages should be managed according to the facility's material-control procedure. Once opened, the package and remaining wipes must be handled under the applicable sterile-use and in-use requirements.
Packaging Confirmation: TX3214 CASE contains 20 flexpacks of 50 sterile pre-wetted wipers each, totaling 1,000 wipes. Do not use older manufacturer documents describing 24 flexpacks per case as the current purchasing specification.
About the Manufacturer:
Texwipe, an ITW company, manufactures cleanroom wiping products, sterile and non-sterile swabs, pre-wetted cleaning materials, and contamination-control consumables for pharmaceutical, biotechnology, medical-device, semiconductor, laboratory, and other controlled environments.
The TechniCloth® family uses polyester/cellulose nonwoven substrates designed for routine cleaning, liquid sorption, and general contamination-control applications. Sterile TechniSat® combines this substrate with controlled IPA/DIW pre-wetting and validated gamma irradiation.
SOSCleanroom is an authorized Texwipe distributor offering manufacturer technical information, assistance with lot-documentation requests, and cleanroom supply procurement support.
TX3214 Features:
- 45% polyester / 55% cellulose nonwoven substrate
- Hydroentangled construction without added chemical binders
- Cleanroom-manufactured cut-edge material
- 9" x 11" nominal wiping format
- Durable and absorbent blended-fiber construction
- Manufacturer-characterized particles, fibers, ions, and extractables
- Factory pre-wetted with 70% USP-grade IPA / 30% DIW
- 0.2 µm filtered wetting solution
- Ready-to-use pre-wetted presentation
- Gamma irradiation
- Validated sterility assurance level of 10-6
- Manufacturer AAMI-based sterile qualification
- Certificates of Compliance, Analysis, and Processing/Irradiation available by lot
- Lot coding for traceability
- ISO Classes 5-8 manufacturer application positioning
- EU GMP Grades B-D application positioning
- Peel-and-reseal sterile flexpacks
- Reduced need for manual alcohol mixing and wetting
- Three-year manufacturer-published shelf life
- 50 wipers per flexpack
- 20 flexpacks per case
- 1,000 sterile wipers per case
TX3214 Benefits:
- Validated Sterile Processing: Gamma irradiation and the manufacturer sterilization-validation program support use where sterile wiping material is required.
- Lot Documentation: Manufacturer certificates support receiving inspection, traceability, and quality records.
- Controlled Chemistry: Factory-prepared 70% IPA / 30% DIW reduces variability associated with manual dilution.
- Reduced Wetting Preparation: Pre-wetted wipes eliminate routine manual saturation steps.
- Flexible Nonwoven Material: Hydroentangled polyester/cellulose provides useful absorbency and working contact.
- General Surface Coverage: The 9" x 11" format accommodates controlled wiping of compatible equipment and work surfaces.
- Reduced Overspray: Pre-wetted materials apply cleaning liquid through the wiper instead of relying on direct spraying.
- Dispensing Convenience: Peel-and-reseal flexpacks allow controlled access to the contents.
- Evaporation Management: Prompt package closure helps preserve the remaining pre-wetted condition.
- Defined Procurement: Full 1,000-wiper manufacturer cases support routine facility consumption planning.
Common Applications:
- Qualified sterile wiping of production equipment and fixtures
- Cleaning compatible environmental surfaces in sterile manufacturing areas
- Controlled wiping during pharmaceutical and biotechnology operations
- Cleaning laboratory benches and approved workstations
- Wiping tools, trays, carts, and transfer accessories
- Cleaning compatible stainless steel work surfaces
- Removing selected manufacturing residues and handling soils
- Approved wipe-down of items entering controlled environments
- Cleaning in sterile suites and preparation rooms
- Controlled surface wiping in qualified ISO Classes 5-8 environments
- Applications specifying a sterile nonwoven polyester/cellulose substrate
- Workflows requiring manufacturer sterility documentation and material traceability
- Approved wiping of gloved hands where specifically permitted by the site procedure
- General contamination-control tasks using a validated sterile consumable
Polyester/Cellulose Nonwoven Construction and Limitations:
TX3214 uses a 45% polyester / 55% cellulose hydroentangled nonwoven substrate. The two materials contribute different characteristics to the finished wiper, including strength, absorbency, flexibility, and liquid pickup.
- Polyester Component: Contributes strength and durability during suitable wiping.
- Cellulose Component: Contributes liquid absorption and the handling characteristics of the blended substrate.
- Hydroentanglement: Mechanically binds the fibers without added chemical binders.
- Cut Edges: Do not provide the fiber containment of a sealed-border polyester wiper.
- Material Cleanliness: Manufacturer testing characterizes typical particle, fiber, ion, and extractables results.
- Critical Residue Applications: Compare the cellulose blend with an appropriate polyester alternative where extremely low residues or fibers are required.
- Mechanical Limits: Avoid abrasive contact with sharp edges, burrs, or damaged surfaces that can disrupt the nonwoven substrate.
- Surface Compatibility: Confirm the IPA solution and substrate are suitable for coatings, adhesives, plastics, and equipment finishes.
Material Selection Guidance: TX3214 is a cut-edge polyester/cellulose nonwoven wipe. Its sterile status does not make its particle, fiber, or residue performance equivalent to a sealed-border 100% polyester substrate. Select using the process's actual contamination-control requirements.
Gamma Irradiation, SAL and Lot Documentation:
Texwipe states that sterile TX3214 undergoes gamma irradiation and is validated to a Sterility Assurance Level of 10-6 under its AAMI-based sterilization program. The SAL describes the validated sterilization process and must not be interpreted as a guarantee that improper handling, damaged packaging, or an expired product remains sterile.
For documentation-controlled receiving and use, the applicable manufacturer certificates should be matched to the specific received product lot. General product literature is not a substitute for actual lot records.
- Gamma Irradiation: Manufacturer-confirmed sterilization method.
- Validated SAL: 10-6, according to the manufacturer's sterilization qualification.
- Certificate of Compliance: Available for individual lots.
- Certificate of Analysis: Available for individual lots.
- Certificate of Processing/Irradiation: Available for individual lots and supports review of recorded irradiation processing.
- Actual Irradiation Dose: Review the applicable lot certificate rather than assuming a fixed dose.
- Validation Documentation: Available from Texwipe upon request.
- Expiration Dating: Verify the package label and applicable receiving requirements.
- Packaging Integrity: Do not use compromised sterile packages in applications requiring intact sterile supply.
- Lot Traceability: Preserve lot references for quality records and investigations.
Important Sterility Qualification Guidance: TX3214 has manufacturer-confirmed gamma sterilization and a validated SAL of 10-6. Specific processing doses, certificate numbers, and lot-release evidence must be verified from the actual certificates accompanying or associated with the received lot.
70% USP-Grade IPA / 30% DIW Cleaning Chemistry:
TX3214 uses a factory-prepared 70% USP-grade IPA / 30% DIW solution filtered to 0.2 µm. The chemistry is intended for approved surface-cleaning procedures requiring a pre-wetted sterile consumable.
- 70% IPA: Provides the alcohol component used for cleaning compatible soils and residues.
- 30% DIW: Provides the water component of the wetting formulation.
- USP-Grade IPA: Explicitly identified by Texwipe for sterile TX3214.
- 0.2 µm Filtration: Used in preparing the pre-wetting solution.
- Factory Pre-Wetting: Reduces manual IPA mixing and individual wipe saturation.
- Controlled Initial Wetness: Supports consistent starting conditions when packages are stored and handled correctly.
- Specific Liquid Loading: The manufacturer TDS does not provide a numerical mL-per-wiper fill specification.
- Evaporation: Prolonged opening may alter the remaining wetness and solvent concentration.
- Surface Compatibility: Check plastics, coatings, adhesives, labels, electronics, and sensitive finishes before use.
- Disinfection Efficacy: The manufacturer documents reviewed do not establish a TX3214-specific registered disinfectant claim or universal microorganism contact time.
- Sporicidal Efficacy: A separate qualified sporicidal process is necessary where specified.
- Regulated Use: Follow the facility's approved cleaning, disinfection, and environmental-control procedures.
Sterility Versus Disinfection: Gamma-sterilized wiping material is not the same as a validated surface disinfectant. Avoid treating sterile processing as proof of surface disinfection efficacy. TX3214 should be used according to an approved method, with a separately qualified disinfectant or sporicide when required.
Sterile Package Transfer and Handling:
The condition of sterile wipes at the point of use depends on maintaining appropriate package integrity and cleanroom transfer controls. Follow the facility's procedures for introducing sterile consumables into classified work areas.
- Receiving Inspection: Verify SKU, lot, expiration, packaging condition, and documentation.
- Material Introduction: Follow the approved transfer sequence for the destination room.
- Exterior Decontamination: Clean or disinfect the package exterior only using a method approved for the packaging material and transfer procedure.
- Package Integrity: Inspect before opening; do not use torn, leaking, or compromised packages where sterility is required.
- Opening Procedure: Avoid contacting the sterile contents with uncontrolled surfaces, gloves, or package exteriors.
- Resealing: Close the peel-and-reseal package promptly to help limit evaporation.
- Opened-Pack Use: Apply facility-approved in-use time and sterility-handling limits.
- Handling Contamination: Discard wipes whose sterile condition has been compromised.
- Unused Material: Do not return used wipes to the original package.
- Records: Preserve the relevant lot and cleaning-use information where required.
Transfer Guidance: Sterile validation applies to the manufacturer's qualified product and packaging condition. Reclosing an opened flexpack does not independently reestablish sterile integrity. Apply the approved transfer and in-use procedure for the specific cleanroom operation.
Recommended Controlled Wiping Procedure:
TX3214 supports repeatable wiping when the substrate, 70% IPA chemistry, sterile package handling, operator technique, and change-out requirements are controlled together. The following general sequence should be adapted to the facility's approved SOP.
- Confirm Product Approval: Verify that the sterile polyester/cellulose material and IPA chemistry are suitable for the task.
- Verify the Lot: Confirm identification, expiration, and required certificates.
- Inspect the Flexpack: Check integrity before material transfer and opening.
- Complete Material Transfer: Follow approved cleanroom introduction and packaging decontamination steps.
- Use Required PPE: Follow gowning and chemical protection procedures.
- Control Ignition Sources: Confirm that alcohol-containing wipes may be used safely in the work area.
- Open Carefully: Avoid contaminating sterile wiping material during dispensing.
- Remove the Needed Wipe: Do not expose more material than the procedure permits.
- Reseal Promptly: Close the flexpack to limit evaporation, subject to approved opened-pack requirements.
- Fold for Control: Create manageable wiping faces when permitted by the SOP.
- Use Directional Strokes: Wipe in consistent, overlapping passes following the approved clean-to-less-clean sequence.
- Change Wiping Faces: Avoid returning a contaminated face to an already cleaned surface.
- Monitor Surface Condition: Follow defined acceptance criteria for residues, wetness, and drying.
- Discard as Required: Replace wipes when soiled, damaged, dry, compromised, or at the specified change-out point.
- Document the Activity: Record the required cleaning and material information.
Operational Guidance: Texwipe does not publish a universal surface-coverage area, fixed number of passes, or validated microbial wet-contact time for TX3214. These operating limits must be defined through the site-specific cleaning and contamination-control procedure.
Typical Particle, Fiber, Ionic and Extractables Performance:
Texwipe's US-TDS-003 Rev. 4/23 reports the following typical laboratory values for the TechniCloth® polyester/cellulose substrate family. These are material-selection reference values, not guaranteed lot-specific TX3214 acceptance limits.
| Typical Manufacturer Characteristic |
Reported Value |
| Particles ≥0.5 µm |
72 x 106 particles/m² |
| Fibers >100 µm |
55,000 fibers/m² |
| Nonvolatile Residue - IPA Extractant |
0.01 g/m² |
| Nonvolatile Residue - DIW Extractant |
0.03 g/m² |
| Nonvolatile Residue - Ethanol Extractant |
0.01 g/m² |
| Sodium |
12 ppm |
| Potassium |
1 ppm |
| Chloride |
10 ppm |
| Sorptive Capacity |
360 mL/m² |
| Sorptive Rate |
Less than 0.3 seconds |
| Basis Weight |
69 g/m² |
These typical results describe manufacturer substrate testing. They should not be confused with the release testing documented on the Certificate of Analysis for a particular lot or with the actual liquid volume contained in each pre-wetted wiper.
Performance Data Guidance: The manufacturer TDS states that its analytical data represent typical results rather than product specifications. For regulated applications, use the actual lot certificates and approved acceptance limits.
Safety, IPA Hazards and Transportation:
TX3214 contains flammable IPA and requires appropriate chemical handling even though the wiping substrate is sterile. The applicable manufacturer SDS identifies occupational hazards and separate dangerous-goods transportation requirements.
- Reviewed SDS: Texwipe 60%-70% IPA pre-wetted wipers, Version 3.1, July 2, 2025.
- Occupational Flammability: Flammable Liquids, Category 2.
- Eye Irritation: Category 2A.
- Single-Exposure Toxicity: Specific Target Organ Toxicity, Category 3 (narcotic effects).
- Signal Word: Danger.
- Hazard Statements: H225, H319, and H336.
- Ignition Control: Keep away from heat, sparks, flames, hot surfaces, and other ignition sources.
- Ventilation: Use according to the workplace IPA vapor-exposure assessment.
- PPE: Wear suitable gloves, eye or face protection, and other required protective equipment.
- Surface Compatibility: Verify compatibility with plastics, coatings, adhesives, labels, and sensitive materials.
- Electrical Equipment: Follow approved shutdown, cooling, and electrical-safety procedures.
- Oxidizing Materials: Avoid contact with incompatible oxidizers.
- Controlled Fill: The SDS describes saturated cloth material with no free liquid in the finished package.
- Transport Reference: UN3175, solids containing flammable liquid, n.o.s. (isopropyl alcohol).
- Transport Hazard Class: 4.1.
- Packing Group: II.
- Limited-Quantity Provisions: Apply only when the package and transport mode meet current requirements.
- Shipping Services: Confirm carrier acceptance, marking, documentation, and service eligibility for the actual shipment.
- Disinfectant Limitations: Sterile wiping material is not independent evidence of registered disinfectant efficacy.
- Disposal: Follow approved procedures for solvent-containing and contaminated waste.
Important Safety Notice: TX3214 is sterile, but its 70% IPA solution remains flammable. Follow the current Texwipe SDS, approved facility EHS requirements, and applicable transport regulations. Sterility does not remove chemical hazards, and the transport classification does not automatically establish a universal ground-only rule.
Selection Notes: TX3214 and Related Wipers:
Texwipe offers different sterile and non-sterile wiping materials using similar IPA formulations. The correct selection depends on substrate cleanliness, sterility, package size, surface compatibility, and required lot documentation.
| Product |
Configuration |
Selection Consideration |
| TX3214 |
9" x 11", sterile polyester/cellulose, 70% IPA, 50/flexpack |
Routine sterile wiping with larger dispensing packs |
| TX3217 |
9" x 11", sterile polyester/cellulose, 70% IPA, 20/flexpack |
Smaller dispensing packs for controlled consumption |
| TX1065 |
9" x 11", non-sterile polyester/cellulose, 70% IPA |
Similar material and chemistry where sterile supply is not required |
| TX1041 |
9" x 11", non-sterile polyester/cellulose, 70% IPA |
Alternative non-sterile TechniSat packaging format |
| TX3285 |
9" x 9", sterile sealed-border polyester, 70% IPA |
Different substrate and edge configuration for critical applications |
- Choose TX3214: When sterile 9" x 11" polyester/cellulose pre-wetted wipes in 50-count flexpacks are specified.
- Choose TX3217: When smaller sterile 20-count flexpacks better match the consumption pattern.
- Choose TX1065 or TX1041: When non-sterile polyester/cellulose material meets the approved procedure.
- Choose TX3285: When sterile sealed-border polyester is better suited to the particle, fiber, or residue requirements.
- Verify Lot Documentation: Review the applicable certificates when sterile-material acceptance requires documented irradiation and processing.
- Approve Substitutions: Do not change sterility, edge construction, chemistry, or packaging without the appropriate process review.
Product Selection Guidance: TX3214 and TX3217 share the Sterile TechniSat® family but have different flexpack quantities. Non-sterile TechniSat® and sterile sealed-border polyester products are not automatically interchangeable with TX3214.
Shelf Life, Storage and Disposal:
- Manufacturer Part Number: TX3214
- SOSCleanroom SKU: TX3214 CASE
- Inner Packaging: 50 sterile pre-wetted wipers per flexpack
- Manufacturer Case: 20 flexpacks / 1,000 wipers
- Purchasing Unit: Complete manufacturer case
- Sterility: Gamma irradiated, SAL 10-6
- Published Shelf Life: 3 years from manufacture
- Expiration: Follow manufacturer labeling
- Traceability: Retain lot information and applicable certificates
- Sterile Package Integrity: Inspect before use
- Storage: Follow the manufacturer SDS and facility chemical-storage requirements
- Ignition Control: Keep away from heat, sparks, and open flames
- Dispensing: Protect sterile contents from contamination
- Evaporation Control: Reseal promptly when permitted by the approved sterile-use procedure
- Opened-Pack Handling: Follow facility-defined sterility and in-use limits
- Reuse: Single use only
- Disposal: Follow applicable solvent-containing waste requirements
Manufacturer Technical Documents:
Other Similar Products Available From SOSCleanroom.com
Sterile TechniSat® and Related Cleanroom Wiper Alternatives
Notes: Need assistance selecting sterile TechniSat® products, confirming TX3214 manufacturer case quantities, or obtaining applicable irradiation and compliance documentation? SOSCleanroom provides product-selection assistance, manufacturer technical resources, and procurement support.
SOSCleanroom.com supports pharmaceutical, biotechnology, medical-device, laboratory, semiconductor, and other controlled environments with sterile and non-sterile cleanroom wiping materials and contamination-control supplies.
Product description updated: November 5, 2026 (SOS Technical Staff)
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