Texwipe TX3343 TOC Cleaning Validation Kit with TX761K Long-Handle Sampling Swabs - 12 Samples/Kit - 18 Kits/Case
Texwipe TX3343 is a Total Organic Carbon (TOC) cleaning validation kit designed for controlled surface sampling in pharmaceutical manufacturing, biotechnology processing, medical device production, and other contamination-sensitive environments. Each kit combines certified low-TOC collection vials, long-handle polyester sampling swabs, and cleanroom-compatible labels to support consistent sampling, sample identification, and transportation to the analytical laboratory.
The TX3343 kit contains 12 clear 40 mL glass vials with bonded septa caps, 24 TX761K Low TOC Alpha® polyester knit long-handle swabs, and 12 blank vial labels. Each vial provides a collection position for a designated surface sample or analytical control, with two TX761K swabs available per vial position when required by the approved method.
Unlike the Texwipe TX3340 and TX3342 kits, which contain the shorter and wider TX714K sampling swab, TX3343 includes the TX761K long-handle sampling swab. Its narrow polyester head and extended polypropylene handle support sampling of recessed surfaces, narrow channels, equipment corners, and other difficult-to-access locations where a shorter sampling device may be less practical.
Texwipe uses specialized cleaning processes to control the organic background of the kit components. The prewashed glass vials are certified below 10 µg/L TOC, while the TX761K swabs are certified below 50 µg/L TOC under the manufacturer's applicable testing methods.
TX3343 is available as an individual 12-vial kit or a manufacturer case containing 18 kits. The cleanroom-compatible polypropylene storage container, double-bagged packaging, and lot identification help support organized material handling and traceable cleaning validation workflows.
Long-Reach Cleaning Validation Advantage: TX3343 combines certified low-TOC vials with TX761K long-handle, narrow-head polyester sampling swabs. This configuration is particularly useful for controlled sampling of recessed manufacturing equipment features, while its organized packaging, break-away swab handles, and identification labels support sample integrity and traceability from collection through laboratory analysis.
Specifications:
- Manufacturer: Texwipe, an ITW company
- Manufacturer Part Number: TX3343
- SOSCleanroom SKU: TX3343 KIT
- Product Name: TOC Cleaning Validation Kit with Long-Handle Swabs
- Product Family: Cleaning Validation Swabs and TOC Kits
- Product Type: Low-TOC Surface Sampling Kit
- Kit Capacity: 12 collection vials
- Standard Manufacturer Case: 18 kits
- Available Purchase Options: Individual kit or manufacturer case
- Collection Vials per Kit: 12
- Vial Capacity: 40 mL
- Vial Construction: Prewashed glass
- Vial Appearance: Clear
- Vial Closures: Bonded septa caps with one-piece cap-and-septum design
- Septum Thickness: 1.34 mm (0.053 inch)
- Vial Protection: Polyethylene overcap
- Vial Design: Sloped shoulder to minimize headspace
- Certified Vial TOC Level: Less than 10 µg/L (10 ppb)
- Included Swab: TX761K Low TOC Alpha® Polyester Knit Swab with Long Handle
- Swabs per Kit: 24
- Swabs Available per Vial Position: 2
- Swab Head Material: 100% polyester knit
- Swab Head Construction: Double-layered, double-knit polyester
- Swab Head Bonding: Thermal bonding without adhesives
- Swab Handle Material: 100% polypropylene
- Swab Handle Color: Light green
- Handle Design: Long, rigid, notched break-away handle
- TX761K Head Width: 7.0 mm (0.276 inch)
- TX761K Head Thickness: 3.0 mm (0.118 inch)
- TX761K Head Length: 16.8 mm (0.661 inch)
- TX761K Overall Length: 163.0 mm (6.417 inches)
- Certified Swab TOC Level: Less than 50 µg/L (50 ppb)
- Labels per Kit: 12 blank cleanroom-compatible vial labels
- Kit Container: Cleanroom-compatible polypropylene box
- External Packaging: Double bagged
- Traceability: Manufacturer lot coded
- Primary Application: Surface sampling for TOC cleaning validation
- Additional Application: Cleaning validation and compatible contamination-source investigations
- Published Kit Shelf Life: 5 years from manufacture
- Sterility: Standard kit is not designated as sterile
- Manufacturer Technical Reference: TOC Cleaning Validation Kits Technical Data Sheet, covering TX3340, TX3342, and TX3343
What Is Included in Each TX3343 Kit?
Every TX3343 kit provides the collection and identification components for up to 12 vial-based sampling positions. The allocation of vials between equipment samples, blanks, and controls is determined by the validated sampling protocol.
| Kit Component |
Per Kit |
Per 18-Kit Case |
| 40 mL low-TOC glass vials with bonded septa caps |
12 |
216 |
| TX761K long-handle low-TOC polyester sampling swabs |
24 |
432 |
| Cleanroom-compatible blank vial labels |
12 |
216 |
| Complete TX3343 kits |
1 |
18 |
Ordering Quantity: One TX3343 kit contains 12 vials, 24 TX761K swabs, and 12 labels. A full manufacturer case contains 18 individual kits, equivalent to 216 vials, 432 TX761K swabs, and 216 labels. Choose the individual-kit or case purchasing option according to the required sampling volume.
About the Manufacturer:
Texwipe, an ITW company, develops precision cleanroom swabs, wipers, cleaning-validation consumables, and specialized contamination-control supplies for pharmaceutical manufacturing, biotechnology, medical devices, semiconductor processing, and other critical environments.
Texwipe's cleaning validation products use specially processed sampling materials and low-background collection components designed to minimize contamination introduced during the sampling procedure. The company's Low TOC Alpha® swabs combine controlled polyester knit construction with polypropylene handles and break-away notches for direct swab-head transfer into collection vials.
SOSCleanroom supports customers with Texwipe cleaning validation kit selection, sampling swab comparisons, manufacturer technical documentation, lot traceability, and procurement support for regulated cleaning-validation programs.
TX3343 Features:
- Complete 12-vial TOC cleaning validation kit
- Includes 24 TX761K long-handle polyester sampling swabs
- Includes 12 blank cleanroom-compatible vial labels
- 40 mL clear prewashed glass collection vials
- Bonded septa cap construction
- Polyethylene protective vial overcaps
- Certified vial TOC background below 10 µg/L
- Certified TX761K swab TOC background below 50 µg/L
- Long-handle sampling design for recessed and narrow locations
- 7.0 mm-wide polyester sampling heads
- Double-layered, double-knit polyester swab construction
- Adhesive-free thermal swab-head bonding
- Notched break-away polypropylene handles
- Controlled swab-head transfer into collection vials
- Cleanroom-compatible polypropylene kit box
- Double-bagged external kit packaging
- Manufacturer lot identification for traceability
- Five-year manufacturer-published shelf life
- Individual kit and 18-kit case purchasing options
TX3343 Benefits:
- Extended Sampling Reach: TX761K swabs provide access to recessed equipment locations where shorter swabs may be difficult to use.
- Precision Sampling: The narrow polyester head helps operators maintain controlled contact in small channels and equipment features.
- Controlled Background TOC: Certified low-TOC vials and swabs help reduce analytical background attributable to consumables.
- Consistent Kit Components: Matched supplies reduce variation from assembling vials and swabs sourced separately.
- Reduced Direct Handling: The break-away handle allows swab-head transfer without touching the collected sample.
- Improved Sample Organization: The polypropylene box provides a defined system for storage, staging, and transport.
- Traceable Sampling: Lot information and blank vial labels help connect sampling materials with equipment and laboratory records.
- Workflow Flexibility: Individual kits can be assigned to separate production areas, cleaning cycles, or sampling teams.
- Case Purchasing Efficiency: The 18-kit manufacturer case supports repeated smaller sampling campaigns.
- Analytical Qualification Support: Published component characteristics support cleaning validation method development and material evaluation.
Common Applications:
- Pharmaceutical equipment cleaning validation
- TOC surface residue sampling
- Sampling of recessed manufacturing equipment surfaces
- Biotechnology process equipment cleaning verification
- Cleaning qualification of equipment with narrow channels or grooves
- Surface sampling around accessible valves, fittings, and gaskets
- Residue sampling of suitable stainless steel equipment
- Cleaning validation investigations involving difficult-to-reach areas
- Controlled sampling following product changeovers
- Method development and swab recovery studies
- Routine residue monitoring under validated protocols
- Contamination-source investigations involving compatible non-organic liquids
Best-Practice Use:
- Follow the Approved SOP: Use the validated method for sampling area, swab wetting, collection technique, extraction, and TOC analysis.
- Verify Kit Identification: Confirm TX3343, kit lot, packaging condition, and expiration information.
- Identify Sampling Locations: Use the approved equipment sampling map and location identifiers.
- Prepare the Diluent: Select the required low-background solution and specified wetting volume.
- Control Swab Handling: Avoid touching the polyester head or contacting unqualified work surfaces.
- Maintain Consistent Contact: Apply the defined pressure and number of strokes over the intended surface.
- Use the Longer Handle Carefully: Avoid excessive bending, levering, or unintended contact with surrounding equipment.
- Transfer the Swab Head: Use the polypropylene handle notch to place the sampled head into the collection vial.
- Cap Promptly: Minimize unnecessary exposure of the sample to the surrounding environment.
- Label Immediately: Identify each vial before moving to the next sampling location.
- Reserve Control Vials: Allocate appropriate collection positions for blanks and quality controls.
- Maintain Chain of Custody: Document the sample's transfer to the laboratory.
- Observe Holding Conditions: Follow the validated time and temperature requirements.
- Document Deviations: Record inaccessible surfaces, swab damage, handling incidents, or departures from the approved procedure.
TOC Sampling Workflow:
Texwipe's technical documentation outlines a basic sampling sequence involving swab wetting, surface collection, break-away transfer, vial closure, and identification. The exact sampling area, technique, extraction conditions, and acceptance criteria are determined by the facility's validated protocol.
- Prepare the Sampling Plan: Confirm equipment identification, sampling locations, required controls, and acceptance criteria.
- Inspect the Kit: Confirm that the vials, TX761K swabs, and labels are present and protected.
- Prepare the Approved Solution: Use the specified diluent for wetting and extraction.
- Wet the Swab: Dip the TX761K sampling head in the solution as required by the SOP.
- Sample the Area: Apply the method-defined strokes, pressure, overlap, and sampling direction.
- Use the Second Swab: Where required, collect the additional sample using the prescribed second-swab technique.
- Open the Collection Vial: Remove the vial cap without contaminating its internal surfaces.
- Transfer the Swab Head: Position the head inside the vial and break the handle at the notch against the vial rim.
- Avoid Direct Contact: Do not touch the sampled polyester material with gloves or other surfaces.
- Close the Vial: Replace the cap promptly and securely.
- Label the Sample: Apply a unique identifier and complete the sampling record.
- Protect During Transport: Use the approved transport procedure and sample holding conditions.
- Analyze the Sample: Perform the validated extraction and TOC analysis.
- Review the Results: Evaluate analytical controls, recovery, blank contribution, and cleaning acceptance criteria.
Manufacturer Sampling Guidance: Texwipe's basic procedure is to consult the written SOP, dip the swab in solution, sample the area, remove the vial cap, snap the swab head into the vial using the notch at the vial rim, replace the cap, and label the sample. The facility's validated procedure controls all method-specific sampling parameters.
Long-Handle TX761K Swab Advantages:
TX3343 includes TX761K because some manufacturing equipment locations require greater reach and a smaller sampling head than the TX714K provides. These differences can be important when collecting residue from geometry-specific locations.
- Longer Overall Length: TX761K measures approximately 163.0 mm.
- Narrow Sampling Head: The 7.0 mm head width supports controlled contact in suitable confined features.
- Recessed Equipment: Extended reach assists sampling in accessible recesses, grooves, and deeper equipment features.
- Reduced Hand Proximity: The extended handle helps keep the operator's hand farther from the actual sampling surface.
- Flexible Polyester Head: The narrow head can conform to suitable small-scale equipment features.
- Rigid Handle: Provides controlled positioning while the swab head contacts the surface.
- Break-Away Transfer: Allows the polyester head to be separated for direct vial extraction.
- Material Consistency: Uses the same low-TOC Alpha® polyester family as the shorter TX714K swab.
- Recovery Qualification: Sampling in confined areas should be qualified using representative equipment geometry and residue recovery studies.
Long-Reach Sampling Guidance: A longer swab improves access but does not automatically increase residue recovery. Validate the head contact area, sampling pressure, swab orientation, stroke pattern, and extraction efficiency for the actual recessed surface being sampled.
Method Blanks and Background TOC Control:
TOC measurements can be influenced by organic material from the sampled equipment surface and by sampling consumables, diluent, vial closures, handling, and laboratory preparation. TX3343 provides low-background components, but appropriate analytical blanks remain necessary.
- Swab Blank: Evaluates organic background contribution from the unused TX761K swab under the method's extraction conditions.
- Vial Blank: Helps characterize contribution from collection vessels and closures.
- Diluent Blank: Evaluates the carbon background of the sampling or extraction solution.
- Field Blank: Where required, follows the relevant field-handling sequence without collecting equipment surface residue.
- Transport Blank: May be used to assess background introduced during sample transport and storage.
- Method Blank: Evaluates background from the applicable analytical preparation sequence.
- Recovery Controls: Determine how effectively the sampling procedure collects and extracts a known residue.
- Control Identification: Clearly distinguish control vials from equipment surface samples.
- Acceptance Criteria: Use the approved blank, recovery, and system-suitability requirements.
- Elevated Background: Investigate possible contamination from swab handling, diluent, vial exposure, storage, and laboratory preparation.
The manufacturer's certified component levels of less than 10 µg/L for vials and less than 50 µg/L for swabs are measured under defined testing conditions. These figures should not be treated as direct sample acceptance limits or as guarantees of the background measured by the complete analytical procedure.
Blank Allocation Guidance: A TX3343 kit provides 12 collection vials, not necessarily 12 equipment sample locations plus additional controls. If the sampling plan reserves one vial for a field blank and one for another required control, ten remain for equipment samples. The exact allocation must follow the approved protocol.
Sample Identification and Chain of Custody:
TX3343 includes 12 cleanroom-compatible blank vial labels. These labels help associate collected samples with equipment locations and analytical records. Complete traceability should extend beyond the vial label to the manufacturing equipment, cleaning cycle, sampling materials, and laboratory results.
- Sample Identification: Assign a unique sample identifier.
- Equipment Number: Record the applicable manufacturing equipment or production line.
- Sampling Location: Document the exact surface, recess, groove, or port sampled.
- Cleaning Cycle: Associate the sample with the relevant cleaning event or batch.
- Collection Date and Time: Record the sampling time.
- Sampler: Identify the responsible operator.
- Kit Lot: Record the TX3343 lot information.
- Sample Type: Identify equipment samples, blanks, and controls.
- Method Reference: Record the approved sampling SOP and applicable revision.
- Collection Conditions: Document any unusual handling or sampling limitations.
- Laboratory Transfer: Follow the established chain-of-custody procedure.
- Holding Conditions: Record any specified storage or time-to-analysis requirements.
- Analytical Result: Link laboratory data to the original sample and cleaning event.
Traceability Guidance: A defensible sampling record connects the TX3343 kit lot, collection vial, TX761K sampling procedure, equipment location, cleaning event, operator, transport record, and TOC analytical result. Maintain these connections through the approved quality-management documentation system.
Selection Notes: TX3343 vs. TX3340 vs. TX3342:
Texwipe provides three TOC cleaning validation kit configurations. All contain low-TOC glass vials and polyester sampling swabs, but the swab model, kit capacity, and manufacturer case quantity differ.
| Feature |
TX3343 |
TX3340 |
TX3342 |
| Vials per Kit |
12 |
12 |
72 |
| Swab Model |
TX761K |
TX714K |
TX714K |
| Swabs per Kit |
24 |
24 |
144 |
| Labels per Kit |
12 |
12 |
72 |
| Swab Geometry |
Longer, narrower |
Shorter, wider |
Shorter, wider |
| Manufacturer Case |
18 kits |
18 kits |
1 bulk kit |
| Typical Selection |
Recessed-area sampling |
Accessible surface sampling |
Larger sampling campaigns |
- TX3343: 12-vial kit containing TX761K long-handle swabs for narrow or recessed areas.
- TX3340: 12-vial kit containing TX714K swabs for suitable accessible surfaces.
- TX3342: 72-vial bulk kit containing TX714K swabs for larger campaigns.
- Same Certified TOC Levels: The three kits use vials certified below 10 µg/L TOC and swabs certified below 50 µg/L TOC.
- Method Selection: Choose the swab geometry based on the actual equipment surface, sampling access, and validated recovery.
- Purchasing Unit: Compare individual-kit and case quantities when evaluating inventory and order requirements.
Kit Selection Guidance: TX3343 and TX3340 have the same number of vials, swabs, and labels per kit, but they contain different swab models. TX3343 uses the long-handle TX761K; TX3340 uses the shorter, wider TX714K. TX3342 also uses TX714K but provides 72 vials in one bulk kit. Substituting swab types should be evaluated through the approved sampling and recovery process.
TX761K vs. TX714K Sampling Geometry:
Although both models use certified low-TOC Alpha® polyester knit heads and notched polypropylene handles, the two swabs are intended for different sampling access requirements.
| Specification |
TX761K |
TX714K |
| Head Width |
7.0 mm |
13.2 mm |
| Head Length |
16.8 mm |
25.7 mm |
| Overall Length |
163.0 mm |
127.5 mm |
| Head Style |
Narrow, flexible |
Wider polyester paddle |
| Handle |
Long, notched polypropylene |
Shorter, notched polypropylene |
| Certified Low TOC |
<50 µg/L |
<50 µg/L |
A different swab geometry may affect sampling pressure, contact area, residue pickup, and extraction efficiency. Changes from TX714K to TX761K, or vice versa, should be assessed within the facility's sampling-method qualification program.
TOC Results and Recovery Interpretation:
Total Organic Carbon testing measures the organic carbon contribution present in the analyzed sample. The measurement is nonspecific and does not by itself identify a particular product residue, cleaning agent, or other organic compound.
- TOC Method: Use a validated analytical method suited to the expected residues.
- Residue Recovery: Qualify collection and extraction for representative equipment surfaces and contaminants.
- Sampling Geometry: Confirm method suitability for narrow or recessed surfaces sampled with TX761K.
- Extraction Volume: Use the defined extraction liquid volume when calculating sample results.
- Analytical Blanks: Apply the approved background and blank acceptance criteria.
- Calculation: Follow the laboratory's validated procedure for converting measured concentration to an applicable surface residue result.
- Acceptance Limits: Compare the correctly calculated result with the facility's approved cleaning criteria.
- Unexpected Results: Evaluate possible residue, sample handling, consumable contribution, recovery, and instrument factors.
- Data Integrity: Retain the original sampling, laboratory, and calculation records.
Analytical Interpretation Guidance: Certified low-TOC swabs and vials help reduce sampling-system background but do not establish a method detection limit, recovery factor, or cleaning acceptance criterion. These requirements must be determined and documented through the validated analytical and sampling methods.
Packaging and Storage Recommendations:
- Manufacturer Part Number: TX3343
- Individual Kit Quantity: 12 vials, 24 TX761K swabs, 12 labels
- Manufacturer Case Quantity: 18 complete kits
- Vials per Full Case: 216
- TX761K Swabs per Full Case: 432
- Labels per Full Case: 216
- Kit Container: Cleanroom-compatible polypropylene box
- External Kit Packaging: Double bagged
- Lot Traceability: Manufacturer lot coded
- Published Shelf Life: 5 years from manufacture
- Storage: Protect unused kits from contamination, moisture, damage, and uncontrolled handling
- Vial Protection: Keep prewashed vials closed until sampling or control preparation
- Swab Protection: Avoid contact with unused sampling heads
- Opened Kits: Protect remaining components according to the facility's approved procedure
- Sterility: Standard TX3343 kit is not identified as a sterile presentation
- Sample Transport: Follow the analytical method's validated holding and transportation requirements
- Disposal: Follow applicable facility and laboratory procedures for used swabs, glass vials, and sampled residues
Manufacturer Technical Documents:
Texwipe TX3343 Manufacturer Product Information: Click Here
Texwipe TX3340 / TX3342 / TX3343 TOC Cleaning Validation Kits Technical Data Sheet and Sampling Instructions (PDF): Click Here
Texwipe Cleaning Validation Product Family and Kit Selection: Click Here
Texwipe Technical Data Sheets and Sampling Documentation: Click Here
SOSCleanroom TX3343 Product Information: Click Here
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TOC Cleaning Validation Kits and Sampling Swabs
Notes: Need assistance selecting a TOC cleaning validation kit, comparing TX761K and TX714K sampling swabs, or establishing a traceable sampling procedure? Open the SOSCleanroom Technical Vault tab above for additional guidance on long-reach sampling, swab-to-vial transfer, analytical blanks, sampling recovery, contamination prevention, and sample chain of custody.
SOSCleanroom.com supports pharmaceutical, biotechnology, medical device, laboratory, and other critical environments with Texwipe cleaning validation kits, low-TOC sampling swabs, cleanroom wipers, and contamination-control consumables. Our team provides manufacturer documentation, product selection assistance, packaging information, and procurement support.
Product description updated: October 26, 2026 (SOS Technical Staff)
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