Texwipe TX3342 Bulk TOC Cleaning Validation Kit - 72 Samples - 144 TX714K Swabs - 1 Kit/Case
Texwipe TX3342 is a bulk Total Organic Carbon (TOC) cleaning validation kit designed to simplify surface sampling, sample identification, and transportation from manufacturing equipment to the analytical laboratory. Developed for pharmaceutical, biotechnology, medical device, and other contamination-sensitive operations, the kit brings together certified low-TOC vials, low-TOC polyester sampling swabs, and identification labels in a cleanroom-compatible polypropylene transport container.
Each TX3342 bulk kit contains 72 clear 40 mL glass vials with bonded septa caps, 144 TX714K Low TOC Alpha® polyester knit sampling swabs, and 72 blank vial labels. This provides the components for up to 72 vial-based sampling positions, with two TX714K swabs available per vial. The actual number of equipment sampling locations depends on the validation protocol and the number of vials allocated to blanks, controls, or additional testing.
The prewashed vials are certified to a TOC level below 10 µg/L, while the included TX714K swabs are certified below 50 µg/L TOC under the manufacturer's applicable test procedures. The swabs feature a double-layered polyester knit head and a rigid polypropylene handle with a break-away notch, allowing the swab head to be placed directly into the collection vial with minimal handling.
TX3342 is supplied as one complete bulk kit per manufacturer case. Its 72-vial configuration is especially useful for scheduled cleaning validation campaigns, multi-location sampling, and facilities that prefer one organized supply of matched components rather than multiple individually packaged small kits.
Cleaning Validation Advantage: TX3342 provides a complete 72-vial TOC sampling system with 144 certified low-TOC TX714K swabs, cleanroom-compatible vial labels, and an organized transport container. The kit supports standardized sampling, controlled swab-to-vial transfer, sample identification, method-blank collection, and traceable movement of samples from the production area to the laboratory.
Specifications:
- Manufacturer: Texwipe, an ITW company
- Manufacturer Part Number: TX3342
- SOSCleanroom SKU: TX3342 CASE
- Product Name: Bulk TOC Cleaning Validation Kit
- Product Family: Cleaning Validation Swabs and TOC Kits
- Product Type: Complete Surface Sampling Kit for TOC Analysis
- Kit Configuration: Bulk 72-vial sampling system
- Manufacturer Case Quantity: 1 complete kit
- Collection Vials: 72
- Vial Capacity: 40 mL each
- Vial Material: Prewashed borosilicate glass
- Vial Appearance: Clear
- Vial Cap: Bonded septum cap with one-piece cap-and-septum design
- Septum Thickness: 1.34 mm (0.053 inch)
- Vial Protection: Polyethylene overcap
- Vial Geometry: Sloped shoulder to minimize headspace
- Certified Vial TOC Level: Less than 10 µg/L (10 ppb)
- Included Sampling Swabs: 144
- Included Swab Part Number: TX714K
- Swab Family: Low TOC Alpha® Polyester Knit
- 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
- Swab Handle Design: Rigid, notched, break-away handle
- Certified Swab TOC Level: Less than 50 µg/L (50 ppb)
- TX714K Swab Head Width: 12.7 mm (0.500 inch)
- TX714K Swab Head Thickness: 4.2 mm (0.165 inch)
- TX714K Swab Head Length: 25.7 mm (1.012 inches)
- TX714K Handle Length: 101.8 mm (4.008 inches)
- TX714K Overall Length: 127.5 mm (5.020 inches)
- Swabs per Vial Position: Two available per collection vial
- Blank Vial Labels: 72
- Label Type: Cleanroom-compatible identification labels
- Transport Container: Cleanroom-compatible polypropylene box
- External Kit Packaging: Double bagged
- Traceability: Lot coded for quality control and traceability
- Published Shelf Life: Five years from manufacture
- Recommended Storage Temperature: 15-30°C (59-86°F)
- Sterility: No sterile presentation specified for the standard TX3342 kit
- Country of Origin: Philippines, per manufacturer technical data sheet
- Primary Application: Surface sampling for TOC cleaning validation
- Additional Application: Compatible contamination-investigation sampling under an approved analytical method
- Manufacturer Technical Reference: Cleaning Validation Swabs & TOC Kits Technical Data Sheet
What Is Included in One TX3342 Case?
Each manufacturer case contains one complete TX3342 bulk kit. The kit provides the sampling supplies for 72 vial-based positions, together with two sampling swabs for each position.
| Kit Component |
Quantity |
Purpose |
| 40 mL low-TOC glass vials with bonded septa caps |
72 |
Collection and transport of extracted surface samples or assigned controls |
| TX714K Low TOC Alpha® polyester sampling swabs |
144 |
Surface sampling using the approved collection procedure |
| Cleanroom-compatible blank vial labels |
72 |
Sample identity, location, and traceability |
| Organized polypropylene transport container |
1 |
Protected organization and transportation of kit components and samples |
Case Quantity: 1 TX3342 kit = 72 vials + 144 TX714K swabs + 72 labels. Blanks and other control samples use collection positions from the available 72 vials unless separately supplied components are allocated. The kit does not contain 72 separate kits or 144 complete sample containers.
About the Manufacturer:
Texwipe, an ITW company, manufactures cleanroom swabs, wipers, and contamination-control products used in pharmaceutical manufacturing, biotechnology, medical devices, precision cleaning, and other critical environments.
Texwipe's cleaning validation products are designed to support repeatable sampling and reduce contamination contribution from the sampling materials themselves. The Alpha® low-TOC sampling swab family uses precision-manufactured polyester heads and polypropylene handles, while its TOC kits combine certified collection vials, swabs, and labels into organized sampling systems.
SOSCleanroom provides Texwipe cleaning validation supplies and supports customers with product selection, sampling-kit configurations, manufacturer documentation, and procurement for regulated cleaning programs.
TX3342 Features:
- One complete 72-vial bulk TOC cleaning validation kit per case
- 72 certified low-TOC glass collection vials
- 144 certified low-TOC TX714K Alpha® polyester sampling swabs
- 72 cleanroom-compatible vial labels
- Certified vial TOC level below 10 µg/L
- Certified swab TOC level below 50 µg/L
- Prewashed borosilicate glass vial construction
- Bonded septa caps for controlled sample handling
- Protective polyethylene vial overcaps
- Sloped vial shoulders designed to reduce headspace
- Double-layered polyester knit sampling heads
- Thermally bonded swab construction
- Rigid polypropylene handles with break-away notches
- Swab-head transfer with minimal direct handling
- Cleanroom-compatible polypropylene transport box
- Double-bagged external kit packaging
- Lot identification for traceability
- Five-year manufacturer-published shelf life
TX3342 Benefits:
- Consistent Sampling Materials: Matched vials and swabs help limit variation introduced by sourcing different sampling components.
- Controlled TOC Background: Certified low-TOC consumables support analytical methods requiring attention to blank contribution.
- 72-Vial Bulk Capacity: Supports larger sampling campaigns and scheduled equipment-cleaning validation activities.
- Two Swabs per Vial: Provides flexibility for validated sampling methods using paired swabs or multiple passes.
- Reduced Handling: Notched swab handles support transfer of the swab heads without direct contact.
- Improved Sample Identification: Included labels support consistent vial tracking from sampling to analysis.
- Protected Transport: The polypropylene container organizes supplies and helps reduce uncontrolled handling.
- Lot Traceability: Manufacturer lot codes support investigation of material background and qualification records.
- Workflow Standardization: One defined kit configuration helps operators and laboratory personnel use repeatable sampling procedures.
- Audit Support: Documented sampling materials, controls, and chain-of-custody records support data review and cleaning validation investigations.
Common Applications:
- Pharmaceutical equipment cleaning validation
- Total Organic Carbon surface sampling
- Cleaning verification of shared manufacturing equipment
- Biotechnology process equipment sampling
- Active pharmaceutical ingredient production equipment
- Excipients and drug manufacturing equipment
- Cleaning studies covering multiple sampling locations
- Controlled investigation of suspected organic contamination
- Repeatable surface residue trending
- Qualification of cleaning procedures and sampling methods
- Swab recovery studies for appropriate surfaces and residues
- Investigations involving compatible liquid samples under an approved method
Best-Practice Use:
- Use an Approved SOP: Follow the written sampling and analytical method established for the equipment, surface, and cleaning residue.
- Define Sample Locations: Identify locations using approved equipment maps and sample identifiers.
- Use a Defined Area: Apply a qualified sampling area or template where the method requires a known surface area.
- Control the Diluent: Use the validated wetting and extraction solution at the specified volume and quality.
- Protect Sampling Materials: Avoid touching swab heads, the interior of vial caps, and the collection surfaces of vials.
- Maintain Consistent Technique: Use the same prescribed pressure, direction, overlap, and number of passes.
- Use the Break-Away Handle: Transfer the swab head into the vial without handling the head directly.
- Cap Promptly: Minimize vial-open time and avoid placing caps on uncontrolled work surfaces.
- Label Immediately: Link each vial to its location, equipment, cleaning cycle, and sampling record.
- Include Method Blanks: Collect the controls required to identify contribution from sampling materials, diluent, handling, and transport.
- Control Transport: Follow the validated sample storage conditions and maximum time to analysis.
- Document Deviations: Record any difference from the approved collection or handling procedure.
TOC Cleaning Validation Sampling Workflow:
A controlled sampling workflow helps distinguish actual surface residue from variation introduced during sample collection, swab handling, transport, and laboratory preparation. Texwipe's manufacturer instructions describe wetting the swab, sampling the surface, breaking the swab head into the collection vial, capping, and labeling the sample.
- Prepare the Sampling Plan: Confirm the equipment identification, sample locations, sampling sequence, acceptance criteria, and required controls.
- Verify the Kit: Check TX3342 identification, lot information, expiration, and the availability of vials, labels, and TX714K swabs.
- Prepare the Diluent: Use the analytical method's approved low-background solution and specified wetting volume.
- Establish the Sample Area: Use the validated area template or defined equipment surface location.
- Wet the Swab: Dip the TX714K swab into the approved solution in accordance with the written SOP.
- Sample the Surface: Apply the validated stroke pattern, overlap, pressure, and swab orientation.
- Use the Second Swab: If required by the method, perform the specified additional passes with the second TX714K swab.
- Open the Collection Vial: Remove the cap only when the swab heads are ready for transfer.
- Snap the Swab Head: Position the handle notch against the vial rim and break the head into the vial without touching the collection material.
- Transfer Additional Swab Heads: Place any required second swab head into the same vial according to the validated method.
- Close the Vial: Replace the cap promptly using the proper sample-handling technique.
- Identify the Sample: Apply the label and complete the associated sampling record.
- Transport to the Laboratory: Keep the vial protected and follow the approved sample holding conditions.
- Analyze and Review: Complete the TOC measurement, blank assessment, recovery correction, and acceptance evaluation required by the approved analytical method.
Sampling Technique Guidance: Texwipe's published procedure describes dipping the swab in solution, sampling the area, snapping the swab head into the vial at the handle notch, replacing the cap, and labeling the sample. The facility's approved method determines sampling area, number of swabs, wetting volume, extraction conditions, and analytical acceptance criteria.
Blank Controls and Background TOC Management:
Total Organic Carbon analysis is sensitive to organic contribution from collection materials, extraction liquid, laboratory glassware, operator handling, and environmental exposure. Although TX3342 uses certified low-TOC components, the entire sampling and analytical procedure must be evaluated using suitable blanks and controls.
- Method Blank: Process the approved blank materials through the relevant analytical steps without collecting residue from the equipment surface.
- Field Blank: Where required, expose and handle a blank using the defined field procedure without swabbing the target surface.
- Diluent Blank: Evaluate the organic background of the sampling or extraction liquid.
- Swab Blank: Assess the contribution from unused swabs under the method's extraction conditions.
- Vial Blank: Evaluate container and closure contributions when required by the method.
- Transport Blank: Where appropriate, use a control to assess contamination introduced during storage or transportation.
- Control Identification: Clearly identify blanks separately from equipment surface samples.
- Consistent Handling: Use the same relevant vials, swabs, diluent, and handling conditions specified by the method.
- Review Blank Results: Compare measured blank contribution with the established method limits before accepting sampling results.
- Investigate Elevated Blanks: Examine diluent preparation, vial-cap handling, swab handling, open-vial time, and transport conditions.
A certified vial level below 10 µg/L and swab level below 50 µg/L describe component background characteristics under manufacturer-defined testing. These values are not direct substitutes for the laboratory's method-blank acceptance criteria and should not automatically be added together to predict the final sample result.
Blank-Control Guidance: Reserve sufficient kit positions for the blanks and quality controls required by the validation plan. For example, when a protocol assigns one of the 72 vials to a field blank, the remaining 71 vials are available for other samples and controls. The number of control vials and their preparation must be defined in the approved method, not assumed from the kit configuration.
Sample Identification and Chain of Custody:
TX3342 includes 72 cleanroom-compatible blank vial labels to support sample identification. A complete traceability system should connect each vial with the specific equipment, sampling location, cleaning event, sampler, kit lot, and laboratory result.
- Unique Sample ID: Assign an identifier that cannot be confused with another vial.
- Equipment Identification: Record the equipment or process line sampled.
- Sampling Location: Identify the precise surface, location code, and relevant area.
- Cleaning Event: Link the sample to the cleaning batch or cleaning verification event.
- Sampling Date and Time: Record when collection occurred.
- Sampler Identification: Identify the operator who collected the sample.
- TX3342 Kit Lot: Retain the manufacturer's relevant kit or component lot information.
- Control Classification: Identify blanks, recovery controls, and actual surface samples.
- Sample Condition: Record deviations, leakage, damaged containers, or unusual collection conditions.
- Storage and Holding: Document required temperatures and time limits.
- Laboratory Receipt: Record sample receipt and any condition requiring investigation.
- Analytical Result: Link the final TOC result to the original sample and approved calculation.
Traceability Guidance: A vial label identifies the container; the complete chain of custody connects that container to the equipment, cleaning record, sampling location, collection procedure, transport history, laboratory analysis, and result review. Use the included labels together with the facility's approved paper or electronic documentation system.
TX714K Swab Construction and Sampling Performance:
The TX714K swabs included in TX3342 use Texwipe's Low TOC Alpha® polyester knit construction. Their double-layered heads provide a defined contact surface for collecting residues from suitable equipment surfaces and releasing collected material into the extraction solution.
- Double-Layered Knit Head: Supports collection of residues within the polyester knit structure.
- 100% Polyester Head Material: Provides a controlled textile sampling surface.
- Thermal Bonding: Avoids adhesives at the swab-head attachment.
- Rigid Polypropylene Handle: Provides controlled contact pressure and handling.
- Break-Away Notch: Allows separation of the sampling head for placement into the vial.
- Low TOC Certification: Supports methods requiring controlled organic background contribution.
- Light-Green Handle: Provides a recognizable manufacturer identification feature.
- Large Flat Head: Supports sampling of suitable broad and relatively flat surfaces.
- Surface Compatibility: Verify appropriate swab contact on coated, soft, rough, or highly textured equipment surfaces.
- Sampling Recovery: Establish residue-specific recovery using the actual material, swab technique, diluent, and analytical method.
TOC Results, Recovery and Interpretation:
TOC measurements represent total organic carbon detected in the analyzed solution. They do not independently identify which chemical produced the carbon signal. Cleaning validation programs should establish how results are compared with residue limits and how contributions from blanks, swab recovery, sampling area, and extraction volume are handled.
- TOC Is Nonspecific: It can detect organic contribution from multiple sources without identifying an individual compound.
- Sampling Area: A defined surface area supports comparison of results across locations.
- Extraction Volume: Follow the approved method's volume because concentration results depend on the amount of liquid analyzed.
- Swab Recovery: Validate the recovery of representative residues from the relevant equipment surfaces.
- Blank Contribution: Evaluate background using the procedure's established blank criteria.
- Analytical Calibration: Follow the TOC analyzer manufacturer's validated calibration and suitability requirements.
- Acceptance Limits: Compare appropriately calculated results with the approved cleaning validation limits.
- Unexpected Results: Investigate possible residue, sampling inconsistency, contaminated diluent, or handling contribution.
- Method Changes: Evaluate changes to swabs, containers, diluent, area, or extraction method through the applicable quality process.
- Documentation: Retain raw results, calculations, associated controls, and deviation records according to site requirements.
Analytical Interpretation Guidance: Certified low-TOC consumables help control one source of analytical background, but they do not establish the method detection limit, cleaning acceptance criterion, or sample recovery. Those parameters must be validated for the equipment, residue, and analytical system used.
Selection Notes: TX3342 vs. TX3340:
TX3342 and TX3340 use the same TX714K Low TOC Alpha® sampling swab and certified low-TOC collection vials. The primary difference is the quantity and packaging format.
| Specification |
TX3342 |
TX3340 |
| Configuration |
Bulk kit |
Small kit |
| 40 mL Vials per Kit |
72 |
12 |
| TX714K Swabs per Kit |
144 |
24 |
| Labels per Kit |
72 |
12 |
| Swab Type |
TX714K |
TX714K |
| Manufacturer Case |
1 bulk kit |
18 small kits |
| Typical Selection |
Large sampling campaigns |
Smaller independent sampling events |
- Choose TX3342: When a single organized 72-vial kit fits the sampling campaign.
- Choose TX3340: When 12-vial kits are better suited to separate sampling events or teams.
- Same Sampling Swab: Both contain TX714K, so the primary difference is kit capacity rather than swab-head design.
- Manufacturer Case Quantity: Compare one TX3342 kit/case with 18 TX3340 kits/case, not one bulk kit against one small kit without considering the purchasing unit.
- Sampling Controls: Reserve vial capacity for blanks and controls according to each method.
Kit Selection Guidance: TX3342 is the larger 72-vial bulk format. TX3340 is the smaller 12-vial format containing the same TX714K swab. Choose according to sampling campaign size, material staging, and the number of independently controlled sampling events.
Packaging, Shelf Life and Storage:
- Manufacturer SKU: TX3342
- Manufacturer Case: 1 complete kit
- Vials: 72 clear 40 mL low-TOC glass vials
- Swabs: 144 TX714K Low TOC Alpha® polyester knit sampling swabs
- Labels: 72 blank cleanroom-compatible vial labels
- Container: Cleanroom-compatible polypropylene transport box
- Outer Protection: Double-bagged kit configuration
- Lot Identification: Manufacturer lot coding for traceability
- Published Shelf Life: Five years from date of manufacture
- Recommended Temperature: 15-30°C (59-86°F)
- Storage Conditions: Clean, protected ambient storage according to manufacturer instructions
- Before Use: Inspect packaging, vials, caps, swabs, and labels
- Vial Protection: Keep closed until collection or blank preparation
- Swab Protection: Avoid handling sampling heads or exposing them unnecessarily before use
- Sample Transport: Follow the validated holding conditions and time-to-analysis limit
- Sterility: Standard kit is not identified as sterile
- Disposal: Follow applicable laboratory and facility requirements for used swabs, glass vials, and sampled residues
Manufacturer Technical Documents:
Texwipe TX3342 Manufacturer Product Information: Click Here
Texwipe Cleaning Validation Swabs & TOC Kits Technical Data Sheet - TX3342 Components and Physical Specifications (PDF): Click Here
Texwipe TX3340 / TX3342 Cleaning Validation Kit Technical Data Sheet and Sampling Instructions (PDF): Click Here
Texwipe Cleaning Validation Product Family and Sampling Resources: Click Here
SOSCleanroom TX3342 Product Information: Click Here
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Notes: Need assistance selecting a TOC cleaning validation kit, comparing TX3342 with TX3340, or establishing a controlled swab sampling workflow? Open the SOSCleanroom Technical Vault tab above for additional information on sampling technique, method blanks, swab recovery, vial handling, sample traceability, and TOC result interpretation.
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 supplies. 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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