Texwipe TX3360 HPLC Cleaning Validation Kit with TX718 Alpha® Polyester Sampling Swabs - 12 Samples/Kit - 18 Kits/Case
Texwipe TX3360 is a surface and cleaning validation sampling kit designed to support the controlled collection of residues for High-Performance Liquid Chromatography (HPLC), ultraviolet-visible (UV-Vis) spectroscopy, and other suitable analytical methods. Developed for pharmaceutical manufacturing, biotechnology, medical devices, and contamination-sensitive production environments, TX3360 provides an organized system of sampling swabs, collection vials, and identification labels.
Each kit contains 12 clear 40 mL prewashed borosilicate glass vials with bonded septa caps, 30 TX718 Alpha® Polyester Knit Large Sampling Swabs, and 12 blank cleanroom-compatible vial labels. These components are organized inside a cleanroom-compatible polypropylene box and double bagged to support controlled transfer between storage, production, and laboratory areas.
The included TX718 swabs feature a large, flat polyester knit sampling head, a translucent polypropylene handle, adhesive-free thermal bonding, and a notched break-away design. The polyester head is manufactured using low-titanium-dioxide fabric and is intended for controlled surface sampling with appropriate solvent-based solutions.
TX3360 is particularly useful when a facility's validated method measures specific manufacturing residues, such as an active pharmaceutical ingredient or cleaning-agent component, by HPLC or UV-Vis. Unlike TOC analysis, which measures total organic carbon without identifying individual compounds, these analytical approaches may provide compound-specific measurement when the method has been appropriately developed and validated.
The manufacturer supplies 18 complete TX3360 kits per case. SOSCleanroom offers individual-kit and full-case purchasing options.
Cleaning Validation Advantage: TX3360 combines TX718 polyester sampling swabs, protected 40 mL collection vials, and identification labels in one organized kit. The system supports repeatable sample collection, controlled swab-head transfer, and traceable movement of samples to the analytical laboratory. Analytical suitability, extraction recovery, interference limits, and residue acceptance criteria must be established by the facility's validated method.
Specifications:
- Manufacturer: Texwipe, an ITW company
- Manufacturer Part Number: TX3360
- SOSCleanroom SKU: TX3360 KIT
- Product Name: HPLC Cleaning Validation Kit
- Product Family: Surface and Cleaning Validation
- Product Type: Surface Sampling and Collection Kit
- Primary Analytical Application: HPLC-based cleaning validation
- Additional Analytical Applications: UV-Vis and other suitable separation or residue analysis methods
- Collection Vials per Kit: 12
- Vial Capacity: 40 mL each
- Vial Material: Prewashed borosilicate glass
- Vial Color: Clear
- Vial Closure: Bonded septum cap with one-piece cap-and-septum construction
- Septum Thickness: 1.34 mm (0.053 inch)
- Vial Protection: Polyethylene overcap
- Sampling Swabs per Kit: 30
- Included Swab Part Number: TX718
- Swab Name: Alpha® Polyester Knit Large Sampling Swab
- Swab Head Material: Low-titanium-dioxide polyester knit
- Swab Head Geometry: Large, flat paddle
- Head Width: 12.70 mm (0.500 inch)
- Head Thickness: 4.20 mm (0.165 inch)
- Head Length: 25.70 mm (1.012 inches)
- Swab Handle Material: 100% polypropylene
- Handle Color: Translucent
- Handle Width: 5.20 mm (0.205 inch)
- Handle Thickness: 3.00 mm (0.118 inch)
- Handle Length: 101.80 mm (4.008 inches)
- Overall Swab Length: 127.50 mm (5.020 inches)
- Swab Head Attachment: Thermal bond without adhesives
- Swab Handle Feature: Break-away notch for collection-vial transfer
- Typical TX718 Nonvolatile Residue, IPA Extractant: 0.0075 mg/swab
- Nonvolatile Residue Data: Manufacturer-reported typical analysis, not a specification limit
- Identification Labels per Kit: 12
- Label Type: Blank cleanroom-compatible vial labels
- Kit Container: Cleanroom-compatible polypropylene box
- Outer Kit Packaging: Double bagged
- Lot Identification: Manufacturer lot coded for traceability
- Supplied Sterility: Non-sterile
- Published Shelf Life: 5 years from date of manufacture
- Recommended Storage Temperature: 15-30°C (59-86°F)
- Manufacturer Case Quantity: 18 complete kits
- Total Vials per Manufacturer Case: 216
- Total TX718 Swabs per Manufacturer Case: 540
- Total Labels per Manufacturer Case: 216
- Manufacturer Technical Reference: US-TDS-066 Rev. 11/25
TX3360 Kit Contents and Case Configuration:
Texwipe packages TX3360 as an individual sampling kit containing 12 collection vials, 30 TX718 swabs, and 12 identification labels. A full manufacturer case contains 18 individual kits.
| Component |
Per Kit |
Per Case |
| 40 mL glass vials with bonded septa caps |
12 |
216 |
| TX718 Alpha® polyester sampling swabs |
30 |
540 |
| Blank vial labels |
12 |
216 |
| Complete kits |
1 |
18 |
Sampling Capacity: One kit contains 12 vials and 30 TX718 swabs. The additional swabs provide flexibility for the approved collection procedure, recovery work, or controls; they do not increase the number of included collection vials. Sampling positions assigned to blanks and quality controls reduce the number of vials remaining for equipment samples.
About the Manufacturer:
Texwipe, an ITW company, develops precision cleanroom swabs, wipers, and contamination-control consumables for pharmaceutical manufacturing, biotechnology, medical devices, laboratory operations, and other critical environments.
Texwipe's surface and cleaning validation kits are designed to simplify the collection and handling of samples by combining compatible swabs, vials, identification materials, and protective packaging. The TX718 Alpha® swab is specifically designed for surface collection and cleaning-validation applications involving suitable solvent-based solutions.
SOSCleanroom supports customers with Texwipe product selection, cleaning-validation sampling supplies, manufacturer documentation, kit configurations, and procurement assistance for controlled manufacturing environments.
TX3360 Features:
- HPLC surface and cleaning validation sampling kit
- 12 prewashed 40 mL borosilicate glass vials
- 30 TX718 Alpha® polyester sampling swabs
- 12 cleanroom-compatible vial identification labels
- One-piece cap-and-septum vial closures
- Protective polyethylene septum overcaps
- Large, flat polyester sampling heads
- Low-titanium-dioxide polyester knit head material
- Translucent polypropylene swab handles
- Notched break-away swab-head transfer design
- Thermal bonding without adhesives
- Designed for appropriate solvent-based sampling
- Manufacturer-published typical extractables data
- Lot identification for traceability
- Cleanroom-compatible polypropylene transport box
- Double-bagged kit packaging
- Five-year manufacturer-published shelf life
- 18 kits per manufacturer case
TX3360 Benefits:
- Organized Sampling: Combines collection vials, swabs, and labels into one controlled kit.
- Reduced Assembly Work: Limits the need to gather sampling components from multiple inventory locations.
- Controlled Handling: Protective packaging helps reduce unnecessary contact with collection materials.
- Sample Integrity: Prewashed vials and protected septa support careful sample preparation and transport.
- Repeatable Sampling: Consistent TX718 head dimensions support standardization of the approved swabbing technique.
- Reduced Transfer Contact: Break-away handles allow sampled heads to be placed into collection vials without direct handling.
- Solvent-Based Method Compatibility: TX718 construction is intended for sampling using suitable solvent-based solutions.
- Analytical Traceability: Labels and lot identification support connections between sampling locations and laboratory results.
- Flexible Sampling Programs: Individual kits support separate equipment trains, cleaning events, and sampling teams.
- Controlled Transport: The polypropylene box helps organize materials during movement from production to the laboratory.
Common Applications:
- Pharmaceutical cleaning validation using HPLC analysis
- UV-Vis cleaning residue analysis under a suitable validated method
- Active pharmaceutical ingredient residue sampling
- Cleaning-agent residue investigations
- Manufacturing equipment cleaning verification
- Biotechnology processing equipment
- Medical device manufacturing equipment sampling
- Shared-equipment cleaning studies
- Surface residue recovery studies
- Cleaning validation method development
- Controlled surface sampling during manufacturing investigations
- Trace residue collection from suitable equipment surfaces
- Evaluation of cleaning effectiveness after product changeovers
- Other laboratory analysis requiring appropriate swab-based sampling
HPLC/UV-Vis vs. TOC Cleaning Validation:
The analytical technique determines what information can be obtained from a cleaning validation sample. HPLC, UV-Vis, and TOC can all be useful in appropriate cleaning validation programs, but their selectivity, sensitivity, interferences, and method requirements differ.
| Consideration |
HPLC |
UV-Vis |
TOC |
| Measurement |
Separated analyte with a suitable detector |
Light absorbance at selected wavelengths |
Total organic carbon |
| Selectivity |
May be compound-specific when validated |
Depends on spectral characteristics and interferences |
Nonspecific organic-carbon measurement |
| Key Method Requirement |
Chromatographic separation and analyte recovery |
Suitable absorbance response and interference control |
Low organic background and carbon recovery |
| Typical Kit Selection |
TX3360 with TX718 |
TX3360 when method-qualified |
TX3340, TX3342, or TX3343 low-TOC kits |
An HPLC method may separate an individual residue from other sample components before detection. A UV-Vis method measures optical absorbance and requires evaluation of possible interfering compounds. TOC measures the total organic-carbon contribution without independently identifying its source.
Analytical Method Selection: TX3360 is intended to support HPLC and related surface-sampling workflows. The kit does not establish that any particular API, detergent, solvent, or cleaning residue can be accurately measured. The analytical method must demonstrate suitable specificity or selectivity, sensitivity, precision, recovery, stability, and interference control for the intended residue and equipment surface.
TX718 Alpha® Polyester Sampling Swab Construction:
The TX718 included in TX3360 is a large polyester sampling swab designed for controlled surface contact and suitable solvent-based sampling. Its material construction and notched handle help support consistent transfer of collected residues into analytical collection vials.
- Polyester Head: Low-titanium-dioxide knit polyester minimizes the use of certain potential contaminating materials.
- Large Paddle Geometry: Provides a relatively broad contact area for sampling accessible equipment surfaces.
- Polypropylene Handle: Translucent material without added handle colorants supports low-interference construction.
- Adhesive-Free Bonding: Thermal attachment avoids adhesive at the head-to-handle interface.
- Break-Away Notch: Supports separation of the sampled head inside a compatible collection vial.
- Solvent-Based Sampling: Designed for suitable organic solvent-based collection procedures.
- Water Interaction: The manufacturer notes that the swab may exhibit hydrophilic properties with water.
- Surface Contact: Swab geometry and sampling pressure should be appropriate for the surface material and residue.
- Lot Identification: Supports material traceability and analytical investigations.
- Cleaning Validation: The swab should be qualified within the complete sampling and analytical method.
TX718 Selection Guidance: TX718 is designed for HPLC/UV-Vis and related residue-sampling applications. It should not be described as interchangeable with certified low-TOC TX714K or TX761K swabs without qualification. The approved method determines the correct swab, extraction solvent, recovery requirements, and interference limits.
Typical TX718 Extractables and Nonvolatile Residue:
Texwipe provides typical laboratory data for TX718 ionic extractables and nonvolatile residue. These measurements may assist in evaluating sampling-material background and potential analytical interference.
| Typical Ionic Extractable |
TX718 (µg/swab) |
| Calcium |
0.0031 |
| Chloride |
0.0012 |
| Fluoride |
0.0066 |
| Magnesium |
0.0023 |
| Nitrate |
0.0041 |
| Phosphate |
0.0049 |
| Potassium |
0.0054 |
| Sodium |
0.0055 |
| Sulfate |
0.0035 |
Typical Nonvolatile Residue: 0.0075 mg/swab with IPA as the extraction solvent.
Analytical Background Guidance: Texwipe identifies the listed extractables and nonvolatile residue measurements as typical analyses, not product specification limits. These figures do not establish a chromatography blank profile, UV absorbance spectrum, compound-specific detection limit, or absence of interfering peaks. Test the actual TX718 extraction under the intended analytical conditions.
Best-Practice HPLC Cleaning Validation Sampling:
- Review the Sampling SOP: Use the approved method for the actual residue, equipment surface, and analytical technique.
- Confirm Kit Identity: Verify TX3360, kit lot, packaging condition, and expiration information.
- Establish Sampling Locations: Follow the approved equipment sampling map and location identifiers.
- Define the Sampling Area: Use a qualified surface area or geometry-specific sampling procedure.
- Prepare the Extraction Solvent: Use only the analytical method's specified solvent and volume.
- Control Swab Wetness: Apply the validated wetting technique rather than using an arbitrary amount of solvent.
- Follow the Stroke Pattern: Maintain the prescribed pressure, direction, overlap, and number of passes.
- Avoid Unintended Contact: Keep the swab head away from gloves, clothing, surrounding equipment, and unqualified surfaces.
- Transfer into the Vial: Use the notched handle to break the swab head into the collection vial as required by the method.
- Close Promptly: Protect the sample from evaporation, uncontrolled exposure, and handling contamination.
- Label Immediately: Associate the sample with its equipment and sampling location.
- Collect Required Controls: Include method blanks, field blanks, and recovery controls as specified.
- Observe Sample Holding Conditions: Follow the validated storage temperature and maximum time before analysis.
- Document Deviations: Record incomplete sampling, damaged consumables, unexpected exposure, and departures from the procedure.
Step-by-Step Sampling and Swab Transfer:
The purpose of a consistent sampling sequence is to reduce variation introduced before the sample reaches the laboratory. The TX718 notched handle supports direct transfer of the sampled head into an appropriate extraction vial.
- Plan: Confirm the equipment ID, cleaning cycle, residue of interest, sampling area, and sample identification number.
- Inspect: Check the TX718 swab and 40 mL collection vial before use.
- Prepare: Use the specified solvent and wetting procedure.
- Collect: Swab the defined area using the approved number of passes, pressure, and direction.
- Repeat as Required: Use additional swabs only as specified by the approved sampling method.
- Open the Vial: Handle the vial closure without touching its internal or sample-contact surfaces.
- Position the Swab Head: Insert the sampled head into the vial opening.
- Break at the Notch: Separate the handle using the designed break-away point without contacting the swab head.
- Complete Extraction Preparation: Add or retain the required extraction solution according to the method.
- Cap: Close the vial promptly and securely.
- Label: Apply the unique sample identifier and complete the sampling record.
- Transport: Maintain approved storage and chain-of-custody controls.
- Extract and Analyze: Follow the validated laboratory preparation and measurement procedure.
- Review: Evaluate blanks, analyte recovery, analytical performance, and cleaning acceptance criteria.
Sampling Method Guidance: The kit supplies collection materials, but it does not define the correct extraction solvent, swabbing area, extraction time, mixing procedure, recovery correction, or chromatographic conditions. These details must be established by the laboratory's approved method and documented in the relevant sampling SOP.
Blanks, Recovery Studies and Analytical Interferences:
HPLC and UV-Vis cleaning validation methods require evaluation of possible background and interference from sampling materials, extraction solvents, vials, closures, and the surrounding environment. TX3360's organized configuration helps standardize material selection, but method qualification must establish analytical suitability.
- Solvent Blank: Evaluates potential contribution from the selected extraction solvent.
- Swab Blank: Uses unused TX718 sampling material under the defined extraction conditions.
- Vial Blank: Evaluates possible contribution from the vial and closure.
- Field Blank: Assesses contamination from prescribed sampling-area handling without surface residue collection.
- Method Blank: Evaluates background introduced by the complete applicable analytical preparation sequence.
- Chromatographic Interference: Examine whether extracted material causes peaks that overlap or otherwise affect the analyte measurement.
- UV-Vis Interference: Evaluate absorbance contributed by solvent, swab extractables, or other sample components.
- Swab Recovery: Determine recovery of the target residue from representative equipment materials.
- Extraction Recovery: Evaluate how effectively the selected solvent releases collected residue from the swab head.
- Method Precision: Assess repeatability of the complete collection and measurement process.
- Sample Stability: Confirm the analyte remains suitable for measurement during defined handling and storage.
- Detection and Quantitation: Establish method sensitivity at concentrations relevant to the cleaning acceptance limit.
Validation Principle: Product suitability is method-dependent. A TX718 swab that performs acceptably with one solvent and analyte may require additional testing with another solvent, compound, detector wavelength, or chromatographic method. Evaluate actual blanks and spiked recovery samples before relying on the sampling system for routine cleaning verification.
Vial, Septum and Sample-Handling Guidance:
The TX3360 collection vials use prewashed borosilicate glass, bonded septa caps, and polyethylene protective overcaps. Correct handling helps reduce the likelihood of contamination, sample loss, and unintended variation during laboratory preparation.
- Prewashed Glass: Use the manufacturer-supplied vials in accordance with the laboratory's approved material specifications.
- 40 mL Capacity: Follow the method's required extraction volume rather than filling to maximum capacity.
- Bonded Septum: The one-piece cap-and-septum design supports appropriate handling and laboratory extraction operations.
- Protective Overcap: Keep the septum protected until the approved access step.
- Solvent Compatibility: Assess the extraction solvent against the glass vial, septum, and closure materials.
- Volatile Solvents: Control evaporation and sample stability using the validated method.
- Sample Integrity: Inspect closures for leakage, damage, or improper seating.
- Container Labeling: Apply a unique sample identifier before transport.
- Laboratory Receipt: Record the condition and receipt time of the samples.
- Extraction Procedure: Use the prescribed agitation, contact time, and sample preparation technique.
- Safety: Follow the extraction solvent SDS and applicable flammable-liquid handling requirements.
Traceability and Chain of Custody:
TX3360 includes 12 blank vial labels per kit. A complete sample record should link each collection vial to the equipment, cleaning event, collection method, sampling materials, and resulting analytical data.
- Sample Identification: Assign a unique vial identifier.
- Equipment: Record the manufacturing equipment or process line.
- Sampling Location: Identify the exact site and surface area.
- Cleaning Event: Connect the sample with its relevant batch or cleaning cycle.
- Sampling Date and Time: Record collection details.
- Sampler: Identify the operator who collected the sample.
- Kit Lot: Retain TX3360 manufacturer lot information.
- Sampling Procedure: Record the applicable SOP and revision.
- Extraction Solvent: Identify the solvent or solution specified by the method.
- Sample Type: Distinguish routine samples, field blanks, method blanks, and recovery controls.
- Transport: Document the required chain of custody and holding conditions.
- Laboratory Receipt: Record receipt and condition of the collection vial.
- Analysis: Associate the sample with the method, instrument sequence, and reported result.
- Data Review: Retain applicable calculations, acceptance assessments, and deviation records.
Documentation Guidance: The vial label is one part of the sampling record. The complete chain of custody should preserve the connection among the equipment surface, cleaning event, TX3360 lot, collection operator, sample preparation, laboratory method, and final analytical result.
TX3360 vs. Texwipe TOC Cleaning Validation Kits:
Texwipe offers different kit configurations to support HPLC-based and TOC-based cleaning validation. The kits share an organized sampling concept but include different swabs and packaging quantities.
| Manufacturer SKU |
Primary Kit Type |
Swab |
Vials/Kit |
Swabs/Kit |
Kits/Case |
| TX3360 |
HPLC / UV-Vis |
TX718 |
12 |
30 |
18 |
| TX3340 |
TOC |
TX714K |
12 |
24 |
18 |
| TX3342 |
TOC bulk |
TX714K |
72 |
144 |
1 |
| TX3343 |
TOC long-reach |
TX761K |
12 |
24 |
18 |
- Choose TX3360: For a qualified HPLC, UV-Vis, or other applicable residue-specific analytical method using TX718.
- Choose TX3340: For TOC methods requiring the shorter, wider TX714K low-TOC swab in a 12-vial kit.
- Choose TX3342: For larger TOC sampling campaigns using 72 collection vials and TX714K low-TOC swabs.
- Choose TX3343: For TOC sampling requiring the longer, narrower TX761K low-TOC swab.
- Evaluate Substitutions: Changes to swab material or geometry can affect analyte recovery and analytical interference.
- Confirm Purchasing Units: Manufacturer kit and case quantities differ among configurations.
Kit Selection Guidance: TX3360 includes TX718 Alpha® polyester sampling swabs and is intended for HPLC and related cleaning validation workflows. TX3340, TX3342, and TX3343 include certified low-TOC swabs. Choose the analytical approach and sampling kit based on the actual residue, method sensitivity, sampling geometry, required recovery, and facility-approved validation procedure.
Sampling Solvent and Chemical Compatibility:
TX718 is intended for suitable solvent-based surface sampling. The selected extraction solution must be evaluated for analytical performance, swab compatibility, residue recovery, and safe handling.
- Solvent Selection: Choose the solvent specified in the validated analytical method.
- Residue Solubility: Evaluate the target compound's recovery into the sampling and extraction solution.
- Swab Compatibility: Confirm that the solvent does not degrade or interfere with the polyester head or polypropylene handle.
- Vial Closure Compatibility: Evaluate the solvent against the bonded septum and cap materials.
- Background Interference: Test the solvent and extracted sampling materials for chromatographic peaks or UV absorbance that could affect measurement.
- Evaporation: Control solvent loss where volatile materials are used.
- Extraction Conditions: Follow validated contact time, agitation, temperature, and dilution requirements.
- Safety: Use the appropriate personal protective equipment and controls identified in the solvent SDS.
- Sample Stability: Verify that the analyte remains stable in the selected vial and solvent for the required holding period.
Packaging and Storage Recommendations:
- Manufacturer SKU: TX3360
- Individual Kit: 12 vials, 30 TX718 swabs, 12 labels
- Manufacturer Case: 18 complete kits
- Total Case Contents: 216 vials, 540 TX718 swabs, 216 labels
- Kit Container: Cleanroom-compatible polypropylene box
- External Packaging: Double bagged
- Product Traceability: Manufacturer lot identification
- Supplied Condition: Non-sterile
- Published Shelf Life: 5 years from manufacture
- Storage Temperature: 15-30°C (59-86°F)
- Storage Environment: Clean, protected ambient conditions
- Vial Handling: Protect collection vessels and septa from uncontrolled contact
- Swab Handling: Keep unused sampling heads protected until collection
- Opened Kits: Follow the facility's approved clean material-storage procedures
- Sample Transportation: Use validated holding times and temperature requirements
- Disposal: Follow applicable chemical, glass, and laboratory waste procedures
Manufacturer Technical Documents:
Texwipe TX3360 Manufacturer Product Information: Click Here
Texwipe TX3360 HPLC Cleaning Validation Kit Technical Data Sheet - US-TDS-066 Rev. 11/25 (PDF): Click Here
Texwipe Cleaning Validation Kits and Swab Selection: Click Here
SOSCleanroom TX3360 Product Information: Click Here
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Notes: Need assistance selecting an HPLC cleaning validation kit, comparing TX718 with low-TOC sampling swabs, or establishing a controlled sample-collection workflow? Open the SOSCleanroom Technical Vault tab above for additional information about HPLC versus TOC testing, sample blanks, swab recovery, extraction solvents, analytical interferences, sample identification, and traceability.
SOSCleanroom.com supports pharmaceutical, biotechnology, medical device, laboratory, and other critical environments with Texwipe sampling swabs, HPLC and TOC cleaning validation kits, 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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