Cleaning Validation Swab Sampling Procedure

Swab Requirements• Minimal

background interference

• High recovery rate• Low particle

generation

Typical Swab Sampling Locations• Irregular Surfaces• Hard-to-reach areas• Presence of product/

cleaning residue• Heated surfaces• Porous surfaces

Example of Contaminant Release from TX714K Clean swab (5x magnification)

Swab after use (5x magnification)

Swab after contaminant release (5x magnification)

Comparative TOC AnalysisTOC Test Results

TOC

(µg/

L)

160

120

80

40

0Standard Polyester

Swab

TX714K Low TOC

Swab

Manually Cleaned Polyester

Swab

140

70

15

HPLC/UV-Vis AnalysisUV Spectrometer Comparison

Abso

rben

ce

TX715 Standard Polyester Swab

0.2

0.18

0.16

0.14

0.12

0.1

0.08

0.06

0.04

0.02

0

Wavelength (nm)210 215 220 225 230 235 240 245 250 255 260

Proprietary cleaning process to remove interference in the 230 nm range

Preparation

1. Select appropriate swab (see below Swab Selection Guide)

2. Define area/region to be tested

3. Do not touch the swab handle below the notch line.

4. Dampen swab with diluent

1. Snap swab head at the notch along edge of swab handle

2. Allow swab head to fall into vial

3. Replace the cap, label the sample and transfer for TOC or HPLC analysis

STEP 1. Begin sampling by swabbing the surface using horizontal, unidirectional, parallel strokes

STEP 2. Flip the swab over and swab in a perpendicular direction using the same technique

STEPS 3 & 4. Repeat procedure with second swab at 45° angles. Flip the swab over for Step 4

STEP 5. Swab the perimeter with the swab tip

Sampling TransferStep 1 Swab 1 / Side 1

Step 3 Swab 2 / Side 1

Step 4 Swab 2 / Side 2

Step 5 Swab 2 / Tip

45 degrees45 degrees

Step 2 Swab 1 / Side 2

NOTE: Swab using the entire head flat against testing surface.

Cleaning Validation Series Swabs

Low TOC Alpha® Swab – cleaned to a level of <50 µg/L TOC. This minute level makes this swab the ideal tool for use in Cleaning Validation of equipment used in the manufacture of APIs, excipients and drugs.

Alpha® Sampling Swab – Polyester swab for HPLC sampling in cleaning validation

Large Absorbond® Sampling Swab –Ideal tool for use in Cleaning Validation of equipment used in the manufacture of APIs, excipients, drugs, and biotech products

TX3343 12 vials + 24 TX761K swabs/kitfor 12 sampling areas

TX3340 12 vials + 24 TX714K swabs/kit for 12 sampling areas

TX3342 72 vials + 144 TX714K swabs/kit for 72 sampling areas

Low TOC Alpha® Swab with long handle

• Packaged in cleanroom-compatible polypropylene boxes• Contain all the components necessary to sample different areas• Provide for efficient transport from production to laboratory with minimal chance

of contamination.

TX714K TX761K TX715 TX716

Swab Selection GuideTOC Cleaning Validation Kits

Americas +1 336 996 7046 | EMEA +31 88 1307 410 | Philippines +63 49 843 0241 | China +39 2884 0510 www.texwipe.com TE

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