Cleaning validation is an important process in pharmaceutical manufacturing as it ensures that maximum allowable carryover (MACO) or cross-contamination limits between batches are not compromised.
Therefore, cleaning validation is critical to patient safety. A common procedure for cleaning validation is the Total Organic Carbon (TOC) swab method, which wipes clean surfaces of the equipment. After that, the TOC of the swab stick was analyzed using a TOC analyzer.
Yousite cleaning and verification detachable sampling swab TOC. The sampling head and the sampling rod can be separated, and they are serially connected together.
Cleaning validation is a well-documented process that demonstrates that the cleaning of manufacturing equipment in the pharmaceutical industry is effective and consistent. 70% of the pharmaceutical companies in the country will use the TOC cleaning and verification wiping sampling cotton swabs to inspect and clean the inner and outer surfaces and dead corners of the equipment, remove the surface burrs, and make sure that the shaft can see the light, the groove can see the bottom, and the equipment can see the true colour.
No oil stains, no debris, no standing water, no dirt, the inner and outer surfaces of the equipment are clean, and the equipment and components are inspected visually.
TOC Cleaning Validation Sampling Stick
While TOC analysis itself is a reliable method, sampling has flaws.
These factors are changes due to:
1) analyst variability in recovery and area;
2) Wipe position;
3) Surface finish;
and 4) drug concentration.
Features of Cleaning Verification Swabs:
The wiper sticks produced by Yousite’s unique process are extremely clean.
No adhesive, good acid and solvent resistance.
Its sealed edges produce no loose fibres or particles, and the seams are strong and resistant to splitting, making them ideal for rubbing around protruding objects.
A Class 10 (ISO Class 4) cleanroom process guarantees ultra-low ionic and non-volatile residual content of the wiper bar, as well as ultra-low particle generation.
Note: When using the cleaning swab, be careful not to touch the sampling head or other objects other than the sampling sample, so as to clean and verify that the swab is contaminated.
How to use the cleaning verification swab
①Tear off the sealing paper on the packaging tape of the sampling cotton swab, and gently take out the sampling swab from the bag. Be careful not to touch the sampling head or other objects other than the sampling sample to avoid contamination.
③The application area is generally 25cm2-100 cm2, 3-6 squares in size.
④Dry naturally or gently with a hair dryer.
⑤Moisten a wiping swab with the selected wiping solvent, and place the swab on the surface to be sampled. And wipe the entire sample surface. The direction and pressure of wiping are defined in the Cleaning Standard Operating Procedure (SOP).
⑥This sampled swab is then extracted. Put a cleaning swab into a vial containing an acidic solution, then perform sonication or centrifugation. Finally, analyze the TOC concentration of the acidic solution. The swab extract can also be analyzed by placing the swab in a sealed glass ampoule containing 5% phosphoric acid and 100 g/L sodium persulfate solution. Carbon dioxide in the form of inorganic carbon is purged into the environment, and the glass bottle is then sealed. The glass bottle was heated to 100°C and stored for the specified time. Finally, the glass bottle is opened and TOC is blown out in the form of carbon dioxide and detected.
Uses pharmaceutical industry, biology, GMP, laboratory, quality inspection department, QA, special cleaning verification, equipment wiping cleaning,
Packing: 100 pcs/pack, 100 packs/carton and individually packaged, TOC wiper, individually packaged,
Place of Origin: Bao’an District, Shenzhen
Email（beck）：beck@yaostbio.com