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MT-Messtechnik C-Tec Vaisala Systec & Solutions GmbH



  • Translated with AI
Author
Gisela Rasche

Counterstatement regarding a statement in the article "Specialist for Cleanroom Hygiene Optimization"

In the Cleanroom Online Newsletter, Issue DE 02/2016, an article "Specialist for the Optimization of Cleanroom Hygiene" by Hydroflex, Gladenbach, was published:

Excerpt:

… “Special attention is also paid to the development of single-use mop systems for maximum safety and efficiency in cleaning and disinfection. Increasingly, applications require seamless traceability and documentation, and those responsible avoid risks such as dirt residues or material deterioration due to wear and tear when reusing used (multi-use) mops. …”

We would like to contradict this statement.

If multi-use mops are decontaminated in specialized cleanroom laundries and sterilized if necessary (for sterile pharmaceutical cleanrooms, GMP Class A/B), they can be used for cleaning without concern.

Especially in cleanrooms, seamless process documentation and proof of compliance with high-quality standards are extremely important. The procedures used meet the highest international standards.

Each mop is equipped with a barcode and/or chip. This ensures clear assignment and traceability of each individual item at all times.

Upon receipt, the delivered mops are scanned. This allows, for example, precise tracking of their usage duration or the number of washes. During sorting, the mops are carefully checked for damage and foreign objects.

Any mop that needs repair is scanned to record the number and causes of repairs as part of the item's history. If it is found that the maximum usage duration has been reached or the mop shows irreparable wear, it is replaced.

Subsequently, the mops are cleaned and disinfected at clearly defined temperatures over a specified period. Dirt residues are removed. During the washing process, microorganisms on the mops are reduced by six log steps.

Additionally, random samples of wash loads are tested for germs and particles (Helmke Drum Test Method - IEST-RP-CC003.4) to demonstrate that as few residual particles and germs as possible remain on the cleaned mops. Samples are placed in a rotating drum after drying. Particles released by the rotation are detected and counted using a particle measuring device.

At the same time, the entire wash load is checked at the end of the drying process in the dryer with a special sensor for residual particles. If the analysis shows that the maximum permissible particle count is exceeded, an intelligent control electronics restarts the dryer. All process parameters are precisely and traceably documented.

The mops are folded in cleanrooms of ISO Classes 5 or 7. Ultimately, all parts are hermetically packaged for contamination protection, sterilized by agreement, and prepared for delivery.

It should be noted that the use of multi-use mops offers maximum safety when they are decontaminated and sterilized in specialized cleanroom laundries if necessary.


Initial Textil Service GmbH & Co. KG
50739 Köln
Germany


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