More than just a box

More than just a box

Actually, it sounds very simple: take a stainless steel box, place several mop covers into the box, moisten them with a liquid, e.g., a disinfectant solution, and then remove this pre-moistened mop with the help of a mop holder from the box and now mop the floor. But is this so easy to do in production areas where validated processes and the highest safety in preventing contamination through effective cleaning and disinfection are required? How can one be sure that the pre-moistened mop cover delivers an adequate amount of active substances to the surface to achieve thorough cleaning and the desired disinfection? How is compliance with the EU-GMP guideline, Annex 1, maintained, which states that all items and consumables used in the manufacture of sterile medicinal products must be sterilized before use?

EasyMop GMP©

This is a pre-preparation method in which the mop cover is moistened in a defined process [Image 1]. The validated and reproducible wetting of the mop cover is ensured by a system box developed for this process, which allows, due to its design and components, complete soaking of the mop cover with liquid through a defined rotation of the box. This statement is confirmed by a bachelor thesis conducted at the University of Applied Sciences for Technology and Economics Albstadt-Sigmaringen [1].

EasyMop© GMP System Box

The EasyMop© GMP system box, as already described, is the centerpiece of the EasyMop GMP© pre-preparation method [Image 2]. In addition to the application of pre-preparation, the autoclave compatibility of the system box and the use of materials certified for use in cleanrooms, e.g., the triple seal for securely closing the box, are of great importance. The GMP compliance is confirmed by the test seal "Tested Device" from the Fraunhofer Institute for Production Technology and Automation (IPA) Stuttgart [2].

To meet the requirement of Annex 1 of the EU-GMP guideline, which states that all items needed in the cleanroom must be sterilized before use, not only must the system box itself be sterilized and introduced into the cleanroom, but also the mop covers necessary for wiping. Here, another advantage of the EasyMop© GMP system box becomes apparent, as it can be used to insert the mop cover due to its special design. The special design of the locking mechanism allows autoclaving of the mop cover directly in the system box. The lid is closed on one side, and through the special closure, the lid opens on the opposite side [Image 3]. This opening is sufficient for steam to penetrate thoroughly into the entire system box.

Process

The mop covers, in the required quantity, up to a maximum of 10 pieces, are placed flat into the box via the MopJump© system before autoclaving. Although the mop covers are autoclaved lying down, contrary to general recommendations, a study has shown that complete sterilization of all mop covers in the box can still be achieved [3]. After filling the system box with the mop covers, the lid is closed on one side as described. After autoclaving, the system box is fully closed once cooled and can be easily continued in use. The triple seal of the lid guarantees the secure closure of the system box and thus maintains sterility. The addition of sterile cleaning or disinfectant solution is done without removing the mop covers by filling through a special funnel. Subsequently, the pre-preparation of the mop covers takes place.

Conclusion

Simple and practical solutions are always sought, especially for work in sterile areas, but these must be validated and safe for pharmaceutical operations. Additionally, it must be ensured that the tools are sterilized before use and that the materials themselves do not pose sources of contamination. With the EasyMop© GMP method, a new system has been developed that not only meets legal requirements but also provides users with a practical implementation and daily operational safety [4].

References
[1] Punscher Daniela: Verification of compliance with standards and practical functionality of the cleanroom cleaning system EasyMop GMP of Pfennig Reinigungstechnik GmbH; Bachelor thesis, Hochschule Albstadt-Sigmaringen, Sigmaringen, unpublished; October 2011
[2] Pfennig, Dietmar: Development and certification of a validated cleaning and disinfection system for cleanrooms; cleanroom printline 01/2012, pp. 30 – 32, online at cleanroom; January 2012
[3] Witt-Mäckel, Margarete: Autoclaving of the mop cover in the EasyMop© GMP system box, unpublished investigation report of Pfennig Reinigungstechnik GmbH; July 2012
[4] Witt-Mäckel, Margarete: Wipe disinfection with a cloth; Reinraumtechnik 02/2012, pp. 18 – 19, git Verlag; April 2012