Prerequisites for process safety in surface disinfection

Image 1: Cleanroom-compatible and autoclavable special rollers

Image 2: Processing according to the recommendations of the European Hygienic Engineering & Design Group (EHEDG)

Image 3: EasyMop© GMP System Box with its components

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Image 4: Mop covers King GMP and MicroSicuro CR/A. Both have been tested for their suitability in cleanrooms and carry the "Tested Device" certificate related to their intended use.

Image 5: System Cart Clino CR 9 GMP

Avoidance of Misoperation

Even if ceilings, walls, and floors are not in direct contact with the product, cleaning and disinfecting these surfaces is an important measure to restore and maintain the desired cleanliness in production areas and thus ensure product safety. Since cleaning and disinfecting larger surfaces in the cleanroom are usually performed manually, simple and systematic procedures are necessary to achieve the desired process validation. The less possible misoperation, the more reproducible and safer the process implementation. Below, an example of a simple, validated, and cleanroom-specific implementation of wipe disinfection for GMP areas is presented and described.

Equipment Requirements

In addition to GMP compliance in design, processing, and material selection, and the general requirement that equipment for cleaning and disinfection must not be a source of particles and microorganisms, user safety through simple procedures and ergonomics shapes the system cart. All components of the system cart are autoclavable and therefore suitable for use in sterile areas. The suitability for cleanroom use and GMP compliance are confirmed by the test seal "Tested Device" from the Fraunhofer Institute for Production Technology and Automation (IPA) Stuttgart (Image 1, Image 2).

Intrinsic User Safety of the System

The pre-preparation is a closed system and offers greater process safety than open systems. This is demonstrated, among other things, by the secure avoidance of misoperations such as mop reuse. Unlike systems with press or humidifier units, which can vary by up to 100% depending on operation, a validated wetting of surfaces for effective disinfection and reduction of residues is achieved by applying only the necessary amount of liquid.

The wetting of the mop cover in the EasyMop® GMP System Box occurs independently of the operator. Defined stand, storage, and removal times ensure the wipe is evenly saturated. The uniform distribution of the liquid over the entire width of the wipe is supported by the MopJump® system, a specially shaped sheet made of pharmaceutical stainless steel, which is perforated and manufactured to the same width as a wipe. The special shape of the MopJump® system matches the form of the open mop holder, making it easier to remove the wipe additionally. In a bachelor’s thesis from the Hochschule für Technik und Wirtschaft Albstadt-Sigmaringen, which has since been awarded the best work of the year at the CMS in Berlin by the Association for Cleaning Technology, the necessary stand, storage, and removal times, as well as liquid quantities for uniform saturation, were determined and documented in an operating instruction. These parameters enable a reproducible and validated wipe disinfection process.

EasyMop® GMP System Box

The EasyMop® GMP System Box is the centerpiece of this process. In addition to its special design for pre-preparation, the autoclavability of the system box and the use of materials certified for use in cleanrooms, such as for the triple seal to securely close the box, are of great importance. The GMP compliance is confirmed by the "Tested Device" test seal from the Fraunhofer Institute for Production Technology and Automation (IPA) Stuttgart.

The EasyMop GMP system box can also be used as a stand-alone solution, so that in small cleanrooms, no cleaning cart needs to be accommodated. All necessary process steps can also be performed solely with the system box, and the space requirement for cleaning equipment is minimized. (Image 3)

Requirements for Wipe Textiles

For pre-preparation, wipe textiles made of microfiber that have a defined liquid absorption behavior are suitable. Cleanroom wipes must also be suitable for their intended use in the cleanroom and tested for GMP compliance. Since the wipe serves as a carrier for active substances, disinfectants and wipe textiles must be compatible. This means that, in addition to material compatibility, the interaction between textiles and chemicals must be considered. Only the actual release of active substances onto the surface and sufficient wetting lead to the desired disinfection result. (Image 4)

Touchless Operation: Mop-drop®

The Mop-drop® — an almost automatic opening mechanism for the mop holder — enables touchless opening of the mop holder. It is mounted directly above the disposal bag, so that the used wipe falls directly into the disposal bag without further contact. Contamination from the used wipe is thus excluded, and further transport can be carried out without additional contact in the closed bag.

Introduction into Sterile Areas

To meet the requirements of Annex 1 of the EU-GMP guidelines, which stipulate that all items needed in the A/B cleanliness classes must be sterilized before entry, not only the system carts and system boxes but also the wipes necessary for the wiping process must be sterilized. Here, another advantage of the EasyMop® GMP System Box becomes evident, as it can be used for the sterilization of wipes due to its special construction. The special design of the locking mechanism allows the wipes to be autoclaved directly in the system box.

Safe Workflow at the System Cart

Working with the system cart is ergonomic and follows a clear procedure. In front are the EasyMop® GMP System Boxes in the specified number. The amount of wipes and system boxes is calculated in advance. The front system box is opened, and the lid is hung on the side. The mop holder is released from the holder, opened contactlessly via the Mop-drop®, and the first wipe is removed. After wiping, the mop holder is reopened via the Mop-drop® above the disposal bag, and the moist mop falls into the bag by its own weight. A new wipe is then removed using the open mop holder. (Image 5)

Conclusion

Humans and manual processes are difficult to validate. However, logically structured and easy-to-learn workflows reliably prevent errors such as insufficient surface wetting or re-dipping of the wipe. Ergonomically designed equipment with simple operation increases motivation and thus the willingness of staff to work thoroughly and safely.
A system that is inherently protected against accidental misoperation through its design and reliably reproducible offers a significant safety advantage.

Thus, despite the human factor, effective cleaning and disinfection of large surfaces can be achieved while considering regulatory requirements.

References

Available upon request.