Easy to use, practical and effective

Abbildung 1 / Figure 1

Abbildung 2 / Figure 2

Abbildung 3 / Figure 3

Cleaning and disinfecting smaller sterile productions, such as chemists, has special challenges for process planning and employees alike. Innovative cleaning equipment such as the EasyMop© GMP system can provide advantages here in terms of application safety, efficiency and cost effectiveness during the cleaning and disinfecting process. Small clean room productions can comply with regulatory guidelines in their cleaning processes with certainty and make the work processes easier due to smart equipment.   

Easy and practical solutions for GMP-compliant cleaning and disinfecting are needed above all in smaller sterile areas, such as chemists. Many such statutory regulations are easy to implement for pharmaceutical operations with a high degree of automation and specialising in one or just a few pharmaceutical products. For smaller sterile rooms with a high level of manual work and constant change in the work flows, however, it is a big challenge. The measure which initially appears easiest, that of cleaning and disinfecting the room surfaces, is no exception here. The pre-prepped EasyMop© GMP is an innovative solution which gives users the possibility to meet GMP in a practical way whilst providing valid safety in the process.

GMP-conform

Any materials and equipment used in sterile GMP rooms must not themselves be a source of particles or micro-organisms. In addition, they must be sterile–or sterilisable–, easy to clean and resilient to the usual cleaning agents and disinfectants. In summary, the entire mopping system must correspond to the current cleanness requirements, may not have a negative influence on the manufacturing process and the products produced and must provide high effectiveness and process safety in relation to the activity in question. As with all processes, the cleaning and disinfecting measures must be validated and the properties assigned to the operating means must be verified as being present. All components in the EasyMop© GMP system are correspondingly rated and inspected.

Requirements of small rooms

In addition to complying with regulations, smaller clean rooms operators are confronted with very different, important issues such as space and logistics. The most optimal mopping systems are those which require little space and are easy to use but still are highly efficient and high-performing without being logistically too complex. The pre-prepped EasyMop© GMP has achieved an advance here with its mop covers that can be prepared ahead of time for the work week in the EasyMop© GMP System box, and then the equipment can be left sitting at the ready in the sterile area. This avoids the time-consuming daily loading. And, all of the advantages of the EasyMop© GMP method can also be applied to small sterile rooms.  

Disposable or multiple-use mop covers – a question of application

The main application purpose of a mop cover is to clean away contamination and/or to apply disinfectants. In addition to the suitability of a mop cover for use in a sterile clean room, the suitability of the mop cover for planned activities in this area is very important. For efficient cleaning and disinfection, impregnating the mop cover evenly and sufficiently as well as sufficiently spraying the surface with the fluid and thereby also applying the active substances is a prerequisite. Whilst multi-use mop covers have a significantly higher surface performance and efficiency in cleaning and disinfecting, in many areas where critical substances such as cytostatic or biological agents are used, disposable mop covers are preferred due to safety concerns. In contrast to the floor mop cloths, the use of disposable mop covers takes place without contact. In addition, they demonstrate better surface performance and more efficacy. To meet the varying requirements, different types of mop covers are offered for the pre-prepped EasyMop© GMP, depending on the application area, all of which are compatible with the system.

Executing the pre-preparation

The validation of the advanced preparation is determined by the use of defined parameters, such as the amount of time the system boxes are left sitting and the storage time of the system boxes, in order to achieve an optimal spraying of all mop covers. This means that the method takes place according to predefined work guidelines (see figure 1).

The system box is initially filled with a defined volume of application solution and then fitted with the pre-calculated number of mop covers (maximum of 10). After filling the system box, it is tightly sealed by closing the special fasteners. The triple sealing of the cover guarantees that the system box is securely closed and that the microbiological safety is maintained [2, 3] which is decisive for the storage of the impregnated mop covers over the work week. After sealing the system box, it is rotated. The system box remains in this position until the mop covers are removed. If mop covers remain in the system box, it is again rotated on its head and stored this way until another cover is removed. After opening the system box, the pre-impregnated mop cover is removed without contact and the intended surface mopped. As soon as the spraying is no longer even and mopping streaks can be seen, the mop cover must be changed. Because of the system, it is no longer possible to re-dip or reuse the now "empty" mop cover. This prevents cross-contamination with certainty.

Leaving pre-preparation sitting over a work week: Immanent contamination risk in the system?

The pre-preparation of multiple mop covers in a closed system and leaving the entire system parked in the clean room is a particular advantage of the innovative EasyMop GMP© System box. It avoids important sources of error – but only if this process does not itself result in a microbiological contamination or a dilution of the efficacy of the disinfectant. basan, the clean room division of VWR International GmbH, initiated a cooperative study [3] with the Diversey and Pfennig Reinigungstechnik GmbH companies to test if this was the case. The aim of this study was to prove that by using the new EasyMop© GMP System box, no additional risk of contamination occurs. In addition, it was to demonstrate that allowing it to sit for an additional length of time has no effect on the disinfecting action of the solution used and that the active ingredient remains sufficiently active to prevent the growth of microbes in the solution as before. Ten sterile mop covers were placed according to the procedural guidelines into the EasyMop© GMP box and impregnated with 4 litres of sterile disinfectant (ClearKlens Tego 2000 RTU). From Tuesday until Monday (extending the time left sitting to seven days), two mop covers were removed and wrung out daily. The amount of amphotensides in the wring-water was exactly traced and the total bacterial count determined microbiologically. Each mop cover was wrung out individually using a funnel in a re-closable glass jar. The concentration of disinfectant in the wring-water was determined for each glass jar content. Another millilitre of wring-water was swiped onto a sterile disposable petri dish prepared with CASO agar and left to grow for 48 hours (see figure 2).

The evaluation of the nutrient medium over the entire study period showed that no culture grew on the agar that had been swiped with wring-water (see figure 3). The study demonstrates convincingly that the EasyMop© GMP System box is a safe system, entailing no system-immanent risks for microbiological contamination.

Conclusion

EasyMop© GMP provides a system that not only meets all guidelines of relevant regulations but also offers a safe and efficient solution for operators of smaller sterile clean rooms, such as chemists. The well-conceived equipment offers advantages in process safety by being an integrated system that can be autoclaved and parked in the clean room, where it is demonstrably safe to be left sitting over the work week. The logistical construction of the system also offers far-reaching benefits for operator safety – an important aspect for smaller sterile productions where manual processes are sensitive to errors. The working processes are easy to learn, which avoids mistakes such as insufficiently applying or releasing the active disinfectant, or unsanitary work caused by re-dipping. By using this qualified and flexible system in combination with highly effective cleaning agents and disinfectants you will be able to meet the constantly increasing requirements for sterile clean rooms.

Literature

[1] Punscher Daniela: Überprüfung der Normenkonformität und der praktischen Funktionalität des Reinraumreinigungssystems EasyMop GMP der Pfennig Reinigungstechnik GmbH; Bachelor thesis, Albstadt-Sigmaringen University, Sigmaringen, unpublished; October 2011.
[2] Witt-Mäckel, Margarete: Autoklavieren der Moppbezüge in der EasyMop© GMP Systembox; unpublished research report by Pfennig Reinigungstechnik GmbH; July 2012.
[3] Reinigung und Desinfektion von großen und kleinen Flächen: basan initiiert Kooperationsstudie zum Nachweis der mikrobiologischen Prozesssicherheit.  Research report by VWR International GmbH in collaboration with the companies of Pfennig Reinigungstechnik and Diversey. www.basan.de