16th VolumeSeptember 2014

4

Title story A Focus on Cleanrooms Willy Viethen

Industry focal point Pharmaceutical

Master cleanroom monitoring using multi-sensor technology Annette. v. Kieckebusch-Gück

Safety in the use of consumables Frank Bürger, Dr.Ing. Udo Gommel, Mathias Brückner, Sven Käfer

STERILE TECHNOLOGY | HYGIENE | PRODUCTION

ing an disinfection processes. In summary, all components of the entire wiping system must be in line with the respective cleaning require-ments, must not negatively influence the manu-facturing process and the manufactured prod-ucts, and – in terms of the respective task – it must have a high degree of effectiveness and process reliability. As is the case with all pro-cesses, the cleaning and disinfection measures must be validated and the assigned properties of the operating agents must be detectable. All EasyMop GMP system components have been correspondingly evaluated and tested.

Requirements of small spaces

Aside from the conformity with the standards, the operators of small cleanrooms must deal with entirely different challenges, such as space and logistics. Therefore, the place-saving and easy to use wiping systems are a perfect fit; they have a high degree of efficiency and per-formance, but do not create a major logistical effort. With the EasyMop GMP impregnation, a further development has been successful with which mop covers can be prepared in the Easy-Mop GMP system box for the requirements of a work week and the equipment can be stored in

Simple and effective cleaningInnovative and practical solution for small sterile cleanroom areas

The cleaning and disinfecting of small

sterile production areas, such as in phar-

macies, is a special challenge for both

the process planning and the employees.

Innovative cleaning equipment – such as

the EasyMop GMP system – offers advan-

tages in terms of user safety, efficiency

and cost-effectiveness in the cleaning and

disinfection process. Through the use of

intelligent equipment, small cleanroom

production areas can safely fulfil the

cleaning process requirements and

simplify the work processes.

For the cleaning and disinfection of smaller sterile areas, such as in pharmacies, simple and practical solutions for the implementation in accordance with GMP requirements are sought. This is due to the numerous requirements from pertinent policies, which are easy to implement for pharmaceutical operations with a high level of automation and specialisation on one or just a few pharmaceuticals. For smaller areas un-der sterile conditions that have a high level of manual activity and constantly changing manu-facturing processes, this is very challenging. The cleaning and disinfection measures of the room areas that initially appear straightforward is no exception. For this reason, the impregnation of the EasyMop GMP offers an innovative solu-tion that does not only enable the user with a GMP-conform and practical implementation, but also offers them valid safety in the cleaning process.

GMP conformity

All materials and equipment that are used in sterile GMP areas must themselves not be a source for particle and micro-organisms. They must also be sterile or sterilisable, easy to clean and durable in terms of the established clean-

the area under sterile conditions for the entire week. In this fashion, a complicated daily trans-ferring process is avoided and all advantages of the EasyMop GMP process can also be used in smaller sterile rooms and areas.

Single-use or multi-use mop covers – a question of application

The main area of use of a mop cover is the cleaning process of contaminations and/or the

EasyMop GMPThis is the impregnation method in which the mop covers are impregnated using a defined process. The valid and reproduc-ible wetting of the mop covers is ensured through a system box newly developed for this process. The system box – because of its structure and its components – enables a thorough impregnation of the mop cov-ers with liquid through defined turning of the system box. This statement was con-firmed by a Bachelor's Thesis conducted at the University of Applied Sciences in Alb-stadt-Sigmaringen [1].

lid's triple seal does not only guarantee the safe closure of the system box, but also the retention of the microbiological safety (2,3) that is impor-tant for the storage of the impregnated mop covers during the time frame of one work week. After closing, the system box is turned. The sys-tem box remains in this position until the remov-al of the mop covers. If any mop covers remain inside the system box, then this is again turned upside-down and stored until mop covers are again taken out. After the system box has been opened, the impregnated mop covers can be removed in a contactless manner and a defined surface can be wiped. As soon as the wetting is no longer uniform and the traces of wiping become recognisable, the mop cover must be changed. The system prohibits a reinsertion or re-use of the now "empty" mop cover. Therefore, a cross-contamination can safely be avoided.

application of disinfection solution. Therefore, aside from the mop covers' suitability for use in a sterile cleanroom, it is also very important that the mop covers must also be suitable for the intended use in this area. The prerequisites for an efficient cleaning and disinfection are a consistent and sufficient impregnation of the mop covers as well as the sufficient wetting of the surface with liquid and therefore the release of agents. While multi-use mop covers have a significantly higher surface performance and efficiency in cleaning and disinfection, in many areas that have critical substances such as cy-tostatic drugs or biological agents; single-use mop covers are recommended and preferable due to safety reasons. As opposed to surface mop covers, the application of the single-use mop covers is contactless. In addition, these are characterised by better surface performance

and effectiveness. In order to cover the different requirements, several mop covers, which are all compatible with the system, are required for the impregnation EasyMop GMP.

Implementation of the impregnation

The validity of the impregnation is determined through prescribed parameters such as the downtimes and storage times of the system boxes in order to attain an optimal wetting of all mop covers. Therefore, the process is conducted through prescribed instructions (see Ill. 1, Pro-cess-reliable workflow).

The system box is initially filled with a de-fined amount of solution and then loaded with a pre-determined number of mop covers (maxi-mum 10 pieces). After filling, the system box is closed using a special closing mechanism. The

EasyMop GMP System Box

The EasyMop GMP System Box is the heart of the EasyMop GMP system. It was developedfor the impregnation method for which spe-cial mop covers are available. The system box itself consists of pharmaceutical stain-less steel and is entirely autoclavable. The three-layer sealing required for the impreg-nation and for the impermeability of the sys-tem box is made up of a special FDA-conform material that has an extremely high durability, even for frequent or even daily autoclaving.

The GMP conformity is confirmed by the "Tested Device" seal awarded by Fraunhofer Institute for Production Technology and Automation (IPA), Stuttgart (Germany). Depending on the room size and storage possibility, the EasyMop GMP System Box can be used by itself or in combi-nation with a system trolley that holds, for ex-ample, a sterile release bag. The use of a ster-ile release bag facilitates the unloading of the moist and, if applicable, the contaminated mop covers after use. The system trolley including the wheels is also made of GMP-conform materials and can be autoclaved daily, if required.

Ill. 1:Process-reliable workflow

Impregnation downtime over one work week: A system-inherent contamination risk?

The impregnation of several mop covers in a closed system and storing the entire system in the cleanroom is a special advantage of the innova-tive EasyMop GMP System Box. This eliminates an important source of errors – if the process in itself does not result in a microbiological contamination or if the effectiveness of the disinfectant subsides. basan, the cleanroom division of VWR Internation-al, initiated a cooperation study (3) with the firms Diversey and Pfennig Reinigungstechnik in order to verify these problems. It should be proved that no risk of new contamination occurs through the use of the EasyMop GMP System Box. Moreover, it should be shown that an increase in downtime does not have an impact on the disinfecting effect of the op-erational solution, and that the agent is sufficiently dosed in order to prevent the micro-organic growth in the solution. For this, 10 sterile mop covers were placed into the EasyMop GMP system box accord-ing to the working instructions and impregnated with 4 litres of sterile disinfection agent (ClearKlens Tego 2000 RTU). From Tuesday through Monday of the following week (increasing the downtime to 7 days), 2 mop covers each were removed and wrung out. In this wrung-out water, the content of amphotenside was precisely traceable and the total bacterial count micro-biologically determined. The mop covers were each wrung out into a resealable glass with the help of a funnel. In this wrung-out water, the concentration of disinfection agent was determined. Another millilitre of wrung-out water was plated to a sterile single-use petri dish with CASO-Agar and incubated for 48 hours.

Test results

The analysis of the culture media for the dura-tion of the tests led to the fact that no cultures grew in the plated wrung-out water. The study also convincingly showed that the EasyMop GMP System Box is a secure system that does not bear any system-inherent risks for micro-biological im-purities.

Conclusion

EasyMop GMP is a system that does not only ful-fil the requirements of the pertinent policies, but also the safe and efficient solution for operators of small sterile cleanrooms such as, for example, pharmacies. The well-conceived equipment of-fers advantages in the process reliability through which the entire system can be autoclaved and transferred into the cleanroom where it can be securely stored for an entire work week. Due to the logical structure of the system, in addition there are even more advantages in terms of user safety – an important aspect in the smaller ster-ile production areas in which manual processes are more susceptible to errors. Through the easily comprehensible workflows, errors such as insuf-ficient absorption or release of active substances or unhygienic working by re-immersing the mops can be safely avoided. Using this qualified and flexible system in combination with highly ef-fective cleaning and disinfection agents, you will always meet the increasing requirements in your sterile areas.

Literature[1] Punscher, Daniela: Validation of the

standard conformity and the practical functionality of the EasyMop GMP cleanroom cleaning system made by Pfennig Reinigungstechnik GmbH; Bachelor's thesis, University of Applied Sciences, Albstadt-Sigmaringen, Sigmarin-gen, unpublished; October 2011

[2] Witt-Mäckel, Margarete: Autoclaving the mop covers in the EasyMop© GMP System Box, unpublished inspection report of Pfennig Reinigungstechnik GmbH; July 2012.

[3] Cleaning and disinfection of large and small areas: basan initiates cooperation study for the detection of micro-biological process reliability. Inspection report from VWR International GmbH in cooperation with Pfennig Reinigungstechnik and Diversey.

KONTAKTbasan – the cleanroom division of VWRVWR International GmbH65451 KelsterbachPhone: +49 6107 9008 500info.basan@de.vwr.comwww.basan.com Technical customer service:Gonzague VallièreProduct Managementgonzague.valliere@fr.vwr.comPhone: +33 476 676 008

AUTHORMargarete Witt-Mäckel, Pfennig Reinigungstechnik GmbH

Ill. 3: The analysis of the culture media during the entire duration of the study period showed that no cultures grew on the culture medium with the plated wrung-out water.

Ill. 2: Course of active agent and total bacterial count for 7 days