The sanitation process varies depending on the industry, but Patricia Sitek from CR Konsulting talks about common ways to categorise areas in a facility from any sector, and some golden rules to follow for them
Control of micropollutants is a key aspect in the process of maintaining ISO and GMP cleanliness. Dust and microbiological contamination affects the maintenance of environmental parameters of cleanrooms, the personnel, materials and waste flow and, most importantly, contributes to the risk of cross-contamination and, consequently, the risk of contamination of the final product.
The sanitation process is multi-stage and varied depending on the industry to which it is applied. Cleaning will be different in rooms where automotive details or electronics are produced, versus the areas of pharmacy and medical device manufacturing. However, a set of parameters can be distinguished, identical for each of the areas requiring the sanitation process, which include:
Depending on the declared ISO class, we can also indicate questions/areas for discussion that will allow for an effective and optimised approach to the selection of the system. Considering the processes in terms of their criticality, we can divide the areas into main (production and auxiliary) and the so-called 'production-related' (preparatory rooms for passenger and material locks and service windows).
Why is the bucket method not always the best?
These areas require a sanitation validation process and regular control/monitoring of airborne contamination, surfaces and those transferred on the personnel.
In order to prepare well for choosing a proper washing system, you need to conduct a risk assessment and analyse a few key issues:
Auxiliary zones are essential in the process of maintaining the appropriate parameters of critical and production zones. Properly prepared SOP procedures and a properly developed sanitation schedule and cleaning programme make it possible to reduce the amount of pollution brought into the main rooms by up to 80%.
In the area of auxiliary rooms, additional considerations should be made related to:
Facilities can be divided into ‘main’ areas and so-called ‘production-related’ areasPersonal and material locks
The area of passenger and material locks carries the greatest risk of contamination transmission to the production area. Contamination is most often caused by a poorly handled process of changing protective clothing, the lack of hand washing and disinfection, as well as an excessively liberal approach to the subject of regular sanitation and disinfection of the mucus surfaces.
In order to properly implement the cleaning programme, in addition to the issues mentioned in the above content, you should take into account such aspects as:
The easiest way to restore the proper microbiological and particle cleanliness is to use the standard, traditional bucket method. The bucket method is a method that uses a system that usually consists of two or more buckets, into which clean water is introduced - without a washing-disinfectant - dedicated to rinsing mop pads, and water with a washing-disinfecting agent, used to soak the pad and distributing the fluid on a dedicated surface. The bucket method can use disposable or reusable pads, most often polyester or non-woven cellulose-polyester mops. This method is a two-stage process, that gives a great saving in the consumption of mop covers by rinsing them in clean water and allowing for the sanitisation of even very large areas of cleanroom at a time.
At the same time, the bucket method may generate some limitations when sanitising clean zones so it is not always the best to choose? This is mainly due to the following aspects:
The above examples confirm that the use of the bucket method in cleanrooms is not always possible and does not always have a positive effect on the sanitation process of the clean zone.
Areas can be divided into ‘main’ areas and so-called ‘production-related’ areas
Achieving the maximum level of pollution control, as well as appropriate ergonomics and cost savings, is only possible with good optimisation of the cleaning and disinfection process. Where the bucket method cannot be used, or where the user is anxious to bring the sanitation process down to one comprehensive step, the pre-treatment method is the best choice.
This method is based on the use of a cuvette system into which an appropriate, calculated number of mop covers is inserted. This amount is determined by dividing the total area of the room by 20, as one overlay can be used to sanitise 20 sqm of space (internal validation of the sanitation process must be performed). The overlays are placed in a cuvette and poured over with the appropriate amount of the washing-disinfecting agent working solution. Importantly, there is 200-250 ml of solution for one cap.
The most important advantages of the pre-washed system are:
Regardless of the method used to sanitise the controlled zone, the system must meet the requirements of maximum control of particle pollution and bio-pollutants, including determination of the ISO/GMP cleanliness class of the room, material and personnel load, identification of ESD zones, zones particularly exposed to microbiology, and staff numbers. All these elements will have an influence on the choice of system.
Additional components such as ergonomics and economic considerations will determine user preferences. It is important that the chosen method of cleaning brings the best results to maintain the environmental parameters of the rooms, and thus the safety of the product, materials and personnel.