CLEANING, HYGIENE & DISINFECTION
Choosing the right disinfectants for cleanrooms
and factors influencing their performance To maintain a high level of cleanliness, a sound cleaning and disinfection system needs to be established and controlled. This is key to manufacturing quality products, meeting regulatory requirements and ensuring patient safety. Sascha Rother of basan highlights basic considerations regarding disinfectant choices and provides guidance on the factors impacting the performance of cleaning operators.
T
he rule of thumb is that no disinfectant will tick all the boxes. The best approach is to pick the right disinfectant (or a combination thereof) for the right application and prevailing in-house flora. Some observations made in South Africa are that manufacturers of pharmaceutical and nutraceutical products will only use one disinfectant or two products with a similar chemical composition and basically the same kill range. In some instances, manufacturers will only apply a sporicidal product. According to EC GMP and ISO 13408.3 Part 11.1.8 rotating two different disinfectants to reduce the potential risk of developing resistant strains should form part of your regime. Environmental monitoring is required to understand the in-house flora and decide on the most suitable disinfectants. The daily disinfection should be a biocide that has broadspectrum efficacy effective against vegetative organisms, e.g. gramnegative and gram-positive bacteria. The rotational product is commonly a sporicidal product. The choice and frequency are determined based on the prevailing organisms. The usage of sporicidal products should be minimised as they can potentially damage
Did you know? Grade A/B cleanrooms require a separate cleaning step to remove potential dirt, grease and residues. This is done with a neutral detergent.
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It is important to achieve the required contact time after applying the disinfectant
surfaces, require special PPE or leave residues if not removed.
CONTACT TIME AND KILL RATE Choosing suitable products is only half the job. There are multiple factors than can determine the effectiveness of a cleaning and disinfection system – which are highlighted in this article. It is essential to understand and follow the instructions printed on the labels of disinfectant products. It is also of utmost importance to achieve the required contact time. If after applying the disinfectant a surface dried up before the required contact time, it is unlikely that the kill rate will have been achieved as per manufacturer recommendation.
"It is essential to understand and follow the instructions printed on the labels of disinfectant products" Contact time can sometimes be a challenge if it’s 10 to 15 minutes, especially in areas with high air changes. Chances are also that operators might spray and wipe without waiting long enough. This is why shorter contact times are easier to adhere to. So-called “ready-to-use products” reduce the potential for operator errors. Concentrates require correct dilution,
