Cleaning Critical GMP Areas including Clean rooms
Organizations have to apply well defined GMP practices in Clean rooms and labs in order to maintain particulate and pathogen free environments. There are formal requirements and guidelines for food, drug, medical device and cosmetics manufacturing such that sanitized conditions are maintained. There are several cleaning standards including the ISO14644 and the Federal Standard 209E standards. This can bring up some unique challenges when it comes to tracking assets inside these areas. Since they are operated under strict guidelines, they are subject to several cleaning methodologies. Some of the common SOPs (standard operating procedures) include chemical wipe downs, autoclaving etc.
This means the RFID tagged assets in the clean rooms are also going to be subjected to the cleaning SOPs. Wipe downs can be done with oxidizing agents like hydrogen peroxide or non-oxidizing agents like alcohols. RFID tags have to be rugged enough to withstand these wipe downs. Particular attention has to be applied to tag selection. Not only should the tag have a good read range, as is the default requirement, but it should be made of material that will remain unaffected when exposed to such chemical wipe downs. It’s also important to note that equipment in clean rooms tend to last many years, which implies that the tags chosen should also be rugged enough to withstand wipe downs for many years.
Further, several types of equipment will need to be cleaned in autoclaves. Autoclaves use a combination of steam and pressure over a significant period of time. They need to run at very high temperatures and pressures so the pathogens, microorganisms and spores can be destroyed. Metal, glass and various plastic materials may be autoclaved. Not only should tags for the specific type of material be chosen, but also it must be ensured that they can tolerate autoclave environments repeatedly for a period of years.
Tag mounting methodologies should also be considered carefully. Often, commonly available adhesives will not withstand chemical or autoclaving environments for a long period of time. Special adhesives or alternate mounting techniques need to be employed.
AssetPulse, with its decades long experience in such ruggedized environments, has deployed such tags in multiple clean rooms. Not only is selection of tag important, but also the location of the tags should be optimally specified. AssetPulse personnel study the SOPs employed in the areas to see what the best location for the tag is, so read range can be maximized while at the same time, protecting the tag from unnecessary mechanical impact, shock and vibration.
Further, in case a fixed RFID infrastructure is needed in clean rooms, the readers, antenna, cables etc. need to be situated in appropriate configurations such that they deliver the required performance, but at the same time, are able to tolerate the environment. This can be challenging, but is well within the AssetPulse wheelhouse.