When we come across the word ‘cleanroom’, an instant thought that arises is one of a room – all spic & span. But, cleanliness goes well beyond the basic traits of the pharmaceutical technology and healthcare industry. Therefore, to ensure that a cleanroom lives up to its name, it must be made and maintained absolutely contaminant free, leaving no room for impurities and inadequacies.
However, the medical cleanroom is replete with possibilities of contamination, so much so, that even an iota of infection can jeopardise the efficacy of the cleanroom environment. As a result, there can be adverse and far-reaching implications on the lives of the working personnel.
Thus, for a cleanroom to be leak-proof and contaminant free, and work efficiently in a controlled space, great importance must be attached to understanding the nuances of the risks that a cleanroom may encounter. Here, having an ISO classification for the cleanroom can help measure and operate according to industry-wide standards.
From design to installation, there are many sources through which contaminants may enter a cleanroom. These threats call upon everyone to be well acquainted with the criticalities of factors that may disrupt the efficient operation of the cleanroom.
We have hereunder spelt out some factors that act as a gateway to several impurities in a medical cleanroom:
While one may believe that broader protections like frequent handwashing and gowning protocol by the working staff can keep the contaminants at bay, other elements like skin particles, hair strands, perfumes and cosmetics are quite likely to go unnoticed thereby posing great risk for medical cleanrooms. For example, a lapse in following the gowning protocol or a slight disregard for handwashing can give access to thousands of contaminant particles to the environment. In fact, some cleanroom inspections have attributed the cause for 80% of the identified particles to personnel.
Cleanroom operators are exposed to microbiological and high potency substances that must be contained and controlled in most appropriate manner. Protective gears play an important role in protecting the cleanroom from potential biosecurity risks. So, infectious diseases arising from work samples and materials must be effectively taken care of. Dealing with bodily fluid samples can also greatly help safeguard the health of the cleanroom personnel.
Cleanroom equipment is not only confined to machinery and tool emitting gases, lubricants and airborne particles but also include everyday essential items capable of posing varying levels of contamination risk in the cleanroom. Therefore, to achieve the optimum cleanroom environment, attention must be paid to regular sanitisation of the wide range of articles and equipment viz. pens, trays, beakers and other cleaning items.
Dysfunction Filtration Systems
Cleanroom filtration systems like fans, pre-filters, and HEPA or ULPA filters ensure good air quality by effectively treating contaminated air supplies and maintaining consistent air change rates. However, if the operation of the filtration system isn’t up to the mark, there is a strong likelihood of its effect being seen on the cleanroom environment. Besides, over a period of time, wears and tears of the components may result in a lower capacity that may further augment the chances of higher article counts and dead zones.
Static in cleanrooms
Static electricity in cleanrooms may not be an overriding concern, but its risk factor must not be overlooked. The production of static ‘cling’ affects particulate contamination, thereby drawing airborne dust particles to surfaces, otherwise required to remain sterile. Also, sensitive electronic components can be adversely affected and permanently damaged if static attracts particles to draw in, especially in applications involving medical device development.
While absolute sterilisation of a cleanroom may be virtually unworkable, what comes as a respite are the various preventive and protective ways by which a low-risk cleanroom environment can be achieved. In addition, the implementation of appropriate tools, technologies, and procedures can also significantly reduce risk and help build up the overall quality and adequacy in the cleanroom.
Below are a few preparation tips that must be duly considered during the design and installation processes.
INSTALLATION AND PERIODIC MAINTENANCE OF A FULLY FUNCTIONING FILTRATION SYSTEM
Installation of a quality filtration system is a prerequisite to building a cleanroom that meets the ISO classification requirements. The filtration system should be made such that it can provide the required percentage of ceiling coverage and maintain consistent air exchange rates.
Subsequent to the proper designing and installation, a regular filtration system inspection and preventive maintenance schedule must be followed. Moreover, periodic replacement (minimum six times a year) of pre-filters and HEPA or ULPA filters (at least once every three years) that play a crucial role in filtration maintenance must be undertaken to avoid failure of the system and counter the possible threat to the cleanroom environment.
CORRECT PRESSURIZATION OF CLEANROOM’S APPLICATION
In the pharma industry, the usage of positive and negative cleanrooms is subject to specific application.
Most cleanrooms operate with positive pressure, using HEPA filters and an external airflow pattern, whereas some applications involving hazardous substances operate under negative pressure to prevent contaminants from escaping and causing harm to the surrounding environment.
INCLUSION OF PASS BOX IN THE CLEANROOM DESIGN
Pass boxes are essentially chambers for material movement in and out of a cleanroom within a controlled environment. Introducing one or more pass boxes to the cleanroom can enable faster material transfer and bring more efficiency into the process. At the same time, pass boxes also act as barriers that minimise cross-contamination between different cleanliness levels of a cleanroom with which a relatively less compromised work environment can be attained.
IMPLEMENTATION OF COMPLETE CLEANROOM CLEANING PROTOCOLS
It is a settled principle that cleanrooms require efficient design, features, technology, and adherence to some of the most stringent ISO standards; however, sheer cleanliness remains the mainstay behind the overall success of a cleanroom.
How one cleans is just as important as how frequently one cleans. Therefore, apart from undertaking cleaning procedures as per the needs and demands, setting a daily and weekly cleaning task can help maintain sterilisation level to the maximum. Specified cleaning products for medical cleanrooms such as distilled water, neutral chemical solvents, and non-shedding cloth or wipes that act as disinfectants and curb the growth of micro-organisms must also be used to enhance overall cleanliness.
USE OF ANTI-STATIC CLEANROOM COMPONENTS
Static control may seem to be too extensive and unachievable, but the right disposal of issues can make it possible. For example, adopting specialized products meant for controlling static within a cleanroom, viz. anti-static flooring, wall panels can decrease the vulnerability to microbes. Above all, clothing and gowning guidelines, including anti-static garments, ESD cuffs, low-static shoes, basic lab coats, are an essential component of cleanroom contamination control and must be duly followed.
Fabtech works under a strong framework with the best practices necessary for an efficient cleanroom. In line with our promise of solving for our customers, we tailor-customise our expertise to suit your application
So, if you are looking to build a cleanroom facility, please speak to our expert Neeraj Mishra and get the most effective turnkey solution (from designing to installation) for your next project.