COVID-19 has fundamentally altered many industries and disrupted normal lives around the world. The impact was far too serious on the healthcare sector. During these uncertain times, healthcare facilities, diagnostic laboratories and pharmaceutical manufacturers had to boost capacities, retrofit existing facilities and add safeguards to contain the spread in an attempt to meet the unprecedented health crisis and lower human casualties.
Between 2020 and early 2022, frontline medical workers and hospital staff had to be extra cautious about contamination control protocols to combat the spread of COVID-19. It became evident that to effectively combat the spread, laboratories had to alter existing facilities and invest in cleanroom technology with HEPA filters as the most preferred alternative to protect medical staff and patients.
General Laboratories
A biomedical laboratory is a facility where experimental research, clinical trials, and analysis is performed on suspected medical samples. A simple laboratory is characterised by an uncontrolled environment with simple protocols confined to maintaining cleanliness with surface cleaners, disinfectants and maintaining a level of personal hygiene with common sanitizers, disposable gowns, masks and gloves. Often, laboratories can be used in a more typical manner without having to adhere to strict standards for cleanliness or air quality.
With the outbreak of COVID-19 and subsequently Monkeypox, many of the existing laboratories found themselves severely ill equipped to handle virulent samples and this added to the burden on the healthcare sector.
Cleanrooms
Biomedical research, hospital facilities, diagnostic centres, etc., have an increasing demand for stringent contamination control during sample handling, preparation, separation, and material transfer. Therefore, the establishment of a clean and controlled environment is crucial as well as mandatory.
When addressing cleanrooms, controlling the generation of particulate matter is critical. Following defined ISO standards and cGMP regulations, cleanrooms control particles of any type and size and prevent contamination arising from chemical or biological agents within the environment.
Unlike general laboratories, cleanrooms are designed to offer maximum environmental control to ensure no contamination occurs or sensitive manufacturing processes get adversely impacted by external factors and to boost overall production yield.
Hence, for various workplace settings, including sterile manufacturing facilities, scientific research facilities, and hospital laboratories, cleanrooms are an ideal solution to keep surfaces clean from organisms, particles, and contaminants, during operations.
Cleanrooms or general laboratories?
From the healthcare sector to the manufacturing and aerospace industries, the need for reliable and accurate measurements of cleanliness and a contaminant-free environment is now a well established norm. And needless to mention that pharmaceutical and healthcare industries especially, require a reliable solution to maintain a controlled and isolated laboratory environment as such facilities deal with virulent microbiological and chemical agents that can compromise the safety of the personnel and patients. This is where the benefits of adopting cleanrooms outweigh a general laboratory setup.
While both terms are used interchangeably, they are considered for different applications, depending on the risk assessments performed by manufacturing facilities and research laboratories. Let’s take a closer look at some of the key factors you should consider to make a switch to cleanrooms
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It prevents cross-contamination
Since cleanliness can be assured in carefully isolated, regulated and sterile environments, cleanrooms have become critical for pharmaceutical manufacturing sites, healthcare facilities, medical research and diagnostics centres directly involved in the collection and handling of virulent samples (including Monkeypox and COVID-19).
Cleanrooms are designed with many safeguards, including supply air filtration via HEPA filters in the AHU (Air Handling Unit), terminal HEPA filters, replacing a set percentage of laboratory air with fresh air supply after HEPA filtration (removes any suspended particulates generated during operations), and most importantly maintaining relative pressure differences between rooms classified as “high risk” vs. those with general operations to ensure any comprise in physical containment is effectively isolated.
In addition to the physical infrastructure, cleanroom operations also dictate certain personnel entry and exit protocols via Air Showers with sterile gowns, gloves, masks and shoes etc to target contamination sources from personnel movement. Pass Box (aka cleanroom material transfer hatch) provides a safe and sterile passage for material movement inside cleanrooms, eliminating further contamination sources.
Although the initial investment in cleanrooms may seem steep, cleanrooms and associated operating practices offer excellent protection for the personnel, processes and other sensitive operations that may be susceptible to cross-contamination. This is especially true for laboratories and hospital testing facilities involved in handling highly contagious samples.
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ISO guideline approved
Cleanroom manufacturers like Alpha Linear adhere to the strictest guidelines set forth by various organisations, including ISO (International Organization for Standardization). Since it has the authority to impose strict regulations across several commercial markets, an ISO 14644-1 cleanroom setting is more reliable and secure for sample handling, virus outbreak protection, sensitive material transfer, and pharmaceutical production etc.
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It offers clean and controlled environments
Some raw materials used in the pharmaceutical manufacturing process or workplace can result in contamination that poses a risk to personnel. Through the use of air filtration systems, personnel entry protocols, and protective gear, cleanrooms guarantee the immediate safety of the environment for personnel, production processes and the integrity of the products manufactured. Being an isolated room, it actively cleans and prevents contamination from a wide variety of pathogens and suspended matter, for instance, airborne organisms, dust, grime, chemical vapours, etc.
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Advanced technology
Cleanrooms function as a fully centralised and integrated Heating, Ventilation and Air Conditioning (HVAC) system with an added level of protection provided via HEPA and/or ULPA filters, in addition to a higher rate of fresh air circulation (much greater than general comfort air conditioning systems) to ensure all sources of cross-contamination are effectively eliminated at source, thereby, purging the facility of any possible contaminants. The most common filters employed in cleanrooms include
- High-efficiency particles in the air (HEPA).
- Ultra-low penetration air (ULPA).
These filters ensure that the air approaching the cleanroom is optimally purified and uninterruptedly circulated and that contaminants generated by personnel, tools and equipment, supplies, facilities, fluids, and so on remain within the specified limits.
Conclusion
In the post COVID era, when sterile and clean environments are necessary, a cleanroom setting is ideal for various applications. It ensures personnel safety, predictable product quality outcome and prevents cross-contamination in every working environment.
Cleanrooms, in fact, prevent particulates and pathogens from entering a controlled environment and adversely affect sensitive processes, manufacturing operations, raw materials, research samples, etc. If you are involved in operations requiring refined and sterile environments, delicate research and innovation projects, and, most importantly, protecting public health by preventing the release of unwanted particles, cleanrooms are more reliable than a general laboratory.
Alpha Linear, a reputed cleanroom equipment manufacturing company, ensures workspace safety by adhering to the globally accepted specifications for contamination control and meeting international standards. Our cleanroom specifications offer industries an opportunity to secure the safety of their personnel, workplace, and operational environment.