Feature by James Miller, Director at Dustcontrol UK

Cleaning Up Pharma's Act

There are a great many considerations needed when providing regular cleaning in the post-COVID-19 landscape, chief of all is the safety of any pharma workplace's staff

The dangers of dust in any workplace environment are well documented. From a business point of view, a build-up of dust can negatively impact productivity and potentially harm the quality of a product through contamination. While from a health perspective, regularly inhaling dust can cause respiratory illnesses and diseases.

In recent years, there has been a strong focus in the UK to improve the health and safety of workers, and it has been great to see a rise in the uptake of providing safe and clean work environments. The coronavirus pandemic brought with it new challenges of keeping workspaces safe, and, while all industries have had to endure an extremely difficult and unprecedented period, one positive is that we will be better prepared for such events in the future. Indeed, the pandemic has put a stronger need for stringent infection control in every sector. The pharma sector is renowned for having strict hygiene and cleanliness requirements, and COVID-19 has only heightened the need to maintain such a high level of health and safety in the industry, especially with the production of consumable synthetic and organic substances.

Standard cleanrooms, prevalent in pharma facilities, already offer a high level of protection to both workers and the products they produce, but can more be done? In short, yes.

Centralised vacuum systems, which can be tailored to fit a client's requirements, ensure clean products are ready for the next stage in the manufacturing process by eliminating dust, liquid, or smoke at the source, and can also be used for efficient general cleaning. So, imagine a cleanroom with an outlet in the wall that could be closed with a flap valve or shutter that connects to a piped system. It would extract dust or other harmful material out of the room without risk of contamination. A hose is fitted to the outlet, avoiding the need for mobile vacuum equipment to be transported in and out the room, which can increase cleaning costs and contamination risk.

It is important that the hose offers flexibility, and is tough enough to withstand the abrasion created when transporting any extracted material. Considerations should also be given to chemical and heat resistance, as well as conductivity to static electricity.

Cleaning tools, suction casings, and special nozzles are the components that actually capture the contaminant. The design and effectiveness of these will determine the efficiency and acceptance of the entire system. Of course, such a comprehensive offering demands a varied and complete assortment of specially designed products. For instance, the spring- loaded flap valves that connect to the centralised vacuum system in a pharma cleanroom need to meet the requirements for cleanroom applications. The valve body is typically antistatic, while the exposed surfaces of the valve are brushed stainless steel of hygienic design, and specially developed for the industry. Inductive sensors provide automatic start/stop functionality.

The system itself can be controlled by control panels that operate both the vacuum producers and cleaning of the filter. A variety of other control functions can be installed as required, and intelligent features can be included, such as the control of the motor speed according to the number of users, and thereby reduce energy consumption.

In this COVID-19 landscape we find ourselves in, it is also important to consider adding high efficiency particulate air (HEPA) filtration to the centralised vacuum system to contain and remove coronavirus particles. Indeed, the European Centre for Disease Prevention and Control suggests placing HEPA filters, also known as high- efficiency particulate absorbing filters, over vents and exhausts in workspaces to reduce the spread of the virus, by capturing and removing it from the room. HEPA-13 filtration has been tested to capture at least 99.95% of particles between 0.15 to 0.3μm.

A typical pharma company will have clientele consisting of healthcare service providers and professionals, such as doctors, pharmacies, hospitals, healthcare centres, clinics, and laboratories. To ensure a high level of cleanliness on both surfaces and in the air, the company would need an effective suction system to guarantee the quality and capacity of its production, as well as improve workers' health.

A central vacuum system, along with piping and accessories, could be installed to help the business reach and sustain their high level of cleanliness through the system's efficiency, reliability in service, and longevity, providing a total economic solution.

It is important to note, however, that while centralised vacuum systems are the most effective way of ensuring ultimate cleanliness in pharma cleanrooms, mobile vacuum equipment can also be used.

While they may be a secondary option to centralised vacuum systems due to the risk of contamination when manoeuvring the equipment in and out the room – unless they permanently stay in the room – there are products available that are suited to the sector's stringent requirements of cleanliness.

Stainless steel industrial vacuums that are cyclone based with HEPA-13 filtration, for example, are an ideal solution for Equipment for explosive atmospheres (ATEX) Zone 22 settings and the high hygienic demands within the pharma and food industries. Having a high resistance to acids, with its stainless steel design enabling use of alkaline wash solutions, and a brushless motor, this equipment is suitable for operation in environments with potentially combustible dust, being non-conductive.

In addition to industrial mobile vacuums, there are other solutions on the market that have been specifically developed to help offer a comprehensive range of accessories and fixed equipment, built to high standards.

Accessories, such as flap valves, suction brushes, flat nozzles, hose connectors, full stainless steel tubing systems, joints, pre-separators, automatic shutter valves, and stainless steel filter units, offer increased safety, hygiene, and cost efficiency in production. These accessories are typically antistatic and electrostatic discharge certified, which means they can also be used in ATEX Zone 22, where dust explosions can occur. The brushes and nozzles are also approved for surface contact with pharma products and the system for pharma transport, being both FDA and EMA compliant. In addition, their material composition makes them detectable via metal detector, as well as being autoclavable up to 121°C, allowing for high-pressure saturated steam cleaning. Ultimately, they combine to provide a flexible system where all parts are approved for contact with the compounds being developed and produced.

Overall, there are many considerations to take into account when looking to improve the cleanliness and safety of pharma cleanrooms and similar working environments. Due to the stringent hygiene protocols of developing and producing drugs and other medications, cleaning must be at the highest standard to remove dust and airborne virus particles, thereby avoiding the contamination of products, and being inhaled by workers. Centralised vacuum systems are the most effective way of removing fine and harmful particles from a cleanroom at its source, via a simple flap valve in the wall with a hose connected to capture the particles at source. Through this method, along with the use of high-quality accessories, HEPA-13 filtration and complementary industrial vacuum cleaners, pharma companies can operate with the reassurance that their product is of the highest quality, and their workers are safe from developing respiratory illness on-site.

In regards to COVID-19 and other airborne viruses, a further and comprehensive guide on how cleaning equipment can be used to help limit the spread of viral particles can be found in a COVID-19 guidance report, put together by the American National Standards Institute/ American Society of Heating, Refrigeration and Air Conditioning Engineers/American Society for Health Care Engineering Standard 170 Committee (1). It addresses isolation rooms, negative air machines, layered approaches to eliminating infections, and practical facility and room diagrams that show how and where to use infection control equipment.

Cleaning Up Pharma's Act

This article is taken from Pharmaceutical Manufacturing and Packing Sourcer October 2021, pages 96-97. © Samedan Ltd.

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