Minimising particulates is a critical concern in pharmaceutical manufacturing as they directly impact part quality and rejection rates. This is where cleanrooms come into play, acting as a crucial step in minimising particulate levels through a controlled and monitored environment.
These specialised environments are designed with advanced filtration systems, stringent procedures and constant monitoring to maintain a suitable atmosphere for pharmaceutical components. But on the other hand, they bring a significant cost as a result of the over-specification of cleaning requirements for certain components.
In this article, we unpack cleanrooms and the benefits they bring to pharmaceutical manufacture, before assessing how important they are in the context of over-specification.
What are cleanrooms?
Cleanrooms are specialised environments used in pharmaceutical manufacturing to control the presence of airborne particles such as dust, microbes and aerosol particles. Their primary function is to minimise the risk of contamination during the production of medical devices, medications and other sensitive products.
Through the use of sophisticated air filtration systems and strict protocols, cleanrooms maintain regulated air quality, temperature, and humidity levels, ensuring the safety and reliability of pharmaceutical products critical for patient health. Cleanrooms are separated into standardised classifications based on the requirements of cleanliness in different applications.
ISO clean room classifications
ISO Class 1, 2 and 3: These are the cleanest environments, crucial for the manufacturing and research of products that demand the utmost precision and minimal contamination.
- ISO Class 1: Advanced semiconductor chip manufacturing.
- ISO Class 2: Nano-technology research and quantum computing.
- ISO Class 3: Production of hard disk drives and high precision optics.
ISO Class 4 and 5: Suitable for industries where high cleanliness is necessary but not to the extent of semiconductor fabrication.
- ISO Class 4: Precision manufacturing of medical devices and aerospace components.
- ISO Class 5: Pharmaceutical compounding and sterile product manufacturing.
ISO Class 6 and 7: Environments that require controlled conditions for product quality and research integrity.
- ISO Class 6: Tissue culture labs and some pharmaceutical packaging areas.
- ISO Class 7: Medical device manufacturing and pharmaceutical production processes - this is the classification commonly used for pharmaceutical manufacture.
ISO Class 8 and 9: These classes provide controlled but less stringent environments, suitable for a range of applications where basic cleanliness is required.
- ISO Class 8: Hospital pharmacies, general electronics manufacturing and some scientific research labs.
- ISO Class 9: Acts as a buffer zone or is used for less sensitive scientific research, comparable to typical urban indoor air quality.
What are the features of cleanrooms?
- Advanced filtration systems: Cleanrooms employ advanced air filtration systems, including HEPA and ULPA filters, to remove particulate matter from the air, thus maintaining the required cleanliness levels.
- Material flow and personnel access: The design of cleanrooms includes controlled access points and specific protocols for material and personnel flow to minimise the risk of contamination.
- Specialised cleanroom garments: Personnel working in cleanrooms are required to wear specialised garments designed to minimise the release of contaminants from the body and clothing into the cleanroom environment.
- Regular monitoring and maintenance: Cleanrooms undergo regular monitoring to ensure they remain within the required cleanliness specifications. This includes routine testing of the air for particulate levels and other potential contaminants.
What are the benefits of clean rooms?
Minimised particulate matter
Cleanrooms drastically reduce the presence of particulate matter, ensuring the manufacturing environment is free from contaminants that could compromise the quality and safety of medical devices.
Compliance with medical standards
By meeting stringent cleanliness standards, cleanrooms help manufacturers adhere to both regional and international regulatory requirements, facilitating legal compliance and market approval for medical products.
Minimised scrap rates
Cleanrooms help reduce rejection rates due to particulate contamination, minimising scrap rates and enhancing productivity. This results in more efficient use of materials and resources, significantly lowering the costs associated with rework and waste, while also maintaining high production outputs.
How to specify cleaning requirements to avoid over-specification and unnecessary cost
While clean rooms are clearly valuable for eliminating the presence of particulates, the pharmaceutical industry tends to over-specify the cleaning requirements and cleaning processes used on their products. While well-intentioned, this practice often leads to increased production costs, extended lead times and potentially reduced profitability.
To address these challenges, it is essential to evaluate the entire manufacturing process rather than specify the same cleaning routines for every component. This approach helps avoid unnecessary expenditures and the potential damage to fragile components caused by excessive cleaning processes.
Manufacturers should focus on designing components to reduce the likelihood of particulate contamination. This can include integrating in-line deburring methods or adopting advanced manufacturing techniques that inherently minimise the presence of particulates. In this respect, a one-size-fits-all approach will never work for all components and medical devices; this is where the value and importance of an experienced manufacturing partner becomes clear.
Get expertise, experience and industry-leading support from Advanex Medical
Cleanrooms are critical in pharmaceutical manufacturing for controlling particulates and ensuring products meet stringent safety standards. But at the same time, reevaluating your entire manufacturing process can be equally beneficial in maintaining cleanliness and minimising contamination risk without bringing significant and unnecessary costs.
Advanex Medical stands as a prime example of a partner that can help you optimise and refine your manufacturing process with unparalleled professional expertise. Our comprehensive understanding of minimising particulates places us as leaders in the industry, providing solutions that enhance manufacturing repeatability, facilitate the passage through rigorous medical trials and optimise production with minimal scrap rates. Our dedication to precision, quality and efficiency makes us an indispensable ally for pharmaceutical manufacturers.
This commitment to excellence and attention to detail underscores Advanex Medical's position as a leader in the manufacturing of safe, reliable medical products in an efficient way. To find out how we can provide this same service for you and your medical device, get in touch with one of our experts.
