The pharmaceutical industry is a highly regulated and competitive field. It was worth $534.21 billion in 2020 and is growing fast. The numbers show the fierce competition in this high-value field. To stand out from the competition in such a competitive space, you must abide by all regulations.
Hence, if you want to set up a pharmaceutical cleanroom, ensuring it meets the necessary rules is essential. Additionally, it should be tailored to meet your organization’s specific needs and requirements. A cleanroom is designed to ensure that you can produce pharmaceuticals in a safe, sterile environment. It prevents contaminants from entering the space and onto your equipment or products.
In this blog post, we’ll take you through setting up your pharmaceutical cleanroom and how it will benefit you as an organization.
What is a Pharmaceutical Cleanroom?
A pharmaceutical cleanroom is a room designed to prevent the spread of contaminants. Contaminants can be biological, chemical, or physical and can cause problems for the equipment used in this industry.
These rooms must meet specific standards. Customers need assurance that they get quality products when they buy them off the shelf at their local pharmacy store. Cleanrooms are also used in other industries, such as electronics, where they’re used for making semiconductors.
Why Do You Need a Pharmaceutical Cleanroom?
Cleanrooms are used to produce pharmaceuticals, medical devices, and other products that require a sterile environment. These cleanrooms provide a controlled environment that protects workers from potential contaminants while also protecting the end product from contamination.
The air change rate in such rooms is quite high to maintain sterile conditions. So, the energy consumption of such cleanrooms can be 15 times more than that of normal commercial establishments.
Cleanroom standards vary depending on the product type, but they generally fall within two categories: Class 100 or Class 1000. The difference between these standards lies in how many particles per cubic meter can be in your room during production. Class 100 allows up to 100 particles per cubic meter, while Class 1000 allows only 10.
How to Set Up a Pharmaceutical Cleanroom
Setting up or installing a pharmaceutical cleanroom is a critical step in ensuring the production of safe and high-quality pharmaceutical products. A pharmaceutical cleanroom installation can be challenging if you don’t have the right knowledge of the process. Hence, it is always best to seek help from a professional cleanroom installation agency.
However, you can still go ahead and install a cleanroom yourself. Here is a general guide on how to set up a pharmaceutical cleanroom:
Determine Your Space Requirements
The first step in setting up a pharmaceutical cleanroom is determining your needed space. This will depend on the number of people working in the cleanroom at any given time. It will also depend on the activities they will be performing there, as different tasks may require varying amounts of space.
For example, if you plan on having only one employee work in your cleanroom, you may only need about 100 square feet. On the other hand, if multiple scientists will work in the cleanroom, 150 square feet per worker might be more appropriate.
There should also be extra room for equipment storage and waste disposal. Consider all such scenarios and decide on a space requirement that allows all your workers to work efficiently.
Select the Right Equipment for Your Pharmaceutical Cleanroom
Select the right equipment for your pharmaceutical cleanroom.
- Select the right equipment according to the size of your space. Suppose you only have a small space. In that case, buying smaller machines and replacing them as needed might be more cost-effective.
- Consider how many employees will work in the space and what pharmaceutical products are handled there. If many people need access to certain system parts simultaneously, consider looking for something that allows multiple users access. Ensure that this is done without compromising safety or sterility standards. Preferably, you can use features like automatic doors and turnstiles so only authorized personnel can enter anytime.
- Finally, consider what processes will occur within an area before choosing what equipment best suits those needs. Consider how often something gets cleaned and where it should be cleaned most frequently. Depending on their functionality, different areas may require higher cleaning frequency levels than others.
Air Quality Control and Filtration
Air quality control and filtration are paramount in pharmaceutical cleanrooms to maintain the required cleanliness standards and ensure the integrity of pharmaceutical products. These aspects play a pivotal role in creating a controlled environment that minimizes the presence of particles, contaminants, and microorganisms.
Airflow Management
Proper airflow management is fundamental to cleanroom design. Cleanrooms typically employ a unidirectional or laminar airflow pattern. This pattern directs filtered air uniformly across the workspace from a clean source, such as ceiling HEPA or ULPA filters.
This controlled airflow minimizes the introduction of contaminants and promotes their removal through exhaust systems. Additionally, air pressure differentials are maintained to prevent the ingress of external contaminants.
HEPA and ULPA Filtration
High-efficiency particulate Air (HEPA) and Ultra-Low Penetration Air (ULPA) filters are essential for pharmaceutical cleanroom HVAC systems. HEPA filters are designed to remove particles down to 0.3 microns with an efficiency of 99.97%. In contrast, ULPA filters are even more efficient, capturing particles as small as 0.12 microns at a 99.9995% efficiency rate.
These filters ensure that the air entering the cleanroom is virtually free of particulate matter, bacteria, and viruses. They contribute to the stringent cleanliness standards of the facility.
Filter Maintenance
Regular maintenance of HEPA and ULPA filters is crucial to their performance. Filters must be replaced or tested and recertified at defined intervals, as industry standards and regulatory guidelines specify. Proper filter maintenance ensures the cleanroom meets cleanliness requirements and prevents filter degradation that can compromise air quality.
Temperature and Humidity Control
Pharmaceutical processes often require precise temperature and humidity control. Cleanroom HVAC systems must maintain these parameters within specified limits to ensure product quality and consistency. Temperature and humidity variations can impact product stability, so tight control is critical.
Contamination Control Strategies
The first step toward a clean room is to prevent contamination from entering the room. This can be accomplished with careful maintenance and cleaning practices.
For example, an air filter for your cleanroom should be regularly cleaned. This is done to remove any airborne particles that might have been collected on its surface. The same goes for other surfaces in your pharmaceutical production facility–they should all be kept clean.
In addition to keeping your equipment clean and tidy, you must take steps to maintain good housekeeping practices throughout the day. If a spill or other mess occurs in one area of your pharmaceutical manufacturing plant or laboratory, take prompt action.
Ensure that someone cleans up after themselves immediately. This is important to avoid leaving behind any residue that could contaminate other areas later. This includes spills of chemicals used during production processes.
As rightly stated in a Forbes article, pharmaceutical cleanrooms assumed a lot of importance due to Covid-19. This is when pharma companies had to speed up the production of certain vaccines. If the air-handling unit falters, it can contaminate the sterile environment of the lab. Consequently, the vaccine batch being processed will have to be thrown away.
Validation and Compliance
Validation is a process of confirming that a system meets its requirements. In other words, validation determines if your pharmaceutical cleanroom can meet all regulatory requirements. Compliance is the ability to meet those same regulatory requirements.
Regulatory agencies require validation and compliance for pharmaceutical cleanrooms to ensure your facility produces safe consumer products. To do this, they’ll ask that you complete two processes: validation and compliance testing at regular intervals.
You have to abide by different regulations based on what you will use your pharmaceutical cleanroom for. For instance, the clean room should be in the range of ISO 5 to ISO 8 for medical device manufacturing.
Cleanroom Walls, Floors, and Ceilings
The materials and finishes used for cleanroom walls, floors, and ceilings are crucial for cleanroom design. They significantly impact cleanliness, ease of cleaning, and overall functionality. Here’s an expanded explanation of considerations for cleanroom walls, floors, and ceilings:
Wall Materials
Cleanroom walls should be constructed using smooth, non-porous materials and resistant to microbial growth. Common materials include stainless steel, fiberglass-reinforced plastic (FRP), or coated gypsum board.
Stainless steel is a popular choice for its durability, corrosion resistance, and ease of cleaning. It’s often used in higher-class cleanrooms. FRP is another option, particularly for lower-class cleanrooms, as it’s cost-effective, lightweight, and resistant to most chemicals.
Floor Materials
Cleanroom flooring should be seamless, non-shedding, and resistant to chemicals and microbial growth. According to American Cleanroom Systems, epoxy flooring is an ideal choice. It is commonly used due to its durability, easy cleaning, and chemical resistance. It provides a smooth, seamless surface that prevents the accumulation of particles.
Vinyl flooring is another option, particularly in less stringent cleanroom environments. It’s available in various finishes and is relatively easy to maintain. You can also go with industrial VCT tiles. However, they are usually chosen for industrial cleanrooms.
Ceiling Materials
Cleanroom ceilings should be designed to minimize the accumulation of particles and facilitate the efficient distribution of filtered air. Suspended ceilings with removable ceiling tiles often provide access for maintenance and modifications. Perforated or non-perforated aluminum or stainless steel panels are used for higher-class cleanrooms to maintain a smooth surface.
Conclusion
We hope this article has helped you understand the importance of having a pharmaceutical cleanroom. Setting up a pharmaceutical cleanroom can be challenging. Hence, you should contact a professional today if you’re looking for a facility validated by an independent third-party agency. With the right expertise, skills, and resources, professionals will be in the best position to help you.
