The pharmaceutical industry is responsible for manufacturing medications that are safe and effective. For this to happen, all areas of the process must remain free from contaminants. Using cleanrooms is integral to pharmaceutical manufacturing as it helps maintain these standards. A report by Grand View Research, Inc. estimates that the global cleanroom technology market will reach $5.0 billion by 2028.
What Is a Cleanroom?
A cleanroom is any environment engineered to reduce contamination, particulate matter, and other contaminants. This environment allows for manufacturing products that require low levels of contamination. Pharmaceuticals are often manufactured in cleanrooms because of the high precision required and the sensitivity of the equipment used.
The purpose of cleanrooms is to provide a controlled and consistent environment for manufacturing processes. This helps ensure that products are made with the highest quality possible.
Why Do We Need Cleanrooms?
The pharmaceutical industry is responsible for producing life-saving medications, so it’s no surprise that cleanrooms are a critical part of the manufacturing process. Cleanrooms are used in pharmaceutical manufacturing because they provide an environment with low contamination levels and particulate counts.
It helps ensure that all the pharma drugs manufactured are not contaminated and will work on the body as intended. Cleanrooms also help manufacture packaging for drugs. Hence, the medicines developed within a cleanroom environment remain safe even during delivery.
How Do Cleanrooms Work?
When you visit a cleanroom, you may first notice that the air feels different. It’s usually cool and dry, with no perceptible odor. The reason for this is that cleanrooms are designed to remove contaminants from the air using several methods, including:
- Air filter systems remove particles as small as 0.3 microns from the air by passing them through HEPA filters or other specialized filters that trap even smaller particles
- UV lights kill microbes in your breathing space, so even if you sneeze or cough on your way into a cleanroom, there won’t be any lingering germs for others to catch
- Recirculation systems use sophisticated ducting systems that re-circulate filtered and dehumidified air throughout the room
How Are Cleanrooms Classified?
Cleanroom classifications are determined by the standard used. While there are three main international standards for classifying cleanrooms, they don’t entirely overlap because of differences in basic principles.
- ISO 14644-1 (formerly ISO 14644-2)
- EU GMP Grade A/B/C/D
- US Federal Standard 209E: Cleanroom Standards
Points to Consider When Setting Up a Cleanroom
When setting up a cleanroom, several factors must be considered. This includes the design and construction of the cleanroom as well as its layout. Here are some of the elements to consider when building a pharma cleanroom.
HEPA Filters
They’re a type of air filter that helps clean the air you breathe, removing 99.97% of particles that are 0.3 microns or larger, about 1/30th the width of a human hair.
In pharmaceutical manufacturing, these filters help keep your workspace safe from contamination, which could cause products to fail quality control and lead to recalls or lawsuits. They also help keep your employees healthy by reducing their risk of exposure to allergens and other airborne contaminants.
Ventilation
The ventilation system in a cleanroom can be divided into two types: general ventilation and local exhaust ventilation. General ventilation supplies clean air to all areas of the facility, while local exhaust ventilation removes contaminants from specific zones within the facility.
Ventilation systems must be designed to handle large amounts of airflow without becoming clogged with particles or other contaminants that could reduce efficiency.
Temperature and Humidity
The temperature in a clean room must be maintained at a constant level to keep the room from becoming too cold or too hot. Too much heat can cause problems like condensation, mold growth, and even fires. On the other hand, if it gets too cold, processes will slow down, and products will not be as effective. In manufacturing and storage facilities, the temperature is generally maintained between 15°C to 25°C.
The humidity level must also be kept within certain parameters. Too much moisture can lead to mold growth as well as corrosion of equipment and materials. If there is not enough moisture in the air, then static electricity might build up, damaging sensitive electronic components. The relative humidity in a clean room should be between 30–60% RH.
Material Used
Materials used in the cleanroom can also impact the quality of the products manufactured or maintained inside it. Hence, cleanroom surfaces must not shed particles that can contaminate the air. Static dissipative cleanrooms are designed to prevent static from building up to protect sensitive electronic components. These are designed to control humidity and have ionized bars for optimal manufacturing.
What Will Happen if You Don’t Use Cleanrooms for Pharma Manufacturing?
If you didn’t use cleanrooms in your manufacturing process, you’d risk contaminating your drugs with anything from dust particles to bacteria or mold spores. This means that some of your medicines might not work as intended, or worse, they could be dangerous for patients who need them.
The FDA requires all manufacturers to meet certain standards regarding cleanliness and sterility before they can distribute their products. If a company isn’t using cleanrooms to keep their equipment sterile, then they’re breaking those rules and putting people at risk by distributing products that aren’t safe for them.
Contamination Control Is Integral to Pharmaceutical Manufacturing
In pharmaceutical manufacturing, cleanrooms are an essential tool for preventing contamination. According to the 16th Annual Report of Biopharmaceutical Manufacturing Capacity and Production, more than 8,000 ISO 5-9 biopharmaceutical cleanrooms are in use worldwide.
Contamination control is an integral part of the manufacturing process, and cleanrooms help to control contaminants that could affect the quality of the product. Cleanrooms are also used to maintain humidity and temperature to ensure that all equipment works properly.
The safety of patients depends on these factors being controlled so that they receive only high-quality medication with no adverse effects on their health.
Conclusion
Cleanrooms are an essential part of pharmaceutical manufacturing and ensure that the product is pure. They also help to prevent contamination from outside sources, such as dust particles or bacteria, which can ruin production lines. Cleanrooms come in many different sizes, from small rooms to large facilities, so your company’s needs will determine how much space you need for each specific section of your facility.
