Cleanroom manufacturing for packaging is a process that ensures products are packed in a controlled environment. As a result, it protects patients, staff, and their environments from contamination and the potential health risks it poses. Below, we discuss what a cleanroom is, how they’re classified, and how we ensure sterility through our cleanroom manufacturing and cleanroom filling.
What is a Cleanroom?
A cleanroom is an environment designed to minimise the level of contamination in a space. This means that airborne pollutants and contaminants such as microbes, dust, and other particles are kept out of the packaging process.
Through a combination of air filtration, controlling air pressure, and controlling airflow, among many other controls, a cleanroom ensures stringent standards are met consistently to preserve sterility while adhering to strict industry regulations.
This process is an essential part of ensuring products contained in pharmaceutical packaging are safe.
How is a Cleanroom Classified?
For a space to be classed as a cleanroom, there are many standards to be fulfilled. The first is that a High-Efficiency Particulate Air (HEPA) filter must be used to filter all the air entering the cleanroom. This is because the HEPA filter traps particles of 0.3 microns and above.
Secondly, outside contamination risks must be minimised by adhering to rigorous wash and gown procedures for anyone entering and exiting the room.
Lastly, surfaces must be designed and built to reduce the accumulation of contaminants. That means they have to be as smooth and flush as possible.
The Problem of Contamination
Contamination in many sectors, especially the pharmaceutical industry, can be devastating for all involved. This is because it has the potential to compromise the safety of the patients taking the pharmaceuticals, the staff that administer them, and even the environment in which they are used. All of these can seriously impact the reputation and profitability of the business that supplied them.
That is why so much effort is put into building and developing cleanroom spaces that minimise the potential for contamination.
How is Cleanliness Measured in a Cleanroom?
The cleanliness of a cleanroom is measured by the number of particles of 0.5µm and above that are present in one cubic foot of air. The level of cleanliness required will differ between industries and according to government legislation. However, the lower the volume of particles per cubic foot of air, the higher the level of cleanliness.
How Are Cleanrooms Classified?
Cleanrooms are classified in line with the stringent International Standards Organisation (ISO) standards. Cleanrooms can be given a rating from ISO 1- to IOS 9. ISO class 1 cleanrooms have the strictest air purity and cleanliness standards. ISO class 9 cleanrooms are on the other end of the scale and have the lowest air purity and cleanliness standards. Although, it is worth noting that these will still be significantly higher than in a typical manufacturing environment.
What Are the Different Types of Cleanrooms?
There are different types of cleanrooms, which can vary in their purposes and the building and operational costs involved. The types of cleanroom are as follows:
- Modular cleanrooms
- Soft wall cleanrooms
- Medical device cleanrooms
- Pharmaceutical cleanrooms
Modular Cleanroom
Modular cleanrooms are popular for several reasons, including that they’re cheaper and faster to build than most options, and that they can be created from or inside another structure.
Modular cleanrooms can be built to any standard necessary and can be disassembled and reused if the needs and requirements of the organisation using them change.
Soft Wall Cleanrooms
Soft wall cleanrooms are another more cost-effective opinion. They provide a room-in-room solution within an existing structure and are best suited for smaller-scale operations and development projects.
Medical Device Cleanrooms
Medical device cleanrooms are designed specifically for the safe production of devices that are used in a medical context.
Medical device cleanrooms are designed to ensure that both people and equipment can easily move around the space. They also need to be large enough and ensure proper construction, which helps to keep them clean. Indeed, surfaces must be designed for easy cleaning, and unlike some other types of cleanrooms, humidity and temperature must also be controlled.
Space for storage and equipment must be provided so every item can be returned to its correct home, which also helps to reduce the likelihood of contamination. Airflow must be HEPA filtered and air pressure positive, and all equipment and the room itself must be regularly disinfected.
Pharmaceutical Cleanrooms
Pharmaceutical cleanrooms are some of the highest level of controlled spaces there are. They are built to meet strict guidelines that result in maximum control of the environment inside of the space. This is necessary to ensure the safe manufacture and packaging of the pharmaceutical product.
With this in mind, pharmaceutical cleanrooms usually include several features that maintain the level of cleanliness. The first of these are easy-to-wipe surfaces, which help to stop any accumulation of contaminants. Next, in pharmaceutical cleanrooms, you can expect doors and windows to be semi-flush for easy cleaning and to prevent the settling of dust.
Lastly, in a pharmaceutical cleanroom, an anti-microbial UPVC coating that is pharmaceutical-grade will be applied to the walls to further enhance its efficacy.
Stringent Cleanroom Manufacture and Filling at Origin
Now you know more about the different cleanroom facilities available, you must choose the correct one for the needs of your business.
The good news is that as UK manufacturing specialists, we at Origin offer a cleanroom production facility that meets both ISO 7 class 10,000 and ISO 8 class 100,000. This means we can prevent and control the presence of airborne particles in the packaging process.
We offer such a high standard of environmental cleanliness in several ways, including changing the air in the cleanroom between 10-15 times an hour. Our manufacturing processes, including injection moulding, inject stretch-blow moulding, and automatic assembly, are all electrically driven. Additionally, our processes are all designed to meet the recommendations of the BRC.
We also offer an automated aseptic filling facility, where an aseptic filler sterilises the packaging material, allowing the sterile product to be packaged and then hermetically sealed within a sterile environment. This thermoformed sterile barrier packaging process is perfect for the stringent rules associated with the pharmaceutical market and any PET, PP, HDPE, or LDPE packaging requirements.
Contact Us
If you would like to know about our cleanroom facilities further or have any other questions about our range of packaging products, get in touch with us today. A member of our team will be more than happy to discuss your options further.
