Injection moulding plays a crucial role in modern manufacturing, producing everything from medical devices and healthcare components to consumer products and electronics. However, the manufacturing process can be complex and sensitive, requiring a controlled environment to ensure the highest quality and safety standards are met. This is where cleanrooms come into play.
Cleanrooms are specialised environments designed to minimise the presence of airborne particles and contaminants in the air. They are essential in the injection moulding industry due to the fact that even small particles can affect the quality and consistency of the final product. In fact, contaminants as small as a few microns can impact the performance and reliability of critical components. As a result, manufacturers must ensure that the air in the moulding area is free from any pollutants that may cause defects.
At Biplas we take the cleanliness of our environment incredibly seriously to ensure we maintain and continuous and reliable process that consistently produces high quality products. We’ve invested in state-of-the-art cleanrooms to ensure our products meet the highest standards for quality and safety.
Class 5 and Class 7 Cleanrooms and their role in the medical industry
Cleanrooms are classified according to the ISO 14644-1 standard, which specifies the maximum number of particles allowed in a range of particle sizes. For example, Class 5 (also known as Class 100) and Class 7 (also known as Class 10,000) have strict limits on the number of particles allowed per cubic metre.
| Particle Size | Class 5 | Class 7 |
| 0.1 micron | 100,000 | N/A |
| 0.2 micron | 23,700 | N/A |
| 0.3 micron | 10,200 | N/A |
| 0.5 micron | 3,520 | 352,000 |
| 1.0 micron | 832 | 83,200 |
| 5.0 micron | 29 | 2,930 |
You can have confidence ordering from Biplas, knowing that we not only have vast experience and a wide range of design qualifications, but we also have two of the highest standards of cleanrooms that meet Federal Standard 209E.
Our Class 5 cleanroom is used for producing products that will be used in a medical operating theatre environment by surgeons and come into contact with the human body. These products must meet the highest standards of cleanliness to ensure patient safety.
Our Class 7 cleanroom is also used for operating theatre products, but these do not come into contact with the human body. These products and/or devices would be double bagged using sterile packaging which is suitable for sterilisation processes prior to use.
Cleanrooms are particularly critical in the medical device industry because the products manufactured are intended for use in healthcare settings, where any contamination can have serious consequences for patient health. Medical devices, including implants, diagnostic equipment, and surgical instruments, must be manufactured in a controlled environment to prevent contamination by bacteria, viruses, or other particles that can cause infections.
To achieve these standards, here at Biplas we use high-efficiency particulate air (HEPA) filters to remove particles from the air. These filters are designed to capture particles as small as 0.3 microns with an efficiency of 99.97%. We also carefully control the airflow in our cleanrooms to maintain positive pressure and prevent contamination from outside sources.
In addition to using HEPA filters, we also have changing atriums for gowning and storage of packaging materials. These areas are essential for maintaining the necessary level of cleanliness in our cleanrooms that protect the quality and consistency of our client’s manufactured products.
Bioburden Testing
Another way to improve the cleanliness of a cleanroom is through bioburden testing. Biplas use bioburden testing on products produced in our cleanrooms to confirm their level of cleanliness prior to production. This testing measures the number of viable microorganisms on a product and helps us ensure that our products meet the necessary standards for cleanliness. This reduces problems during the production process and ensures a high-quality end product.
Capacity and Lead Times in cleanroom manufacturing
Thanks to the modular construction of our cleanrooms, we have the flexibility to increase capacity as demand requires. This allows us to quickly and easily expand our operations to meet the needs of our customers.
Our lead times are dependent on material availability, but generally, repeat orders can be supplied on a monthly basis according to a schedule. We work closely with our customers to ensure that their needs are met in a timely and efficient manner.
The importance of meeting cleanroom requirements
Cleanrooms help ensure that the final product meets the highest quality and safety standards, meets regulatory requirements, and improves efficiency and productivity. By investing in cleanrooms and other quality control measures, we can ensure that patients receive safe and effective products.
Biplas are committed to providing the highest quality products in a clean and safe environment. Our state-of-the-art cleanrooms and strict protocols ensure that our products meet the highest standards of cleanliness and allow us to meet industry regulatory requirements. Our exceptional customer service and commitment to meeting your specifications is second to none; our staff have years of experience in the injection moulding industry, allowing us to manufacture your product quickly with exceptional accuracy.
Contact us
If you’re looking for a partner to help you manufacture your medical devices, contact us today. Our experienced team will work with you to understand your specific needs and requirements and develop a customised solution that meets your specifications. With over 40 years of experience, you can be confident that your products are being manufactured to the highest standards of quality and safety. Contact us today to learn more about how we can help you with your cleanroom manufacturing needs.
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