For any manufacturing unit associated with medical products, maintaining proper hygiene and cleanliness is mandatory. And that’s where the cleanroom technology came into existence. Clean rooms in the medical industry refers to a highly controlled environment which has been specifically designed to ensure minimal contamination. This room has several restrictions in terms of temperature, humidity, pressure and personal entry.
Cleanrooms are important to ensure safe and contaminants free medical products and that’s why Mednetic ensures that all its medical device production takes place in class D clean room facilities.
Mednetic is a renowned name in the medical manufacturing sector. Mednetic expertise lies in manufacturing a wide range of medical products, with endoscopic accessories being the main product category.
The cleanroom has several legal and quality requirements that make them perfect to ensure medical product quality and safety. These features are:
- Controlled airflow to prevent recirculation of contaminants
- High filtration systems to trap dust, microbes and other airborne particles
- Strict monitoring and control to ensure optimal hygiene and cleanliness
- Suitable cleanroom garments for the persons working in the cleanroom
- Regular Surface decontamination to prevent microbial build-up
- Cleanrooms materials should be compatible with the controlled environment of cleanrooms be it filtration systems, lights or doors.
- Strict protocols for entry and exit of cleanroom personnel
- Compliance to industry manufacturing standards and regulations
Why are cleanrooms important for endoscopic accessories production?
Mednetic always ensure that all its endoscopic accessories are manufactured in class D cleanroom facilities due to following reasons:
- Controlled contamination: Due to a controlled environment, cleanrooms have limited dust, microbes and aerosols, which is important to maintain the sterility of these accessories.
- Safety and efficacy: Cleanrooms ensure that endoscopic accessories meet all health and safety standards, making them suitable to use in the internal organs of the human body.
- Compliance to regulations: Manufacturing of endoscopic accessories requires compliance to certain regulations and industry standards. As cleanrooms maintain temperature, humidity and pressure meticulously, such controlled environments help meet those requirements.
- Maintain product integrity: As cleanrooms prevent medical products from contamination, it maintains product integrity and keeps them safe for human use.
- Quality assurance: Medical products like endoscopic accessories are directly used on the human body and thus need to be of high quality. Cleanrooms with enhanced standards ensure such high-quality medical products.
Cleanrooms classify in four different grades; grade A, Grade B, Grade C and Grade D.
Mednetic’s endoscopy accessories are manufactured in Grade D cleanroom facilities. These cleanrooms allow a maximum concentration of 3,520,000 particles per cubic meter of area.
Based on the European standards, Mednetic’s cleanroom and other controlled environments are designed and constructed to control contamination from airborne particulates. Also, these standards ensure that cleanrooms follow the required level of cleanliness, which is vital for products safety and quality.
Working in a controlled environment and adhering to industry standards, Mednetic manufactures high quality, safe and reliable products. Maintaining a highly controlled environment in cleanrooms, Mednetic ensures that all its medical products are safe for humans.