Vertical autoclaves with super-drying and fast cooling system
What are the characteristics of FDA autoclaves?
Specifically, when we talk about an FDA laboratory autoclave, we are referring to Part 11 of Title 21 of the Code of Federal Regulations (FDA 21 CFR Part 11). This code regulates the security and privacy requirements of the electronic records generated by the equipment and is mandatory for any laboratory autoclave marketed in that country and used to sterilize food or medicines.
To adhere to these regulations, an autoclave must ensure that its data management system and electronic signatures fulfill precise and stringent criteria. The regulation oversees various aspects, including the validation mechanisms that verify the authenticity of generated reports, protocol management, the management of user and administrator hierarchies, the traceability of all operations conducted within the autoclave, and the confidentiality of the produced data.
For instance, an FDA-compliant autoclave should establish a clear hierarchy of users and administrators, with defined rights and permissions for each role. Moreover, every operation performed on the autoclave must be properly recorded and authenticated, ensuring that this data cannot be altered or deleted under any circumstances, while also maintaining its confidentiality at all times.
Meeting these regulations is understandably challenging. Often, compliance must be verified by specialized firms adept at validating such processes, which then provide certification attesting to adherence to these standards. Consequently, manufacturers of FDA autoclaves ensure that the microprocessors and management software governing their autoclaves are in compliance with FDA 21 CFR Part 11.
Thus, utilizing an FDA-compliant sterilizer, or FDA autoclave, ensures that any test or project involving the sterilization of materials or products will have its process meticulously documented from beginning to end, adhering to very high-quality standards. This is of utmost importance in industries where precision, dependability, and adherence to regulations are paramount for ensuring the quality and safety of the final products, as well as protecting consumer health.
FDA-certified autoclaves
At RAYPA, we offer a range of autoclaves that are in compliance with FDA 21 CFR Part 11, designed specifically for quality control and research laboratories in the pharmaceutical, biotechnology and food industries that work under FDA quality standards.
We invite you to contact our sales team to recieve expert guidance on our range of FDA autoclaves. Beyond our standard services, we also provide customized developments, either based on private centralized management or on a cloud platform, and always accompanied by the advice and support of our technical experts. Additionally, we offer services to qualify the installation and operation of the autoclave, as well as to verify that both the controller and management software conform to FDA regulatory standards.
Why RAYPA?
GLOBAL REACH
With half a century of experience, we have a lengthy list of satisfied customers around the world. Currently, we export 85% of our annual turnover and have a stable network of distributors in over 100 countries.
EFFICIENT TECHNICAL SERVICE
Our team of highly qualified technicians and engineers is expert in our products. If you experience a technical issue, it will be our priority to rectify it. When you purchase a RAYPA unit, you’re guaranteed top-level support and technical assistance.
EXPERT MANUFACTURER
RAYPA is a global leader in manufacturing laboratory autoclaves. Each of our autoclaves is designed and built entirely at our facilities in Barcelona, ensuring the highest levels of production excellence.
FULL AND CUSTOMIZABLE RANGE
We offer an extensive portfolio of laboratory autoclaves to cover multiple applications and market segments. Discover the combination of autoclave model and accessories that best fits your needs within our 11 series and 35 available models.
INNOVATION AND QUALITY
Our products feature advanced technology, ongoing innovation, superior construction quality, and are designed for a long service life. Our technical and engineering staff works tirelessly every day to optimize our products and exceed our customers’ expectations.
COMPREHENSIVE CONSULTATION
Our team of specialists assesses each project and provides guidance to clients on the option that best suits their requirements. After the sale, we offer training on the use and recommended maintenance of each unit to ensure its optimal operation and extend its lifespan.
