Vertical autoclaves with super-drying and fast cooling system
What are the characteristics of GMP autoclaves?
Good Manufacturing Practices (GMP) set the baseline requirements that human medicine manufacturers must adhere to in their production processes. These standards are developed and overseen by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). Both agencies coordinate inspections to ensure that all pharmaceutical manufacturers, regardless of their global location, comply with these standards if their products are intended for the European Union or U.S. market.
These practices aim to guarantee that drugs consistently maintain high quality, are suitable for their intended use, and comply with the specifications of their marketing authorization.
When we mention a GMP autoclave, we refer to one that is in line with these good practices described by the European Union and the United States. Its application is mandatory for large autoclaves used for the production of medicines for human consumption. This implies that its design obeys a set of rigorous criteria that range from the selection of materials in its construction, through safety specifications, to the quality of the water used in the sterilization process.
Specifically, when we talk about a GMP laboratory autoclave, we are referring to GMP Annex 11, which describes the rules governing the security and privacy requirements of the electronic records generated by the equipment. In order for an autoclave to comply with these regulations, its record keeping and electronic signature control system must follow very strict and specific requirements.
This regulation mandates several key aspects, including validation mechanisms to ensure the authenticity of generated reports, protocol management, the organization of user and administrator hierarchies, the traceability of all operations carried out within the autoclave, and the confidentiality of the data produced.
GMP-certified Autoclaves
At RAYPA, we offer a range of autoclaves that are in compliance with this annex, suitable for quality control and research laboratories in the pharmaceutical, biotechnology, and food sectors that operate in accordance with GMP quality standards.
This means that laboratories operating under this regulation can be confident that our equipment will not only perform effective sterilization over a wide range of temperature and pressure values, but will also handle, store and protect data according to the highest safety 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.
We invite you to contact our sales team to recieve expert guidance on our range of GMP 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.
