Vertical autoclaves with super-drying and fast cooling system
The sterilization process in the pharmaceutical industry using autoclaves
An autoclave for the pharmaceutical industry employs high-pressure saturated steam to sterilize the load. This involves arranging the items or pharmaceutical products within a completely sealed sterilization chamber. Within this space, a steam generator warms up purified water before injecting it into the chamber, reaching pressures and temperatures surpassing water’s typical boiling point. The synergy of elevated temperature and pressure facilitates the rapid extermination of all microorganisms.
However, not all pharmaceutical products are compatible with this sterilization method. Some materials, especially those sensitive to heat or that can degrade at high temperatures, require alternative sterilization methods. These may include radiation, filtration or chemical agents, depending on the specific characteristics and formulation of the pharmaceutical product.
Time is an invaluable asset in all sectors, particularly in the pharmaceutical industry, where efficiency, safety, and economic considerations are paramount. Optimizing the duration of autoclave sterilization cycles is essential. Prolonged cycles can lead to higher operational costs, increased consumption of energy and water, and potentially slow down the overall production timeline. However, it’s critical to ensure that the sterilization process is comprehensive, necessitating a careful balance between swift operation and the assurance of safety and effectiveness in sterilization.
Regarding quality standards, what sets pharmaceutical autoclaves apart from those in other industries is the strict adherence to regulations set forth by authoritative bodies like the FDA and EMA, along with other global entities. Key factors such as data traceability, real-time process monitoring, equipment validation, and certification of process quality hold significant importance. Data traceability ensures that every phase of the sterilization process is documented and verifiable, thereby safeguarding the integrity of the final product and consumer safety.
Furthermore, routine maintenance and calibration of autoclaves are crucial. These practices ensure that the equipment functions at optimal efficiency, providing proper sterilization of products and preventing malfunctions that could compromise the quality of pharmaceuticals and related supplies.
The vertical autoclave stands out as one of the most prevalent types within the pharmaceutical industry, available in various designs and sizes. These autoclaves are characterized by their top-loading feature, where access to the chamber is facilitated through the upper section.
In terms of applications, in the pharmaceutical industry, autoclaves are required a to be able to handle a broad spectrum of items, ranging from solid instruments like tweezers and cuvettes to wrapped goods and items with complex geometries. Importantly, these devices should also feature a pressure support system to ensure the effective sterilization of hermetically sealed containers, an essential capability for treating liquid substances.
Among the items commonly sterilized with autoclaves for the pharmaceutical industry are intravenous solutions, used in hospitals and clinics, pre-filled syringes, and bags made of materials such as PP (Polypropylene), PE (Polyethylene), and PVC (Polyvinyl Chloride), essential for storing different medical fluids. Plastic and glass bottles, which are used to contain individualized or bulk doses of liquids and other pharmaceutical products, are also included. Similarly, ampoules or vials, which may be made of glass, PP (Polypropylene), or PE (Polyethylene), also require a sterilization process, especially when they are already filled with medication or solutions.
Autoclaves for the pharmaceutical industry of certified quality
At RAYPA we have developed the Top Line range of autoclaves for the pharmaceutical industry, with a modern design and professional traceability to operate in GMP and FDA environments. This lineup features models from the TLV-S, TLV-PD, TLV-FA and TLV-DUAL Series, all of which incorporate state-of-the-art process optimization technology to save time in each sterilization cycle. Moreover, autoclaves from the TLV-FA Series are equipped with fast cooling and pressure support, enabling them to process hermetically sealed containers and sensitive materials of any type, including vials and pre-filled syringes.
It is also important that the autoclave is able to log and track data from every cycle conducted, ensuring all this information is traceable. To meet this challenge, our autoclaves feature cloud-based connectivity that securely archives all data in accordance with the highest security protocols. Furthermore, all generated databases and reports are designed to be auditable. Additionally, if necessary, our autoclaves can be outfitted with supplementary accessories like ticket printers and a basket lifting crane.
These autoclaves for the pharmaceutical industry are ideal for performing pasteurization and sterilization operations in research centers and microbiological control, in pilot batch production areas, in designated clean rooms, in R&D departments, and in quality control laboratories.
Among the options available to adapt the autoclaves exactly to the required tasks are:
- 7” PLC touchscreen with modern design.
- AISI-316L stainless steel sterilization chamber in accordance with the Pressure Equipment Directive (PED), ASME and other regulations.
- Push-button-controlled mechanically assisted door.
- Versions equipped with super-drying system with heated jacket and liquid ring pump for fractioned pre-drying and complete moisture removal at the end of the cycle.
- Versions equipped with a rapid cooling system that includes a water coil and an internal radial fan. In combination with the pressure support system, it drastically accelerates the cooling process for liquid loads.
- Integrated steam generator to obtain high-quality saturated steam.
- Vacuum pump intended for single-pulse prevacuum or fractionated prevacuum on TLV-PD Series models.
- Automatic feeding from the own water network, with cooling of the discharge and condensation of steam produced with cold water.
- In addition, to improve ergonomics and safety, an integrated crane or an external crane with casters and battery can be installed.
- Professional traceability according to GMP and FDA in controller and also in the external management software.
- The cloud-based management and documentation system, RAYPAcloud, offers the option of a public installation in the cloud or private installation on a local server using Docker, LIMS or Active Directory, allowing automatic documentation of all processes executed in the autoclave. Connectivity is provided via Ethernet or Wi-Fi connection.
- In cases where external management software is not available, the controller has a memory for storing up to 1000000 cycles, which can be easily expanded with the use of a USB memory stick.
- Advanced technical support including appointment scheduling through the controller, screen sharing via TeamViewer®, and remote diagnosis of equipment status and failures.
- Comprehensive IQ, OQ and PQ qualification services of the autoclave, the controller and the external management software.
At RAYPA, we provide comprehensive solutions tailored to meet our customers’ sterilization requirements. With our wide selection of autoclaves and the expert advice of our team, we assist you in finding the equipment that best suits your requirements.
For more detailed and customized guidance on choosing the ideal autoclave for your laboratory, do not hesitate to contact our experts. Working together, we can identify and provide a solution that ensures both efficiency and safety in all your sterilization operations.
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.
