Aleix Nin

In many laboratories, advanced sterilization and culture media preparation depend on something as basic as it is essential: having a stable water supply, a functional drain, and a responsible approach to water consumption. Modern autoclaves and media preparators require large volumes of water for cooling and drainage systems, which can result in intensive—and sometimes inefficient—use of this resource. Additionally, some facilities operate with inconsistent water supply, insufficient flow, or no drainage at all, making it challenging to keep processes running smoothly without increasing water waste.

For these environments—and for any laboratory that wants to ensure operational continuity while measurably reducing water consumption—RAYPA has developed AUTOFILL, a closed-loop external water-supply and management system for sterilization, cooling, and drainage processes.

What AUTOFILL is and how it works

AUTOFILL is an accessory that functions as an external water-supply and management system, built around a storage tank and integrated pumps. It guarantees continuous operation even when the laboratory lacks a stable water network, has insufficient flow, or has no operational drain.

The system operates as a closed loop: it supplies water to the equipment and recirculates the water used during sterilization, cooling, and drainage, ensuring a stable flow while significantly reducing both consumption and waste.

It also includes audible alarms that notify users of low water levels or a full tank—preventing unexpected interruptions during a cycle.

AUTOFILL-TLV-200: application for Top Line autoclaves

The AUTOFILL-TLV-200 version is designed specifically for Top Line autoclaves – TLV Series. Its role is clear: to keep the autoclave running even when the facility does not provide optimal water utilities.

In installations without a constant water network, with insufficient flow, or without drainage, AUTOFILL-TLV provides autonomy through its tank and pressure pump, managing the water involved in sterilization, cooling, and drainage processes.

Download the technical datasheet for AUTOFILL-TLV-200

AUTOFILL-MP-200: application for AE-MP and TLV-MP media preparators

The AUTOFILL-MP-200 version is the equivalent solution for Classic Line (AE-MP) and Top Line (TLV-MP) media preparators.

These units include a sterilization phase followed by a rapid-cooling phase, the latter performed through a water-cooling coil. For this reason, having a reliable water supply and proper drainage management is essential for productivity and reproducibility. AUTOFILL-MP guarantees that continuity even when the laboratory lacks a stable hydraulic infrastructure.

Download the technical datasheet for AUTOFILL-MP-200

Technical advantages of AUTOFILL

1. Continuous operation: Designed to ensure uninterrupted operation in environments with water-supply or drainage limitations.

2. Closed-loop system: Recirculates the water used during sterilization, cooling, and drainage, eliminating dependence on a permanent external supply.

3. Safety and alarms: Equipped with audible alarms to signal low water level or a full tank, minimizing potential interruptions.

4. Efficient water management: Optimizes water use by supplying only what is needed and enabling its recovery.

5. Ready to install: AUTOFILL is supplied as a complete set that includes:

• Transport cart with wheels and braking system
• 200 L tank with minimum and maximum level sensors
• Pressure pump with adjustable switch
• Heat exchanger
• Connection hoses and 1.5 m power cord

ECO benefits: tangible sustainability in daily operations

AUTOFILL stands out as an ECO-focused system designed to maximize water efficiency in sterilization and media-preparation workflows. Its closed-loop operation optimizes water consumption, enables reuse, and significantly reduces waste—supporting a more sustainable and controlled laboratory operation.

These advantages are especially relevant in laboratories with limited supply, insufficient flow, or discharge restrictions. In such environments, AUTOFILL transforms infrastructure limitations into a real operational improvement, ensuring more responsible, efficient, and consistent water use without compromising sterilization performance, cooling efficiency, or process reproducibility.

Recommended use cases

1. Absence of drainage: Allows collection of cooling water without requiring an external drain.

2. Lack of a cooling-water supply: Provides water for cooling; water is later discharged through the drain, without reuse.

3. Lack of both cooling-water supply and drainage: Operates as a closed-loop water system with integrated cooling, eliminating the need for continuous water consumption and discharge. This is the most efficient and sustainable option.

Enhance your autoclave or media preparator with the AUTOFILL system

AUTOFILL-TLV-200 and AUTOFILL-MP-200 are designed for labs that don’t want infrastructure limitations to restrict their sterilization or media preparation capacity. They provide operational continuity, efficient water management, and a realistic ECO approach—especially valuable in settings with constrained water resources.

If you want to confirm compatibility with your model or determine which configuration best fits your installation, reach out to our technical team.

 

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Validating an autoclave is not simply about checking whether it reaches the correct temperature.

In regulated environments—such as the pharmaceutical and biotechnology industries—validation means demonstrating, through documented evidence, that the equipment performs according to its design, meets the applicable sterilization standards, and that data management processes comply with the corresponding regulations.

Two Areas of Qualification

For our Top Line autoclaves, validation can be approached from two complementary angles:

1. Functional Performance of the Autoclave
Ensures that installation, operation, and performance comply with the manufacturer’s specifications and applicable standards. It includes all necessary thermal and safety tests required to prove that the sterilization process is reproducible, safe, and compliant.

2. Electronic Records Management
Ensures that the acquisition, storage, and traceability of data and electronic signatures comply with FDA 21 CFR Part 11 and GMP Annex 11, both in the equipment’s microprocessor and, when applicable, in the external management platform (RAYPAcloud).

Qualification Options: By RAYPA or Through Third Parties

We understand that every laboratory has its own compliance strategy. For this reason, RAYPA offers two flexible approaches:

• Full Qualification
  Performed by RAYPA technicians or authorized entities. It includes commissioning, complete qualification of the autoclave and its software, and the generation of all required documentation to meet the most demanding regulatory standards.
• Qualification Through Third Parties
  We provide detailed protocols and documentation so that your internal team or a trusted qualification agency can execute the qualification independently. This option maximizes flexibility and alignment with your internal processes.

Both approaches are designed to ensure efficiency, safety, and regulatory compliance, adapting to the degree of outsourcing you prefer.

Download the Qualification Services Datasheet

Qualification Phases: IQ, OQ and PQ

Autoclave validation is normally structured into three phases:

• IQ – Installation Qualification: Verifies that the equipment has been installed according to the manufacturer’s specifications and configuration requirements.
• OQ – Operational Qualification: Confirms that the system operates consistently within the defined parameters, including alarms, interlocks, and critical controls (temperature, pressure, time, F0 when applicable).
• PQ – Performance Qualification: Demonstrates that the process meets specifications under real-world operating conditions and with a representative load.

After completing IQ and OQ, an IOQ Report (IOQR) is issued, consolidating all results and evidence of compliance. This provides full project traceability and paves the way for PQ and routine operation under a validated state.

Software Qualification and Data Integrity (FDA 21 CFR Part 11)

In regulated environments, what is not recorded does not exist. Therefore, in addition to qualifying the equipment itself, it is essential to validate the controller software and, when applicable, the external management platform (RAYPAcloud).

This qualification applies specifically to computerized systems and aims to demonstrate compliance with FDA 21 CFR Part 11 and GMP Annex 11.

We offer two software-qualification packages (controller and/or platform), delivered with complete documentation required for FDA/GMP audits:

• VP (Validation Plan): scope, methodology, resources, and schedule.
• URS (User Requirements Specification): user and system requirements.
• RA (Risk Assessment): system or process risk analysis.
• Software IQ and OQ: verification of proper installation and operation according to specifications.
• IOQR: final report with results and objective evidence.

This approach ensures full traceability, data integrity, and regulatory compliance throughout the entire system lifecycle.

Why Choose RAYPA

• 360º approach: from equipment IQ-OQ-PQ qualification to software validation and FDA/GMP-compliant data management. A single point of contact—less friction, faster execution.
• Compliance-ready technology: Top Line autoclaves are designed with the connectivity and data-control capabilities needed for paperless operation, reducing data-integrity risks and accelerating inspections.
• True flexibility: choose between full RAYPA-managed qualification or third-party documentation packages, and select the software-qualification model that best aligns with your IT policies and workflow.

When Validation Is Essential

• When manufacturing or testing pharmaceutical, biotechnology or medical products.
• When your processes require data integrity and traceability with electronic records and digital signatures.
• When you need solid documented evidence for audits or for technology transfer to new facilities or production lines.

In all these cases, RAYPA helps translate regulatory requirements into executable protocols and clear evidence.

Take the Next Step

Do you want to qualify your Top Line autoclave or need to align your electronic records with FDA 21 CFR Part 11?
Our technical team can guide you toward the most efficient qualification pathway and help you define the digital quality-management approach that best integrates into your environment.

 

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In laboratories and research centers with a high workload, every minute counts. Reducing cycle times, planning for technological upgrades, and ensuring continuous operation are key factors to increasing productivity without compromising quality or safety.

In this article, we introduce three accessories specifically designed to make your Top Line autoclave work faster, more efficiently, and without unnecessary interruptions.

1. Internal Radial Fan

Cooling up to 80% faster

Compatible with autoclaves from the TLV-FA and TLV-DUAL Series with rapid cooling systems, this accessory is factory-installed and works alongside the water coil to drastically reduce cooling times:

• Up to 80% in the TLV-FA Series.
• Up to 60% in the TLV-DUAL Series.

With a speed of 1300 rpm and a compact design (Ø200 mm x 173 mm), the fan enables more cycles per day, boosting the overall performance of the equipment. It is ideal for laboratories that sterilize large volumes of liquids, where cooling speed is critical.

Note: Its installation reduces the usable chamber height by 70 mm, a factor to consider depending on the type of load.

Download technical datasheet

2. Adaptation Kit for the TLV-DUAL Series

Modular evolution of your autoclave

This kit allows any Top Line autoclave from the TLV-S, TLV-PD, or TLV-FA Series to be prepared for a future upgrade to the TLV-DUAL Series.

Key benefits:

• Modular evolution: start with a simpler unit and upgrade when needed.
• Cost optimization: reduce initial investment and avoid replacing the unit.
• Operational flexibility: adapt the technology as your needs change.
• Sustainability: extend the service life and minimize waste.

The adaptation must be requested at the time of purchase and leaves the unit ready to integrate super-drying and/or rapid cooling systems in the future, while maintaining quality and certification standards.

Download technical datasheet

3. Water Supply and Management System

ECO solution for efficient consumption and water reuse

A closed-loop water supply system designed for environments without constant access to a water network, with insufficient flow, or without drainage.

Key functions:

• Reuses water employed in sterilization, cooling, and drainage processes.
• Maintains a stable flow thanks to integrated tanks and pumps.
• Reduces consumption and water waste, improving costs and sustainability.

Ideal for facilities with infrastructure limitations or for those seeking an eco-efficient solution.

With these three accessories, you can shorten cycle times, plan upgrades without replacing your unit, and ensure uninterrupted operation—even in environments with infrastructure limitations.

Contact us and discover how to take your Top Line autoclave to the next level.

 

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In regulated environments, digital quality management is not optional—it is a strategic necessity. Traceability, regulatory compliance, and immediate access to information are essential to ensure safe, auditable, and efficient processes.

At RAYPA, we develop advanced digital quality management solutions tailored to the specific requirements of each laboratory. We offer 6 options to manage the quality of data stored both in the autoclave’s microprocessor and in the RAYPAcloud management platform, with different levels of connectivity, privacy, and FDA compliance.

Our Top Line autoclaves and media preparators are our flagship products and the preferred choice of pharmaceutical companies, biotechnology firms, and research centers in more than 100 countries. Designed with cutting-edge technology, they enable compliance with GMP and FDA regulations, operation in fully private environments, or seamless integration with LIMS and Active Directory systems.

Below, you will find all the available options, their features, and benefits—so you can choose the one that best fits your laboratory.

Most Popular Options

Private Standard

Maximum security and FDA compliance

Data is stored both in the autoclave controller and on a private server, with access to the offline management platform via a local area network. Both the controller and the platform are fully FDA 21 CFR Part 11 compliant. Includes automatic backups, complete audit trails, synchronous remote diagnostics via TeamViewer®, and manual updates.

✅ Ideal for industries that require maximum security, complete control, and certified traceability.

Cloud Standard

Full connectivity from anywhere

Stores data in both the controller and the cloud (AWS USA or EU), allowing online access to the platform from any device. Provides centralized management of multiple units, remote administration of users and programs, alert notifications, asynchronous remote diagnostics, and over-the-air updates.

✅ Perfect for those seeking flexibility, remote management, and high availability without the need for FDA compliance.

Other Options

Cloud-comply

Partial FDA compliance with advanced connectivity

Data is stored in both the autoclave controller and the cloud (AWS USA or EU), allowing online access to the management platform from any internet-connected device. Controller management complies with FDA 21 CFR Part 11, but cloud storage is not Part 11 compliant.

✅ Designed for users who require regulatory compliance on the equipment itself while also benefiting from advanced monitoring and remote administration features.

Essential-comply

FDA compliance without connectivity

All data is stored exclusively in the autoclave controller, configured to enable features such as audit trails, backups, and other tools that ensure compliance with FDA 21 CFR Part 11. It does not support remote access or cloud connection.

✅ Recommended for laboratories that do not require remote access but need to guarantee the integrity, traceability, and legal validity of their records.

Private Basic

Total privacy without connectivity

Data is stored on a private server, with access to the offline management platform through the local area network. While it is not FDA 21 CFR Part 11 compliant, it offers maximum internal security for those who prefer to keep all data within their own infrastructure without relying on cloud services.

✅ Ideal for environments with strict internal privacy policies.

Essential

Basic solution without connectivity

Stores data exclusively in the autoclave controller, with no cloud access or advanced digital management functions. It is not FDA 21 CFR Part 11 compliant.

✅ The simplest and most economical option for users who require direct, straightforward management.

Comparative Overview of the Options

We have prepared a summary document with the specifications of each option so you can easily compare levels of connectivity, privacy, and regulatory compliance, and choose the one most suitable for your laboratory.

See Comparative Overview

Expert Support and Comprehensive Assistance

At RAYPA, we don’t just provide technology—we also ensure its successful implementation:

• Personalized consulting
• Custom developments and tailored integrations
• Equipment and software qualification
• Training on use and maintenance
• Advanced technical support and maintenance

Take the Next Step Towards Full Digital Traceability

Optimize your laboratory’s quality management, reduce audit times, and enhance the security of your processes.

Request an expert consultation or a demo today and discover which option is best suited for your laboratory.

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With over 50 years of experience manufacturing autoclaves, RAYPA introduces the innovative TLV-DUAL Series, designed to provide advanced sterilization of both liquid and solid loads.

This cutting-edge series stands out for its superdrying and fast cooling systems, optimizing process times and significantly enhancing operational efficiency.

Advanced Technology for Optimal Sterilization

The TLV-DUAL Series offers solutions specifically tailored to meet the most demanding sterilization requirements, combining state-of-the-art technology with functional, ergonomic design.

These autoclaves are available in four capacities – 58, 83, 124, and 169 liters – allowing easy adaptation to different laboratory spaces and load volumes.

A distinctive feature of this series is its dual system, which includes:

• Superdrying, utilizing a vacuum pump and heating jacket to ensure complete removal of residual moisture, thus preserving the integrity of sterilized materials.
• Fast cooling, achieved via an integrated water cooling coil, substantially reducing cycle times and increasing laboratory productivity. An optional internal radial fan can further shorten the cooling phase.

Safety and Ease of Use

Safety remains a top priority for RAYPA. TLV-DUAL autoclaves are equipped with multiple safety features, including:

• Bacteriological filters that ensure air entering and exiting the chamber remains sterile.
• Push-button, mechanically-assisted automatic door, minimizing physical effort and enhancing operator safety.
• A modern 7” capacitive touchscreen with digital controls, providing intuitive, precise management of all processes.

Exceptional Build Quality and Sustainability

Constructed from high-quality stainless steel (AISI-304 externally and AISI-316L internally), TLV-DUAL autoclaves exhibit exceptional corrosion resistance and longevity with minimal maintenance required.

Their fully electric design eliminates reliance on fossil fuels, optimizing water and energy consumption, thus aligning with sustainable practices.

Comprehensive Traceability and Advanced Digital Management

Effective process management and traceability are critical in today’s highly regulated environments. The TLV-DUAL Series offers:

• Batch process control to ensure consistent, documented results.
• The RAYPAtrace system, including label printers and barcode scanners for complete traceability.
• Optional integration with RAYPAcloud digital platform, meeting FDA and GMP standards for secure, centralized management of sterilization cycles from any location.

Flexibility and Adaptability

Designed for swift, straightforward installation, the TLV-DUAL Series integrates essential functionalities into a compact, user-friendly unit:

• Simplified water and electrical connections.
• Antistatic casters with integrated brakes for easy mobility.
• Optional basket lift system, either integrated (FIX-LIFT) or mobile (MOB-LIFT), ensuring safe handling of heavy loads.

Comprehensive Technical Support and Consulting

When you choose a RAYPA autoclave, you benefit from specialized technical support at every stage – from installation and commissioning to predictive and corrective maintenance. Our global network of authorized technicians guarantees prompt, effective service whenever needed.

Ready for More Information or a Customized Quote?

If you’re interested in learning more about the TLV-DUAL Series or need a personalized quote, please contact our sales team.

We’re here to assist you in finding the ideal autoclave for your laboratory.

 

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