Qualification Services for Top Line Autoclaves
In this article, you will learn why qualification is important and explore the different IQ, OQ, and PQ service options for RAYPA’s Top Line autoclaves.
Qualification is an essential process to ensure that equipment meets the required standards in terms of safety, performance, and regulatory compliance.
In the case of autoclaves, qualification is crucial to verify their proper operation in sterilization processes, ensuring that the equipment functions reliably under established regulations.
This process is particularly critical in industries such as pharmaceuticals and biotechnology, where sterilization must meet strict regulatory requirements to guarantee product safety and end-user protection.
Phases of the Autoclave Qualification Process
The qualification of an autoclave consists of three main phases, each designed to ensure the safe and efficient operation of the equipment:
1. Installation Qualification (IQ)
The first phase of the validation process verifies that the autoclave has been installed correctly according to the manufacturer’s specifications. This initial step includes:
- Inspection of components and connections.
- Verification of technical documentation.
- Validation of Standard Operating Procedures (SOPs) for maintenance, calibration, and cleaning.
2. Operational Qualification (OQ)
During this phase, tests are conducted to ensure that the autoclave consistently operates within predefined parameters. This involves:
- Functional tests under different conditions.
- Evaluation of sterilization cycles.
- Identification and correction of any deviations before actual operation.
3. Performance Qualification (PQ)
The final phase of the qualification process confirms that the autoclave maintains reliable performance under real production conditions through:
- Sterilization tests using standard materials and processes.
- Documentation of results and implementation of corrective measures if necessary.
Available Qualification Options
Top Line autoclaves offer the possibility of qualifying both their functional performance and the management of electronic records within their software.
Autoclave Qualification
To ensure optimal performance and maximum safety, the autoclave must comply with the latest standards and regulatory requirements.
ISO 17665 establishes the requirements for the safe and effective sterilization of healthcare products using moist heat processes.
Compliance with this standard ensures the effectiveness of sterilization cycles, preserves product integrity, and guarantees end-user safety.
Software Qualification
Software qualification is essential for customers who must comply with FDA Title 21 CFR Part 11 and/or Annex 11 of the Good Manufacturing Practices (GMP) of the European Union. These regulations set requirements for the storage of electronic records, digital signatures, and the management of computerized systems.
In this context, the available qualification options include:
- Controller Software Qualification: Validates that the autoclave microprocessor manages information in compliance with FDA Title 21 CFR Part 11.
- Management Platform Software Qualification: Verifies that the external RAYPAcloud platform, installed on a private server, meets the requirements of FDA Title 21 CFR Part 11.
Complying with these regulations ensures data integrity, security, and reliability, preventing risks that could compromise product quality or safety.
Additionally, it is crucial for passing audits and obtaining regulatory certifications, supporting traceability and transparency throughout the software lifecycle.
Qualification Service Options for RAYPA Autoclaves
At RAYPA, we offer two qualification service options to adapt to the specific needs of each customer:
1. Comprehensive Qualification by RAYPA
Our team of specialized technicians or authorized entities manages the entire process, ensuring compliance with the highest standards. This service may include:
- Commissioning of the equipment.
- Complete qualification of the autoclave and its software.
- Detailed documentation for audits and certifications.
2. Third-Party Qualification
For customers who prefer to work with their trusted agency, we provide:
- Comprehensive technical documentation and detailed protocols.
- Technical support for inquiries throughout the process.
Both options ensure that autoclaves comply with regulatory requirements and operate with maximum efficiency and safety.
Whether you choose our comprehensive qualification, where we handle the entire process, or our third-party qualification service, we always provide the necessary documentation and support.
Choose the option that best suits your needs and ensure reliable, certified sterilization. For more information about our autoclave qualification services, contact us.
Our Top line autoclaves
