Oven & Dry Heat Sterilization

Autoclave Validation is a comprehensive service designed to ensure that your sterilization processes are effective and compliant with regulatory standards. Our validation service includes a series of tests and assessments performed by our expert Validation Engineers and Microbiologists to guarantee that your equipment operates at its best, ensuring the sterility of your tools and products.

An Autoclave Validation IOPQ refers to the combined processes of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), which are sequential and interdependent assessments that ensure an autoclave is installed, operating, and performing correctly. Here's what each section entails:

• Installation Qualification (IQ): IQ is the first step in the Autoclave Validation IOPQ process. It verifies that the autoclave has been delivered as designed and specified, confirming that it is properly installed in the facility. This stage includes checking the installation of all system components, ensuring that electrical and piping connections are correct, and confirming that the hardware and software are properly set up.

• Operational Qualification (OQ): The OQ follows the IQ and focuses on ensuring that the autoclave operates according to its operational specifications. This phase tests the autoclave's functions in detail, assessing its performance under different settings to ensure it works as expected across its entire range of operation, including any alarms, sensors, and control systems.

• Performance Qualification (PQ): The final phase, PQ, is conducted after the IQ and OQ have been successfully completed. It tests the autoclave's ability to consistently deliver the required sterilization performance over successive runs. This phase simulates actual working conditions to validate that the autoclave can effectively sterilize the items, ensuring that they meet the necessary sterility assurance levels for their intended use.

Collectively, the IOPQ process is critical to not only validating the proper installation, operation, and performance of an autoclave but also to ensuring compliance with industry regulations and safety standards.

Yes, calibration is an integral part of Autoclave Validation and is typically included within the Operational Qualification (OQ) phase. Calibration ensures that the instruments and sensors of the autoclave are providing accurate and precise readings, which is essential for reliable sterilization.

• During the OQ phase, we conduct a thorough calibration of the autoclave's temperature and pressure sensors, timers, and any other critical measuring devices. This step is vital to confirm that the autoclave will operate within the specified parameters and consistently achieve the required sterilization conditions.

Ensuring that the calibration is accurate is essential not only for validation but also for ongoing compliance with regulatory standards. Properly calibrated equipment helps in maintaining the effectiveness of the sterilization process and ensures that the autoclave produces reliable and repeatable results.

The frequency of autoclave validation can depend on a variety of factors including the type of autoclave, its usage, and specific regulatory requirements. However, it is generally recommended to perform validation at least annually to ensure ongoing compliance with Good Manufacturing Practice (GMP) standards.

Our GMP-grade Autoclave Validation Services are delivered across a broad range of industries, including but not limited to the Life Sciences sector, these include: biotech, medical device, pharmaceutical, hospitals, universities, and 503A and 503B pharmacies. We ensure that any industry that requires sterilization as part of its process can benefit from our top-tier quality control.

We can begin drafting your validation protocol within 1-2 weeks and can be onsite anywhere in the United States shortly after receiving QA approval. If you provide a pre-approved protocol or choose to utilize our quick-launch, off-the-shelf templated protocol, we can usually initiate our services within 2 weeks.

We pride ourselves on rapid delivery. You can anticipate receiving your final reports within two weeks following the completion of the validation tests. Our ready-to-use templates, support for custom requirements, and ability to integrate with your existing protocols are all designed to expedite compliance.

Autoclave Validation Re-Qualification Service, often referred to as RQ or Periodic Qualification, is a process to verify that an autoclave continues to perform accurately and reliably over time. This service is critical for ensuring ongoing compliance with various regulatory standards such as those set by the FDA, WHO, and EU, especially for machines used in the biomedical and pharmaceutical industries.

The Re-Qualification includes a detailed examination and testing of the autoclave, which is divided into two main parts:

• Physical verification and critical operational control checks: This step ensures that the equipment's physical state is in control, including checks for any damage, correct labeling of utility lines, calibration of instruments, proper operation of doors and vacuum pumps, and functional heat systems.

• Performance evaluation: The autoclave is tested with pre-established worst-load items to map thermal effects during sterilization and to challenge the equipment's ability to achieve and maintain the required sterilization parameters. Biological indicators are also used to test the microorganism challenge efficiency.

This periodic review is essential for challenging the autoclave's ability to perform at set standards, ensuring that time/temperature relationships are maintained throughout the equipment's lifecycle. Re-qualification is generally recommended at ANNUAL intervals, after significant changes, or as part of regular maintenance schedules.