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Cleaning & Sterilisation Validation

Medical Device Cleaning & Sterilisation Validation Services

Trust us to be your independent validation team for your cleaning and sterilisation methods. With over 25 years’ experience delivering cleaning validation services, it’s no wonder the top names in the orthopaedic and wider medical devices arena choose our experts to support their cleaning and sterilisation method validation processes.

Medical Devices

 

Whether you are looking to validate existing or in-house methods, or are looking to outsource the development of your cleaning and sterilisation methods, Lucideon can help.

Using a tried and tested partner who understands not just FDA (US Food and Drug Administration), CE, or UKCA requirements, but the needs of the manufacturer and their end-user, ensures a smooth and robust solution to your cleaning validation process.

We work from GMP (Good Manufacturing Practice) laboratories and work to ISO (International Organisation for Standardisation) standards, so you can be sure of a professional and reliable service. Our thorough approach satisfies ANSI/AAMI ST98 and provides clients with security and confidence that their working practises are of the highest quality.

Reprocessing validation - medical devices

Reprocessing of 'single use' medical devices and instruments has become more common place to help reduce costs, but it also increases the chances of cross-contamination and pathogen infection. Reprocessing methods have therefore become a focus for regulatory bodies, including the FDA. We can help to develop and validate your Instructions for Use (IFU) to industry-accepted levels.

Repeat processing can, over time, lead to mechanical weaknesses and failures or a slow build-up of contamination that is not safely removed by your cleaning and sterilisation processes. Cyclic simulation, using the IFU defined for your devices, gives you confidence that your products are mechanically sound, as well as achieving acceptable levels of cleanliness repeatedly through their approved lifecycle.

Worst-case scenario testing

Our method development capabilities are where our cleaning validation services really stand out, developing scenarios that test your devices and instruments to the worst case, and validating that your cleaning processes are effective and safe to use. 

We develop your methods, specific to your device, considering the hard-to-reach, high risk areas (hinges, crevices, knurled handles, etc.) and the most stubborn contaminants that your device will encounter.

 

Test soils

Test soils can be bought off the shelf, but are they right for your product? As part of our evaluation for your cleaning validation assays, we will ensure that the test soil used is the most appropriate to simulate the soils that your devices will encounter. This helps to make up our worst-case testing scenario to ensure your IFUs (Instructions for Use) are fit to effectively remove the most troublesome contaminants.

Whether you require routine testing, quality control, or regulatory submission support, we have a depth and breadth of experience to provide the quality consultancy you need to help you get your products to the market faster.

We provide validation of single-use device cleaning and sterilisation processes (for devices delivered in a sterile state) as well as validation of reusable device cleaning, reprocessing, and sterilisation.

Lucideon can also verify the cleanliness of single-use devices, implants, instruments, and reusable devices.

Cleaning validation of medical device manufacturing equipment

In addition to devices, Lucideon can verify the cleanliness of manufacturing equipment between batches and at timed intervals to ensure compliance with current Good Manufacturing Practice (GMP). Validation of your cleaning method ensures that your processes specific to your medical device manufacturing equipment, products, processes, and operators are safe, and consistently and repeatedly achieve the required levels of cleanliness.

We will produce a complete list of residues, cleaning agents, and other materials that could contaminate your equipment during the manufacturing process. Then we develop the methods that detect the presence of, identify, and quantify, any residues remaining after your medical device manufacturing equipment has been cleaned.

Making changes to any validated process will often mean a requirement for revalidation. Working with Lucideon means you have a partner that understands the sensitivities of your process. Any changes that require revalidation will be carried out thoroughly, and with as little disruption to your process as possible.

White Papers

Reusable Medical Devices
Cleaning and Sterilisation Validations for Reusable Medical Devices

This process involves ensuring cleaning procedures used to clean medical devices and instruments are effective at removing contaminants and microbes

Stent
Design Optimisation in Medical Devices: Materials Matter

The goal of this white paper is to demonstrate the risk of working with the wrong material, to highlight the upside when the right material is selected

Ensuring Reliable Performance from Ceramic Components in Medical Applications

This white paper highlights some of the testing involved in ISO 13356 and discusses how recent and ongoing research into ceramic processing provides opportunities to meet product improvement challenges

Wear Testing
Extremity Wear Testing - Total Ankle and Shoulder Replacement Testing

Wear simulation for implantable knee, hip and intervertebral spinal disc prostheses have all been well documented and standardised tests methods have been created to assess the performance of these medical device implants

Tribology and Testing of Orthopaedic Implants

In this white paper we review the key tribology & testing techniques available for orthopaedic implants

The Advantages of Including Adverse Event Wear Testing in the Design of Orthopaedic Implants

In this white paper we look at why the testing of implants is so important. Traditional test methods and their limitations are detailed and adverse event testing is discussed

Case Studies

Dental Implant
Method Development Helps Nobel Biocare in Medical Device Optimisation

Characterisation of the surface chemical composition of medical implants

Lucideon Helps Greatbatch Medical to Gain FDA Acceptance

Lucideon has worked with Greatbatch Medical to help them gain FDA approval

Knee Joint
Raw Material Validation for TiGenix Ltd

Testing and analysis provided by Lucideon

Syringes
Spontaneous Failure of a Medical Device During Secondary Processing

Lucideon's additive manufacturing expertise helped identify root cause of product failure

Hip Joint Replacement
Lucideon Expertise Helps with Additive Manufacturing HIP Issues

We helped our client with discolouration issues after hot isostatic pressing