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Cleaning & Sterilisation Validation

Dental Device Cleaning & Sterilisation Validation Services

Dental devices require an effective and validated cleaning process to ensure customer safety. Lucideon helps you develop and validate your processes and products for regulatory authorities, including the FDA.

Regulatory submission support

We provide quality data and technical support with full documentation. In the heavily scrutinized area of medical device regulations, it is reassuring to have experts on your side who have prior experience of performing the tests.

Dental device cleaning and sterilisation validation

 

VALIDATA

With Lucideon's VALIDATA program you get a complete validation service for your medical devices to determine the effectiveness of your cleaning process and environment on an ongoing basis.

VALIDATA quantifies residual contamination using advanced surface analysis techniques, to detect what has not been removed by your cleaning processes. This is then compared to what is expected to be there and, by the application of a proprietary combinatorial algorithm, expresses the result as a single "Cleanliness Index" parameter in the form of a "% clean" figure.

Single use devices

We can:

  • implement a new cleaning procedure to gain regulatory approval
  • ensure continual cleanliness of your manufacturing and cleaning processes
  • identify the presence and source of contaminants
  • develop effective cleaning protocols for products (including ALM devices)
  • determine why residue limits are being exceeded, and set appropriate limits
  • verify and validate that a process change has not negatively affected cleanliness
  • perform residue analysis of detergents and manufacturing lubricants

 

Reusable devices

We offer:

  • process design and development for the reprocessing of a dental device
  • validation of the effectiveness of a reprocessing method (cleaning, disinfection and sterilization)
  • validation of the compatibility of a device with the method
  • choice and identification of appropriate soils and detergents.

Cleaning validation of dental device manufacturing equipment

Dental device manufacturing equipment requires thorough cleaning between batches and at timed intervals to ensure the cleanliness and safety of manufactured products, and to comply with current Good Manufacturing Practices (cGMP). Outsourcing the cleaning validation of your medical device manufacturing equipment can speed up the process, minimize disruption and provide a greater sense of security.

Additive manufacturing

Lucideon offers specialist cleaning validation services for your ALM products. We develop cleaning methods and procedures to ensure that your ALM product is clean and safe for use.

» Read about our Additive Manufacturing consultancy services

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