Dentistry

Validation and Sterilization for Dental Clinics

Compliance with RDC 15/2012, biosafety, and autoclave qualification. Complete solutions to ensure the safety of your sterilization processes.

The Risks of Inadequate Sterilization

Inadequate sterilization in dental clinics poses serious risks to patients and professionals.

Risk of cross-infection from ineffective sterilization processes
Stringent Health Surveillance requirements for licensing and renewals
Lack of technical documentation to prove regulatory compliance
Professional liability for sterilization process effectiveness
RDC 15/2012

Requires all health services to prove sterilization process effectiveness with proper technical documentation

85%

Of Brazilian dental clinics have non-conformities in sterilization processes

Our Dental Solutions

Autoclave Qualification

Complete IQ/OQ/PQ: temperature distribution, steam penetration, and sterilization cycle effectiveness per ISO 17665.

Sterilization Process Validation

Testing with biological and chemical indicators, cycle integrators, and sterilization process effectiveness analysis.

Equipment Thermal Mapping

Complete temperature mapping of ovens, autoclaves, and sealers with detailed reports and statistical analysis.

Installation Qualification (IQ)

Document verification, instrument calibration, and installation verification per manufacturer specifications.

Health Surveillance Reports

Complete technical documentation for licensing and renewals, ready for Health Surveillance presentation.

Team Training

Training in good sterilization practices, correct autoclave handling, and biosafety procedures.

Applicable Legislation and Standards

RDC 15/2012

Good Processing Practices

Establishes requirements for processing health products in healthcare services, including sterilization and disinfection.

ISO 17665

Steam Sterilization

Defines requirements for qualification and validation of steam sterilization processes in autoclaves.

RDC 6/2012

Health Service Operations

Establishes Good Operating Practices for health services, including infrastructure and process requirements.

Autoclave Qualification Process

Equipment Analysis

Detailed inspection of autoclave, installation verification, documentation, and operating conditions.

Sensor Positioning

Installation of minimum 9 RBC-calibrated sensors at strategic points inside the chamber.

Cycle Execution

Complete test cycles simulating real operating conditions and load patterns.

Data Collection & Analysis

Data processing with statistical analysis and deviation identification.

Technical Report

Complete report with charts, tables, and technical conclusions.

Certificate

Valid qualification certificate ready for Health Surveillance presentation.

Frequently Asked Questions

Annual qualification is recommended, or whenever significant maintenance, repairs, or changes occur to the equipment or process.
Yes. ANVISA's RDC 15/2012 requires health services to prove sterilization process effectiveness. Autoclave qualification with technical reports is essential for licensing.
The complete process takes 3 to 7 business days on average, including site visit, data collection, analysis, and final report issuance.
Beyond the risk of cross-infection for patients, the clinic can be penalized by Health Surveillance with fines up to R$ 1,500,000, interdiction, and even suspension of activities.
IQ (Installation) verifies correct equipment installation. OQ (Operation) tests operation within specifications. PQ (Performance) proves sterilization process effectiveness under real conditions.

Schedule an Assessment

Request a site visit for evaluation of your autoclave and receive a customized proposal.

Schedule Assessment

Get in Touch

We are ready to help your company achieve the compliance and safety you need.

Contact Information

Our team is available Monday through Friday, 8am to 6pm.

Headquarters — São PauloRua General Góis Monteiro, 660 – sala 01 – Pompéia
ZIP: 05029-000 — Tel: +55 (11) 2924.2404
Branch — São José dos CamposAv. Lisboa, 53 – Jd. Augusta
ZIP: 12216-630 — Tel: +55 (12) 92000.1137
Emailcontato@biologger.com.br

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