RESUMEN
A Contamination Control Strategy (CCS) is a document that focuses on how to prevent contaminations with microorganisms, particles, and pyrogens within sterile and/or aseptic and preferably also in nonsterile manufacturing facilities. This document determines to what extent measures and controls in place are efficient in preventing contamination. In order to efficiently evaluate and control all potential hazards associated with sources of contamination within a CCS, the Hazard Analysis Critical Control Point (HACCP) methodology could be a useful tool to monitor all Critical Control Points (CCPs) related to various sources of contamination. This article describes a way to set up the CCS within a pharmaceutical sterile and aseptic manufacturing facility (GE HealthCare Pharmaceutical Diagnostics) by applying the HACCP methodology. In 2021, a global CCS procedure and a general HACCP template became effective for the GE HealthCare Pharmaceutical Diagnostics sites having sterile and/or aseptic manufacturing processes. This procedure guides the sites through the setup of the CCS by applying the HACCP methodology and helps each site to evaluate whether the CCS is still effective taking all (proactive and retrospective) data following the CCS into account. A summary of setting up a CCS using the HACCP methodology, specifically for the pharmaceutical company GE HealthCare Pharmaceutical Diagnostics Eindhoven site, is provided in this article. Use of the HACCP methodology enables a company to include proactive data within the CCS, making use of all identified sources of contamination, associated hazards, and/or control measures and CCPs. The constructed CCS allows the manufacturer to identify whether all included sources of contamination are under control and, if not, which mitigatory actions need to be performed. All current states are reflected by a traffic light color to reflect the level of residual risk, thereby providing a simple and clear visual representation of the current contamination control and microbial state of the manufacturing site.
Asunto(s)
Contaminación de Medicamentos , Análisis de Peligros y Puntos de Control Críticos , Estudios Retrospectivos , Contaminación de Medicamentos/prevención & control , Instalaciones Industriales y de Fabricación , Preparaciones Farmacéuticas , Contaminación de Alimentos/análisis , Contaminación de Alimentos/prevención & controlRESUMEN
Dental patients with parafunctional habits (clenching and grinding of the teeth) may pose unique treatment problems for the dentist. Several patients suffering from such muscle hyperactivity disorders were studied longitudinally by use of the occlusalgraph method to preserve the photocclusal data recorded by each patient. This report suggests that the use of the described technique provides a quick and simple method of visualizing the problem and long-term monitoring of the treatment.
Asunto(s)
Bruxismo/terapia , Oclusión Dental Traumática/terapia , Oclusión Dental , Registro de la Relación Maxilomandibular , Bruxismo/fisiopatología , Calibración , Color , Oclusión Dental Balanceada , Oclusión Dental Traumática/fisiopatología , Cloruro de Etilo/uso terapéutico , Humanos , Estudios Longitudinales , Maloclusión/fisiopatología , Maloclusión/terapia , Músculos Masticadores/fisiopatología , Polímeros , Férulas (Fijadores) , Estrés Mecánico , Síndrome de la Disfunción de Articulación Temporomandibular/fisiopatología , Síndrome de la Disfunción de Articulación Temporomandibular/terapia , Diente/fisiopatologíaRESUMEN
A case of localized juvenile periodontitis with bone loss affecting molars and premolars with advanced destruction around the lower first molars is described. These lesions were associated with areas of excess occlusal trauma. The ramifications of combined therapy aimed at the elimination and control of both the inflammatory and occlusal components of the disease are discussed relative to the successful treatment of this case. A description of the periodontal status of a sibling of the patient has been included. Extensive defects are associated with the anterior teeth and in this case the patient presented with excessive trauma in the anterior region. Considering the localities of the disease and the similarities between the inflammatory components in both cases, a link between occlusal trauma and juvenile periodontitis is discussed.