On Thursday, October 18 at 12:40 p.m., Gustavo Enriquez will be lecturing on "Sterilization by ethylene oxide. Validation of the process " during the 10th Congress and exhibition for pharmaceutical, biotechnological, veterinary and cosmetic science and technology, that will be carried out at ETIF, Costa Salguero, Buenos Aires.
For information and registration: http://www.etif.com.ar
To implement ISO 13485 is to develop a quality management system for medical devices and related services to then demonstrate that the organization is able to provide products and services for medical devices and at the same time evaluate their ability to consistently provide these products and services in line with the characteristics of the organization and its multiple risks, threats and opportunities. All this fulfilling the requirements of the client and all the relevant regulatory requirements. In that sense, in 1998 Asisthos SRL made its first certification of the pioneering Standard in this sense, ISO 46002: 1996 (Quality systems, Medical devices, Particular requirements for the application of the EN ISO 9002 Standard) through the Notified Body. 0318, the Spanish Agency of Medicines and Health Products. From that moment and in pursuit of the goal of constant improvement, year after year we achieved and exceed the harsh requirements of the inspections of the Notified Body to, in a continuous manner, recertify the successive revisions and updates of the standard, being Asisthos SRL the only Company that provides sterilization for third parties in Argentina, fulfilling and certifying this recognized international standard.
Provision 3266/13 issued by the ANMAT establishes the MERCOSUR Technical Regulations for Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use. In turn, and understanding sterilization processes as a necessary part of the manufacture of a sterile medical product, compliance with this regulatory requirement is mandatory for a Company that performs Sterilization of Medical Products in Argentina to fit within the legal framework current, giving in turn the necessary legal coverage necessary to its customers. In that sense, having been Asisthos the first company of its category enabled before the Department of Medical Technology of ANMAT for the sterilization of Medical Products, we present our clients our new certificate in accordance with the last Disposition already mentioned.
On Thursday, September 27 at 12 am, Gustavo Enriquez will be speaking on "Accreditation and evaluation of a sterilization plant" in the 22nd Day of Sterilization "From theory to practice in Hospital Sterilization", organized by FUDESA ( Foundation for the Development of Sterilization Argentina) in EXPOMEDICAL.
Informes e inscripción: http://fudesa.org.ar
Once again, ASISTHOS accompanies the Argentine Maintenance Committee (CAM) in the Hospital Maintenance Congress. This year we will be lecturing on "Biodecontamination of biological safety cabinets in Laboratories". We Will be expecting you on Thursday, August 30 at 3 pm at the Auditorium FLENI, Olazábal 1561 - Buenos Aires - Argentina.
Event information: https://www.facebook.com/congresomantenimientohospitalario
Durante el mes de Julio realizaremos la validación del proceso de Esterilización por Óxido de Etileno para nuestros clientes. Estaremos recibiendo materiales hasta el 05/07. Para solicitar información, comuníquese a firstname.lastname@example.org.
Validaciones de procesos para Vapor de Agua y Plasma de Peróxido de Hidrógeno y validaciones de equipo se realizan a pedido.
On Friday, September 28th from 2:00 to 4:00 pm, Asisthos will be speaking on "Criteria for acceptance of sterile surgical materials" in Expomedical.
Registration is open and free. To participate, it is only necessary to register for the activity and to pre-register to access ExpoMEDICAL. Certificates of Assistance will be delivered.
-Methods and fundamentals.
Speaker: Dr. Gustavo Luis Enriquez - Technical Director of Asisthos
Registration to the seminar: http://www.expomedical.com.ar/programa/
This year Gustavo Enriquez, Asisthos Technical Director and pharmacist specialized in industrial sterilization, will provide your contribution during the discussion table “Sterilization by third parties” along with the pharmacists Hilda Motal and María Amalia Mildenberger.
We invite you on Thursday, June 7th at 9:30 p.m. at ARISTON Hotel, Rosario city.
For more info: http://fudesa.org.ar
Being a World Class company is not something simple, but it is not impossible either, not even for PyMEs. With this goal and in line with the path of proactive World Class service provision, started almost 20 years ago with our first certification of Quality Management System ISO 9002: 1994, we are pleased to announce that after a difficult but profitable way, we have recertified our current Quality Management System, according to the latest revision of said standard: ISO 9001: 2015.
In November we will be participating in the 2nd National Sterilization Conference, organized by the Argentine Association of Technicians and Auxiliaries in Sterilization (AATAE) with a technical dissertation on "Industrial Sterilization". We invite you on Friday, November 17 at 3:20 p.m. at Paseo La Plaza, Pablo Neruda conference room (Corrientes Avenue No. 1660, CABA). For more info: www.aatae.org
Once again, ASISTHOS acompannied FUDESA at the annual event. This time it was held from October 25th to 27th at the Sheraton Hotel, Mendoza City.
The activities focused upon the slogan "Quality Assurance in the reprocessing of Medical Products".
None of the many materials used daily in different medical care institutions , defies both the technical boundaries of the sterilization processes and packaging material as well as the boxes containing instruments for surgery:
-Different load configurations.
-Different sizes and weights.
-Different designs of holders and handles.
-Different designs regarding the screening of container boxes.
-Identifications not always unequivocal.
For this purpose, it is essential to combine criteria related to the inspection of sterile material: integrity of the conditioning material, chemical indicators / integrators, labels, presence of moisture, and subsequent conservation of post-processing sterile material.