WHAT IS THE EXPIRATION DATE OF STERILIZATION FOR A MEDICAL PRODUCT?
There is no such thing. The expiration date featured on the packaging of a medical product does not correspond to an eventual "expiration" of its sterilization. It concerns the expiration of such device. If the package is kept in unaltered conditions, the sterility of the product inside it should not be modified.
REQUIREMENTS FOR THE VALIDATION OF A LOAD
Initial research on product-package compatibility.
Previous studies on similar products.
Availability of representative loads.
CLEANING CONDITIONS FOR INCOMING MATERIALS
When entering our facilities, all materials must be intact, clean and dry. Asisthos SRL does not assume the responsability of a Reception Inspection in regard to these requirements.
Enabled by the Buenos Aires Ministry of Health as a Medical Products Sterilization Laboratory.Abrir PDF Abrir PDF
Enabled by the Ministry of Health and Environment (ANMAT) under File 605:
A- Plant Enabled by Disp. ANMAT N ° 2319/02.
B- Processes certified by Disp. ANMAT N° 194/99 regarding compliance with Good Practices for the Manufacture of Medical Products in "Division, packaging and sterilization of medical products for third parties".
ASISTHOS QUALITY POLICY
QUALITY POLICY: In order to increase competitiveness and efficiency, ASISTHOS S.R.L. considers it necessary to adapt the organization to a Quality Assurance System that meets the highest national and international Standards. The Quality Policy is of vital importance, since it expresses the intentions of our Company in terms of Quality. It is guided by the following basic principles:
CUSTOMER COMES FIRST: To constantly meet the needs and expectations of our customers through the supply of solutions in sterilization, timely and in due form, in accordance with regulatory frameworks.
QUALITY ASSURANCE SYSTEM: To maintain, update and steadily improve a quality assurance system structured in compliance with the latest and current revisions of ISO 9001 and 13485 standards.
COMMUNICATION: To maintain permanent communication channels with our clients in order to learn their needs and with our suppliers in order to collaborate with their development.
TRAINING: To elaborate personnel training programs in order to achieve personal and professional growth.
LATEST EQUIPMENT VALIDATIONS
We make available to our clients the documents of the latest equipment validations of Ethylene Oxide, Steam and Hydrogen Peroxide Plasma.
To request them, contact firstname.lastname@example.org
ASISTHOS ORGANIZATION CHART
Whenever possible, according to the characteristics of incoming products and their primary and/or secondary packaging, the process of sterilization by water steam will be taken as the primary process of choice.
In case the product and their primary and/or secondary packaging are thermosensitive and/or deliquescent and/or hygroscopic, etc, the material may be asigned to a different sterilization processes at low temperature. It could be either Ethylene Oxide or Hydrogen Peroxide Plasma, depending on the final choice of qualitative and quantitative characteristics of the load and expected delivery times.
PROTOCOLOS DE PROCESO
The Sterilization Protocols of processed materials are issued daily by Asisthos SRL Quality Department. These documents group all the material processed and available in our facilities
DIRECCIÓN DE E-MAIL PARA AUTORIZAR CICLO EXCLUSIVO DE PLASMA
PICK UP AND DELIVERY OF MATERIALS AT OUR FACILITIES
In order to optimize picking up and deliveries, Asisthos has an scheduled process. An appointment must be requested by contacting the Coordinator or the Production Manager by phone at 011-4713-1681