Moist heat sterilization
Also known as Steam Sterilization, this is a physical process based on coagulating protein structures in microorganisms. It is the choice method for materials that tolerate high process temperatures, and that are not sensitive to humidity. It is used on surgical instruments, textiles, borosilicate glass materials, paper, ceramics, culture media, prostheses and implants, water and aqueous solutions, among others.
The process times are comparatively short, which is why processing and deliveries are generally scheduled within 24 hours. The system has been validated as a method that can ensure a sterility assurance level (SAL) of at least 10-6.
Advantages
Process and delivery times are comparatively short and can be scheduled within 24 hours.
Ethylene Oxide Sterilization
A chemical process based on a low temperature (45-55ºC) sterilizing agent that is applied to packaging, medical products, electrical/electronic instruments in general, raw materials, surgical instruments, active ingredients, disposable laminated textiles, rubber, plastic, optical instruments, among others.
This process is one of the most effective gaseous sterilization methods because it uses, in relative terms, a very small, unstable and active molecule with a high capacity to penetrate and work in hard to reach places.
The net technical time of an Ethylene Oxide sterilization process is always more than 24 hours. The system has been validated as a method that can ensure a sterility assurance level (SAL) of at least 10-6.
Advantages
Process with a high margin of safety during sterilization.
Very compatible with most packaging materials.
Able to sterilize devices at low temperatures.
High diffusion capacity in packaging materials and items to be sterilized
Wide range of application in medical product sterilization.
Process times are greater than 24 hours.
Hydrogen Peroxide Plasma Sterilization
Hydrogen peroxide plasma sterilization is a low temperature process based on hydrogen peroxide action in the plasma phase (typically called the “4th state of matter”) performed by biocidal action. It is a process conducted at a low temperature (less than 40°C) and low humidity, offered as an alternative to Ethylene Oxide sterilization to apply to thermolabile materials with process times under 24 hours. It is used to sterilize medical products that have a thermolabile structure or packaging or that are sensitive to humidity, electric/electronic instruments in general, batteries, endoscopes and surgical instruments in general.
The system requires the use of fabric that is not woven with polypropylene or Tyvek-Mylar pouches as packaging materials, and has been characterized as a method that can ensure a sterility assurance level (SAL) of at least 10-6
Advantages
Short release times during sterilization of thermolabiles (approximately one hour).
Able to schedule processing and deliveries within 24 hours. This makes it possible to reduce stocks of costly reusable material.
On a daily basis, non-thermolabile materials (textiles, surgical instruments, etc.) are processed using steam and thermolabile materials (reusable medical products, electronic equipment, endoscopes, etc.) are processed using Ethylene Oxide or Hydrogen Peroxide Plasma depending on the required time frames or type of product in question.
On a daily basis, non-thermolabile materials (filter elements, lab materials, culture media, etc.) are processed using steam and thermolabile materials are processed using Ethylene Oxide. The latter is the choice process for bulk treatment of a wide variety of primary packaging material, including jars (glass or plastic), lids, inserts, knobs, caps, aluminum seals, etc. Furthermore, it is applied when treating certain active ingredients that require sterility
On a daily basis, non-thermolabile materials (metal implants, textile products, silicone products, etc.) are processed using steam and thermolabile materials are processed using Ethylene Oxide or Hydrogen Peroxide Plasma depending on the required time frames or type of product in question.
On a daily basis, non-thermolabile materials (filter elements, lab materials, culture media, etc.) are processed using steam and thermolabile materials are processed using Ethylene Oxide. This is the choice process for bulk treatment of a wide variety of primary packaging material.
On a daily basis, non-thermolabile materials (filter elements, lab materials, culture media, etc.) are processed using steam and thermolabile materials are processed using Ethylene Oxide. The latter is the choice process for bulk treatment of a wide variety of primary packaging material.
