MICROBIOLOGICAL STATUS
Our products can be sold with the following microbiological status:
Non sterile: Devices that are neither produced in contamination controlled conditions nor subjected to a following sterilization process, therefore they cannot be defined as “sterile” or “aseptic”. Anyway Bioburden (medium microbial charge) of Devices is constantly controlled in order to verify contamination level of Devices to guarantee the Device quality.
Aseptic: Devices produced and packed under controlled contamination conditions. For these Devices it’s granted a SAL (Sterility Assurance Level) of 10-3 for integral packaging. Every lot of material is subject to specific tests in order to verify microbiological status and afterwards deliberated.
Sterile: by “sterile” it’s meant a Device that is devoid of vital organism. Theoretically only a sterilization process that lasts forever could assure that all microorganisms get destroyed. A Device is defined as “sterile” when it’s possible to assure or certify, on statistic basis, that the probability that it results non sterile is equal or lower than a chance of 1 in 1.000.000 i.e. SAL (Sterility Assurance Level) of 10-6, that is the one we guarantee for our “sterile” products. All our sterilization processes, carried out by irradiations of ionizing radiations (Gamma and Beta rays) or by Ethylene Oxide, are validated and constantly monitored in accordance with ISO 11137, ISO 11737, EN 552, F.UI:XI and F.EU:IV Norms. The packaging of sterile Devices is validated and constantly monitored in order to guarantee the microbiological status for the indicated validity period of the integral packaging.
Apyrogenic or non-Pyrogenic: Devices where absence or presence within detection limits of endotoxins by Gram-negative bacteria is granted. For Devices declared as Apyrogenic a limit of ≤ 0.125 EU/ml (EU=Endotoxin Unit) FDA Endotoxin on integral packaging is granted. Endotoxins presence is determined by LAL tests.
ABOUT STERILIZATION
> Before starting sterilization process of any Devices verify if there are any traces or residual contaminating substances and if they are completely dry: their presence might damage the Device’s material during sterilization or autoclave processes. Before starting sterilization process rinse carefully all disposables with distilled water till they are completely clean.
> Remove all closure devices (caps, lids) before sterilization process, otherwise during autoclaving process or gas sterilization pressure differences that occur may cause container’s collapse.
> Make sure that the adopted sterilization method is tting to all components (caps, lids, spoons, accessories, etc.). Otherwise, we suggest to proceed to their separate sterilization, according to the most appropriate method. Sterilization might reduce mechanical/functional/aesthetic features of the Device.
STERILIZATION METHODS
- Radiation sterilization: This type of sterilization is used when heat is to be avoided for heat-sensitive products such as plastic resins. UV radiation (Non-ionizing radiation) is used to treat surfaces, water and air. Ionizing radiations (eg Beta or Gamma Radiation) are very penetrating and they are able to by destroy any form of life. They are commonly used for sterilization of disposable medical equipment.
- Chemical sterilization: This type of sterilization is used for material that can be damaged by heat (heat-sensitive materials such as biological materials, fiber optics, electronics, and many plastics). It is Ethylene oxide (EO, EtO), formalin, hydrogen peroxide and other products. Ethylene oxide gas treatment is one of the common methods used to sterilize items because of its wide range of material compatibility. EtO is highly effective, as it penetrates all porous materials, and it can penetrate through some plastic materials and films.
- Steam (autoclaving): A widely used method for heat sterilization is the autoclave, sometimes called a converter or steam sterilizer. Microorganisms are quickly destroyed by steam heated. This type of sterilization is obtained with autoclave and is typically used for nutrient media, aqueous solutions, and inactivation of cultures or samples at the end of use. Autoclaves use steam heated to 121-134 °C under pressure for 15/20 minutes.
- Dry Heat: Dry heat was the first method of sterilization, and is a longer process than moist heat sterilization. The destruction of microorganisms through the use of dry heat is a gradual phenomenon. With longer exposure to lethal temperatures, the number of killed microorganisms increases. This type of sterilization is used for metal, glassware and everything that can be corroded by steam or must remain dry before use. Dry heat sterilization requires greater times and temperatures compared to steam: The standard setting for a hot air oven is at least two hours at 160 °C / 170 °C.
- Flaming: This type of sterilization is used for metal inoculation loops and metal inoculation needles in microbiology labs and small glass object. It is carried by leaving them in the flame of a Bunsen burner or inside an incinerator.