Pyrogens are fever producing substances. The FDA is primarily concerned with endotoxins. Endotoxins are found in certain bacteria, and if present in an injection can cause a range of symptoms and possibly lead to death. Depyrogenated products have reduced endotoxin content by 99.9% or 3 logs. Depyrogenation includes dry heat treatment to destroy the pyrogens and multiple WFI rinses to remove the pyrogens. (Certifications: Certificate of Process, Certificate of Analysis).
E-beam Irradiation Sterilization
E-beam sterilization uses an E-beam generator (between 1 MeV and 12 MeV) to produce a beam of high energy electrons that destroys organisms by breaking the chains of DNA in living organisms, such as bacteria, resulting in microbial death and rendering the space they inhabit sterile.
Ethylene Oxide (EtO) Sterilization
Ethylene oxide gas kills bacteria and their endospores, mold and fungi, and can therefore be used to sterilize substances that would be damaged by sterilizing techniques that rely on heat. Gas is commonly used to sterilize objects sensitive to temperatures greater than 60°C. Ethylene oxide treatment is generally carried out between 30°C and 60°C with relative humidity above 30% and a gas concentration between 200 and 800mg/L for at least three hours. Ethylene oxide is the most common sterilization method, used for over 70% of total sterilizations, and for 50% of all disposable medical devices.
Fluorination of plastic containers prevents container distortion and reduces chemical permeation, weight loss and odor emission.
Gamma Irradiation Sterilization
Gamma rays are produced from a Cobalt (Co60) source and have a high penetrating power. Applying this radiation dose (typically 25-40kGy) is sufficient to destroy all viable forms of life, including bacterial spores, to an acceptable sterility assurance level (SAL). The products that typically receive this treatment are glassware, stoppers, seals, certain caps and plastic bottles. Components must be radiation stable. Clear glass (USP Type I) will discolor. (Certifications: USP Sterility, Certificate of Process).
High purity electronics grade water, filtered to sub-micron levels, is used to wash containers, removing all particulate. This processed water not only meets, but far exceeds all criteria specified by the USP for Purified Water and Water for Injection Rinse (WFI Rinse) depending on the size of the container. (Certifications: Certificate of Process).
Steam Sterilization (Autoclave)*
The application of steam, heat and pressure to destroy all viable forms of life, including bacterial spores, to an acceptable sterility assurance level (SAL). Steam sterilization is attained at a temperature of 121oC, a pressure of 15 psi, and an exposure time of 30 minutes minimum. Typically a SAL of 10-6 is required; probability of a non-sterile unit is greater than one in a million. The products that typically receive this treatment are glassware, stoppers, seals, certain caps and polypropylene bottles. (Certifications: USP Sterility, Certificate of Process).
Sterile Foil Wrap*
Sterile foil wrap process is a method for producing a sterile/depyrogenated product through exposure to dry heat. This process is used mainly for small vials. The vials are particulate cleaned, dried in Class 10 HEPA filtered dryers, wrapped in multiple layers of clean room grade aluminum foil and baked at 250oC in a depyrogenation oven for a minimum of 2 hours and 45 minutes. Once cool, foil packs are removed from the oven, placed into polypropylene trays, shrink wrapped and double clean room bagged. The vials are never exposed to non-sterile conditions after they are sterilized. (Certifications: Certificate of Analysis- Endotoxins, USP Sterility, USP Particulates).
TOC (Total Organic Carbon)
Cleaning containers for Total Organic Carbons testing. This process is done outside of the cleanroom environment and is not used in conjunction with USP/WFI rinses. This process uses very high temperatures (500oC). TOC products have reduced TOC levels to 10-20 ppb. (Certification: Certificate of Analysis- TOC).
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