Products & ServicesSee also: Categories | Featured Products | Technical Articles | More Information
Standards and Technical Documents - EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE STEAM PROCESS -- CSA Z314.3
Description: This Standard specifies essential elements in implementing a program for using steam to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care facility personnel and patients. Notes
Standards and Technical Documents - SELECTION AND USE OF RIGID STERILIZATION CONTAINERS -- CSA Z314.14
Description: sterility assurance programs in health care facilities; or (b) textile packs. Note: CSA Z314.2 and CSA Z314.3 provide requirements for ethylene oxide and steam sterilization in health care facilities. CSA Z314.10.1 provides requirements for the selection and use of reusable surgical textiles
Standards and Technical Documents - CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE FACILITIES -- CSA Z314.23
Description: of sterilized medical devices; (j) sterility assurance, including process challenge device (PCD) construction and use; (k) sterilizer maintenance and quality assurance; and (l) occupational health and safety issues specifically related to chemical sterilization. Note: "Process challenge device"
Supplier: Sartorius Group
Description: small microorganisms that could possibly pass a 0.2 µm rated sterilizing grade filter. Featuring a unique hydrophilic Polyethersulfone membrane, Sartopore 2 0.1 µm cartridges are compatible from pH 1 to pH 14 and to numerous steam sterilization cycles. Therefore they are also ideally
- Trigger: Filter Element / Cartridge
- Assembly / Element Type: Cartridge
- Filter Medium Material: Polyethersulfone (PES)
- Industry Use: Biopharmaceutical
Filter Elements - Polyethersulfone Absolute Rated Membrane Filter Cartridges for Reduction of Microbiological Contaminants -- MicroVantage® MAS-B SeriesSupplier: Shelco Filters - Division of Tinny Corp.
Description: retention from 0.1 to 1.2 microns 100% flushed and integrity tested to ensure rated pore size Manufactured in Class 10,000 clean room for highest purity Meets applicable CFR criteria and USP Class VI Biological Test for plastics Suitable for steam or autoclave sterilization and hot water
- Range: Micro Filtration
- Industry Use: Aerospace / Defense, Electronics, Food and Beverage, Other
- Filtration Product: Chemicals, Water, Other
- Filter Media Material: Polyethersulfone (PES)
Find Suppliers by Category Top
Featured Products for Steam Sterilization Assurance Top
Shelco Filters - Division of Tinny Corp.
Membrane Filter Cartridges
. Suitable for steam or autoclave sterilization and hot water or chemical sanitization. Constructed of FDA listed materials and meets USP Class VI Biological Test for plastics. . MicroVantage ™ MAS Series - Beverage Grade. Polyethersulfone Absolute Rated Membrane Filter Cartridges for Reduction of Microbiological Contaminants. Specifically designed for for reduction of bacteria and spoilage organisms in beverage applications. High surface area polyethersulfone membrane filter cartridges... (read more)
Browse Datasheets for Shelco Filters - Division of Tinny Corp.
Conduct Research Top
Medical Device Link . Recent Developments in Sterilization Technology
Sterilization, as a specific discipline, has been with us for approximately 120 years, since the invention of the steam autoclave by Charles Chamberland in 1879. Since that time, we have seen progressive refinement in steam sterilizers: from the early, manually operated equipment to modern
Medical Device Link . An Introduction to Gas-Diffusion Sterilization
with the final sterility assurance level (SAL) achieved by the cycle.2 Since gas-diffusion sterilization can be integrated into the manufacturing environment, the products can be continuously processed at the same conditions under which they were manufactured, thus avoiding climatic variations
Medical Device Link . Sterilization Firms Strive to Cut Costs, Turnaround Times
are ethylene oxide (EtO), gamma irradiation, steam sterilization, and e-beam processing. All offer different advantages to medical manufacturers seeking to rid their devices of biological contaminants. Sterilization by EtO gas is in widespread use among device manufacturers. EtO is a toxic gas
Medical Device Link . Tracking Trends in Industrial Sterilization The industrial sterilization market will grow in the next few years and will see the emergence of low-temperature oxidative technologies.
Medical Device & Diagnostic Industry Industrial sterilization is a dynamic field. In addition to the two most common techniques, EtO and gamma radiation, electron-beam (E-beam) and steam processes also are used by some medical device manufacturers and contract sterilizers. Several emerging
Medical Device Link . EtO Sterilization: Principles of Process Design
process. The four phases are: (1) air removal, (2) steam injection and conditioning dwell, (3) EtO injection and gas dwell, and (4) gas purge and air inbleed. Mid-infrared gas spectrometer measures EtO and water vapor during sterilization. Photo courtesy Spectros Instruments, Inc. (Whitinsville, MA
Medical Device Link . How Design Controls Affect Sterilization Process Development and Validation Design control demands that all factors affecting a product's performance be considered before production. For sterile medical devices, that means the s
with sterilization cycle development is directed toward the ultimate safety of the processed device. Risk can be considered the probability of occurrence of a hazard causing harm; safety, the freedom from unacceptable risk. A 10 6 sterility assurance level (SAL; the probability of one nonsterile unit
Medical Device Link .
. If a bioburden approach were applied to steam sterilization, as it is toward radiation methods (without looking at thermophiles, thermotolerant spores, and anaerobes), low-temperature steam (e.g., 90 -100 C) would likely be sufficient to achieve 10 -6 sterility assurance for ultraclean (low bioburden
Medical Device Link .
, while the remaining 10% is held by steam and electron beam (E-beam). When using any of these four sterilization methods, manufacturers must validate the process in order to provide documented evidence that it will consistently yield the desired sterility and sterility assurance level (SAL). Upon
Medical Device Link .
�primarily gamma�as well as some saturated steam. This was mainly due to the proliferation of disposable medical devices. For the most part, they were constructed of heat-labile plastics and required a low-temperature (below 121.1�C) sterilization process. This trend continues
Medical Device Link . Speeding EtO-Sterilized Products to Market with Parametric Release
experts, ethylene oxide (EtO) is used for more than half of all medical devices sterilized. Despite its popularity, EtO sterilization, as it is performed by most companies today, has one major disadvantage when compared with steam or radiation methods. Unlike these methods, EtO typically involves
More Information on: Steam Sterilization Assurance Top
Cleaning and preparation of glassware for cell culture
To assure ade- quate steam sterilization , temperature-moni- toring aids such as Temptubes, autoclave tape, and autoclave temperature chart recor- ders should be used.