One part that contributes to the Risk Management Plan is the process of performing a Risk Analysis. During this step, the goal is to define and analyze the dangers to individuals and/or businesses posed by potential adverse events. In a broad definition, Risk Analysis can include risk assessment, risk communication, risk characterization, and any policies…Details
ISO 14971 breaks down all aspects of risk management. One of the first steps to take in creating your risk management program is to create a Risk Management Plan. For each medical device manufactured, “the manufacturer shall establish and document a risk management plan in accordance with the risk management process.” (ISO 14971:2007) The Risk…Details
ISO 13485 is a stand-alone document that is similar in subject to ISO 9001, but with a direct focus regarding the manufacture and design of medical devices. There are a few key differences between the two standards, though. ISO 9001 has requirements for continual improvement of a company’s QMS while ISO 13485 just requires the…Details
ISO 9001 has put an emphasis on the concept of continual improvement. In the most recent version, Clause 10.3 states “The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.” The organization must consider the results of evaluations and the outputs from management review to determine if there are needs…Details
Contract Testing Services
Mesa offers third-party confirmation of BI label claims, D-value and Z-value determinations, custom indicator development, autoclave cycle validation, and a variety of BIER vessel testing services for the medical device and pharmaceutical industries.
Mesa has created a service network specifically suited to provide in-house services to our customers. Whether your needs call for equipment repair, calibration or process validation, Mesa’s Global Services team is uniquely qualified to provide you with specialized service, expert protocol development and execution and complete validation services to suit every need.
PharmTech 100% vs. Oxyfume
As of Dec. 31, 2014, the United States Environmental Protection Agency Clean Air Act will prohibit the sale and use of HCFC-based (hydrochlorofluorocarbon) products in the US, and that will include Oxyfume ethylene oxide (EtO) sterilant blends such as Oxyfume 2000, often used by BI manufacturers for assessing BI EtO D-value label claims. To see how this change impacts the BI manufacturing community, read the complete, peer-reviewed article by signing up for Mesa’s Spore News newsletter today.
Custom Biological Indicators
Can’t find an off-the-shelf biological indicator that’s right for your sterilization process? Our engineers can work with you to design a custom indicator that will work for even the most challenging applications.
Inside Biological Indicators
According to the International Organization for Standardization (ISO), a biological indicator is a test system containing viable microorganisms providing a defined resistance to a specified sterilization process. Biological Indicators (BIs) have been in use for several decades and are used in hospitals, food processing, tattoo parlors, dentist offices, pharmaceutical and medical device manufacturing, ambulatory surgical centers and anywhere else where validation and verification of an adequate sterilization cycle is required.
BIs come in many different shapes, sizes and configurations. Spore Strips have been in use for several decades and are still very widely used for a variety of sterilization processes. Self-Contained Biological Indicators (SCBIs) have become much more popular over the past 30 years, as they are more user friendly and often offer reduced incubation times. For situations where typical BIs are not appropriate, suspensions are widely used to directly inoculate product/substances and Mesa’s line of industrial use BIs are available to test the lethality of a sterilization cycle in a very specific area of a product or load.
Steam sterilization is the most popular type of sterilization and Mesa offers several different indicators to monitor the wide variety of items that are sterilized in steam. The variety of items being monitored is what has predicated the development of the variety of indicators that Mesa offers. Porous items (towels, hard goods, etc…) are easily monitored with Spore Strips while the use of test packs with SCBIs is ever increasing. Ampoule indicators are best utilized in liquid loads sterilization (bottles, media, etc…) and offer a variety of sizes for flexibility. Mesa also offers a complete line of Chemical Indicators including Class 5 (Integrators) and Class 6 (Emulators), Class 1 Chemical Indicator tapes, Bowie-Dick type test packs and more.
Ethylene Oxide sterilization is one of the most common sterilization methods for medical devices including specialty device kits used for specific surgical procedures. EO sterilization is most useful due to the fact that it uses a reduced amount of heat and is therefore safe for heat sensitive materials and devices. Because of this, a completely separate type of biological indicator must be used for sterility assurance testing and monitoring. Utilizing a different species than our steam products, Mesa’s offers EO BIs as spore strips, SCBIs, test packs, suspensions, custom BIs and chemical indicators as well.
Dry heat sterilization requires longer cycle times, higher temperatures and specialty biological indicators. Spore strips can be used in dry heat sterilization however as temperatures rise, charring becomes an issue and the indicator itself burns. Mesa offers a couple alternatives to spore strips with stainless steel discs and with its product DriAmp. DriAmp is an ampoule containing sand inoculated with spores which can withstand extreme temperatures. Additionally, Mesa offers chemical indicator labels for use with this process.
Mesa has created a host of biological indicators for specialty sterilization processes including hydrogen peroxide (H2O2), chlorine dioxide (ClO2), low-temperature steam with formaldehyde (LTSF), gamma irradiation, propylene oxide and more.