Industry News

2024-04

Стерилизаторы Оксидом Этилена

Что такое стерилизация? Стерилизация - это процесс, который удаляет, уничтожает или делает неактивными все формы жизни. Понятие стерильности означает полное отсутствие жизнеспособных микроорганизмов или микробов, способных к размножению. Поэтому стерильные изделия, проходящие стерилизацию, часто подвергаются химической или тепловой обработке после упаковки. Химическая или тепловая стерилизация уничтожает все микроорганизмы внутри продукции (которые могут появиться в процессе производства и упаковки). Этот процесс химической или тепловой стерилизации после упаковки конечного продукта известен как финальная стерилизация. В данной статье рассматривается газовая стерилизация этиленоксидом медицинских изделий и ее особенности. Что такое оксид этилена и стерилизация им? Оксид этилена, или этиленоксид (ЭО), - это газ, обычно используемый для химической стерилизации медицинских инструментов и изделий. Оксид этилена является сильным алкилирующим агентом с высокой проникающей способностью. Эти свойства делают его очень эффективным стерилизующим средством. Однако при определенных уровнях этот газ способен вызывать рак. Стерилизация оксидом этилена происходит путем воздействия газообразного оксида этилена в условиях вакуума и влажности, что позволяет уничтожить микроорганизмы. Оксид этилена может применяться в чистом виде или в сочетании с диоксидом углерода или другими газами.

2024-02

Autoclaves For Mushroom Cultivation

For mushroom growers, contamination from trichoderma, bacteria, mold, and other factors pose significant risks to crop health. Airborne contaminants and improperly sterilized or pasteurized tools, substrates, and cultivators stand out as key sources of contamination. To mitigate these risks effectively, mycologists must establish a precise and repeatable approach to substrate preparation, ideally leveraging autoclaves tailored for mushroom cultivation. Understanding Mushroom Substrates A mushroom substrate refers to materials providing mushrooms with essential energy, nutrients, and moisture for growth. Growers have a range of substrate options, including straw, soil, coco coir, vermiculite, coffee grounds, logs, and manure. Different mushroom species exhibit preferences for specific substrates; for instance, wood-based substrates like elm, beech, or ash logs suit lion’s mane, reishi, and maitake mushrooms best. While substrate choices vary, all quality mushroom substrates share common features according to GroCycle's expert cultivators: Rich in woody, fibrous components such as lignin, cellulose, and hemicellulose 1%-2% nitrogen content Adequate amounts of magnesium, potassium, calcium, sulfur, and phosphorus Slightly acidic pH levels (~5–6.5), adaptable for different mushrooms Structures enabling air exchange Moisture content ranging from 50% to 70% Free from microbes, mold, and bacteria The absence of contaminants is crucial since any remaining microorganisms can impede spore germination and inhibit mushroom growth. To ensure sterility, cultivators typically employ two primary methods: pasteurization or sterilization. Substrate Preparation Methods: Pasteurization vs. Sterilization Both pasteurization and sterilization are conventional techniques for readying mushroom substrates for spore inoculation. Pasteurization involves subjecting substrates to mild dry or steam heat (often below 100°C or 212°F) for a brief period to eliminate pathogens. While popular among smaller growers due to its simplicity and scalability, pasteurization may not eradicate all microorganisms, potentially leaving weakened non-pathogenic bacteria. Sterilization, on the other hand, completely eradicates all forms of bacteria and contaminants. Steam sterilization is a favored technique, leveraging the efficiency of steam to break down cell walls and achieve total sterilization. This method offers reliable and rapid results, particularly suitable for medium to large-scale operations. Utilizing an Autoclave for Mushroom Substrates Although some use pressure cookers for steam sterilization, their inconsistent results and limited capacity make them impractical for most growers. In contrast, mushroom autoclaves are purpose-built for substrate sterilization, offering control and scalability vital for diverse operations. Mushroom autoclaves possess features like vacuum systems to ensure dry products post-sterilization, critical for preventing mold formation. The industrial-grade autoclaves' greater capacities — ranging from 100 L to over 1,000 L — accommodate operations of varying scales, enhancing efficiency and productivity. Operation of a Mushroom Autoclave Mushroom autoclaves function similarly to standard autoclaves: Loading substrate bags into the chamber and sealing the door Introducing steam to displace air and increase temperature and pressure during the purge phase Controlling interior conditions to desired settings during the exposure phase Releasing pressure through an exhaust valve post-sterilization and utilizing vacuum cycles to ensure dryness Installing a Mushroom Autoclave Installations should align with facility requirements and consider utility needs, water-saving features, and throughput expectations. Ergonomics and workflow efficiency should guide decisions to enhance sterile processing and prevent contamination risks. Best Practices for Substrate Sterilization After successful autoclave installation, cultivators must adhere to best practices: Validate autoclave functionality with biological indicators Utilize automatic shut-off functions for streamlined operations Load substrates evenly to ensure thorough sterilization Opt for vacuum cycles over gravity cycles for faster drying Employ load probes to verify uniform temperature-based sterility across substrates

2024-02

What Is Vaporized Hydrogen Peroxide Sterilization?

What Is Vaporized Hydrogen Peroxide Sterilization? Hydrogen peroxide has been a staple in the healthcare industry for many years, but in the 1970s, its vapor form emerged as a low-temperature sterilization technique that has gained significant popularity. This article will delve into how the hydrogen peroxide sterilization process functions, touching on crucial federal guidelines to adhere to and potential challenges that may arise. Understanding Low-Temperature Sterilization Low-temperature sterilization refers to a sterilization method utilizing gas or specific chemicals for items unsuitable for steam processing. While ethylene oxide was previously prominent in low-temperature sterilization, its slow pace and regulatory obstacles, along with evidence pointing to an elevated risk of certain cancers with prolonged exposure, led to hydrogen peroxide largely supplanting it. Exploring Hydrogen Peroxide Sterilization Vaporized hydrogen peroxide sterilization, alternatively known as hydrogen peroxide sterilization, involves a technique employed to sanitize heat-sensitive devices or materials like select plastics, electrical equipment, and corrosion-vulnerable metal alloys. This non-toxic process (producing solely water vapor and oxygen) finds application in medical implants, electronic gadgets, and temperature-sensitive instruments. Despite initial market and material issues, many have been addressed, establishing it as the primary method for low-temperature sterilization. Various manufacturers offer vapor hydrogen peroxide sterilizers, employing gas plasma or ozone within the sterilization cycle. Despite not contributing to product sterilization, these elements assist in eliminating residual hydrogen peroxide. The Hydrogen Peroxide Sterilization Process A blend of water and highly concentrated hydrogen peroxide transforms into gas, circulating at specified concentrations within the chamber. Post-process, the vapor is vacuumed out, converting into water and oxygen. Operating at temperatures ranging from 37–44°C, the sterilization cycle typically lasts around 75 minutes. Guidelines for Hydrogen Peroxide Sterilization Federal guidelines and recommendations by entities like the U.S. Food & Drug Administration, International Organization for Standardization, and Centers for Disease Control & Prevention govern various sterilization methods. Specific directives dictate exposure times, temperatures, and hydrogen peroxide concentrations. Challenges and Considerations While widely adopted, hydrogen peroxide sterilization isn't devoid of challenges: Smaller sterilization chambers compared to steam autoclaves and load limitations. Materials incompatible with VHP sterilization due to sensitivity to moisture or oxidizing agents. Precise control over parameters like temperature, humidity, and exposure time. Residual hydrogen peroxide concerns necessitating post-sterilization cycles.

2024-01

Ethylene Oxide (ETO) Sterilization Equipment: Market Analysis And Latest Trends

Introduction The Ethylene Oxide (ETO) sterilization equipment serves a vital role in the healthcare industry, ensuring the sterilization of medical devices, instruments, and consumables. ETO sterilization is particularly valuable for heat-sensitive and moisture-sensitive materials, providing a high level of sterility assurance. Market Dynamics Market Growth Factors: The market is witnessing substantial growth primarily driven by the increasing demand for sterilization services in healthcare facilities, rise in surgeries, focus on preventing healthcare-associated infections, technological advancements, and stringent regulatory standards. COVID-19 Impact: The pandemic has further accelerated the demand for ETO sterilization equipment as healthcare facilities prioritize maintaining sterile environments and preventing the spread of infections. Major Market Players Several key players dominate the global ETO sterilization equipment market, including Steris Corporation, Getinge AB, MMM Group, Belimed AG, Tuttnauer, & HANGZHOU BOCON MECHANICAL AND ELECTRICAL EQUIPMENT CO., LTD.., among others. These companies are focusing on research and development, product innovation, and expanding their geographical presence to gain a competitive edge and meet the increasing demand for sterilization equipment. Sales Revenue and Market Size As of now, specific figures for the listed companies' sales revenue are not available. However, as of 2020, the global ETO sterilization equipment market was valued at around USD billion and is expected to grow at a CAGR of over 7% from 2021 to 2028, indicating significant growth opportunities for companies in the industry. Key Opportunities for Manufacturers Manufacturers have ample opportunities due to factors such as technological advancements, increased awareness about healthcare-acquired infections, rising surgical procedures, and the ongoing impact of the COVID-19 pandemic, which has amplified the need for ETO sterilization equipment. Market Segmentation Types of ETO Sterilization Equipment: Large Size Type: Designed for high-capacity sterilization needs, suitable for industries like healthcare and pharmaceuticals. Cabinet Type: More compact and ideal for smaller-scale processes, commonly used in laboratories and small healthcare facilities. Industry Research by Application: Medical Consumable: Single-use items like syringes, gloves, and bandages. Medical Equipment: Devices such as surgical instruments, hospital beds, and imaging machines. Regional Market Presence The ethylene oxide (ETO) sterilization equipment market exhibits significant potential in various regions: North America: Expected to dominate, accounting for around 35% of the market share. Europe: Projected to witness substantial growth, holding a market share of approximately 30%. Asia-Pacific: Anticipated to contribute to a market share of about 25%, particularly in countries such as China and India.

2024-01

6 Methods For Medical Device Sterilization: How They Work And Which Devices Are Ideal

In order to reduce the risk of infection for patients, it is imperative that all medical devices undergo proper sterilization before use. The primary goal of sterilization for medical devices is to eliminate or destroy all forms of microbial life from a device, ensuring its safety for the end user and their patient, irrespective of whether the device is classified as critical or semi-critical based on its level of invasiveness. Sterilization is achieved through a physical or chemical process and is regulated by governmental and other regulatory bodies such as the Food and Drug Administration (FDA), World Health Organization (WHO), and International Organization for Standardization (ISO). Common Sterilization Methods Steam Sterilization Steam sterilization, widely used and considered cost-effective, is nontoxic and acts rapidly in either a gravity displacement autoclave or high-speed pre-vacuum sterilizer. This method exposes devices to direct steam contact along with necessary pressure and temperature levels to kill microorganisms. However, it does not work on electronic components, fiberoptics, biological materials, or most polymers. Ideal devices for steam sterilization include surgical instruments, implantable medical devices, flexible liquid containers (e.g., blood and solution bags), syringes, and vials. Ethylene Oxide (EtO) Sterilization EtO sterilization is widely used for a majority of current medical devices and is estimated to sterilize over half of all sterile medical devices in the U.S. It is especially sought for terminal sterilization of reusable devices and effectively sterilizes devices without causing damage. Ideal devices for EtO sterilization include heart valves, pacemakers, surgical kits, syringes, catheters, and ventilators. Gamma (Irradiation) and E-Beam Sterilization Gamma irradiation, known as a "cold process," is suitable for heat-sensitive devices. It works well on medical devices such as plastic syringes, hypodermic needles, scalpels, surgical blades, and adhesive dressings. E-beam sterilization is a similar process to gamma irradiation and can be identified by your contract manufacturer as ideal for your specific device. Glass Plasma Sterilization Glass plasma sterilization uses a hydrogen peroxide gas plasma system to decontaminate devices, making it ideal for medical devices intolerant to high temperatures and humidity. It works well on devices like laser probes, thermometers, and defibrillator paddles. Sporicidal Chemicals The FDA has approved multiple chemical sterilants for medical device sterilization, although their effectiveness cannot be monitored using a biological indicator. They are commonly used within hospital reprocessing departments for devices such as flexible endoscopes, scissors, stethoscopes, oral and rectal thermometers. Dry Heat Sterilization Dry heat sterilization utilizes high temperatures in a heating cabinet or conveyor tunnel to eliminate microorganisms. This method is ideal for glassware, metal parts, and paper-wrapped products.

2024-01

Which Materials And Medical Devices Are Best For Ethylene Oxide (EtO) Sterilization?

Ethylene Oxide (EtO) sterilization is utilized for gas-compatible devices of all types and configurations, both for terminal sterilization and sterilization of reusable medical devices. EtO has been acclaimed as one of the most effective and ideal sterilization methods. However, the question remains: which materials and devices are best suited to this process? We provide answers, along with an exploration of how and why EtO has become the most widely used medical device sterilization method. EtO as the Ideal Sterilization Method Many delicate devices suffer damage when subjected to sterilization via moist heat or radiation. Early studies quickly revealed that heat- and moisture-sensitive devices could not withstand such methods successfully or achieve reliable sterility assurance, leading to the emergence of EtO as the valued solution used by many sterilization professionals today. Additionally, EtO is the only sterilization method that can reliably penetrate interior chambers or surfaces in contact with each other. More than 50% of all medical devices, totaling over 20 billion annually, are sterilized with EtO, according to the Advanced Medical Technology Association. Furthermore, most surgeries utilize at least one device that has been sterilized using EtO. Which Materials or Devices are Best for EtO? Medical device manufacturers use a variety of materials in their devices, ranging from plastics to non-woven materials to metal. However, other methods of sterilization can potentially melt non-woven materials and plastics. EtO becomes a preferred choice when such materials are present. Common medical devices suitable for EtO sterilization due to sensitive materials or interior chambers include: Fiberoptic endoscopes Surgical kits Catheters IV sets Plastic tubing Surgical telescopes Heart valves Electrical equipment Surgical staplers or drills Respirators Pacemakers What Else Makes EtO the Ideal Sterilization Choice? Many EtO sterilization runs are small batch, resulting in a faster turnaround – a quality often sought after and valued by medical device manufacturers. For those concerned about EtO environmental gas issues, small batch EtO sterilization uses a single gas canister, requiring less gas for processing, thus releasing a very small percentage into the atmosphere.