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Sterilizer Autoclave Machine FAQ
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Can we use Biological Indicator Evaluation Resistometer(BIER) to test our biological indicator?

What is the purpose of the Steam BIER system?The Steam BIER system is designed to provide reproducible reference environmental conditions for evaluating the resistance of microbial populations to steam sterilization.How does the Steam BIER system work?The system incorporates a dynamic air removal system with a leak detection system to ensure the removal of air from the test system. It then undergoes rapid pressurization with steam to achieve preset sterilization temperatures. After exposure, the chamber is rapidly depressurized to atmospheric pressure.What is the significance of the Pre-vacuum Flush and Gravity cycles programmed in Steam BIER units?The Pre-vacuum Flush and Gravity cycles are likely programmed to simulate different sterilization conditions. Pre-vacuum flush involves removing air from the chamber before introducing steam, while Gravity cycles rely on the natural downward flow of steam.How is the BIER system used in quality control for sterilization processes?The BIER system serves as a tool for quality control by providing a controlled environment to assess the effectiveness of steam sterilization. It helps evaluate the resistance of biological or chemical indicators to ensure proper sterilization conditions are achieved.Are there specific guidelines or standards for using the Steam BIER system?China GB 24628-2009/ISO 18472:2006, IDT  Sterilization of health care products—Biological and chemical indicators—Test equipmentChina GB 18282.4—2009/ISO 11140-4:2007, IDT  Sterilization of health care products—Chemical indicators—Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetrationWhat are the advantages of using the Steam BIER system in comparison to traditional methods of assessing sterilization efficacy?The advantages may include improved reproducibility, controlled testing conditions, and the ability to assess the resistance of indicators to steam sterilization in a standardized manner.

Q: Regarding ampoule injection, How to choose between steam sterilizer and superheat water autoclave

Firstly these two kinds of autoclave sterilization machines got their own advantages on heating-up speed and cooling, uniform thermal distribution, and etc. But It mainly depends on the loads packing material and size, if glass ampoule, and size is 1ml, 2ml, 5ml, 10ml, we recommend steam sterilization with advantage of fast heating-up and less cost on utility consumption. However, if the container size over 10ml, then superheated water cascade sterilizer is more appropriate to reduce the broken rate after sterilizing, with advantage of regular heating-up, but it costs more on utility consumption and budget. Customer needs to consider based on own situations and long term operation.

Q: Is it possible for our autoclave and sterilizers idle for years to restart?

Autoclaves and sterilizers are designed to be robust pieces of equipment, but if they have been idle for an extended period, restarting them may pose some challenges. Here are some considerations:    Inspection and Maintenance: Before attempting to restart autoclaves and sterilizers that have been idle for an extended period, perform a thorough inspection. Check for any signs of damage, corrosion, or wear. Ensure that all components, including seals and gaskets, are in good condition.    Manufacturer's Guidelines: Refer to the manufacturer's guidelines and user manuals for specific instructions on restarting the autoclave or sterilizer. The manufacturer's recommendations are crucial for ensuring proper operation and safety.   Calibration and Validation: Calibrate the equipment according to the manufacturer's specifications. Additionally, validate the autoclave's performance to ensure that it meets the required sterilization standards. This may involve running test cycles with biological indicators and monitoring temperature, pressure, and other critical parameters.    Fluids and Lubrication: Check and replace any fluids or lubricants that may have degraded over time. Lubricate moving parts as necessary to ensure smooth operation.    Electrical Components: Inspect electrical components, such as wiring and control systems, for any signs of damage or wear. Ensure that the electrical connections are secure.    Training and Documentation: Ensure that personnel responsible for operating the autoclave or sterilizer are trained on its proper use and maintenance. Update or review documentation, including standard operating procedures (SOPs), as needed.    Regulatory Compliance: Ensure that the autoclave or sterilizer complies with any applicable regulations and standards. This may involve consulting with regulatory authorities or third-party certification organizations.    Run Test Cycles: Before using the autoclave for actual sterilization purposes, run test cycles with load simulators or non-critical items to verify its functionality and to ensure that it achieves the required sterilization conditions.    Consult with Service Professionals: If in doubt or if there are significant concerns, consider consulting with the equipment manufacturer or a qualified service professional for a thorough inspection and any necessary repairs.Restarting an autoclave or sterilizer after a prolonged period of inactivity requires careful attention to ensure safety, efficacy, and compliance with regulatory standards. Always follow the manufacturer's recommendations and guidelines, and consider seeking professional assistance if needed.

Q: How can I get the quote for I.V solution autoclaves?

To match your production capacity and recommend accurate autoclave chamber volume, firstly we need to know your daily output, I.V fluid packing material, shape(bottle or bag), size(with drawing), then we calcualte according to that. Besides, URS(User Requirement Specification) document is preferred.

Q: What's the lead time of cassette autoclave?

Firstly it depends on the order quantity, if less than 5 sets, the cassette autoclave can be ready for delivery within 7 working days as we have enough stock and standard part for assembly.then the lead time taks two weeks if order 5~10 sets, three weeks if 10~15 sets, 30 working days of 20~30 days.And if there is special orders, eg. Electricity is 110V, AIKSMED needs to prepare special electric components, it takes from 7 to 30 days according to supplier's situation. So please contact with our sales managers for your specific requirement.If the distributors got warehouse in the local place, inventory can be an excellent way to improve your service, and AIKSMED can support our distributors any time!And regarding to the transport, AIKSMED can arrange all kinds of transport, including seaway, railway, air, highway.  the cassette autoclave can be ready for delivery within 7 working days as we have enough stock and standard part for assembly, but if there is special orders, eg. Electricity is 110V, AIKSMED needs to prepare special components, it will take from 7 to 30 days. Contact if any questions!

Q: What is FAT and SAT?

FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) are two phases of the equipment validation process commonly used in various industries, including manufacturing and pharmaceuticals. These tests help ensure that sterilizers and autoclaves equipment meets the specified requirements and functions correctly within its intended environment.FAT (Factory Acceptance Testing):Conducted at the manufacturer's facility. Ensures that the equipment meets design specifications and functions according to agreed-upon criteria.Identifies and addresses issues before shipping the equipment to the customer.SAT (Site Acceptance Testing):Conducted at the customer's site after equipment installation.Ensures that the equipment continues to meet specified requirements within its intended operating environment.Addresses site-specific factors and verifies that the equipment operates correctly in its final location.Both FAT and SAT are critical steps in the validation and commissioning process to ensure that equipment performs as intended and meets the user's requirements. The testing procedures and acceptance criteria for FAT and SAT are typically detailed in the project documentation and quality assurance plans.