Over the past decade, including new GMP regulations, there has been an increasing demand for disinfection and sterilization inside freeze dryers. Many methods of sterilization and sterilization have been applied to freeze dryers, each with its own unique advantages and disadvantages, including: Smoking Set,E-Cigarette Disposable,Magic Puff Disposable E Cigarette,Healcier Factory Direct Dongguan Vanilla Bioengineering Co., Ltd. , https://www.healthecigarette.de
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The most common method at present is steam sterilization, which is to increase the temperature and humidity inside the lyophilizer to 121 degrees Celsius and 25 PSI, and maintain a certain time and cycle, although the use of steam sterilization is no problem for the factory, but significant The installation cost and complexity of the lyophilizer are increased and a long cycle time is required. The lyophilizer is usually operated under extremely low temperature and high vacuum conditions, and does not require a pressure level. In order to meet the requirements of autoclaving, the cabin must be used as a pressure vessel to significantly increase the production cost, often doubled. The degree requires both an auxiliary steam generator and a stainless steel piping system.
Because of the significant increase in steam sterilization costs, and the existing lyophilizers cannot be retrofitted to steam sterilization, the use of hydrogen peroxide vapor is another viable option.
How does H2O2 disinfection work?
Hydrogen peroxide H2O2 is a recognized sterilant, and hydrogen peroxide vapor HPV residue-free sterilization technology has been in use for over a decade. More than 85% of aseptic process isolators worldwide use HPV technology as a biodecontamination Choice (ISPE, 2005), in addition to the sterilizing of freeze dryers, HPV has been widely used in isolators, rooms, RABS, filling lines and operating/production areas of different configurations.
This technology converts liquid H2O2 into HPV by "flashing". This process can be carried out efficiently under normal temperature and humidity conditions, so special pretreatment such as dehumidification is not required.
The HPV is uniformly introduced into the confined space, and its inner surface is completely exposed to the HPV to form a hydrogen peroxide film of about 1 micron, which is attached to the surface of the microorganism that may be colonized, and the microorganism itself is wrapped as a micro-condensation formed by the core, and rapidly Killed by this process.
The whole process is controlled outside the confined space by computer and color touch screen, and the loop process is feedbacked in real time. The space or equipment disinfected by HPV needs to be sealed. The handheld HPV sensor with electrochemical principle monitors no leakage and whether the environment is circulating. After returning to a safe level that can be entered.
The goal of sterilization is to achieve a 6-log kill rate of the biological indicator BIs, and the commonly used BI is Bacillus stearothermophilus.
After the disinfection, the HPV is catalytically decomposed into water vapor and oxygen. It can also be completely decomposed by using a powerful ventilation device, or a building air conditioning ventilation system can be used. For the freeze dryer, the vacuum system can be used to quickly remove residual HPV.
H2O2 Compatibility Hydrogen peroxide has been used in a wide range of facilities over a period of nearly a decade or more, validating the compatibility of a wide range of materials including sensitive electronic components, microscopes, stainless steel, and high efficiency filtration.
The typical H2O2 process hydrogen peroxide vapor sterilization process is divided into the following four stages of operation:
1. Conditioning preparation: It takes about 5 to 10 minutes to stabilize the evaporator of the hydrogen peroxide generator at a temperature of about 120 to 130 degrees Celsius.
2. Gassing Intake: Using a readily available pharmaceutical grade 30–35% w/w hydrogen peroxide solution, which is instantaneously vaporized (flashed) in the generator and dynamically injected into the target area. The nozzle is used to increase the steam flow rate to nearly 100 feet. The speed per second, while rotating horizontally and vertically to ensure a uniform distribution.
3. Dwell maintains: Hydrogen peroxide vapor is maintained in the target area for a certain period of time to ensure complete bio-killing, which allows the target area to be fully and additionally exposed to hydrogen peroxide vapor to ensure successful results.
4. Aeration ventilation: Use the facility's ventilation system to remove steam from the target area, or use the ventilation unit to quickly catalyze the decomposition of steam into water and oxygen. When the facility's ventilation system does not have a suitable valve or is difficult to control, use a separate ventilation system. It will make a lot of sense.
The latest hydrogen peroxide generator for H2O2 equipment eliminates the need for pre-dehumidification devices, water ring pumps and built-in special sensors. After the disinfection is completed, the catalytic system is used to decompose hydrogen peroxide without the need to monitor the exhaust vents. Moreover, the latest system can Flexible and portable use of equipment, rooms or suites.
Program development and validation Manufacturers of hydrogen peroxide vapor generators and freeze dryers can help develop procedures and validate the entire system, including factory acceptance test (FAT), installation/operation verification (IQ/OQ), gas cycle development (GCD) And performance verification (PQ), the above verification includes the following:
Document inspection, post-delivery inspection, material inspection, operation certification inspection, operational function inspection, surface temperature inspection, gas distribution study using chemical indicator CIs, BIs position map of biological indicator, and optimization of intake, preparation and ventilation time .
The modification of existing equipment hydrogen peroxide is often used to retrofit to existing freeze dryers, minimizing the need for retrofitting a new system. A valved hydrogen peroxide inlet and outlet are the most basic requirements. This connection requires a 1.5" diameter interface to accommodate proper airflow. Normally hydrogen peroxide enters the lyophilizer from the highest point and exits from the lowest point. The more advanced H2O2 disinfection system provides all the necessary built-in parameters to control the extinguishment. Bacterial process.
In summary, many different disinfection methods can be used, but HPV technology is regarded as the future development direction. It has achieved bioavailability in the pharmaceutical and bio-industry fields, good material compatibility, and proof of a large number of applications. These technologies will continue to help products be safer and more efficient processes now and in the future.
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