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Hydrogen peroxide for isolator measurement system on site
Life science
Ardien consulting services company, founded in 1994, it is aseptic manufacturing, sterile devices used in the detection and control application isolator validation.Rick Nieskes is the founder and chief adviser Ardien, current provides authentication services for more than 50 pharmaceutical companies.Visa for NieskesVisa HPP272 probecollocationIndigo201 transmitterUsed for testing purposes.
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Use originated from the early 1990 s hydrogen peroxide purification method, Nieskes decided to focus on the pharmaceutical industry isolation technique and vaporizing hydrogen peroxide system.In his work, Nieskes identification equipment and the environment not only, also make biological purification cycle and protocols to help the company to ensure the consistency of the process and effect.
When Nieskes have the opportunity to evaluate visa hydrogen peroxide probe tie-in Indigo201 transmitter, he put them with your current hydrogen peroxide (H2O2) measuring equipment are compared.Is the first major difference between his own sensor gives only one over one million (PPM) readings, and visa pull HPP272 probe collocation Indigo201 transmitter can offer three values: H2O2Concentration (PPM), percentage of relative degree of saturation and temperature (humidity).Visa provides two kinds of measuring hydrogen peroxide probe: HPP271 probe measurement only H2O2Concentration (PPM), HPP272 probe can measure several parameters, including H2O2Concentration (PPM), relative saturation, relative humidity, temperature, dew point and steam pressure.
"Will my standard sensor (based on the technology of electronic chemical) and visa HPP272 (polymer film sensors based on technology) in the isolator, less than a foot apart, I began to perform purification cycle", Nieskes said."Electronic chemical H2O2Concentration sensor to response faster, in about 5 to 10 minutes, two basic same sensor readings.However, according to my experience, H2O2Concentration values from a purification cycle without it to another cycle of relative consistency is important.In the validation process, two sensors to ensure the consistency."
Although level was similar, but the value of the different resolution.Two screens are starting from scratch, but the first value of electronic chemical sensor is 10 PPM, subsequent value increment for 5 PPM.Visa Indigo transmitter provides HPP272 sensor readings, the value increment for 1 PPM.
"It became very interesting" in the process of ventilation, Nieskes recalls."At the end of the purification stage, almost the same reading two sensors are given.Electronic chemical sensors for 705 PPM, HPP272 is 710 PPM.In the end of the stage of ventilation, HPP272 readings for 2 PPM, I took another device for low PPM readings."
"I use two different equipment to measure the level of high and low levels of concentration of hydrogen peroxide.Low level equipment indicates the value between 0.1 to 3 PPM.HPP272 readings for the 2 parts per million, the equipment readings for 1 PPM;HPP272 readings 1 PPM, the equipment readings of 0.5 PPM.I want to check out the consistent relationship between the two readings, but was surprised to find that the usually requires two different sensing equipment to ensure a high level and low level in the process of measurement accuracy, HPP272 at all stages of biological purification are relatively accurate."
Nieskes noticed another difference is in the process of measuring the number of variables."Use visa equipment, I can get the humidity (in this case, chose to show the relative saturation value), temperature, and H2O2Concentration.This gives us a more complete picture of what is happening, this is critical in the validation.Check the temperature and relative saturation values, and hydrogen peroxide level is not only important for identification of equipment, but also for equipment troubleshooting between new appraisal is very helpful."
Nieskes think about environmental parameters and H2O2The PPM values can save time and ensure the effective purification process."Suppose some undetected hvac system.If in the winter, indoor temperature may fall.Therefore, in the process of biological purification of PPM may be below normal.You must do a lot of research to determine the root cause lies in the hvac system."
"At the same time, there may be more condensation in the isolator, which leads to lower PPM readings.If you are doing a abnormal PPM purification process of reading, without knowing the other variables in the environment, you must spend time to investigate the problem.If you can see the real-time influence other parameters of the process, can immediately know what has happened: one of the variables are changed."
Nieskes cooperation with pharmaceutical companies for more than 20 years, know that they are under pressure to control costs.In the process of each step must be efficient as possible."If we can make sure consistent biological purification process, a better understanding of influence each of the important parameters in the process, pharmaceutical efficiency will improve, Nieskes said."Downstream manufacturers can not only improve the production efficiency, and reduce the cost of drugs, consumers at the same time will still be able to ensure that drugs under the condition of safe, sterile and controlled processing."
In the validation work, examining the Nieskes assumes that device will work as expected, or change the surrounding environment will not produce harmful effects when the associated costs.
"Your use of the biological indicator and other equipment every year need to identify isolator.In the new appraisal interval, you must make sure that everything is stable.But if use sensors to monitor isolator in each cycle, you can in the new appraisal interval troubleshooting.I think whatever the application, the online monitoring in the isolator is very useful.Sometimes, unfortunately, is not to do so."
Nieskes recognize that if there is no use H2O2Sensor monitoring biological purification process, the only muddle along."I count how many times have seen company had to be identified and found biological indicator indicates growth is positive, then they start to troubleshooting.Using online sensors, these companies will have to help troubleshooting history information.
"I have seen H2O2The injection of normal (i.e., without warning or suspended) but not normal evaporation.In this case, the H2O2Concentration sensor may identify error conditions.The HPP272 sensors provide the relative saturation and density is very important."
Relative degree of saturation (percentage) for Nieskes is one of the new parameter.Indicates a H relative saturation2O2Steam and water vapour to air humidity.In this case, the Nieskes notice about 82% RS began to appear when the condensation.Decades of experience makes Nieskes concluded that a certain degree of condensation for containing hydrogen peroxide vapor efficient biological purification is necessary.
Before using HPP272 Nieskes use his purpose to make binary condensed sensor;Experience has taught him, not present condensation process may cause biological indicator indicates positive growth.Condensation is usually visible - H2O2Steam under different temperature, in different locations in the purification process of gas and liquid (condensate) two states.
"In an ideal biological purification process, the isolator temperature and humidity will be exactly the same every time", Nieskes said."Because you can't do that, so must be" verified ";Included in the room temperature in the process of verification.This shows that you can kill microorganisms through the environment change.You can change the environmental conditions and record results.
"Understanding degree of condensation or relative saturation (%) is very important.If you still can reach kill rate?I noticed that the customer can control and create conditions.Many rely on the design of the isolator, biological purification parameters and isolator around the indoor conditions."Nieskes pointed out some equipment has its own temperature and humidity control system to keep consistency of the process.But, generally, only control the humidity value in H2O2Before the start of vaporization is less than or equal to the set point and vaporization of H2O2The amount."This is at best limited information," said Nieskes."For example, for the specified time period you add 120 grams of hydrogen peroxide;Other conditions in the isolator is what?You need to understand each process of humidity and temperature in order to control the process."
Nieskes know to other related variables can be better control of biological purification process."If you are in indoor to execute the process of temperature or humidity fluctuations, in terms of bactericidal effect or aeration time may affect the biological purification process of isolator."
Nieskes in comparing electronic chemical sensing devices and visa HPP272 probe collocation Indigo201 transmitter, points out the several advantages of visa to pull system, especially good PPM measurement resolution and relative saturation values.In addition HPP272 in each stage of the biological purification is relatively accurate, this is helpful to carry out biological purification.
When Rick Nieskes test HPP270 probe or Indigo200 did not get paid out of visa.
In Rick Nieskes blog"Understanding isolator"On reading aboutComparison of the sensorFor more information, these sensors are used during the period of the cycle development of isolator validation
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