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2012年9月14日 星期五

Stability Testing Chambers in the Pharmaceutical Industry


Stability testing chambers are enclosures used to assess the effects of pre-specified environmental circumstances on biological materials and industrial/electronic components. The most common use of these stability chambers (sometimes referred to as environmental chambers) is that of stand-alone specimen testing for decomposition and reduced efficiency under various temperature and humidity ranges.

Small Scale Stability Testing

Stability chambers were originally large and immobile but the demands of modern testing applications have led to smaller, more portable units. This is often called "Small Scale Stability Testing" and is commonly used in Food and Pharmaceutical product testing.

Using wireless technology provides convenient wireless test kits complete with calibrated sensor caps, logger caps and related logging software compliant software.

How Stability Testing Works

1. Humidity capsules are used to control the humidity within the test chamber

2. The humidity capsule is pierced and placed in the test chamber

3. The test material is placed in one of the other compartments within the test chamber

4. Sensor caps incorporate a temperature and humidity sensor on the inside of the cap

5. The sensor cap is also used to seal the test chamber

6. A logger cap which contains a memory chip and short range transceiver is connected to the sensor cap and is used to collect and transmit data wirelessly to the Control Software

7. Before connection the logger cap must first receive the test settings by docking the logger cap on the basestation which is connected to a computer or laptop.

8. The logger cap is then connected to the sensor cap to initiate the test. The unit is then incubated at the required temperature for the require time.

9. The temperature and humidity test conditions are then transferred wirelessly to the Control Software for presentation and reporting.

Each test monitored in its own micro-humidity chamber and humidity settings can be varied according to the testing requirement. Some Stability Testing are sold complete with customisable control software and built in offsite backups which comes in handy if when testing a large number of samples or when many locations need to share testing data quickly.

If possible try to source your stability testing chambers from a provider that also offers repair and calibration services. The integrity of the data is based on properly calibrated and fully functional units.




Amebis Ltd specialises in small scale stability testing chambers for the pharmaceutical industry. Manufactured in Ireland and available to Europe and the US. http://www.amebisltd.com.





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2012年9月1日 星期六

Embedded Control - Record Layouts Improve Database and RFID Sensor Testing


Software application designers and hardware application developers are working as teams to incorporate control-record layouts into end-to-end XML services for RFID networks. Using these newly formed XML tag sets made up of customized control-records has improved the design and development scenarios across diverse hardware platforms, operating systems, applications, and databases.

As software application developers begin to build RFID-and-sensor networks within key growth areas, it has become common place to witness recent deployments of control-record structures embedded in sensors and their supporting software. These control records contribute immensely to the major functions of any RFID sensor application including inputs, data-lookup and storage, interface programming and outputs.

These five major features are now incorporated into the application as a new and more efficient XML and database schema. This improved configuration has proven to meet growing demands to test multi-vendor RFID and sensor products for their ability to withstand extreme conditions. These conditions include excessive heat and cold, shock, humidity, vibration, altitude, pressure and all are reliably monitored using the new control-record layout approach.

The key design feature in the programming arrangement described in this article is the idea that an intermediate control record receives and distributes signals to and from the software and hardware sides of the full application. This nicely integrates selected signals from both spheres of operation and allows an interface to adapt dynamically to different device types. As new devices are attached and configured with the application, no appreciable interference is noticed in the originally attached devices.

Because the embedded layout of many types of devices can be addressed through the use of control records, new applications are provided with better XML testing languages. Additionally, this feature provides designers with the opportunity to introduce database simulators for a more accurate and dynamic portrayal of RFID and Sensor operation. This dynamic portrayal is added to the accumulated testing history and a better picture of performance emerges.

As RFID becomes more widely deployed, network reliability, security, and data integrity become increasingly critical. And for most companies, the task of ensuring those three things will be overwhelming and complex, especially across multiple hardware platforms and configurations and diverse supplier and partner networks and databases.

But because it is now feasible to virtually attach these control-record layouts to alleviate some of the major complexities associated with the required tests, any company can develop new products that may have been prohibitive in the past.




Tom Gruich is a professional database designer with 40 years experience in systems analysis and design of database software applications. For more database business mapping thoughts and design ideas please visit Database Solutions or his Smart Database website at => http://www.adaptcode.com





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2012年8月22日 星期三

Temperature-Humidity Sensors in Pharmaceutical Testing


Pharmaceutical Products fall under some of the most stringent regulations of any manufactured good out there. Product testing against varying environmental conditions need to be recorded using both accurate temperature-humidity sensors and reliable data logging software.

Such process control testing is referred to as stability testing because test materials are analysed for any degradation or significant physical changes throughout various temperature and relative humidity settings.

The stability of a pharmaceutical product is a measure of its ability to resist deterioration during the period within which its properties and characteristics can be expected to remain with certain limits. All articles intended for use in diagnosis, mitigation, treatment of prevention of disease undergo some form of testing, often multiple times in the product development cycle, from drug development to package selection. ?

Temperature-humidity sensors are just one portion of a stability testing system. Older more cumbersome systems make use of large environmental chambers to contain all the test samples. The disadvantages of environmental chambers are that you can only test the samples for one temperature and relative humidity setting in equipment that takes up a lot space and has high running costs. Modern bench-top stability testing units or "small scale stability testing units" allow for many different sensor readings to be logged at the same time in a relatively small amount of physical space. ?

Calibration requirements for temperature-humidity sensors ?

Generally speaking temperature sensors require less calibration as they tend to maintain better accuracy levels. The humidity sensor will require more frequent calibration as accuracy can shift at higher temperature ranges. This is not a substantial problem if the product in question needs to be tested for relatively low temperature ranges but is the control process requires cycling over a large temperature range then a robust temperature-humidity sensors with frequent calibrations is recommended.?

When purchasing new and used units it is also advisable to ensure that calibration certificates are provided with the purchase (Don't forget to ask if the certificates are traceable and for which regions they are valid). A calibration certificate should be a minimum requirement to conform for international standards. ?

Various international validation requirements also regulate the way electronic signatures are used, how electronic data is stored and other computerized system requirement affecting Stability Testing. So not only must your sensors be compliant but also any associated data storage units. Those interested in further reading would do well to reference the FDA 21 GMP's Eudralex volume 4 requirements.




Their unique temperature-humidity sensor and 21 CFR part II compliant Amebis Control Software provide one of the most flexible solutions available today. http://www.amebisltd.com/temperature-humidity-sensors-pharmaceutical/





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2012年7月20日 星期五

Environmental Chambers: Designed for Product Testing


Environmental chambers are large reactors and are usually made of glass or polytetrafluoroethylene (PTFE) film, in which gas phase chemical reactions are carried out to simulate changes occurring in the atmosphere. Natural sunlight or artificial ultraviolet lighting can be used to initiate the chemistry.

Environmental chambers are made of convenient wireless systems complete with finely calibrated sensor caps, logger caps and complaint software. They are designed for product testing at various temperatures, from extreme cold to extreme hot.

They can also measure humidity, vibration, highly accelerated stress screening, life test or any combination of these. These are used to test the effects of specified environmental conditions on biological items, industrial products, materials and electronic devices and components.

The chambers can be used for:

• As a standalone test for environmental effects of test specimens.

• As preparation of test specimens for further physical test or chemical tests.

• As environmental conditions for conducting testing of specimens.

Environmental test chambers artificially replicate the conditions under which the machinery, materials, devices or components might be exposed. These can include the conditions which might not be expected like: extreme temperatures, sudden and extreme temperatures variations, moisture or relative humidity, electro-dynamic vibrations, rain weathering and others.

Chambers can be small rooms used both to condition test specimens and to conduct the test. They can be smaller units that are used for conditioning test items. There are some test chambers which are small enough to be placed onto a universal testing machine or other test apparatus.

Environmental chambers vary widely in size, they can be small unites designed for placement on bench tops to large walk in chambers. With the wide difference in size, a number of user control options are available, including simple analog indicators up to digital readouts with LCD displays.

Environmental may be computer programmable, and networked or web-enabled test chambers are also available.




I am holding a degree of post graduate. I love to write articles on various topics.This article is on environmental chambers which specially designed for product testing in pharmaceutical companies.





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2012年5月22日 星期二

Embedded Control - Record Layouts Improve Database and RFID Sensor Testing


Software application designers and hardware application developers are working as teams to incorporate control-record layouts into end-to-end XML services for RFID networks. Using these newly formed XML tag sets made up of customized control-records has improved the design and development scenarios across diverse hardware platforms, operating systems, applications, and databases.

As software application developers begin to build RFID-and-sensor networks within key growth areas, it has become common place to witness recent deployments of control-record structures embedded in sensors and their supporting software. These control records contribute immensely to the major functions of any RFID sensor application including inputs, data-lookup and storage, interface programming and outputs.

These five major features are now incorporated into the application as a new and more efficient XML and database schema. This improved configuration has proven to meet growing demands to test multi-vendor RFID and sensor products for their ability to withstand extreme conditions. These conditions include excessive heat and cold, shock, humidity, vibration, altitude, pressure and all are reliably monitored using the new control-record layout approach.

The key design feature in the programming arrangement described in this article is the idea that an intermediate control record receives and distributes signals to and from the software and hardware sides of the full application. This nicely integrates selected signals from both spheres of operation and allows an interface to adapt dynamically to different device types. As new devices are attached and configured with the application, no appreciable interference is noticed in the originally attached devices.

Because the embedded layout of many types of devices can be addressed through the use of control records, new applications are provided with better XML testing languages. Additionally, this feature provides designers with the opportunity to introduce database simulators for a more accurate and dynamic portrayal of RFID and Sensor operation. This dynamic portrayal is added to the accumulated testing history and a better picture of performance emerges.

As RFID becomes more widely deployed, network reliability, security, and data integrity become increasingly critical. And for most companies, the task of ensuring those three things will be overwhelming and complex, especially across multiple hardware platforms and configurations and diverse supplier and partner networks and databases.

But because it is now feasible to virtually attach these control-record layouts to alleviate some of the major complexities associated with the required tests, any company can develop new products that may have been prohibitive in the past.




Tom Gruich is a professional database designer with 40 years experience in systems analysis and design of database software applications. For more database business mapping thoughts and design ideas please visit Database Solutions or his Smart Database website at => http://www.adaptcode.com





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2012年5月19日 星期六

Temperature-Humidity Sensors in Pharmaceutical Testing


Pharmaceutical Products fall under some of the most stringent regulations of any manufactured good out there. Product testing against varying environmental conditions need to be recorded using both accurate temperature-humidity sensors and reliable data logging software.

Such process control testing is referred to as stability testing because test materials are analysed for any degradation or significant physical changes throughout various temperature and relative humidity settings.

The stability of a pharmaceutical product is a measure of its ability to resist deterioration during the period within which its properties and characteristics can be expected to remain with certain limits. All articles intended for use in diagnosis, mitigation, treatment of prevention of disease undergo some form of testing, often multiple times in the product development cycle, from drug development to package selection. ?

Temperature-humidity sensors are just one portion of a stability testing system. Older more cumbersome systems make use of large environmental chambers to contain all the test samples. The disadvantages of environmental chambers are that you can only test the samples for one temperature and relative humidity setting in equipment that takes up a lot space and has high running costs. Modern bench-top stability testing units or "small scale stability testing units" allow for many different sensor readings to be logged at the same time in a relatively small amount of physical space. ?

Calibration requirements for temperature-humidity sensors ?

Generally speaking temperature sensors require less calibration as they tend to maintain better accuracy levels. The humidity sensor will require more frequent calibration as accuracy can shift at higher temperature ranges. This is not a substantial problem if the product in question needs to be tested for relatively low temperature ranges but is the control process requires cycling over a large temperature range then a robust temperature-humidity sensors with frequent calibrations is recommended.?

When purchasing new and used units it is also advisable to ensure that calibration certificates are provided with the purchase (Don't forget to ask if the certificates are traceable and for which regions they are valid). A calibration certificate should be a minimum requirement to conform for international standards. ?

Various international validation requirements also regulate the way electronic signatures are used, how electronic data is stored and other computerized system requirement affecting Stability Testing. So not only must your sensors be compliant but also any associated data storage units. Those interested in further reading would do well to reference the FDA 21 GMP's Eudralex volume 4 requirements.




Their unique temperature-humidity sensor and 21 CFR part II compliant Amebis Control Software provide one of the most flexible solutions available today. http://www.amebisltd.com/temperature-humidity-sensors-pharmaceutical/





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2012年2月24日 星期五

Partial Discharge Testing of Rotating Apparatus


Statistics indicate that up to 37 percent of rotating equipment failures occur due to stator insulation breakdown. For several decades, partial discharge (PD) testing has been a very beneficial tool for assessing the stator insulation condition of medium-voltage rotating apparatus. This article examines how PD activity occurs and why PD testing is unique as applied to generators and motors.

What is Partial Discharge?

Partial discharge is a localized partial breakdown within or on the surface of insulation that causes a spark to occur. This partial failure of the insulation is generally caused by poor design, flaws, voids, or contamination that create a localized stress that exceeds the dielectric breakdown strength of the insulation material. The sparking activity then leads to further insulation decomposition through a combination of thermal, chemical, and electrical phenomena and persists until complete failure occurs. The detection and monitoring of PD activity has been found to be very useful in assessing the condition of electrical equipment. Although PD can occur at lower voltages, equipment operating below 2,000 volts to ground usually does not discharge frequently and usually fails by other mechanisms.

Rotating Apparatus Insulation

Switchgear, cable, and transformer insulation cannot tolerate PD activity very well. Generally, PD activity will lead to further destruction of the insulation and eventual failure. Therefore, these types of equipment should always operate PD free.

The design of rotating apparatus creates inherent difficulties that make producing PD-free equipment impossible. The complex configuration of stator coil insulation, difficulties with the manufacturing impregnation process, and the problems fitting the coils within the stator slots can all create voids which lead to PD activity. Since PD in rotating apparatus is inevitable, the coil insulation employs mica tape which is very resistant to partial discharge damage. So, when assessing the condition of rotating apparatus, it becomes very important to monitor and trend PD activity over the course of many years as opposed to assessing the condition of other types of equipment insulation where periodic PD testing may suffice.

PD Sensors

Effective on-line PD testing of switchgear, cable, and transformer insulation generally involves taking regular (annual) spot checks using temporary sensors that are safely attached to grounded components of the apparatus. The main goal of this procedure is to ensure a PD-free apparatus.

In order to best monitor rotating apparatus, permanent coupling capacitors are connected to the ma- chine output bus during an outage. These sensors provide a standardized method to decouple the PD signals. Additional data can be obtained by using the RTD's that are embedded in the insulation as auxiliary PD measurement points. The RTD's act as antennas that can pick up the high frequency pulses associated with PD.

Valuable Data

As previously stated, the mica insulation is quite im- pervious to most PD activity. However, large amplitude discharges occurring from voids in the insulation or end winding contamination can lead to direct insulation failure.

This is just one category of problems that can be detected.

Since the rotating equipment PD activity is trended over many years, it is more economical to install permanent monitors than conducting regular spot surveys. These moni- tors (see Figure 3) accept other sensors for trending load, temperature, and humidity data along with the PD data so that correlations can be made that provide additional infor- mation for more precise diagnostics of the cause, location, and type of the PD activity occurring.

Insulation can also fail from the thermal or mechanical wear over the course of many years from overheating, ther- mal cycling and loose wedging. In these cases, increases in PD activity will show as a slow rise over time. This type of PD activity relates directly to the machine's overall thermal or mechanical condition, as the PD activity is not the pri- mary problem but is actually an indicator of the presence of other age-related problems.

Conclusion

Monitoring PD activity in rotating apparatus is very im- portant for increasing reliability and prolonging equipment life. All generators and critical motors should be monitored continuously and consideration should be given to perform- ing annual PD spot testing to the balance of plant medium voltage rotating apparatus.

Mr. Genutis received his BSEE from Carnegie Mellon University, has been a NETA Certified Technician for 15 years, and is a Certified Corona Technician. Don's technical training and education is comple- mented by twenty-five years of practical field and laboratory electrical testing experience. He is Vice President of the Group CBS Eastern U.S. Operations and is Technical Manager for their subsidiary, Circuit Breaker Sales & Service located in Central Florida.




Don A. Genutis is author of this article on High Voltage Testing.

Find more information about Partial Discharge Testing here.





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2012年1月5日 星期四

What Is Stability Testing?


In the pharmaceutical industry, stability testing refers to the process that tests how well a product retains its properties over the lifetime of the product. This type of testing offers a highly flexible and compliant way to conduct tests during the development phase of almost any pharmaceutical product.

A small-scale stability testing unit can be set up in minutes and can allow for the simulated exposure of the effects of various environmental conditions, including weather, temperature and humidity, on a pharmaceutical product. It is important to note that there are many small-scale testing units available. When selecting a testing unit, it is important to conduct extensive research in order to find the product that is best suited to the needs of a particular project.

A Step-by-Step Guide

Professionals have established what stability testing is but what does it entail? The next section of this article will give a brief example of how stability testing can be used to test how the properties of a pharmaceutical product reacts to different levels of humidity.

1) A humidity capsule will be used to generate the required humidity. This humidity capsule needs to be pierced and placed in the stability testing unit. Humidity capsules can provide relative levels of humidity in the range 0-95% are available in 5% increasing increments. The appropriate humidity capsule should be selected based on the objectives of the test.

2) Place a sample of the pharmaceutical product in a separate compartment of the stability testing unit.

3) Seal the testing unit with a sensor cap. The sensor cap will measure the level of humidity within the unit for the duration of the test.

4) Dock a logger cap onto the base of the testing unit. Connect the logger cap to a computer via a USB cable to collect and record the humidity readings for the duration of the test. If the initiated tests are outside wireless range for communication with the basestation then cabling and aerials can be used to ensure wireless communication.

5) Incubate tests at the required temperature. When the tests are complete dispose of the humidity capsule and test chamber.

Benefits of Small-scale Stability Testing Units:

Using small-scale testing to conduct tests during the development of a pharmaceutical product allow for a variety of practical benefits.

These benefits include:

• The need for environmental chambers is eliminated

• Each test is monitored in its own micro-humidity chamber

• A full range of humidity and temperature conditions are available

• Continuous data is collected throughout the study for each test

• Improved sample integrity and less risk of cross contamination

• Sensors can be easily calibrated

• Only a small amount of space is requirement

• There isn't a need for salt solutions or desiccators

• It is easy to set-up

• It is ideal for use with toxic materials

• The system can be used for monitoring and mapping applications

• Data can be automatically backed up




Amebis is a technology company offering innovative and compliant Stability testing products and services to the healthcare and food industries.

http://www.amebisltd.com





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2011年12月24日 星期六

Stability Testing Chambers in the Pharmaceutical Industry


Stability testing chambers are enclosures used to assess the effects of pre-specified environmental circumstances on biological materials and industrial/electronic components. The most common use of these stability chambers (sometimes referred to as environmental chambers) is that of stand-alone specimen testing for decomposition and reduced efficiency under various temperature and humidity ranges.

Small Scale Stability Testing

Stability chambers were originally large and immobile but the demands of modern testing applications have led to smaller, more portable units. This is often called "Small Scale Stability Testing" and is commonly used in Food and Pharmaceutical product testing.

Using wireless technology provides convenient wireless test kits complete with calibrated sensor caps, logger caps and related logging software compliant software.

How Stability Testing Works

1. Humidity capsules are used to control the humidity within the test chamber

2. The humidity capsule is pierced and placed in the test chamber

3. The test material is placed in one of the other compartments within the test chamber

4. Sensor caps incorporate a temperature and humidity sensor on the inside of the cap

5. The sensor cap is also used to seal the test chamber

6. A logger cap which contains a memory chip and short range transceiver is connected to the sensor cap and is used to collect and transmit data wirelessly to the Control Software

7. Before connection the logger cap must first receive the test settings by docking the logger cap on the basestation which is connected to a computer or laptop.

8. The logger cap is then connected to the sensor cap to initiate the test. The unit is then incubated at the required temperature for the require time.

9. The temperature and humidity test conditions are then transferred wirelessly to the Control Software for presentation and reporting.

Each test monitored in its own micro-humidity chamber and humidity settings can be varied according to the testing requirement. Some Stability Testing are sold complete with customisable control software and built in offsite backups which comes in handy if when testing a large number of samples or when many locations need to share testing data quickly.

If possible try to source your stability testing chambers from a provider that also offers repair and calibration services. The integrity of the data is based on properly calibrated and fully functional units.




Amebis Ltd specialises in small scale stability testing chambers for the pharmaceutical industry. Manufactured in Ireland and available to Europe and the US. http://www.amebisltd.com.





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2011年12月6日 星期二

Embedded Control - Record Layouts Improve Database and RFID Sensor Testing


Software application designers and hardware application developers are working as teams to incorporate control-record layouts into end-to-end XML services for RFID networks. Using these newly formed XML tag sets made up of customized control-records has improved the design and development scenarios across diverse hardware platforms, operating systems, applications, and databases.

As software application developers begin to build RFID-and-sensor networks within key growth areas, it has become common place to witness recent deployments of control-record structures embedded in sensors and their supporting software. These control records contribute immensely to the major functions of any RFID sensor application including inputs, data-lookup and storage, interface programming and outputs.

These five major features are now incorporated into the application as a new and more efficient XML and database schema. This improved configuration has proven to meet growing demands to test multi-vendor RFID and sensor products for their ability to withstand extreme conditions. These conditions include excessive heat and cold, shock, humidity, vibration, altitude, pressure and all are reliably monitored using the new control-record layout approach.

The key design feature in the programming arrangement described in this article is the idea that an intermediate control record receives and distributes signals to and from the software and hardware sides of the full application. This nicely integrates selected signals from both spheres of operation and allows an interface to adapt dynamically to different device types. As new devices are attached and configured with the application, no appreciable interference is noticed in the originally attached devices.

Because the embedded layout of many types of devices can be addressed through the use of control records, new applications are provided with better XML testing languages. Additionally, this feature provides designers with the opportunity to introduce database simulators for a more accurate and dynamic portrayal of RFID and Sensor operation. This dynamic portrayal is added to the accumulated testing history and a better picture of performance emerges.

As RFID becomes more widely deployed, network reliability, security, and data integrity become increasingly critical. And for most companies, the task of ensuring those three things will be overwhelming and complex, especially across multiple hardware platforms and configurations and diverse supplier and partner networks and databases.

But because it is now feasible to virtually attach these control-record layouts to alleviate some of the major complexities associated with the required tests, any company can develop new products that may have been prohibitive in the past.




Tom Gruich is a professional database designer with 40 years experience in systems analysis and design of database software applications. For more database business mapping thoughts and design ideas please visit Database Solutions or his Smart Database website at => http://www.adaptcode.com





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2011年11月29日 星期二

Temperature-Humidity Sensors in Pharmaceutical Testing


Pharmaceutical Products fall under some of the most stringent regulations of any manufactured good out there. Product testing against varying environmental conditions need to be recorded using both accurate temperature-humidity sensors and reliable data logging software.

Such process control testing is referred to as stability testing because test materials are analysed for any degradation or significant physical changes throughout various temperature and relative humidity settings.

The stability of a pharmaceutical product is a measure of its ability to resist deterioration during the period within which its properties and characteristics can be expected to remain with certain limits. All articles intended for use in diagnosis, mitigation, treatment of prevention of disease undergo some form of testing, often multiple times in the product development cycle, from drug development to package selection. ?

Temperature-humidity sensors are just one portion of a stability testing system. Older more cumbersome systems make use of large environmental chambers to contain all the test samples. The disadvantages of environmental chambers are that you can only test the samples for one temperature and relative humidity setting in equipment that takes up a lot space and has high running costs. Modern bench-top stability testing units or "small scale stability testing units" allow for many different sensor readings to be logged at the same time in a relatively small amount of physical space. ?

Calibration requirements for temperature-humidity sensors ?

Generally speaking temperature sensors require less calibration as they tend to maintain better accuracy levels. The humidity sensor will require more frequent calibration as accuracy can shift at higher temperature ranges. This is not a substantial problem if the product in question needs to be tested for relatively low temperature ranges but is the control process requires cycling over a large temperature range then a robust temperature-humidity sensors with frequent calibrations is recommended.?

When purchasing new and used units it is also advisable to ensure that calibration certificates are provided with the purchase (Don't forget to ask if the certificates are traceable and for which regions they are valid). A calibration certificate should be a minimum requirement to conform for international standards. ?

Various international validation requirements also regulate the way electronic signatures are used, how electronic data is stored and other computerized system requirement affecting Stability Testing. So not only must your sensors be compliant but also any associated data storage units. Those interested in further reading would do well to reference the FDA 21 GMP's Eudralex volume 4 requirements.




Their unique temperature-humidity sensor and 21 CFR part II compliant Amebis Control Software provide one of the most flexible solutions available today. http://www.amebisltd.com/temperature-humidity-sensors-pharmaceutical/





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