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Barrier Technology in Pharmaceutical Processing
A major source of pollution in aseptic manufacturing is personal handling. Therefore, the reduction of human interventions in the critical zone leads to higher purity in the products. For aseptic manufacturing in pharmaceutical processing, Restricted Access Barrier Systems (RABS technology) as well as isolators offer improved sterility assurance for the product and an efficient protection of the staff against risks caused by hazardous substances. These aseptic barrier systems fulfill many applications in pharmaceutical production lines, such as finish manufacturing and packaging.
Isolators include an automated bio-decontamination system and are suitable for long-lasting campaigns. A RABS, on the other hand, is an appealing solution for cleanrooms and guaranties the quality needs for applications which require more flexibility. If necessary, a RABS can be opened to allow for process intervention, while the Isolators must be kept closed during the entire operation.
A major advantage of isolator technology over conventional cleanroom technology in aseptic environments is the high security level of protection of the product which is still not achievable with other methods working with aseptic products.
A RABS provides separation by the barrier on the basis of a closed system for processing, which reduces the risk of contamination of the product because of reduced contact surfaces in comparison with handling in a normal cleanroom. In other words: It contains a barrier system with HEPA-filtered air flow, which allows a faster start and handling of processes compared with isolators and more flexible changes. Also, remodelling and renovations are cheaper.
RABS air handling units operate similar to laminar flow fume hoods in a way that they get clean air from fan units through HEPA filters and the air vents from the unit into the RABS (overpressure airflow). Air exits through openings into the environment at a low level on the equipment. During operation, there should be no reason to open the RABS doors. If there is a severe cause to open the doors, the laminar air flow system and other elements must be able to prevent a collapse of the ISO 5 conditions. Each opening of the doors will be considered as a serious intervention and must be documented.
An open RABS enables measurements and monitoring. RABS can – similar to an isolator – be driven as doors close system, with a very low risk of contamination. But a RABS contains not only a clean air maintenance system, it also includes an air lock zone, a well-designed equipment, laminar air flow, ISO 5 conditions in the critical zone, a quality system in place, SIP (sterilization in place), standard opterating procedures for interventions, disinfection plans and a documentation of all processes.
An isolator is a closed system which has to perform two functions. It is a key control measure in preventing staff-exposure to cytotoxic substances, some of which may be carcinogens. It also has to protect the product from microbiological contamination during drug fabrication.
Overpressured or underpressured isolators are enclosed units which rely on a steady flow of filtered air during use supplying ISO 5 conditions. Air entering and leaving the isolator will do so through HEPA filters. Access to an isolator is performed through glove ports and sterile transfer systems. Isolators can work in an ISO 5 to ISO 8 environment.
Cleaning can be done manually or automated. Bio-decontamination of the isolator occurs through an automated cycle with H2O2 decontamination. Should there be a leak of the isolator, the system is not airtight. For an overpressure system, the leak will allow air, which might be contaminated with cytotoxic substances, to enter the workplace. For a negative pressure system, air that may contain bacteria could enter the isolator and contaminate the preparation.
A good leak detection system should therefore be in place in order to ensure that the leak is identified by once. It is included in an environmental monitoring system with built-in sampling ports.
Understanding Closed-System Transfer Devices: Why They Are Important and How to Select an Appropriate System
CLOSED-SYSTEM TRANSFER DEVICES, OR CSTDS, are defined by the National Institute for Occupational Safety and Health (NIOSH) as, “A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.”
These systems are important in protecting health care professionals from exposure to potentially cytotoxic and teratogenic medications both during product preparation and administration.1
The Importance of CSTDs in Protecting Health Care Professionals
CSTDs help protect health care professionals from hazardous drugs, including pharmacists preparing medications and nurses administering medication. It has been estimated that 8 million health care professionals are exposed to hazardous drugs each year, increasing the risk of chromosomal abnormalities, teratogenicity, and cancer. More than 100 studies substantiate the increased risk, and more than 50 studies have documented harm to health care workers as a result of exposure.2-4
In a 1999 study published in the Journal of Occupational and Environmental Medicine, Valanis and colleagues analyzed pregnancy outcomes in nearly 3000 nurses, pharmacists, and pharmacy technicians and compared those outcomes with those in more than 4000 women who were not health care workers. In health care workers, spontaneous abortion or stillbirth was 40% more likely (OR 1.4; 95% CI, 1.2-1.7) to occur in individuals who reported handling hazardous drugs.5
In 2010, McDiarmid and colleagues published a study in the Journal of Occupational and Environmental Medicine identifying a higher rate of chromosome 5 and 7 abnormalities among health care workers frequently handling antineoplastic medications than in health care workers who handled such medications less frequently.
Researchers collected blood samples from more than 100 health care workers and analyzed the likelihood of chromosomal abnormalities related to the frequency of hazardous drug handling in each individual. Findings indicated significantly higher rates of structural chromosomal abnormalities in a high-exposure subset of health care workers than in a low-exposure group (0.18/person vs 0.02/person, respectively; P = .04).
Significant outcomes included a 24% greater risk of chromosome 5 abnormalities (P = .01) and a 20% greater risk of chromosome 5 or 7 abnormalities (P = .01) in high-exposure individuals.6 These studies are not merely an academic exercise. Exposure to hazardous drugs has real-world consequences.
Before she died of pancreatic cancer, pharmacist and hazardous drug compounding advocate Sue Crump reported, “One of my friends after another was coming down with either some very rare, exotic, bizarre disease; brain tumors; sarcoidosis; arrhythmias; or cancer.”
When Sue developed pancreatic cancer at the age of 55 after a 23-year career in oncology pharmacy practice, she turned to the media and drew attention to the issue of inadequate protective controls in hazardous drug compounding.7
Sue’s case did not occur in isolation. Pharmacist Bruce Harrison, veterinarian Brett Cordes, and nurse Sally Giles all eventually developed cancer or precancerous conditions in their fourth or fifth decade of life after being exposed to the occupational risk of hazardous drug handling.
Sadly, Bruce Harrison, who had a key role in developing hazardous drug handling guidelines, died at the age of 59. Sally Giles died of bile duct cancer in 1992. Brett Cordes has since recovered from cancer, but has left private practice to advocate for improved compounding safety standards.7
Use of CSTDs can help protect health care workers from exposure to hazardous medications. However, when considering a CSTD, it is important to understand that this set of products have very different design characteristics and, with regard to protective efficacy, some products have been studied extensively with high-quality trials—and others have not.
What exactly is the difference between Sterilisation and Disinfection?
At Sychem, we are specialists in Disinfection, Sterilisation and decontamination, and operate in a wide range of industries. Despite many people using the terms Sterilisation and Disinfection interchangeably, there are significant differences between both types of high-level cleaning.
What exactly is the difference between Sterilisation and Disinfection?
Cleaning & Disinfection: A process that removes dirt, dust, large numbers of microorganisms and organic matter, killing most, but not all viable organisms.
Sterilisation: This is a process of removing or killing all viable organisms including spores. Dead microorganisms and toxins (pyrogens) may remain. Decontamination: A process that destroys or removes all microbial contamination to render an item or the environment completely safe.
The process of Disinfection is used to reduce the number of viable micro-organisms on a device, but it is not guaranteed to inactivate them all. Disinfection can be used to reduce the number of viable micro-organisms down to a level that ensures the device is fit for its intended purpose. A reduction in the number of viable micro-organisms to the most minute number via cleaning and Disinfection makes a device sterile.
In comparison, sterilisation is a process designed to kill all types of micro-organisms, including viruses, bacteria, and resistant bacterial spores, but is not necessarily effective against prions. This is because it is simply not possible to detect all organisms on a device. The term sterile can be used when the potential bio-burden (the number of organisms on a device) has been reduced such that there is less than one in a million chance of any surviving.
How To Compare Different Types Of Gloves In Terms Of Thickness, Quality And Strength
However, when comparing all the different types of hand protection, it can be hard to tell the difference and find the best fit for your purpose. Furthermore, most hand protection companies don’t explain all the complex variables that go into the creation of a glove. They use industry jargon and expect you to know what they are talking about.
The Glove Company wants to clear the air around gloves and hand protection. We will explain the industry jargon and provide you with a helpful guide to remember when trying to find the best gloves for your needs. Every situation and glove is different though, so if you have the smallest amount of doubt that the glove you are using is not suited to your use, then please reach out to our Glove Experts, who are specially trained to find the best fit for every situation.
Our hands can end up in all sorts of weird and hazardous situations throughout our lifetime. This means a glove that may suit your needs for one job will not provide adequate protection for another task.
Furthermore, every company’s spec sheets and chemical-resistant sheets have different information on them, making it very hard to physically compare two different gloves.
Generally speaking, in the safety industry, everyone automatically associates thickness with quality and strength. However, when it comes to gloves, especially disposable gloves, this is just not the case. Thickness can be an indicator but is not the principle driver.
The thickness of a glove is not a reliable indicator of strength, quality, or puncture and chemical resistance.
For disposable gloves in particular, it is easy to make a glove ‘thick’ however, if it’s made cheaply, or by someone who does not understand the complexities of glove manufacturing, the ‘thick’ glove will still easily snap or snag, when pulled or punctured.
The only way to tell if a glove is of higher quality is to talk directly to a glove specialist and physically compare / trial the gloves.
The best thing to do is call and have a chat to a Glove Expert, they will more than likely figure out which glove is the best for you, and then they will find the best way for you to trial the gloves. Most glove manufacturers are understanding of the fact that the best way for you to find the best protection is to talk to a specialist and trial the gloves, as every work, task or job is different.
Once you get your hands on the gloves, put them to the test, and it will quickly become apparent, which is the better glove.
Physically comparing and testing gloves is the best way to find the perfect fit for you. However, sometimes, you may need to compare gloves using technical specs and /or certifications.
If you do, there are a few glove expert insider tips and tricks that will enable you to make an accurate comparison.
Comparing the Thickness of Gloves and Disposable Gloves
You can measure thickness in a variety of different ways. In America, they use mils (A “mil” is a unit of thickness equal to one-thousandth of an inch (.001 inch)). For the rest of the world, we use Micro Meters (Microns). A unit of length equal to one-millionth of a metre.
It is important to note when measuring the thickness of a glove, that depending on which part of the glove is measured, there can be completely different results. For example, a thickness measurement taken from the fingertips will always be a lot thicker than a measurement taken on the palm of the glove.
Best practice in the glove industry is to take the measurement from the palm of the glove. However, not everyone does, and this reason is partly why comparing gloves using only spec sheets does not work. You need to get your hands physically on the gloves and feel the difference for yourself.
Membrane Filtration Method for Sterility Testing
The Membrane Filtration Sterility Test is the method of choice for pharmaceutical products. An appropriate use of this test is for devices that contain a preservative and are bacteriostatic and fungistatic under the direct transfer method. With membrane filtration, the concept is that the microorganisms will collect onto the surface of a sub-micron pore size filter. This filter is segmented and transferred to appropriate media. The test media are fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). FTM is selected based upon its ability to support the growth of anaerobic and aerobic microorganisms. SCDM is selected based upon its ability to support a wide range of aerobic bacteria and fungi (i.e., yeasts and molds). Incubation time is 14 days.
This method is the method of choice for medical devices because the device is in direct contact with test media throughout the incubation period. Viable microorganisms that may remain in or on a product after sterilization have an ideal environment within which to grow and proliferate. This is especially true with damaged microorganisms where the damage is due to a sub-lethal sterilization process. All microorganisms have biological repair mechanisms that can take advantage of environmental conditions conducive to growth. The direct transfer method benefits these damaged microorganisms. The entire product should be immersed in test fluid. With large devices, patient contact areas should be immersed. Nova understands that appropriate modifications are required due to the size and shape of test samples. The method requires that the product be transferred to separate containers of both FTM and SCDM. The product is aseptically cut, or transferred whole, into the media containers. After being transferred, the samples are incubated for 14 days.
A major source of pollution in aseptic manufacturing is personal handling. Therefore, the reduction of human interventions in the critical zone leads to higher purity in the products. For aseptic manufacturing in pharmaceutical processing, Restricted Access Barrier Systems (RABS technology) as well as isolators offer improved sterility assurance for the product and an efficient protection of the staff against risks caused by hazardous substances. These aseptic barrier systems fulfill many applications in pharmaceutical production lines, such as finish manufacturing and packaging.
Isolators include an automated bio-decontamination system and are suitable for long-lasting campaigns. A RABS, on the other hand, is an appealing solution for cleanrooms and guaranties the quality needs for applications which require more flexibility. If necessary, a RABS can be opened to allow for process intervention, while the Isolators must be kept closed during the entire operation.
A major advantage of isolator technology over conventional cleanroom technology in aseptic environments is the high security level of protection of the product which is still not achievable with other methods working with aseptic products.
A RABS provides separation by the barrier on the basis of a closed system for processing, which reduces the risk of contamination of the product because of reduced contact surfaces in comparison with handling in a normal cleanroom. In other words: It contains a barrier system with HEPA-filtered air flow, which allows a faster start and handling of processes compared with isolators and more flexible changes. Also, remodelling and renovations are cheaper.
RABS air handling units operate similar to laminar flow fume hoods in a way that they get clean air from fan units through HEPA filters and the air vents from the unit into the RABS (overpressure airflow). Air exits through openings into the environment at a low level on the equipment. During operation, there should be no reason to open the RABS doors. If there is a severe cause to open the doors, the laminar air flow system and other elements must be able to prevent a collapse of the ISO 5 conditions. Each opening of the doors will be considered as a serious intervention and must be documented.
An open RABS enables measurements and monitoring. RABS can – similar to an isolator – be driven as doors close system, with a very low risk of contamination. But a RABS contains not only a clean air maintenance system, it also includes an air lock zone, a well-designed equipment, laminar air flow, ISO 5 conditions in the critical zone, a quality system in place, SIP (sterilization in place), standard opterating procedures for interventions, disinfection plans and a documentation of all processes.
An isolator is a closed system which has to perform two functions. It is a key control measure in preventing staff-exposure to cytotoxic substances, some of which may be carcinogens. It also has to protect the product from microbiological contamination during drug fabrication.
Overpressured or underpressured isolators are enclosed units which rely on a steady flow of filtered air during use supplying ISO 5 conditions. Air entering and leaving the isolator will do so through HEPA filters. Access to an isolator is performed through glove ports and sterile transfer systems. Isolators can work in an ISO 5 to ISO 8 environment.
Cleaning can be done manually or automated. Bio-decontamination of the isolator occurs through an automated cycle with H2O2 decontamination. Should there be a leak of the isolator, the system is not airtight. For an overpressure system, the leak will allow air, which might be contaminated with cytotoxic substances, to enter the workplace. For a negative pressure system, air that may contain bacteria could enter the isolator and contaminate the preparation.
A good leak detection system should therefore be in place in order to ensure that the leak is identified by once. It is included in an environmental monitoring system with built-in sampling ports.
Understanding Closed-System Transfer Devices: Why They Are Important and How to Select an Appropriate System
CLOSED-SYSTEM TRANSFER DEVICES, OR CSTDS, are defined by the National Institute for Occupational Safety and Health (NIOSH) as, “A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.”
These systems are important in protecting health care professionals from exposure to potentially cytotoxic and teratogenic medications both during product preparation and administration.1
The Importance of CSTDs in Protecting Health Care Professionals
CSTDs help protect health care professionals from hazardous drugs, including pharmacists preparing medications and nurses administering medication. It has been estimated that 8 million health care professionals are exposed to hazardous drugs each year, increasing the risk of chromosomal abnormalities, teratogenicity, and cancer. More than 100 studies substantiate the increased risk, and more than 50 studies have documented harm to health care workers as a result of exposure.2-4
In a 1999 study published in the Journal of Occupational and Environmental Medicine, Valanis and colleagues analyzed pregnancy outcomes in nearly 3000 nurses, pharmacists, and pharmacy technicians and compared those outcomes with those in more than 4000 women who were not health care workers. In health care workers, spontaneous abortion or stillbirth was 40% more likely (OR 1.4; 95% CI, 1.2-1.7) to occur in individuals who reported handling hazardous drugs.5
In 2010, McDiarmid and colleagues published a study in the Journal of Occupational and Environmental Medicine identifying a higher rate of chromosome 5 and 7 abnormalities among health care workers frequently handling antineoplastic medications than in health care workers who handled such medications less frequently.
Researchers collected blood samples from more than 100 health care workers and analyzed the likelihood of chromosomal abnormalities related to the frequency of hazardous drug handling in each individual. Findings indicated significantly higher rates of structural chromosomal abnormalities in a high-exposure subset of health care workers than in a low-exposure group (0.18/person vs 0.02/person, respectively; P = .04).
Significant outcomes included a 24% greater risk of chromosome 5 abnormalities (P = .01) and a 20% greater risk of chromosome 5 or 7 abnormalities (P = .01) in high-exposure individuals.6 These studies are not merely an academic exercise. Exposure to hazardous drugs has real-world consequences.
Before she died of pancreatic cancer, pharmacist and hazardous drug compounding advocate Sue Crump reported, “One of my friends after another was coming down with either some very rare, exotic, bizarre disease; brain tumors; sarcoidosis; arrhythmias; or cancer.”
When Sue developed pancreatic cancer at the age of 55 after a 23-year career in oncology pharmacy practice, she turned to the media and drew attention to the issue of inadequate protective controls in hazardous drug compounding.7
Sue’s case did not occur in isolation. Pharmacist Bruce Harrison, veterinarian Brett Cordes, and nurse Sally Giles all eventually developed cancer or precancerous conditions in their fourth or fifth decade of life after being exposed to the occupational risk of hazardous drug handling.
Sadly, Bruce Harrison, who had a key role in developing hazardous drug handling guidelines, died at the age of 59. Sally Giles died of bile duct cancer in 1992. Brett Cordes has since recovered from cancer, but has left private practice to advocate for improved compounding safety standards.7
Use of CSTDs can help protect health care workers from exposure to hazardous medications. However, when considering a CSTD, it is important to understand that this set of products have very different design characteristics and, with regard to protective efficacy, some products have been studied extensively with high-quality trials—and others have not.
What exactly is the difference between Sterilisation and Disinfection?
At Sychem, we are specialists in Disinfection, Sterilisation and decontamination, and operate in a wide range of industries. Despite many people using the terms Sterilisation and Disinfection interchangeably, there are significant differences between both types of high-level cleaning.
What exactly is the difference between Sterilisation and Disinfection?
Cleaning & Disinfection: A process that removes dirt, dust, large numbers of microorganisms and organic matter, killing most, but not all viable organisms.
Sterilisation: This is a process of removing or killing all viable organisms including spores. Dead microorganisms and toxins (pyrogens) may remain. Decontamination: A process that destroys or removes all microbial contamination to render an item or the environment completely safe.
The process of Disinfection is used to reduce the number of viable micro-organisms on a device, but it is not guaranteed to inactivate them all. Disinfection can be used to reduce the number of viable micro-organisms down to a level that ensures the device is fit for its intended purpose. A reduction in the number of viable micro-organisms to the most minute number via cleaning and Disinfection makes a device sterile.
In comparison, sterilisation is a process designed to kill all types of micro-organisms, including viruses, bacteria, and resistant bacterial spores, but is not necessarily effective against prions. This is because it is simply not possible to detect all organisms on a device. The term sterile can be used when the potential bio-burden (the number of organisms on a device) has been reduced such that there is less than one in a million chance of any surviving.
How To Compare Different Types Of Gloves In Terms Of Thickness, Quality And Strength
However, when comparing all the different types of hand protection, it can be hard to tell the difference and find the best fit for your purpose. Furthermore, most hand protection companies don’t explain all the complex variables that go into the creation of a glove. They use industry jargon and expect you to know what they are talking about.
The Glove Company wants to clear the air around gloves and hand protection. We will explain the industry jargon and provide you with a helpful guide to remember when trying to find the best gloves for your needs. Every situation and glove is different though, so if you have the smallest amount of doubt that the glove you are using is not suited to your use, then please reach out to our Glove Experts, who are specially trained to find the best fit for every situation.
Our hands can end up in all sorts of weird and hazardous situations throughout our lifetime. This means a glove that may suit your needs for one job will not provide adequate protection for another task.
Furthermore, every company’s spec sheets and chemical-resistant sheets have different information on them, making it very hard to physically compare two different gloves.
Generally speaking, in the safety industry, everyone automatically associates thickness with quality and strength. However, when it comes to gloves, especially disposable gloves, this is just not the case. Thickness can be an indicator but is not the principle driver.
The thickness of a glove is not a reliable indicator of strength, quality, or puncture and chemical resistance.
For disposable gloves in particular, it is easy to make a glove ‘thick’ however, if it’s made cheaply, or by someone who does not understand the complexities of glove manufacturing, the ‘thick’ glove will still easily snap or snag, when pulled or punctured.
The only way to tell if a glove is of higher quality is to talk directly to a glove specialist and physically compare / trial the gloves.
The best thing to do is call and have a chat to a Glove Expert, they will more than likely figure out which glove is the best for you, and then they will find the best way for you to trial the gloves. Most glove manufacturers are understanding of the fact that the best way for you to find the best protection is to talk to a specialist and trial the gloves, as every work, task or job is different.
Once you get your hands on the gloves, put them to the test, and it will quickly become apparent, which is the better glove.
Physically comparing and testing gloves is the best way to find the perfect fit for you. However, sometimes, you may need to compare gloves using technical specs and /or certifications.
If you do, there are a few glove expert insider tips and tricks that will enable you to make an accurate comparison.
Comparing the Thickness of Gloves and Disposable Gloves
You can measure thickness in a variety of different ways. In America, they use mils (A “mil” is a unit of thickness equal to one-thousandth of an inch (.001 inch)). For the rest of the world, we use Micro Meters (Microns). A unit of length equal to one-millionth of a metre.
It is important to note when measuring the thickness of a glove, that depending on which part of the glove is measured, there can be completely different results. For example, a thickness measurement taken from the fingertips will always be a lot thicker than a measurement taken on the palm of the glove.
Best practice in the glove industry is to take the measurement from the palm of the glove. However, not everyone does, and this reason is partly why comparing gloves using only spec sheets does not work. You need to get your hands physically on the gloves and feel the difference for yourself.
Membrane Filtration Method for Sterility Testing
The Membrane Filtration Sterility Test is the method of choice for pharmaceutical products. An appropriate use of this test is for devices that contain a preservative and are bacteriostatic and fungistatic under the direct transfer method. With membrane filtration, the concept is that the microorganisms will collect onto the surface of a sub-micron pore size filter. This filter is segmented and transferred to appropriate media. The test media are fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). FTM is selected based upon its ability to support the growth of anaerobic and aerobic microorganisms. SCDM is selected based upon its ability to support a wide range of aerobic bacteria and fungi (i.e., yeasts and molds). Incubation time is 14 days.
This method is the method of choice for medical devices because the device is in direct contact with test media throughout the incubation period. Viable microorganisms that may remain in or on a product after sterilization have an ideal environment within which to grow and proliferate. This is especially true with damaged microorganisms where the damage is due to a sub-lethal sterilization process. All microorganisms have biological repair mechanisms that can take advantage of environmental conditions conducive to growth. The direct transfer method benefits these damaged microorganisms. The entire product should be immersed in test fluid. With large devices, patient contact areas should be immersed. Nova understands that appropriate modifications are required due to the size and shape of test samples. The method requires that the product be transferred to separate containers of both FTM and SCDM. The product is aseptically cut, or transferred whole, into the media containers. After being transferred, the samples are incubated for 14 days.