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Question: This is for my industrial design class. We have no lecture for this class at all. We just have submitted a project at the end of the semester. I came up with this idea because one day I broke my insulin bottle (I have diabetes). So I have a new idea of plastic insulin bottle instead of glass bottle so the paper should include:
Insulin is a hormone produced by the beta cells of the Islets of Langerhans in the pancreas that helps in the metabolism of carbohydrates, by converting glucose into glycogen. It enables the cells of the body to use glucose as a source of energy. Individuals with diabetes mellitus produce little or no insulin. Hence, the levels of glucose in the blood rises, and the cells are not able to use it. Normally, the pancreas automatically controls the sugar level in the blood by producing and releasing appropriate amounts of insulin. The hormone is usually available in injection forms as they cannot be absorbed into the blood when administered in the form of pills. Insulin is usually inactivated by the digestive tract if administered in the form of oral preparations.
Usually insulin is self-administered (in the form of injections) because the patient needs to take it at least two times a day. The insulin should be injected at least 30 minutes before the meal. It is available in four different forms, depending on the time it begins to work and the duration it acts. These include rapid-acting (acts within 15 minutes and lasts for 3 to 4 hours), short-acting acting (acts within 30 minutes and lasts for 5 to 8 hours), Intermediate-acting (NPH) (acts within 1 to 3 and lasts for 24 hours), Intermediate- and short-acting mixtures (a mixture of short-acting and intermediate-acting insulin), and long acting (acts within 1 to 5 hours and lasts for more than 24 hours).
Insulin is of different types including bovine insulin (derived from cows), pig insulin (derived from pigs), human insulin (grown by inserting human genetic material in yeast and bacteria that can produce insulin) and insulin analogues (substances that are similar to human insulin and differ only by one or two amino acids). Insulin was first separated at the University of Toronto in 1921 by Dr. Fredrick Banting, Charles Best, Professor J. J. R. Macleod and Dr. James Collip.
At the end of the 19th Century, researchers were feeling a connection between the pancreas and diabetes. In 1921, they studied that dogs that were diabetic benefited following administration of insulin. In 1922, insulin was administered to a boy dying from complications of diabetes, resulting in reduction of the symptoms. In 1923, Bantings and Macleod were given the Nobel Prize for Medicine.
The scientists had taken a long time to invent procedures to make the drug and calculate the right amounts in which the drug should be administered. The drug was manufactured within a year after the discovery. In the beginning, animal sources such as pigs and cattle were utilized to extract insulin. Concerns of their effectiveness, increasing needs of the diabetic patients, safety and long-term supply arouse.
Nowadays, insulin is extracted from yeast and bacteria, after genetically modifying these microorganisms with human genes (to suit the human insulin). The procedure to make such insulin was first discovered in 1978, Genetech and City of Hope National Medical Center. The production of genetically-engineered insulin involves several steps such as expressing the gene, inserting it into the microorganism and producing the drug. E.Coli was first being used to manufacture genetically engineered insulin. Nowadays, more than 20 different types of insulin and insulin analogs exist.
It had been a well-accepted mode previously to pack all injection-drugs (such as insulin) into glass containers because such substances tend to have a higher reactivity rate, and glass seemed to offer good resistance against chemical substances.
The procedure of manufacturing a glass bottle containing insulin is very long. This procedure is known as form-fill-and-seal or FFS. The glass bottles have to be thoroughly washed in 4 steps. At the entrance of the FFS machine film rolls are mounted. As glass carry a lot of difficulties, the FFS process is not fully automated. Some components may require human intervention which increases the chances of contamination. It is difficult to print on glass bottles, hence additional machines that specifically help in printing have to be utilized. The residual air present inside the bottle has to be removed using specialized suction and sealing devices. Cap-welding machines have to be utilized to insert and fix the lid on the bottle.
Glass has several advantages and disadvantages over plastic. One of the main advantages of glass is that it is inert and non-degradable, and unlike plastics does not release any of its components into the drug solution (chemical resistance). Insulin in glass bottles tends to have a longer shelf-life compared to plastic. The insulin tends to be more effective. An inert gas such as nitrogen can be inserted into the bottle to act as a preservative. Glass does not allow moisture and other gases to pass through.
It is fairly strong and the insulin may not leak out from the bottle. Glass tends to tolerate heat and light better. They do not degrade or melt under higher temperature and light conditions and protect the drug solution present in them. As glass can tolerate high temperature conditions better than plastics, heat sterilization can be utilized to destroy any micro-organism that is contaminating the bottle. They can also tolerate gamma-radiation better and hence can be utilized in radiation sterilization. Overall, glass tends to tolerate industrial processes better than plastics.
. However, glass also has certain disadvantages. Newer drugs such as peptides and antibodies tend to react with glass, and hence plastic containers are being utilized. Glass tends to break easily if dropped or if an excessive force is being applied. This is the biggest disadvantages of glass, and people using them have to be extra cautious. Glass bottles may have a silicon coating on them that is made of elastomers. This coating may contaminate the drug solution slowly over a period of time. However, several of the newer drugs coming out of the biotechnology market, do not seem to like glass packaging. Glass contains tiny amounts of alkali ions which tend to leak into the drug, causing a lot of problems to its effectiveness and safety.
Glass also tends to destroy the proteins present in the drugs. Following this protein degradation, other components of the drug may also get destroyed. Newer plastics have solved this problem to some extent. Glass bottles when utilized to carry drugs containing water and lyphophilised chemicals, tends to release hydrogen ions, which makes it tough to control the pH. It is very important to maintain the pH of the drug so that it is effective and safe to use. It is also very difficult to make new types of bottles for drugs as glass is not a flexible material and is heavy.
Plastics previously utilized had many limitations which did not permit total safety. The material could easily degenerate over a period of time and slowly leach away chemicals into the drug, thus making them unsafe for medical use. The plastic container may allow gases and water vapor to pass through, thus making the use of the medication unsafe.
When exposed to heat, chemicals or light, some plastics may even begin to degenerate. Compared to glass, plastics are unable to tolerate the industrial processes. Previous studies conducted; show that the drugs present in the plastic containers were slightly more ineffective than those stored in the glass containers. The shelf life of a drug present in a plastic container is much less compared to that in a glass container. It is also difficult to subject plastics to gamma-irradiations because some plastics may degenerate. Plastics may also not be as scratch resistant compared to glass.
However, recently there has been a trend in using plastic in almost every area of our life such as interior decoration, construction, packaging, computers, information technology and even medical equipment. This is mainly because of a development in the plastic technology. Materials having superior properties have been developed which effectively cancels all the limitations previously existed. In the medical field, plastics have been more meaningful as the material is cheap and can be disposed off once it is used even for a single time.
In this way, the spread of several infectious diseases such as HIV/AIDS, Hepatitis B and syphilis can be prevented. Almost every equipment in the medical field such as syringes, fluid tubing, pre-filled syringes, etc are utilizing plastics. Now-a-days complex plastics, composites and acrylics are utilized to make dentures, cosmetic dental restorations and even implants. They have shown superior quality to all other materials ever known such as plasticity, durability, light-weight, etc.
A new complex form of plastics known as cycloolefin-copolymers or COCs can prevent water vapor and gases from escaping, has high transparency, is resistant to scratches, is not fragile and can tolerate heat during autoclaving. These plastics contain copolymers depended on cyclic and linear olefins. Use of plastics in the field of medicine for specific purposes such as pre-filled syringes, needless injectors, drug containers and drug-delivery systems is considered to be one of the fastest growing industries in the medical field. Plastics can be modified in so many different ways and advancement in technology has really taken medicine forward.
Advanced polymers and plastics are of special interests because they do not seem to have the limitations previous plastics have been offering. COCs has so many technical improvements that it is beginning to challenge glass. Glass does seem to be a barrier to the medical industry because the material is fragile and can even react with certain drugs. COCs have been able to overcome the limitations of glass. Companies manufacturing drugs are able to utilize COCs to pack several drugs, and the customers are being provided with more flexible options (such as drug delivery systems and pre-filled syringes).
Plastics offer a lot of financial saving over glass. The process of making the plastic container than the glass container is usually cheaper. As plastics are trouble-free during manufacture, the entire process can be automated. Glass requires some manual assistance, as the entire procedure of manufacture and packaging cannot be fully automated. The energy consumed making a plastic bottle is significantly lesser than that of a plastic bottle. Besides, due to the light weight of plastics, transportation charges are much lesser. Plastics can also be recycled after use, which additionally brings down the costs. If a good plastic recycling management system exists, the cost per bottle can be lowered significantly.
Using a plastic bottle for insulin is in fact a very good idea. Newer plastics such as COCs can be utilized so that they are able to overcome limitations of glass bottles. Previously, plastics were being considered as a very unsafe material for use in the medical field. Doctors and specialists were feeling safer to stick to the old glass containers. However, studies have shown that the newer plastics can be even more superior to glass in protecting the drug or not reacting with it, until use on the patient.
Regulatory bodies should be demonstrated the advantages of newer plastics over glass in order to get approval for mass production and utilization. We have come a long way in utilizing different types of insulin to treat diabetes mellitus. At first, pork and beef insulin was used. Nowadays, genetically engineered insulin and insulin analogs are utilized. Just as how we are utilizing more safer and effective forms of insulin, in the same way we need better packaging materials that would preserve its effectiveness and safety specifications.
References:
Ann Thayer. Insulin. Chemical and Engineering News (2005): http://pubs.acs.org/cen/coverstory/83/8325/8325insulin.html
Asian Hospital and Healthcare Management. Surgical Specialty Are Pre-Filled Syringes the Future? 2006. AHHM 15 Dec. 2006. http://www.asianhhm.com/magazine/previous_issue/ahhm010/surgical_speciality1.htm
Carol M. Preissner, William M. Reilly, Richard C. Cyr, Dennis J. OKane, Ravinder J. Singh, and Stefan K.G. Grebea. Plastic versus Glass Tubes: Effects on Analytical Performance of Selected Serum and Plasma Hormone Assays. Clinical Chemistry 50 (2004): 1245-1247. http://www.clinchem.org/cgi/content/full/50/7/1245
Paul Goettlich. Report of The Berkeley Plastics Task Force. Mindfully (1996): http://www.mindfully.org/Berkeley/Berkeley-Plastics-Task-Force.htm
U.S. Food and Drug Administration. Insulin Preparations. FDA Consumer magazine (2002): http://www.fda.gov/fdac/features/2002/chrt_insulin.html
U.S. Food and Drug Administration. Diabetes Information. FDA (2005): http://www.fda.gov/diabetes/2
Vertriebsgesellschaft, Plumat M. Future Trends in Primary Packaging of Pharmaceutical Solutions. Business Briefing: Pharmagenerics (2003): http://www.touchbriefings.com/pdf/15/Plumat_tech.pdf
Insulin is a hormone produced by the beta cells of the Islets of Langerhans in the pancreas that helps in the metabolism of carbohydrates, by converting glucose into glycogen. It enables the cells of the body to use glucose as a source of energy. Individuals with diabetes mellitus produce little or no insulin. Hence, the levels of glucose in the blood rises, and the cells are not able to use it. Normally, the pancreas automatically controls the sugar level in the blood by producing and releasing appropriate amounts of insulin. The hormone is usually available in injection forms as they cannot be absorbed into the blood when administered in the form of pills. Insulin is usually inactivated by the digestive tract if administered in the form of oral preparations.
Usually insulin is self-administered (in the form of injections) because the patient needs to take it at least two times a day. The insulin should be injected at least 30 minutes before the meal. It is available in four different forms, depending on the time it begins to work and the duration it acts. These include rapid-acting (acts within 15 minutes and lasts for 3 to 4 hours), short-acting acting (acts within 30 minutes and lasts for 5 to 8 hours), Intermediate-acting (NPH) (acts within 1 to 3 and lasts for 24 hours), Intermediate- and short-acting mixtures (a mixture of short-acting and intermediate-acting insulin), and long acting (acts within 1 to 5 hours and lasts for more than 24 hours).
Insulin is of different types including bovine insulin (derived from cows), pig insulin (derived from pigs), human insulin (grown by inserting human genetic material in yeast and bacteria that can produce insulin) and insulin analogues (substances that are similar to human insulin and differ only by one or two amino acids). Insulin was first separated at the University of Toronto in 1921 by Dr. Fredrick Banting, Charles Best, Professor J. J. R. Macleod and Dr. James Collip.
At the end of the 19th Century, researchers were feeling a connection between the pancreas and diabetes. In 1921, they studied that dogs that were diabetic benefited following administration of insulin. In 1922, insulin was administered to a boy dying from complications of diabetes, resulting in reduction of the symptoms. In 1923, Bantings and Macleod were given the Nobel Prize for Medicine.
The scientists had taken a long time to invent procedures to make the drug and calculate the right amounts in which the drug should be administered. The drug was manufactured within a year after the discovery. In the beginning, animal sources such as pigs and cattle were utilized to extract insulin. Concerns of their effectiveness, increasing needs of the diabetic patients, safety and long-term supply arouse.
Nowadays, insulin is extracted from yeast and bacteria, after genetically modifying these microorganisms with human genes (to suit the human insulin). The procedure to make such insulin was first discovered in 1978, Genetech and City of Hope National Medical Center. The production of genetically-engineered insulin involves several steps such as expressing the gene, inserting it into the microorganism and producing the drug. E.Coli was first being used to manufacture genetically engineered insulin. Nowadays, more than 20 different types of insulin and insulin analogs exist.
It had been a well-accepted mode previously to pack all injection-drugs (such as insulin) into glass containers because such substances tend to have a higher reactivity rate, and glass seemed to offer good resistance against chemical substances.
The procedure of manufacturing a glass bottle containing insulin is very long. This procedure is known as form-fill-and-seal or FFS. The glass bottles have to be thoroughly washed in 4 steps. At the entrance of the FFS machine film rolls are mounted. As glass carry a lot of difficulties, the FFS process is not fully automated. Some components may require human intervention which increases the chances of contamination. It is difficult to print on glass bottles, hence additional machines that specifically help in printing have to be utilized. The residual air present inside the bottle has to be removed using specialized suction and sealing devices. Cap-welding machines have to be utilized to insert and fix the lid on the bottle.
Glass has several advantages and disadvantages over plastic. One of the main advantages of glass is that it is inert and non-degradable, and unlike plastics does not release any of its components into the drug solution (chemical resistance). Insulin in glass bottles tends to have a longer shelf-life compared to plastic. The insulin tends to be more effective. An inert gas such as nitrogen can be inserted into the bottle to act as a preservative. Glass does not allow moisture and other gases to pass through.
It is fairly strong and the insulin may not leak out from the bottle. Glass tends to tolerate heat and light better. They do not degrade or melt under higher temperature and light conditions and protect the drug solution present in them. As glass can tolerate high temperature conditions better than plastics, heat sterilization can be utilized to destroy any micro-organism that is contaminating the bottle. They can also tolerate gamma-radiation better and hence can be utilized in radiation sterilization. Overall, glass tends to tolerate industrial processes better than plastics.
. However, glass also has certain disadvantages. Newer drugs such as peptides and antibodies tend to react with glass, and hence plastic containers are being utilized. Glass tends to break easily if dropped or if an excessive force is being applied. This is the biggest disadvantages of glass, and people using them have to be extra cautious. Glass bottles may have a silicon coating on them that is made of elastomers. This coating may contaminate the drug solution slowly over a period of time. However, several of the newer drugs coming out of the biotechnology market, do not seem to like glass packaging. Glass contains tiny amounts of alkali ions which tend to leak into the drug, causing a lot of problems to its effectiveness and safety.
Glass also tends to destroy the proteins present in the drugs. Following this protein degradation, other components of the drug may also get destroyed. Newer plastics have solved this problem to some extent. Glass bottles when utilized to carry drugs containing water and lyphophilised chemicals, tends to release hydrogen ions, which makes it tough to control the pH. It is very important to maintain the pH of the drug so that it is effective and safe to use. It is also very difficult to make new types of bottles for drugs as glass is not a flexible material and is heavy.
Plastics previously utilized had many limitations which did not permit total safety. The material could easily degenerate over a period of time and slowly leach away chemicals into the drug, thus making them unsafe for medical use. The plastic container may allow gases and water vapor to pass through, thus making the use of the medication unsafe.
When exposed to heat, chemicals or light, some plastics may even begin to degenerate. Compared to glass, plastics are unable to tolerate the industrial processes. Previous studies conducted; show that the drugs present in the plastic containers were slightly more ineffective than those stored in the glass containers. The shelf life of a drug present in a plastic container is much less compared to that in a glass container. It is also difficult to subject plastics to gamma-irradiations because some plastics may degenerate. Plastics may also not be as scratch resistant compared to glass.
However, recently there has been a trend in using plastic in almost every area of our life such as interior decoration, construction, packaging, computers, information technology and even medical equipment. This is mainly because of a development in the plastic technology. Materials having superior properties have been developed which effectively cancels all the limitations previously existed. In the medical field, plastics have been more meaningful as the material is cheap and can be disposed off once it is used even for a single time.
In this way, the spread of several infectious diseases such as HIV/AIDS, Hepatitis B and syphilis can be prevented. Almost every equipment in the medical field such as syringes, fluid tubing, pre-filled syringes, etc are utilizing plastics. Now-a-days complex plastics, composites and acrylics are utilized to make dentures, cosmetic dental restorations and even implants. They have shown superior quality to all other materials ever known such as plasticity, durability, light-weight, etc.
A new complex form of plastics known as cycloolefin-copolymers or COCs can prevent water vapor and gases from escaping, has high transparency, is resistant to scratches, is not fragile and can tolerate heat during autoclaving. These plastics contain copolymers depended on cyclic and linear olefins. Use of plastics in the field of medicine for specific purposes such as pre-filled syringes, needless injectors, drug containers and drug-delivery systems is considered to be one of the fastest growing industries in the medical field. Plastics can be modified in so many different ways and advancement in technology has really taken medicine forward.
Advanced polymers and plastics are of special interests because they do not seem to have the limitations previous plastics have been offering. COCs has so many technical improvements that it is beginning to challenge glass. Glass does seem to be a barrier to the medical industry because the material is fragile and can even react with certain drugs. COCs have been able to overcome the limitations of glass. Companies manufacturing drugs are able to utilize COCs to pack several drugs, and the customers are being provided with more flexible options (such as drug delivery systems and pre-filled syringes).
Plastics offer a lot of financial saving over glass. The process of making the plastic container than the glass container is usually cheaper. As plastics are trouble-free during manufacture, the entire process can be automated. Glass requires some manual assistance, as the entire procedure of manufacture and packaging cannot be fully automated. The energy consumed making a plastic bottle is significantly lesser than that of a plastic bottle. Besides, due to the light weight of plastics, transportation charges are much lesser. Plastics can also be recycled after use, which additionally brings down the costs. If a good plastic recycling management system exists, the cost per bottle can be lowered significantly.
Using a plastic bottle for insulin is in fact a very good idea. Newer plastics such as COCs can be utilized so that they are able to overcome limitations of glass bottles. Previously, plastics were being considered as a very unsafe material for use in the medical field. Doctors and specialists were feeling safer to stick to the old glass containers. However, studies have shown that the newer plastics can be even more superior to glass in protecting the drug or not reacting with it, until use on the patient.
Regulatory bodies should be demonstrated the advantages of newer plastics over glass in order to get approval for mass production and utilization. We have come a long way in utilizing different types of insulin to treat diabetes mellitus. At first, pork and beef insulin was used. Nowadays, genetically engineered insulin and insulin analogs are utilized. Just as how we are utilizing more safer and effective forms of insulin, in the same way we need better packaging materials that would preserve its effectiveness and safety specifications.
References:
Ann Thayer. Insulin. Chemical and Engineering News (2005): http://pubs.acs.org/cen/coverstory/83/8325/8325insulin.html
Asian Hospital and Healthcare Management. Surgical Specialty Are Pre-Filled Syringes the Future? 2006. AHHM 15 Dec. 2006. http://www.asianhhm.com/magazine/previous_issue/ahhm010/surgical_speciality1.htm
Carol M. Preissner, William M. Reilly, Richard C. Cyr, Dennis J. OKane, Ravinder J. Singh, and Stefan K.G. Grebea. Plastic versus Glass Tubes: Effects on Analytical Performance of Selected Serum and Plasma Hormone Assays. Clinical Chemistry 50 (2004): 1245-1247. http://www.clinchem.org/cgi/content/full/50/7/1245
Paul Goettlich. Report of The Berkeley Plastics Task Force. Mindfully (1996): http://www.mindfully.org/Berkeley/Berkeley-Plastics-Task-Force.htm
U.S. Food and Drug Administration. Insulin Preparations. FDA Consumer magazine (2002): http://www.fda.gov/fdac/features/2002/chrt_insulin.html
U.S. Food and Drug Administration. Diabetes Information. FDA (2005): http://www.fda.gov/diabetes/2
Vertriebsgesellschaft, Plumat M. Future Trends in Primary Packaging of Pharmaceutical Solutions. Business Briefing: Pharmagenerics (2003): http://www.touchbriefings.com/pdf/15/Plumat_tech.pdf