Pharmaceutical Water System Case Study
Introduction
The water system in any pharmaceutical organization is of vital importance. It is widely used in pharmaceuticals and related industries. Water used in process and in cleaning must be pure and free from microbial and chemical impurities. Laboratories need pure water free of foreign substances, which could potentially affect the outcome of analyses, and the pharmaceutical industry needs pure water for a variety of purposes – everything from cleaning to the use of pure water as an ingredient in finished pharmaceutical products. The distribution of water requires specially designed systems that focus on specific factors in order to avoid cross-contamination and microbiological growth.
Control in industries refers to the regulation of the process in all its aspects. Precise control of level, …show more content…
What other test could be performed on the water to ensure the quality expectations are met?
Off line tests could be performed such as microbial test, endotoxin test, heavy metal test, nitrate and nitrite tests.
3. If an out of spec result was recorded, what action could be taken to remedy the situation? How could the parameters that are being tested in Table 2 impact the quality of the drug?
If an out of spec result occurs we close down the access point and we get rid of that water and gradually we flush and sanitise the pipes. Investigation must be performed to determine where the water comes from.
Water used to formulate a product should contain no organisms capable of growing in the product. Action or alert limits must be based upon validation data and must be set low enough to signal significant changes from normal operating conditions. Pharmaceutical product cross-contamination refers to the process by which foreign chemical, microbial, or physical substances are not deliberately transferred from one substance to medicines with harmful effects that might affect the purity and quality of the pharmaceutical products leading to health impacts on
The water system in any pharmaceutical organization is of vital importance. It is widely used in pharmaceuticals and related industries. Water used in process and in cleaning must be pure and free from microbial and chemical impurities. Laboratories need pure water free of foreign substances, which could potentially affect the outcome of analyses, and the pharmaceutical industry needs pure water for a variety of purposes – everything from cleaning to the use of pure water as an ingredient in finished pharmaceutical products. The distribution of water requires specially designed systems that focus on specific factors in order to avoid cross-contamination and microbiological growth.
Control in industries refers to the regulation of the process in all its aspects. Precise control of level, …show more content…
What other test could be performed on the water to ensure the quality expectations are met?
Off line tests could be performed such as microbial test, endotoxin test, heavy metal test, nitrate and nitrite tests.
3. If an out of spec result was recorded, what action could be taken to remedy the situation? How could the parameters that are being tested in Table 2 impact the quality of the drug?
If an out of spec result occurs we close down the access point and we get rid of that water and gradually we flush and sanitise the pipes. Investigation must be performed to determine where the water comes from.
Water used to formulate a product should contain no organisms capable of growing in the product. Action or alert limits must be based upon validation data and must be set low enough to signal significant changes from normal operating conditions. Pharmaceutical product cross-contamination refers to the process by which foreign chemical, microbial, or physical substances are not deliberately transferred from one substance to medicines with harmful effects that might affect the purity and quality of the pharmaceutical products leading to health impacts on