Podcast
Questions and Answers
Why is pure water (H2O) considered a 'concept' rather than a practical substance?
Why is pure water (H2O) considered a 'concept' rather than a practical substance?
Pure water is a concept because in practice, it is extremely difficult to produce and maintain without contamination during storage.
What are the primary sources of potable water?
What are the primary sources of potable water?
Potable water is primarily sourced from surface sources like lakes, rivers, and streams, and underground sources like wells and springs.
List three characteristics of potable water that make it suitable for human consumption.
List three characteristics of potable water that make it suitable for human consumption.
Potable water should be clear, colourless, odourless, and tasteless. It should also be free from toxic substances and pathogenic organisms.
What is the EU directive that stipulates maximum permissible levels for minerals and microbes in potable water?
What is the EU directive that stipulates maximum permissible levels for minerals and microbes in potable water?
Name two types of dissolved impurities that might be present in potable water.
Name two types of dissolved impurities that might be present in potable water.
Describe colloidal matter in potable water.
Describe colloidal matter in potable water.
Why is potable water unsuitable for many pharmaceutical purposes without further processing?
Why is potable water unsuitable for many pharmaceutical purposes without further processing?
Besides bacteria and viruses what other types of micro-organisms can be present in potable water?
Besides bacteria and viruses what other types of micro-organisms can be present in potable water?
What is the primary difference in the acceptable endotoxin levels between Purified Water in bulk and Water for Injections in bulk according to the Ph Eur?
What is the primary difference in the acceptable endotoxin levels between Purified Water in bulk and Water for Injections in bulk according to the Ph Eur?
Name two types of impurities commonly found in potable water that could affect its suitability for pharmaceutical use.
Name two types of impurities commonly found in potable water that could affect its suitability for pharmaceutical use.
What is the main purpose of using reverse osmosis in purifying pharmaceutical water?
What is the main purpose of using reverse osmosis in purifying pharmaceutical water?
In the context of a water treatment plant, what is the purpose of 'sanitisation'?
In the context of a water treatment plant, what is the purpose of 'sanitisation'?
What is the primary use of 'Sterilised Water for Injections' according to the Ph Eur?
What is the primary use of 'Sterilised Water for Injections' according to the Ph Eur?
Explain the primary difference between deionization and electrodeionization in water purification.
Explain the primary difference between deionization and electrodeionization in water purification.
What is the main advantage of distillation as a purification method for pharmaceutical water?
What is the main advantage of distillation as a purification method for pharmaceutical water?
According to the USP, which type of water is required for use in the preparation of parenteral products?
According to the USP, which type of water is required for use in the preparation of parenteral products?
Describe the purpose of 'water softening' in pharmaceutical water purification systems.
Describe the purpose of 'water softening' in pharmaceutical water purification systems.
Name one test or control that is specifically performed in industrial pharmaceutical water plants.
Name one test or control that is specifically performed in industrial pharmaceutical water plants.
What is the primary purpose of using sequential unit operations in pharmaceutical water production?
What is the primary purpose of using sequential unit operations in pharmaceutical water production?
What do the decision trees, mentioned in the document, help with in regards to pharmaceutical water?
What do the decision trees, mentioned in the document, help with in regards to pharmaceutical water?
What is the first unit process mentioned for water purification?
What is the first unit process mentioned for water purification?
What type of materials are used in the deionization process to remove impurities?
What type of materials are used in the deionization process to remove impurities?
What type of compounds are primarily removed from water during the deionization process?
What type of compounds are primarily removed from water during the deionization process?
Besides purification processes, where can more detail on control measures be found?
Besides purification processes, where can more detail on control measures be found?
What is the main goal of water purification in pharmaceutical operations?
What is the main goal of water purification in pharmaceutical operations?
What type of water is fed into the deionization unit process?
What type of water is fed into the deionization unit process?
In an EDI system, what are the three channels that feed water enters into?
In an EDI system, what are the three channels that feed water enters into?
Where does ion exchange take place within the EDI system, and what do the ion exchange resins do?
Where does ion exchange take place within the EDI system, and what do the ion exchange resins do?
In an EDI system, toward which electrode are positively charged ions drawn?
In an EDI system, toward which electrode are positively charged ions drawn?
What is the purpose of the selectively permeable membranes in the EDI process?
What is the purpose of the selectively permeable membranes in the EDI process?
Where is the purified water collected in the EDI system after ion exchange?
Where is the purified water collected in the EDI system after ion exchange?
What causes some of the water molecules to split into hydrogen and hydroxyl ions in the EDI system?
What causes some of the water molecules to split into hydrogen and hydroxyl ions in the EDI system?
Why is it not necessary to stop EDI systems for regeneration using chemicals like sodium hydroxide or hydrochloric acid?
Why is it not necessary to stop EDI systems for regeneration using chemicals like sodium hydroxide or hydrochloric acid?
In what industry are EDI systems particularly popular, according to the text?
In what industry are EDI systems particularly popular, according to the text?
What type of impurities are removed by distillation?
What type of impurities are removed by distillation?
In a single-stage still, what phases does water transition through during distillation?
In a single-stage still, what phases does water transition through during distillation?
What is the purpose of a baffle in a distillation setup?
What is the purpose of a baffle in a distillation setup?
What characteristic of impurities allows them to be carried over in the vapor phase during distillation?
What characteristic of impurities allows them to be carried over in the vapor phase during distillation?
Name three volatile substances that might be found in the collected distilled water.
Name three volatile substances that might be found in the collected distilled water.
Why are materials with low volatility removed by distillation?
Why are materials with low volatility removed by distillation?
What is a 'single-effect still' also called?
What is a 'single-effect still' also called?
What materials can baffles be made of?
What materials can baffles be made of?
What is the primary purpose of a water softener in an industrial water purification system?
What is the primary purpose of a water softener in an industrial water purification system?
In industrial water purification, after reverse osmosis, what is the next unit operation mentioned in the text?
In industrial water purification, after reverse osmosis, what is the next unit operation mentioned in the text?
What is the role of the distribution loop in the industrial water purification system described?
What is the role of the distribution loop in the industrial water purification system described?
What are two potential uses of purified water in a manufacturing facility?
What are two potential uses of purified water in a manufacturing facility?
What is mentioned as a particular hazard that requires rigorous scrutiny in industrial water purification plants?
What is mentioned as a particular hazard that requires rigorous scrutiny in industrial water purification plants?
What kind of tests are routinely carried out to monitor the performance of water purification systems?
What kind of tests are routinely carried out to monitor the performance of water purification systems?
Do ‘in-house’ standards typically meet or exceed regulatory stipulations?
Do ‘in-house’ standards typically meet or exceed regulatory stipulations?
Besides the main text, where else can you find additional information on water sampling and the operation of water purification systems?
Besides the main text, where else can you find additional information on water sampling and the operation of water purification systems?
Flashcards
Potable Water
Potable Water
Water suitable for human consumption, usually sourced from surface or underground sources. It must be clear, colorless, odorless, tasteless, and free from harmful substances.
Pure Water
Pure Water
The concept of perfectly pure H2O, which is impossible to achieve in practice due to contamination during storage.
Dissolved Impurities
Dissolved Impurities
Substances dissolved in water, such as salts, carbohydrates, or other compounds.
Particulate Matter
Particulate Matter
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Colloidal Matter
Colloidal Matter
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Microorganisms in Water
Microorganisms in Water
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Water Treatment
Water Treatment
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Pharmaceutical Water Grades
Pharmaceutical Water Grades
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Purified Water
Purified Water
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Water for Injections
Water for Injections
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Water Purification Unit Processes
Water Purification Unit Processes
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Deionisation
Deionisation
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Electrodeionisation
Electrodeionisation
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Distillation
Distillation
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Reverse Osmosis
Reverse Osmosis
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Other Water Purification Unit Processes
Other Water Purification Unit Processes
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Controls and Tests in Industrial Plants
Controls and Tests in Industrial Plants
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Electrodeionization (EDI)
Electrodeionization (EDI)
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Pharmaceutical Water Production
Pharmaceutical Water Production
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Water Quality for Pharmaceutical Purposes
Water Quality for Pharmaceutical Purposes
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Ion Exchange Resins
Ion Exchange Resins
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Diluting Compartment
Diluting Compartment
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Concentrating Compartments
Concentrating Compartments
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Anode
Anode
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Other Unit Operations and Control Measures
Other Unit Operations and Control Measures
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Cathode
Cathode
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Selectively Permeable Membranes
Selectively Permeable Membranes
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Protecting Subsequent Treatment Steps
Protecting Subsequent Treatment Steps
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Sequential Unit Operations
Sequential Unit Operations
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Self-Regeneration
Self-Regeneration
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Single-stage still
Single-stage still
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Baffle
Baffle
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Volatile components
Volatile components
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Non-volatile impurities
Non-volatile impurities
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Dissolved volatile components
Dissolved volatile components
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Distilled water
Distilled water
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Multi-stage distillation
Multi-stage distillation
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Industrial Water Purification System
Industrial Water Purification System
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Water Softener
Water Softener
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Distribution Loop
Distribution Loop
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Water Quality Monitoring
Water Quality Monitoring
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Microbial Contamination
Microbial Contamination
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In-House Water Quality Standards
In-House Water Quality Standards
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Study Notes
Pharmaceutical Water and Water Purification
- Pharmaceutical water is a crucial component in pharmaceutical processing, manufacturing, and finished products.
- Pure water (Hâ‚‚O) is a theoretical concept and is not found in practice due to contamination potential.
- Potable water is suitable for human consumption, derived mainly from surface and underground sources, which in emergencies may be obtained from the sea.
- Potable water must be clear, colorless, odorless, and tasteless, plus free from toxic substances and pathogenic organisms in acceptable quantities.
- EU directive 98/83/EEC specifies maximum permissible levels of minerals and microbes in potable water.
- Unless treated, Potable water is usually not suitable for pharmaceutical purposes.
Types of Impurities in Potable Water
- Four main groups are present:
- Particulate matter (suspended solids)
- Fully dissolved impurities (organic and inorganic salts/compounds)
- Colloidal matter (particles from 0.005µ to 0.2µ that don't settle)
- Microorganisms (bacteria, fungi, viruses, and algae)
- Underground water sources often contain high levels of inorganics (e.g., calcium, magnesium, and clay).
- Surface water sources typically have higher levels of dissolved organic impurities due to contact with vegetation.
- Water is an excellent medium for microbial growth.
Purified Water
- Purified water has specific grades based on standards, with notable ones including European Pharmacopeia (Ph. Eur) and United States Pharmacopeia (USP).
- This water is suitable for making medicines that aren't required to be sterile or apyrogenic.
Purified Water in Bulk Ph Eur
- It's produced via distillation, ion exchange, or any other method approved for drinking water.
- Measures must be taken to prevent microbial growth.
- The total viable aerobic count should be controlled and monitored, typically with a limit of 100 microorganisms per milliliter.
- Additional tests are required, including total organic carbon, oxidizable substances, nitrates, aluminum, and conductivity.
- Endotoxin content is limited if the purified water is for dialysis solutions.
Purified Water in Containers Ph Eur
- It's purified water in containers that are kept under suitable conditions to ensure required microbiological quality.
- It is clear and colorless, and is free from added substances.
- It conforms to bulk water tests and has tests for acidity/alkalinity, residue on evaporation, microbial contamination, and limits for chlorides, sulfates, ammonium, calcium, and magnesium.
Water for Injections
- Purified water is not suitable for preparing injections.
- Water for injections (Ph Eur) is used as a vehicle and for dissolving/diluting substances for parenteral administration.
Sterilised Water for Injections Ph Eur
- Sterilized water for injections (Ph Eur) is water for injections that has been sterilized by heat, distributed into containers, conforms to the water for injections (bulk) tests, is free from any added substances and conforms to additional tests for microbial contamination and for bacterial endotoxins.
Water for Injection USP
- USP has separate monographs for Purified Water and Water for Hemodialysis, both considered bulk monographs.
- It also contains monographs for Sterile Purified Water (not found in Ph Eur), which is purified water that has been packaged and sterilized.
- It also describes bacteriostatic water for injection, a sterile water for injection with added antimicrobial agents, that is used as a diluent for parenteral products.
Water Purification Unit Processes
- Industrial pharmaceutical water purification systems typically employ a series of unit processes.
- Common unit processes include deionization, electrodeionization, distillation, and reverse osmosis.
- Filtration is often used to remove suspended solids from the water.
- Water softening is a process that replaces calcium and magnesium ions with sodium ions to protect downstream equipment from hard water.
- Sanitization aims to remove microorganisms using methods like UV treatment, chlorine, or ozone.
Controls and Tests in Industrial Plants
- Monitoring water quality is paramount in industrial plants due to microbial contamination risks.
- Rigorous scrutiny of the water system's design and operation is vital.
- Regular microbial and chemical tests are used to monitor the performance of the water purification system.
- Standards applied within plants frequently exceed regulatory requirements.
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