Pharmaceutical water
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This document discusses the need for high-quality water in pharmaceutical manufacturing. It notes that water is used directly and indirectly in products and cleaning. It then outlines the goals of understanding water quality systems, sources, and validation/qualification requirements. Various water treatment techniques are explained including filtration, softening, reverse osomosis and more. Validation involves proving the engineering design, operating procedures and maintenance plans. The presentation covers installation qualification, operational qualification, and performance qualification testing over multiple phases to verify long-term control of water systems.
7.specification and test procedure
This document outlines specifications and testing procedures for pharmaceutical products. It discusses the need to validate testing procedures before adopting them routinely. It also describes the requirements for specifications of starting materials, packaging materials, intermediate and bulk products, and finished products. Specifications should include a description of the material, reference standards, qualitative and quantitative requirements, storage conditions, and expiration dates. Periodic revision may be necessary to comply with pharmacopoeia standards.
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Pharmaceutical water
The document discusses pharmaceutical water systems. It begins by defining various types of high purity water like purified water, sterile purified water, water for injection, and sterile water for injection. It then discusses how purified water and water for injection are produced, typically through processes like distillation, ion exchange, or reverse osmosis. The document also covers considerations for storing and distributing high purity water, such as using stainless steel materials, minimizing dead legs, and sanitizing distribution systems through heat, ozone, or chemicals. Finally, it presents different options for setting up hot and cold storage and distribution systems.
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General concept for pharmaceutical water
Water is an inorganic, transparent, tasteless, odorless, and nearly colorless chemical substance, which is the main constituent of Earth's hydrosphere and the fluids of all known living organisms. It is vital for all known forms of life, even though it provides no calories or organic nutrients.
Density: 997 kg/m³
Boiling point: 100 °C
Formula: H2O
Melting point: 0 °C
Molar mass: 18.01528 g/mol
Water travels throughout your body carrying nutrients, oxygen, and wastes to and from your cells and organs. Water keeps your body cool as part of your body's temperature regulating system. Water cushions your joints, and protects your tissues and organs from shock and damage.
Some waterborne pathogenic microorganisms spread by water can cause severe, life-threatening diseases. Examples are typhoid fever, cholera and Hepatitis A or E. Other microorganisms induce less dangerous diseases.
Water is one of the major commodities used by the pharmaceutical industry. It is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents.
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Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
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Water system validation.
This document discusses the need for high-quality water in pharmaceutical manufacturing. It notes that water is used directly and indirectly in products and cleaning. It then outlines the goals of understanding water quality systems, sources, and validation/qualification requirements. Various water treatment techniques are explained including filtration, softening, reverse osomosis and more. Validation involves proving the engineering design, operating procedures and maintenance plans. The presentation covers installation qualification, operational qualification, and performance qualification testing over multiple phases to verify long-term control of water systems.
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This document outlines specifications and testing procedures for pharmaceutical products. It discusses the need to validate testing procedures before adopting them routinely. It also describes the requirements for specifications of starting materials, packaging materials, intermediate and bulk products, and finished products. Specifications should include a description of the material, reference standards, qualitative and quantitative requirements, storage conditions, and expiration dates. Periodic revision may be necessary to comply with pharmacopoeia standards.
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Pharmaceutical water
The document discusses pharmaceutical water systems. It begins by defining various types of high purity water like purified water, sterile purified water, water for injection, and sterile water for injection. It then discusses how purified water and water for injection are produced, typically through processes like distillation, ion exchange, or reverse osmosis. The document also covers considerations for storing and distributing high purity water, such as using stainless steel materials, minimizing dead legs, and sanitizing distribution systems through heat, ozone, or chemicals. Finally, it presents different options for setting up hot and cold storage and distribution systems.
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Water is an inorganic, transparent, tasteless, odorless, and nearly colorless chemical substance, which is the main constituent of Earth's hydrosphere and the fluids of all known living organisms. It is vital for all known forms of life, even though it provides no calories or organic nutrients.
Density: 997 kg/m³
Boiling point: 100 °C
Formula: H2O
Melting point: 0 °C
Molar mass: 18.01528 g/mol
Water travels throughout your body carrying nutrients, oxygen, and wastes to and from your cells and organs. Water keeps your body cool as part of your body's temperature regulating system. Water cushions your joints, and protects your tissues and organs from shock and damage.
Some waterborne pathogenic microorganisms spread by water can cause severe, life-threatening diseases. Examples are typhoid fever, cholera and Hepatitis A or E. Other microorganisms induce less dangerous diseases.
Water is one of the major commodities used by the pharmaceutical industry. It is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents.
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Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
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This document summarizes various water purification methods used in pharmaceutical applications. It discusses different types and grades of water including drinking water, purified water, highly purified water, and water for injection. Key water purification techniques described include deionization, reverse osmosis, distillation, ultrafiltration, and combinations thereof. Advanced processes like microfiltration and double pass reverse osmosis systems are also outlined to produce higher purity water suitable for various future uses.
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8.2 The following list identifies items and a logical sequence for a WPU system inspection or audit:
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– approved piping drawings (e.g. orthographic and/or isometric);
– a sampling and monitoring plan with a drawing of all sample points;
– training programme for sample collection and testing;
– the setting of monitoring alert and action levels;
– monitoring results and evaluation of trends;
– inspection of the last annual system review;
– review of any changes made to the system since the last audit and a check that the change control has been implemented;
– review of deviations recorded and their investigation;
– general inspection of system for status and condition;
– review of maintenance, failure and repair logs;
– checking calibration and standardization of critical instruments
Clean in-place (cip) systems
Neologic Engineers, Clean-in-place (CIP) is an automated method of cleaning the interior surfaces of pipes, tanks, lines, process equipment.(CIP) Systems Reduce Cleaning Time and Costs. CIP Controls of all important parameters like time, temperature, flow, concentration.
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- 2. Types of Water used
- 4. Meeting Global Pharmacopeia Requirements for Water Compliance
- 10. Companies in the field
- 11. The goal of pharmaceutical water system operators is to produce bacteria-free water that meets or exceeds required purity standards. Water systems use several filters to protect system components and to assure that the water dispensed for use is free of bacteria and most other particle contaminants.
- 12. Ultrapure water systems and wastewater treatment systems and services to the pharmaceutical sector, which include: Raw water pre-treatment Softening Generation of PW & HPW Generation of WFI Pure Steam Generation Distribution and storage systems Wastewater treatment Thermal decontamination
- 13. Fully automated systems designed to readily comply with 21 CFR Part 11 from a regulatory perspective as per US FDA norms. Following are key features - •Fully automated operation through PLC/DCS •Operation through HMI/IPC touch panel as per the configuration chosen •Selectable Modes: Production Mode, Recirculation & Standby Mode, Hot Water Sanitization Mode
- 14. • Pharmaceutical Water Purification Systems produce compendial Purified Water, Highly Purified Water, Water For Injection and/or Pure Steam • Variety of systems including Pre- Treatment Systems, Reverse Osmosis Systems, Vapor Compression Distillers, Single or Multiple Effect Distillers, Generators and Tankage • Systems are completely validatable, and suitable for use in FDA and EMA regulated facilities