water for pharmaceutical use

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GOOD PPT BY CHANDRASHEKHAR BHINGARE SIR AND NILESH TRIBHHUVAN FROM AISSMS PUNE

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Presentation Transcript

WELCOME:

WELCOME

Slide 2:

Water for Pharmaceutical Use BY NILESH TRIBHUVAN (AISSMS PUNE) AND PROF. CHANDRASHEKHAR BHINGARE (AISSMS PUNE)

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Introduction Information on Water for Pharmaceutical Use (WPU) Quality of water for APIs, finished products, etc. GMP for design, installation, operation of systems Supplementary to general GMP guidelines See also other guidelines, pharmacopoeia, etc. Water for Pharmaceutical Use

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Objective Water system requirements Water quality specifications Application of specific water to processes and dosage forms Water purification methods Storage and distribution systems Commissioning, qualification, operation and maintenance Water for Pharmaceutical Use

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Principles Systems must be properly validated / qualified Water for parenteral use should not be contaminated with pyrogens or endotoxins Specifications and periodic testing are required Potential for microbial growth Like any starting material, production of water should conform to Good Manufacturing Practice (GMP) norms Water for Pharmaceutical Use

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Background to water requirements and use Water is the most widely used substance / raw material Used in production, processing, formulation, cleaning, quality control Unique chemical properties Able to dissolve, absorb, adsorb, suspend compounds and contaminants Different grades of water quality available Water for Pharmaceutical Use

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Water system requirements Design, installation, commissioning, qualification / validation, operation, performance and maintenance to ensure reliable, consistent production of water of required quality Operate within design capacity Prevent unacceptable microbial, chemical and physical contamination during production, storage and distribution Quality Assurance involved in approval of use after installation and maintenance work Water for Pharmaceutical Use

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Water system requirements (2) Monitoring of water sources regularly Chemical and microbiological Endotoxin level where relevant Monitoring of system performance, storage and distribution systems Records of results, and action taken Validated sanitization procedure followed on a routine basis Water for Pharmaceutical Use

Water for Pharmaceutical Use:

Water for Pharmaceutical Use Drinking water: N atural sources could include springs, wells, rivers and lakes Treatment includes softening, ion removal, particle reduction, antimicrobial treatment

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Types of water used in pharmaceutical processes Purified water Water for Injection s – PFW & WFI Softened Water Water for Final Rinse Pure, or clean Steam Water for cooling Autoclaves

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Purified Water (PW) Prepared from potable water source Meet pharmacopoeia specification for chemical and microbial purity Protected from recontamination Protected from microbial proliferation Water for Pharmaceutical Use

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Highly Purified Water (HPW) Prepared from potable water source Specification only in the European Pharmacopoeia Same quality standard as WFI including limit for endotoxins , but treatment method considered less reliable than distillation Prepared by combination of methods including reverse osmosis (RO), ultrafiltration (UF) and deionization (DI) Water for Pharmaceutical Use

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Water for Injections (WFI) Prepared from potable water source WFI is not sterile WFI is not a final dosage form WFI is an intermediate bulk product According to The International and European Pharmacopoeias – final purification step should be distillation Water for Pharmaceutical Use

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Application of specific water to processes and dosage forms Water used for different stages of: Washing, preparation, synthesis, production, formulation, control Which grade of water is suitable for a particular stage? Consider nature and intended use of intermediate or finished product, and stage at which water is used Let's look at types of water and indicate their use Water for Pharmaceutical Use

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Water purification system considerations Leaching from contact materials Adsorption Hygienic and sanitary design Corrosion resistance Leakage Proliferation of microbiological organisms Water for Pharmaceutical Use

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Pre-treatment steps Primary filtration and m ultimedia filter Coagulation or flocculation Desalination Softening Water for Pharmaceutical Use

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raw water in « S” trap to sewer Water is kept circulating To water softener & DI plant Pretreatment – schematic drawing cartridge filter 5 micrometers activated carbon filter spray ball break tank air break to drain centrifugal pump air filter float operated valve sand filter excess water recycled from deioniser Water for Pharmaceutical Use

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brine and salt tank brine "hard" water in zeolite water softener exchanges Ca and Mg for Na drain "soft" water to deioniser by pass valve Water Softener – schematic drawing Water for Pharmaceutical Use

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Chlorine removal ( Activated-carbon (AC) filtration or bisulphite ) AC removes chlorine but bacteria can then grow AC filtration can remove organic impurities Bisulphite leaves sulphate residues but is antimicrobial Water for Pharmaceutical Use

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Cationic column Anionic column Hygienic pump Outlets or storage. Ozone generator UV light HCl NaOH Eluates to neutralization plant Air break to sewer Drain line from water softener Water must be kept circulating Typical deionizer schematic 1 2 3 4 5 6 1 2 3 4 5 6 Return to d e ioni z er Cartridge filter 5 µm Cartridge filter 1 µm Water for Pharmaceutical Use

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raw water High pressure Feed water under pressure Reject water Semi-permeable membrane Permeate water drain or recycle Low pressure Purified water Reverse osmosis (RO) theory Water for Pharmaceutical Use

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Branch Branch 2nd stage buffer tank Cartridge filter 1 µm Second stage RO cartridge First stage filtrate feeds second stage RO with excess back to 1st stage buffer tank . 1st stage reject concentrate Air break to sewer Second stage reject water goes back to first stage buffer tank Second stage RO water meets Pharmacopoeia standards Outlets or storage 1st stage buffer tank Water from softener or de- ioniser Water returns to 1st stage buffer tank Typical 2-stage RO schematic Hygienic pump First stage RO cartridge High pressure pump Water for Pharmaceutical Use

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Production of Purified Water (PW) Use appropriate, qualified methods for production Factors to consider: Feed water quality and required water quality specification Sequence of purification stages needed Energy consumption, extent of pre-treatment needed Yield and efficiency of unit treatment steps Location and design of sampling points Appropriate instrumentation for measurements Water for Pharmaceutical Use

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Production of Purified Water (2) Measurements: Flow Pressures Temperature Conductivity pH Total organic carbon (TOC), etc. Appropriately controlled, monitored, records maintained Water for Pharmaceutical Use

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Production of Purified Water (3) Ambient temperature PW systems are susceptible to microbiological contamination – especially when static and periods of low or no demand Controls may include: Maintain flow at all times Control temperature in the system ( <25 degrees Celsius) UV disinfection Water treatment components that can be thermally sanitized Chemical sanitization (e.g. with ozone ) Water for Pharmaceutical Use

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Production of Highly Purified Water (HPW) Use appropriate, qualified methods for production Appropriate sequence of techniques As for PW Processes may include: Ion exchange Ultrafiltration Reverse Osmosis Water for Pharmaceutical Use

REFERENCES:

REFERENCES FDA Current Good Manufacturing Practice regulations, Federal Register, Vol.43, No. 190 - Sept. 29, 1978, I. General Comments and Subpart C, para . 211.48. Water Programs, Environmental Protection Agency, National Interim Primary Drinking Water Regulations, Dec. 16, 1985, 40 Code of Federal Regulations, Part 141, para . 141.14 and 141.21. United States Pharmacopeia XXI, Water for Pharmaceutical Purposes, section 1231 and Official Monographs-various types of water, 1985. FDA LETTER TO THE PHARMACEUTICAL INDUSTRY Re: Validation and Control of Deionized Water Systems, - Daniel L. Michels , Bureau of Drugs, Aug. 1981.

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FDA Inspection Technical Guide, Number 36, Reverse Osmosis, Oct. 1980. FDA Inspection Technical Guide, Number 40, Bacterial Endotoxins / Pyrogens , March 1985. Protection of Water Treatment Systems series, PMA Deionized Water Committee, PHARMACEUTICAL TECHNOLOGY - May, Sept. and Oct., 1983; Sept. 1984, and Nov. 1985. Parenteral Drug Association, Design Concepts for the Validation of a Water for Injection System, Technical Report No. 4, 1983. Monitoring and Validation of High Purity Water Systems with the LAL test for pyrogens , T.J. Novistsky , Pharmaceutical Engineering, March-April, 1984. http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/ucm072925.htm

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