Water for Pharmaceutical Use Part 1: Introduction and treatment

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Supplementary Training Modules on Good Manufacturing Practice Water for Pharmaceutical Use Part 1: Introduction and treatment WHO Technical Report Series No 929, 2005. Attach 3

Water for Pharmaceutical Use Objective Water framework necessities Water quality details Application of particular water to procedures and dose shapes Water decontamination strategies Storage and appropriation frameworks Commissioning, capability, operation and upkeep

Water for Pharmaceutical Use Introduction Information on Water for Pharmaceutical Use (WPU) Quality of water for APIs, completed items, and so on. GMP for plan, establishment, operation of frameworks Supplementary to general GMP rules See likewise different rules, pharmacopeia, and so on 1.1

Water for Pharmaceutical Use Additional rules WHO Guideline for Drinking water quality (WHO) Water and steam frameworks (ISPE) Bioprocessing Equipment Standard (ASME – BPE 2000) European Pharmacopoeia, United States Pharmacopeia, International Pharmacopoeia Inspection of Utilities (PIC/S) 1.3

Water for Pharmaceutical Use Principles Like any beginning material, creation of water ought to adjust to Good Manufacturing Practice (GMP) standards Potential for microbial development Systems must be legitimately approved/qualified Water for parenteral utilize ought not be tainted with pyrogens or endotoxins Specifications and occasional testing are required

Water for Pharmaceutical Use Why refine crude water ? Albeit sensibly immaculate, it is constantly factor because of regular varieties, local variety in water quality Must evacuate debasements and control organisms to abstain from sullying items Treatment relies on upon water's science and contaminants, affected by, e.g. precipitation, disintegration, contamination, disintegration, sedimentation, decay

Water for Pharmaceutical Use Contaminants of water (1) There is n o unadulterated water in nature , as it can contain up to 90 conceivable unsatisfactory contaminants Contaminant bunches: I norganic mixes Or ga n ic mixes Solids Gasses Microorganisms

Water for Pharmaceutical Use Contaminants of water ( 2 ) Problem m inerals Calcium, magnesium, c opper, aluminum, substantial metals, arsenic, lead, cadmium, nitrates Iron, manganese, silicates, carbon dioxide Hydrogen sulfide Phosphates

Water for Pharmaceutical Use Contaminants of water ( 3 ) Microorganisms – Biofilm development Protozoa Cryptosporidium Giardia Bacteria Pseudomonas Gram negative, non-maturing microscopic organisms Escherichia coli and coliforms

Water for Pharmaceutical Use Biofilm arrangement Free - swimming sea-going microscopic organisms utilize polymucosaccharides to coloni z e surfaces Complex people group advance which shed microcolonies and microscopic organisms

Water for Pharmaceutical Use Background to water necessities and utilize Water is the most broadly utilized substance/crude material Used underway, handling, plan, cleaning, quality control Unique synthetic properties Able to break up, assimilate, adsorb, suspend mixes and contaminants Different levels of water quality accessible See additionally EMEA "Note for direction on the nature of water for pharmaceutical use" 1.2

Water for Pharmaceutical Use Background to water prerequisites and utilize (2) Control nature of water Production Storage and circulation Contaminants, microbial and compound quality Microbial pollution hazard and concern Water is utilized on request not subjected to testing and clump or parcel discharge before utilize, in this way needs to meet detail "on demand" when utilized Micro test outcomes require hatching periods 1.2

Water for Pharmaceutical Use Water framework prerequisites Design, establishment, appointing, capability/approval, operation, execution and upkeep to guarantee dependable, predictable creation of water of required quality Operate inside outline limit Prevent unsuitable microbial, concoction and physical defilement amid generation, stockpiling and dissemination Quality Assurance required in endorsement of utilization after establishment and support work 2.

Water for Pharmaceutical Use Water framework prerequisites (2) Monitoring of water sources frequently Chemical and microbiological Endotoxin level where pertinent Monitoring of framework execution, stockpiling and appropriation frameworks Records of results, and move made Validated disinfection system took after on a standard premise 2.

Water for Pharmaceutical Use Water quality details Here address water in mass (not for patient organization) Specifications in pharmacopeia – important to national or global proposals. Sorts of water include: Drinking water/consumable water Purified water (PW) Highly Purified Water (HPW) Water for Injection (WFI) 3.

Water for Pharmaceutical Use Drinking water/consumable water Must consent to particular (WHO, ISO and national or provincial organizations) – general testing required Supplied under nonstop positive weight Defect free pipes framework to keep tainting Could be from open water supply framework or common sources Source water quality impacts the treatment required 3.2.

Water for Pharmaceutical Use Drinking water: N atural sources could incorporate springs, wells, waterways and lakes Treatment incorporates softening, particle evacuation, molecule diminishment, antimicrobial treatment 3.2

Water for Pharmaceutical Use Purified Water (PW) Prepared from consumable water source Meet pharmacopeia detail for compound and microbial virtue Protected from recontamination Protected from microbial expansion 3.3.

Water for Pharmaceutical Use Highly Purified Water (HPW) Prepared from consumable water source Specification just in the European Pharmacopeia Same quality standard as WFI including limit for endotoxins, however treatment technique considered less solid than refining Prepared by mix of strategies including reverse osmosis (RO), ultrafiltration (UF) and deionization (DI) 3.4.

Water for Pharmaceutical Use Water for Injections (WFI) Prepared from consumable water source WFI is not sterile WFI is not a last dose frame WFI is a moderate mass item According to The International and European Pharmacopeias – last sanitization step ought to be refining 3.5

Water for Pharmaceutical Use Application of particular water to procedures and measurements shapes Water utilized for various phases of: Washing, planning, blend, generation, detailing, control Which review of water is reasonable for a specific stage? Consider nature and proposed utilization of middle of the road or completed item, and stage at which water is utilized Let's take a gander at sorts of water and show their utilization 4.

Water for Pharmaceutical Use Complete the table

Water for Pharmaceutical Use Water filtration techniques Manufacturer to choose suitable strategy for cleansing Appropriate succession of decontamination steps Influenced by, e.g. Water quality particular Yield (productivity) of the framework Feed water quality Reliability and vigor of treatment framework Supplier support, upkeep and operation costs 5.1

Water for Pharmaceutical Use Water cleansing framework contemplations Leaching from contact materials Adsorption Hygienic and sterile outline Corrosion resistance Leakage Proliferation of microbiological living beings 5.1

Water for Pharmaceutical Use Water refinement framework contemplations (2) Tolerance to cleaning and purifying specialists Capacity and yield ability Instruments, sensors, controls, inspecting focuses Space required for establishment and basic stacking of premises Access required for support Regeneration and purification 5.1

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

Pretreatment – schematic attracting coast worked valve To water conditioner & DI plant enacted carbon channel abundance water reused from deioniser sand channel air channel shower ball Water is continued coursing crude water in break tank cartridge channel 5 micrometers divergent pump air break to deplete « S" trap to sewer Water for Pharmaceutical Use

Water for Pharmaceutical Use Water pre-treatment complex in a pre-treatment room

"soft" water to deioniser "hard" water in zeolite water conditioner trades Ca and Mg for Na Water for Pharmaceutical Use Water Softener – schematic drawing by pass valve saline solution and salt tank brackish water deplete

Water for Pharmaceutical Use Chlorine evacuation ( Activated-carbon (AC) filtration or bisulphite) AC expels chlorine however microorganisms can then develop AC filtration can expel natural pollutions Bisulphite leaves sulfate deposits yet is antimicrobial

Water for Pharmaceutical Use Production of drinking water Derived from crude water (e.g. all things considered, waterway, supply) Processes may include: Filtration, softening Disinfection or purification Iron (ferrous) evacuation Precipitation Inorganic/natural diminishment 5.2

Water for Pharmaceutical Use Production of drinking water (2) When done "in-house" – steps utilized and framework design archived, and water quality routinely checked Change control in the event of changes to framework Storage of water: no debasement, guarantee turnover, routine testing "indirect affect system" – capability not required 5.2

Water for Pharmaceutical Use Production of drinking water (3) System licenses depleting and cleansing Storage tanks: Closed, with secured vents Allows visual examination, depleting and sterilization Care to avoid and control microbiological defilement of sand channels, carbon beds, water conditioners Back-flus