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USASHI GHOSH*, MOUMITA PANDA NSHM KNOWLEDGE CAMPUS- KOLKATA, GROUP OF INSTITUTIONS

Email:usashighosh@gmail.com INTRODUCTION :
Water is the most widely used substance ,raw martial or starting material in the production,processing Membrane based pretreatment typically reduces endotoxin to very low levels such that the and formulation of pharmaceutical products. It has unique chemical properties due to its polarity and still endotoxin challenge is negligible. Multi-effect distillation has the advantage of few hydrogen bonds i.e it can dissolve, absorb, adsorb or suspend many different compounds.GMP moving parts and this can minimize maintenance requirements. provides guidance regarding design,installation and operation of pharmaceutical water systems. The various categories of water used in pharmaceutical fields are: DISADVANTAGES(1) Potable water (2) purified water (3) water for injection (4) bacteriostatic WFI (5) sterileWFI (6) (a)requires high-quality feed water: less than 0.5 ppm chloride; less than1.ppm silica; less sterile water for inhalations. than 5.0 S/cm conductivity higher energy costs than vapor compression distillation, (b) higher cooling water requirements than vapor compression (c) higher life cycle costs OBJECTIVE OF THE PRESENT STUDY : than membrane based system. The objective of the present study is to evaluate the various techniques of preparing water for injection in pharmaceutical fields. Water for Injection, USP, is sterile, non-pyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.The various ways of manufacturing WFI are discussed below.

DISTILLATION BASED WFI SYSTEM :


According to USP requirements, WFI must be produced by distillation as it is effective in quantitative reduction of most water contaminants and can produce water with low conductivity, low TOC, low microbial levels and low endotoxin levels. Almost all pharmaceutical distillation based systems implement either multiple effect or vapour compression stills as both the techniques minimize energy consumption. The FDA Guide states,Pre-treatment systems for stills included only deionization systems without RO, ultrafiltration or distillation. Unless a firm has a satisfactory pre-treatment system,it would be extremely difficult for them to demonstrate the system is validated. DISADVANTAGES(1)Stills are not perfect as they produce pyrogenic product water when(a)Operated incorrectly. (b)fail mechanically (c)the feed water contains contaminant levels beyond the still reduction capability.

MEMBRANE BASED WFI SYSTEMS :


Two-pass RO (TPRO), also known as product staged RO, was the earliest WFI membrane configurations. TPRO systems were more popular prior to the presence of conductivity and TOC tests.

COMPONENTS - (1) multi-media filter (2) softening (3) break tank (4) heat exchanger (5) hot-water-sanitizable activated carbon (6) prefilter (7) Ph adjustment(optional) (8) 254nm UV and (9) two stages of hot-water sanitizable reverse osmosis. The logic of this type of system configuration is that the combination of reverse osmosis and ion exchange easily meet the conductivity and TOC specifications while the final ultrafilter or RO stage assures compliance with the endotoxin and microbial requirements. A typical membrane based WFI system includes dechlorination, softening, a hot-water sanitizable RO device followed by a hot water sanitized CEDI device. A continuous hot-water UF device polishes the water prior to storage and use as WFI if the water will be stored hot. A hot water sanitized UF or RO serves as the final stage if the product water will be stored at ambient temperature.

VAPOUR COMPRESSION DISTILLATION:


They generally implement- (a) scale control (b) dechlorination, (c) reduction of ionized solids and/or endotoxin. COMPONENTS(1) Softening (2) heat exchanger (3) hot-water-sanitizable activated carbon (4) refilter (5) hot-water sanitizable RO (optional) (6) a vapor compression still. The key design consideration is inclusion or exclusion of RO. RO is excluded when ionized solids and endotoxin reduction is not deemed necessary for reliable, consistent attainment of WFI quality parameters. RO is implemented when the user believes that reduction of endotoxin and ionized solids in the still feed assures that WFI quality is consistently attained, maintenance is minimized and hot blow down is minimized. When only endotoxin reduction is desired in the still pretreatment system, UF may be substituted with RO. ADVANTAGES(1)Generally reliable operation (2) Typically more energy efficient than multiple effect distillation. (3) Can be operated on softened /dechlorinated feed (4)does not require a complex system design (5) Relatively low maintainance. DISADVANTAGES(1)It is more labour intensive than multiple effect distillation with compressor and associated drive gear. (2)It have higher life cycle cost than membrane based systems Multiple Effect Distillation.

ADVANTAGES(1)It is the lowest life cycle cost alternative (2) low energy requirements (3)very low conductivity, TOC, endotoxin and microbial levels (4) reliable operation (5)Can be intermittently or continuously hot sanitized. DISADVANTAGES - EP does not allow a WFI production method other than distillation and therefore WFI membrane use is limited to non-EP applications.The RO system requires periodic cleaning, the membranes must be replaced at some point, and membranes can fail just as any technology has failure mechanisms.

DISCUSSION :
Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications. It is a hemolytic agent due to its hypotonicity.Therefore, it is contraindicated for intravenous administration without additives. It should not be used for intravenous injection unless adjusted to approximate isotonicity with a suitable solute. It should not be administered unless solution is clear and seal is intact. The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

USE:
Used in the aseptic preparation of parenteral solutions.

CONCLUSION : MULTIPLE EFFECT DISTILLATION :


COMPONENTS - A multiple-effect distillation (MED) system consists of : (A) multi-media filter (B) softening (C) break tank (D) heat exchanger (E) hot-water-sanitizable activated carbon (F) prefilter (G) pH adjustment(optional) (H) 254-nanometer ultraviolet (UV) light (I) hot-water-sanitizable RO (J) continuous electro deionization (CEDI) followed by the (K) multipleeffect distillation unit. The pretreatment system is comprehensive as the high operating temperature makes MED stills susceptible to chloride stress corossion and scale. The pretreatment system minimizes chloride, silica and total dissolved solid levels. Most WFI systems are distillation based. Distillation has a lengthy successful history in WFI production.USP and JP allow membrane based designs as well as distillation. The EP requirement for distillation eliminates any choice of alternate technologies for companies wanting to comply with EP. Membrane based systems are therefore only employed where EP compliance is not required or where WFI quality water is desired such as for meeting the requirements of EP, Highly Purified Water, preparation of intermediates or other uses.

REFERENCES : (1) Quality Assurance Of Pharmaceuticals, A Compendium Of


Guidelines and Related Materials (2)Methods Of Producing Water For Injection, an article by Siemens Water Technologies Corp. 2010.