7/27/2019 Final Poster(PDF)

1/1

USASHI GHOSH*, MOUMITA PANDA

NSHM KNOWLEDGE CAMPUS- KOLKATA, GROUP OF INSTITUTIONSEmail:usashighosh@gmail.com

RODUCTION :

is the most widely used substance ,raw martial or starting material in the production,processing

rmulation of pharmaceutical products. It has unique chemical properties due to its polarity and

en bonds i.e it can dissolve, absorb, adsorb or suspend many different compounds.GMP

es guidance regarding design,installation and operation of pharmaceutical water systems. The

s categories of water used in pharmaceutical fields are:

able water (2) purified water (3) water for injection (4) bacteriostatic WFI (5) sterileWFI (6)

water for inhalations.

ECTIVE OF THE PRESENT STUDY :

jective of the present study is to evaluate the various techniques of preparing water for injection inceutical fields. Water for Injection, USP, is sterile, non-pyrogenic, distilled water in a single dose

ner for intravenous administration after addition of a suitable solute. It may also be used as a

sing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5

7.0). The osmolarity is 0.The various ways of manufacturing WFI are discussed below.

ILLATION BASED WFI SYSTEM :

ding to USP requirements, WFI must be produced by distillation as it is effective in quantitative

on of most water contaminants and can produce water with low conductivity, low TOC, low

ial levels and low endotoxin levels. Almost all pharmaceutical distillation based systems

ment either multiple effect or vapour compression stills as both the techniques minimize energy

mption. The FDA Guide states,Pre-treatment systems for stills included only deionization

s without RO, ultrafiltration or distillation. Unless a firm has a satisfactory pre-treatment

,it would be extremely difficult for them to demonstrate the system is validated.

DVANTAGES-

s are not perfect as they produce pyrogenic product water when-

Operated incorrectly. (b)fail mechanically

the feed water contains contaminant levels beyond the still reduction capability.

OUR COMPRESSION DISTILLATION:

enerally implement- (a) scale control (b) dechlorination, (c) reduction of ionized solids and/or

xin.

PONENTS-

oftening (2) heat exchanger (3) hot-water-sanitizable activated carbonfilter (5) hot-water sanitizable RO (optional) (6) a vapor compression still.

key design consideration is inclusion or exclusion of RO. RO is excluded when ionized solids

endotoxin reduction is not deemed necessary for reliable, consistent attainment of WFI quality

ameters. RO is implemented when the user believes that reduction of endotoxin and ionized

ds in the still feed assures that WFI quality is consistently attained, maintenance is minimized

hot blow down is minimized. When only endotoxin reduction is desired in the still pretreatment

em, UF may be substituted with RO.

NTAGES-

erally reliable operation (2) Typically more energy efficient than multiple effect distillation.

n be operated on softened /dechlorinated feed (4)does not require a complex system design (5)

atively low maintainance.

DVANTAGES-

more labour intensive than multiple effect distillation with compressor and associated drive

r.

ave higher life cycle cost than membrane based systems Multiple Effect Distillation.

TIPLE EFFECT DISTILLATION :

PONENTS - A multiple-effect distillation (MED) system consists of :

ulti-media filter (B) softening (C) break tank (D) heat exchanger (E) hot-water-sanitizable

ed carbon (F) prefilter (G) pH adjustment(optional) (H) 254-nanometer ultraviolet (UV) light (I)

ter-sanitizable RO (J) continuous electro deionization (CEDI) followed by the (K) multiple-distillation unit. The pretreatment system is comprehensive as the high operating temperature

MED stills susceptible to chloride stress corossion and scale. The pretreatment system

zes chloride, silica and total dissolved solid levels.

Membrane based pretreatment typically reduces endotoxin to very low levels such th

still endotoxin challenge is negligible. Multi-effect distillation has the advantage o

moving parts and this can minimize maintenance requirements.

DISADVANTAGES-

(a)requires high-quality feed water: less than 0.5 ppm chloride; less than1.ppm silic

than 5.0 S/cm conductivity higher energy costs than vapor compression distillatio

(b) higher cooling water requirements than vapor compression (c) higher life cycle

than membrane based system.

MEMBRANE BASED WFI SYSTEMS :

Two-pass RO (TPRO), also known as product staged RO, was the earliest WFI mem

configurations. TPRO systems were more popular prior to the presence of conductivi

TOC tests.

COMPONENTS - (1) multi-media filter (2) softening (3) break tank (4) heat exch(5) hot-water-sanitizable activated carbon (6) prefilter (7) Ph adjustment(optional) (8

nm UV and (9) two stages of hot-water sanitizable reverse osmosis. The logic of thi

of system configuration is that the combination of reverse osmosis and ion exchange

meet the conductivity and TOC specifications while the final ultrafilter or RO stage a

compliance with the endotoxin and microbial requirements. A typical membrane base

system includes dechlorination, softening, a hot-water sanitizable RO device followe

hot water sanitized CEDI device. A continuous hot-water UF device polishes the

prior to storage and use as WFI if the water will be stored hot. A hot water sanitized

RO serves as the final stage if the product water will be stored at ambient temperature

ADVANTAGES-

(1)It is the lowest life cycle cost alternative (2) low energy requirements (3)ver

conductivity, TOC, endotoxin and microbial levels (4) reliable operation (5)C

intermittently or continuously hot sanitized.

DISADVANTAGES - EP does not allow a WFI production method other than distil

and therefore WFI membrane use is limited to non-EP applications.The RO system re

periodic cleaning, the membranes must be replaced at some point, and membranes ca

just as any technology has failure mechanisms.

DISCUSSION :

Sterile Water for Injection, USP is used for fluid replacement only after suitable add

are introduced to approximate isotonicity and to serve as a vehicle for suitable medica

It is a hemolytic agent due to its hypotonicity.Therefore, it is contraindicate

intravenous administration without additives.

It should not be used for intravenous injection unless adjusted to approximate isoto

with a suitable solute. It should not be administered unless solution is clear and s

intact.The administration of a suitable admixture of prescribed additives may be asso

with adverse reactions because of the solution or the technique of administration incl

febrile response, infection at the site of injection, venous thrombosis or phlebitis exte

from the site of injection, extravasation, and hypervolemia.

USE:

Used in the aseptic preparation of parenteral solutions.

CONCLUSION :

Most WFI systems are distillation based. Distillation has a lengthy successful histo

WFI production.USP and JP allow membrane based designs as well as distillation. T

requirement for distillation eliminates any choice of alternate technologies for comp

wanting to comply with EP. Membrane based systems are therefore only employed

EP compliance is not required or where WFIquality water is desired such as for m

the requirements of EP, Highly Purified Water, preparation of intermediates or other u

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

Guidelines and Related Materials

(2)Methods Of Producing Water For Injection, an artic

Siemens Water Technologies Corp. 2010.

http://www.google.co.in/imgres?q=MEMBRANE+BASED+WFI+SYSTEM&hl=en&biw=1366&bih=471&tbm=isch&tbnid=WdbC-IFNj5eU9M:&imgrefurl=http://www.komalwater.com/filtration-plants.html&docid=Ui2UIr7Rzxe2yM&imgurl=http://www.komalwater.com/images/Filtration-plants_1.jpg&w=480&h=320&ei=jDQqUdWfCcTtrAeB2YHYAw&zoom=1&iact=hc&vpx=733&vpy=186&dur=5101&hovh=183&hovw=275&tx=80&ty=95&sig=108341857870792439600&page=2&tbnh=138&tbnw=213&start=15&ndsp=21&ved=1t:429,i:136http://www.google.co.in/imgres?q=reverse+osmosis&hl=en&biw=1366&bih=471&tbm=isch&tbnid=THtE8ZslLl-88M:&imgrefurl=http://www.sdchuanyi.com/shuichulishebei305.htm&docid=67uI4SFAWogZkM&imgurl=http://www.sdchuanyi.com/uploadfiles/%25E8%25B0%2583%25E6%2595%25B4%25E5%25A4%25A7%25E5%25B0%258F%2520%25E7%2585%25A7%25E7%2589%2587%2520007.jpg&w=1845&h=1458&ei=vjUqUfnmIoLqrAeCwoGYCA&zoom=1&iact=hc&vpx=287&vpy=123&dur=3573&hovh=200&hovw=253&tx=136&ty=64&sig=108341857870792439600&page=2&tbnh=143&tbnw=201&start=14&ndsp=19&ved=1t:429,i:190http://www.google.co.in/imgres?q=VAPOUR+COMPRESSION+DISTILLATION&start=272&hl=en&biw=1366&bih=471&tbm=isch&tbnid=yyvPz2KQ-aye2M:&imgrefurl=http://www.steritech.co.uk/vapour-comp-stills.htm&docid=mWXlCLFDFsXa6M&imgurl=http://www.steritech.co.uk/vapour-comp-stills_clip_image006.jpg&w=223&h=174&ei=8jMqUdv1E8K8rAfjhwE&zoom=1&iact=hc&vpx=940&vpy=154&dur=6240&hovh=139&hovw=178&tx=162&ty=112&sig=108341857870792439600&page=13&tbnh=135&tbnw=173&ndsp=22&ved=1t:429,i:256http://www.google.co.in/imgres?q=VAPOUR+COMPRESSION+DISTILLATION&hl=en&biw=1366&bih=471&tbm=isch&tbnid=1jXRkETJziGMTM:&imgrefurl=http://www.esru.strath.ac.uk/EandE/Web_sites/98-9/offshore/fresh.htm&docid=5_C2JtzhYZvtrM&imgurl=http://www.esru.strath.ac.uk/EandE/Web_sites/98-9/offshore/des2.gif&w=849&h=535&ei=NTMqUd6wMo6NrgeUnID4BA&zoom=1&iact=hc&vpx=403&vpy=191&dur=2308&hovh=178&hovw=283&tx=204&ty=135&sig=108341857870792439600&page=2&tbnh=131&tbnw=208&start=14&ndsp=21&ved=1t:429,i:174http://www.google.co.in/imgres?q=DISTILLATION+BASED+WFI&hl=en&biw=1366&bih=471&tbm=isch&tbnid=nyqjA1Nxy5alzM:&imgrefurl=http://www.coldstreamlabs.com/news/bid/206303/Benefits-and-Challenges-of-Real-Time-Release-of-Water-for-Injection&docid=Hc2RcxL05HB7OM&imgurl=http://www.coldstreamlabs.com/Portals/170287/images/wfi1.JPG&w=345&h=159&ei=rzEqUa_ZE8aNrgfO8oHQCQ&zoom=1&iact=hc&vpx=591&vpy=131&dur=5351&hovh=127&hovw=276&tx=113&ty=93&sig=108341857870792439600&page=2&tbnh=127&tbnw=276&start=16&ndsp=23&ved=1t:429,i:166