The pharmaceutical industry in Bangladesh is one of the most developed sectors in the country and has emerged as a major exporter of medicines. It has been growing at a rapid pace over the past few decades, and now meets nearly 98% of the domestic demand for pharmaceutical products. The industry is also a significant contributor to the Bangladeshi economy, generating approximately $3 billion in revenue annually.

1. PHARMACEUTICALS
INDUSTRY
Presented by
Tanvir Siddike Moin
Submitted to
Dr. Rowshan Mamtaz
Professor
DEPARTMENT OF CIVIL ENGINEERING
BUET

2. • 90% of medicines are taken orally with the majority being tablets.
• Other routes of administration include injections, inhalation, rectal and topical.
• In the pharmaceutical industry, clean water is a widely-used raw material in
pharmaceutical manufacturing and plays a decisive role for the quality and safety of each
product.
• Therefore, in every pharmaceutical manufacturer, the water treatment system for
manufacturing activities must be strictly managed, ensuring simultaneous factors: quality,
stable operation.
In the industry, most water, about 60-80%, is used for cleaning.
However, even this water needs to be rather pure.
Therefore, making water viable for use in the pharmaceutical industry is costly and energy intense.
INTRODUCTION

3. Raw Materials
• Active Pharmaceutical Ingredients (APIs). They are the central
ingredients.
• Excipient. The goal of the excipient is to carry and deliver the active
ingredient to its destination.
• While many types of drugs require many kinds of raw materials, there is a
distinction in the type of raw material used.
• According to the function of the raw material, it is categorized into two types.
• They are as follows.

4. Pharmaceutical
Excipients
• Fillers
• Binders
• Disintegrants
• Glidants
• Coloring Agents
• Antiadherent
• Lubricants
• Coating
• Preservatives
• Antioxidants
• Flavoring Agents
• Sweeting Agents
• Sorbents
• Solvent & Co-solvent

5. By route of Administration
•Oral Excipients
•Topical Excipients
•Parenteral Excipients
•Other Excipients
By origin
Inorganic Chemicals
•Calcium Phosphates
•Calcium Carbonate
•Calcium Sulfate
•Halites
•Metallic Oxides
Organic Chemicals
•Carbohydrates
• Sugars
• Actual Sugars
• Sugar Alcohols
• Artificial Sweeteners
•Starch
• Modified Starch
• Dried Starch
• Converted Starch
•Cellulose
• Cellulose Ethers
• Cellulose Esters
• CMC and Croscarmellose
Sodium
• Microcrystalline Cellulose
•Petrochemicals
• Glycols
• Polyethylene Glycol
• Propylene Glycol
•Povidones
•Mineral Hydrocarbons
• Petrolatum
• Mineral Waxes
• Mineral Oils
•Acrylic Polymers
•Other Petrochemical Excipients
•Oleochemicals
• Fatty Alcohols
• Mineral Stearates
• Glycerin
• Lipids
•Other Oleochemical Excipients
•Proteins
Categorization of Excipients
Pharmaceutical excipients can be categorized in different ways. Such as

6. Antacid Tablet
Composition
SERIAL INGREDIENTS
MG / %
PER
UNIT
TABLET
ROLE OF
INGREDIEN
TS
1 Aluminum Hydroxide 200 mg API
2 Magnesium Hydroxide 200 mg API
3 Simethicone 25 mg API
4 Povidone 3.5% Binding Agent
5 Sorbitol Power 14% Sweeteners
6 Magnesium Stearate 1-2% Lubricant
7
Dicalcium Phosphate
Anhydrous
0.5% Filler
8 Sodium Starch Glycolate 3% Disintegrant
9 Aspartame 0.2% Sweeteners
10 Lactose Monohydrate 16% Filler

7. RECEIPT OF RAW
MATERIAL FROM STORE
VERIFICATION OF
MATERIAL & WEIGHTS AT
SHOP FLOOR
SIFTING OF INVIDUAL
MATERIAL
DRYING
MILLING/ GRANULE
SIZING
LUBRICATION/BLENDING[
YIELD CALCULATION]
COMPRESSION
[SIMULTANEOUS
OBSERVATIONS BY
PROD.&IPQA]
VISUAL INSPECTON
[YEILD ANALYSIS]
COATING
[SIMULTANEOUS
OBSERVATIONS ON EACH
LOT BY PROD.&IPQA]
VISUAL INSPECTION
[YEILD ANALYSIS]
PM VERIFICATION AND
BATCH CODING
PACKING
[SIMULTANEOUS
OBSERVATIONS BY
PROD.&IPQA]
FINISHED GOOD
ANALYSIS
TRANSFER TO F.G.STORE
[BPR TO QA]
FLOW CHART TABLET MANUFACTURING AND
PACKING

8. APPROVED RAW
MATERIAL
LINE CLEARANCE
DISPENSING
PRIMARY SYRUP
PREPARATION
FILTRATION
BULK SYRUP
PREPARATION
FILTRATION
FILING OF SYRUP
IN BOTTLES
SEALING OF
BOTTLES
PACKING
TRANSFER TO
FINISHED GOODS
QUARANTINE
TRANSFER TO
FINISHED GOODS
STORE
FLOW CHART SYRUP MANUFACTURING

9. GRANULE
MANUFACTURE
Three principle methods of preparing powder formulations for compression
1. Direct Compression
2. Wet Granulation
3. Dry Granulation
 Granulation is a unit operation in which small powder particles are gathered to
form agglomerates called granules.
 To achieve cohesion between the powders, it is necessary to include adhesive
substances called binders or granulating agents within the formulation.
 It is a common practice to make use of a granulation solution since it is more
effective in comparison with the same quantum of the dry powder binder.
 Powder mixing, in conjunction with the cohesive properties of the binder,
enables the formation of granules which when duly compressed using tablet
press forms tablets with the desired properties.

10. DIRECT
COMPRESSION
• This is the ideal option but is rarely achievable due to:
• Active particle size/density mismatch with excipients
causing poor homogeneity
• Large quantity per tablet of poorly compressible
active resulting in weak friable tablets

11. DIRECT COMPRESSION
Process flow for direct compression
Dispense
Security
Sieve
Blend
• Lubricant
Compress

12. Problems Associated With Direct
Compression
 If the material is a powder rather than a granule:
› it will have poor flow characteristics, which can lead to uneven tablet weights.
› The pressure transmission through a powder mass is poor, due to low packing density.
Consequently particles do not ‘knit’ together very readily.
› Powders, especially fine ones tend to blow out of the die at the top and seep out at the bottom
› Dusty powders tend to mix with oil/grease and eventually cause sticking of the punches in the dies
or turret bores.
 Powders containing two or more components may segregate. The heavier or smaller particle size
components separate to the bottom of the bulk, this is made worse by the vibration of the Tablet Press.
 Direct compression materials are more expensive than non-DC equivalents

13. Advantages of Direct Compression
• Few stages involved
• Low handling costs
• Losses near zero
• No water or heat involved
• Reduces the risk of degradation of the active

14. PROCESS AIDS
 Regardless of whether a tablet is manufactured by direct compression or granulation,
processing aids will be required:
 These materials are called excipients and are either:
› Diluents
› Lubricants
› Disintegrants
› Glidants
› Binders
 Direct compression formulations will contain as a minimum diluents, disintegrants and
lubricants.
› N.B. some excipients have more than one function

15. DILUENTS
• A diluent is simply an ingredient that is used as a bulking agent to make tablets large enough to
handle and swallow.
• Diluents must therefore be:
• Pharmacologically inert
• Cheap
• No supply issues
• Compatible
• Stable
• Processable
• Diluents are commonly easily compressible especially in DC formulations.
• Examples include:
• Micro-crystalline cellulose
• Lactose
• Di-calcium phosphate

16. LUBRICANTS
Lubricants are materials that lubricate powder
mixes and aid tablet ejection.
Without lubrication powder may stick to the
punches especially if is too moist.
Lubricants are typically added at a late stage and
blended for the shortest possible time as they
have adverse effects.
Adverse effects if over-blended are poor
compressibility and increased dissolution due to
waxy layer covering the surface of the granule

17. GLIDANTS
• Glidants are materials that improve the flow of powder
mixes
• An example is Colloidal Silicon Dioxide
• Most powders, without the aid of flow agents, simply
cannot flow at speeds required for high speed tabletting.
• Flow agents can decrease the capacity of powders to
form bridges, create rat holes and stick to contact
surfaces.
• Good flow into the die will lead to
uniform tablet weight as the volume of
material flowing into the die will be constant

18. DISINTEGRANTS
A material to promote disintegration of the tablet when
swallowed
Enhances water penetration by wicking effect
Increases porosity
Swells in contact with water and breaks cohesive bonds
Examples include:
• Starch
• Croscarmellose
• Sodium Starch Glycollate
• Crospovidone

19. BINDERS
• A material that imparts cohesiveness to the formulation
• Helps bind powder particles into granules during
granulation
• Helps bind granules together during the compression
process
• Examples include:
• Hydroxy propyl methyl cellulose (HPMC in water)
• Starch paste in warm water
• Gelatin
• Polyvinyl pyrrolidone (PVP)

20. TRADITIONAL WET GRANULATION
Dispense
Security Sieve
Granulate
Dry
Sieve/Mill
Blend
• Lubricant
Compress

21. TRADITIONAL WET
GRANULATION
• Most performed using a high shear
mixer e.g., ‘Fielder’ but can be
performed using low shear e.g.,
‘Hobart’.
• Fielder Granulator:
• Two blades, main blade and
chopper
• Main blade speed is typically 100-
500rpm
• Chopper blade up to 3000rpm
• Main blade mixes and chopper
breaks wet mass to form granules

22. TRADITIONAL WET GRANULATION
Powders are loaded into
the bowl and mixed for a
defined time before
granulation starts
Granulating solution
added at defined rate or
sprayed (binder is usually
incorporated into the
solution)
Wet mass is chopped to
form granule
Granulation end point
can be measured by
current draw on main
blade
Process is controlled by
the mixing times/speeds
before and after addition
of the granulating
solution and the amount
of solution added.
Process relies on the binder
and/or water-soluble
elements dissolving upon
granulation, then on drying
forming a solid bridge
between particles.

23. ADVANTAGES OF WET GRANULATION
• Increases cohesiveness
• Good for high dose/poorly compressible drugs
• For example Kalms has large amount of poorly
compressible Hops
• Good for distributing soluble low dose drugs
• For example in Kwells the hyoscine is added to the
granulating solution
• Prevents segregation of actives

24. DISADVANTAGES OF WET
GRANULATION
 Processing parameters are derived by trial and error
 Mixing time varies with batch size and can be sensitive to
variation in starting materials
 Danger of over granulation
 Cost (multi-stage process)
 Incompatibilities (chemical instability with moisture or
subsequent drying)

25. A TYPICAL WET GRANULATION
FORMULATION
• Wet Binder
• Polyvinyl pyrrolidone (PVP)
• Increases granule size strength and compressibility
• Enhances dissolution relative to DC
• Granulation process aid
• Micro-crystalline cellulose
• Reduces water/energy requirements
• Reduces process sensitivity
• Less risk of over granulation
• Easier wet massing and screening
• Intra granular filler
• Lactose
• Better wet binding than insoluble fillers
• Intra-granular disintegrant
• Croscarmellose sodium

26. DRYING
• The removal of water or liquid to form a dry solid
• It is necessary as too much residual water can result in:
• Poor flow
• Poor lubrication (sticking to punches)
• Chemical instability
• Susceptibility to microbial growth
• 2 main methods
• Tray drying
• Fluidised Bed Drying
• Others include microwave and vacuum drying
(not commonly used)

27. TRAY DRYING
• Fan assisted convection of hot air over loaded trays
• Not commonly used due to:
• Large floor space
• Manual handling
• Labour intensive
• Long drying times (up to 24 hours)
• Can get non-uniform drying
• Can result in hard caked product

28. FLUIDISED BED DRYING
• Heated air is pulled through the bed of
material in a removable bowl.
• Filters prevent fines from escaping
• Temperature can be controlled by probes
monitoring
input, output and bed temperatures
• Airflow is adjusted according to particle size
and density
• Most efficient drying (minutes vs.
hours)

29. SIEVING AND MILLING
Sieving of the granule may
be performed to remove
large particles that may then
be milled to reduce size
Oversize or all of the dried
granule may be milled.
Various types of mill are
usually used depending
upon the process
requirements
Mills used routinely at GR
Lane include Comill (Cone
mill), Apex and Tornado.

30. MILLING
• Comills (cone mills) produce granule of
more uniform size and shape than Apex or
Tornado mills with a smaller proportion of
fines
• Fines are powders that are very small and
‘dusty’, which will pass through a 200 mesh
screen.
• Fines impede the flow, do not compress well
• Mills may also be used to ‘de-lump’
granules without reducing particle size.

31. MILLING
• Apex mills have the rotational shaft in a
horizontal orientation vs Tornado that is vertical
• Tornado mills have 360° mill screens and
consequently produce marginally less fines than an
Apex mill that has a 180° screen.
• Both tornado and apex mills can be used with
varying numbers of blades that throw material
against the mesh that controls the
maximum particle size
• Hammers may also be used. These pulverize the
material to a finer particle size

32. SPRAY GRANULATION
• This is when granulation and drying is combined in a
one-pot process
• Granulation solution is sprayed into a fluidized
bed
• There is a greater degree of control over the size of
granules formed.
• Control is via spray rate, inlet temperature and air flow.
• There are less losses by this method
• Granule has an even moisture distribution
However
• Higher attrition may lead to fines
• Control of rates is critical
• Longer process time (may lead to de-mixing)

33. DRY GRANULATING
• Dry granulating, also called slugging, or roller compaction, involves
the pressing of mixed powders into an object to be reground into a
precise powder.
• This action increases particle density, improves powder flow
and captures fines.
• Useful for materials which are sensitive to heat and/or moisture.
• Can be performed on tablet press followed by milling or by
using specialized equipment
• However pressure during dry granulation can
result in:
• granules with low porosity
• Weaker tablets
• May produce tablets with longer disintegration time
• Dusty process

34. BLENDING
• There are many different types of blenders
• Y cone blenders
• Double cone blenders
• Drum blenders
• IBC blenders
• Majority are low shear tumble blenders. GR Lane has opted for IBC
blending to reduce handling
• Blend studies are performed to determine the determine the
optimum endpoint
• Given enough time, components will pass from an unblended state to
a relatively homogenous blend and back to an unblended state.

35. WEIGHT VARIATION
• Weight variation can be caused by a number of factors:
• Poor flow of granule
• Granule too wet
• Insufficient glidant
• Poor granule homogeneity
• Over or under-blended
• Material has settled over time
• Separation of fines in hopper
• Poor formulation
• Tablet press set-up
• Dropping punches
• Sticking punches
• Feed frame speed
• Uneven wear or damaged tooling

36. POOR
FRIABILITY
• Poor friability can be caused by a number of
factors:
• Low hardness
• Tablet press set-up
• Overblending
• Poor granule
• Too dry
• undergranulated
• insufficient binder
• too many fines
• Inappropriate tablet shape

37. CAPPING
• Capping is the term used, when the upper or lower segment of the tablet separates
horizontally, either partially or completely from the main body of a tablet and comes
off as a cap, during ejection from the tablet press, or during subsequent handling.
• Reason: Capping is usually due to the air–entrapment in a compact during
compression, and subsequent expansion of tablet on ejection of a tablet
from a die.
• Causes related to the formulation are
• Large amount of fines
• Granule too dry
• Granule too wet
• Insufficient lubricant
• Causes related to the press:
• Ringing in dies
• Lower punch remains below the face of die during ejection.
• Incorrect adjustment of take-off blade.
• High turret speed
• Possible remedial actions are:
• Move position of compression in die
• Adjust take-off blade
• Slow down press

38. LAMINATION
Lamination is the separation of a tablet into two or more
distinct horizontal layers.
Reason: Air–entrapment during compression and subsequent
release on ejection
Causes related to the formulation:
• Over lubrication of formula
• Oily material in formula
Causes related to the tablet press:
• Rapid relaxation of the peripheral regions of a tablet, on ejection from a die.
• Rapid decompression
Possible remedial action:
• Use tapered dies, i.e. upper part of the die bore has an outward taper of 3° to 5°.
• Use pre-compression step. Reduce turret speed and reduce the final compression
pressure.

39. CHIPPING
• There are number of causes of
chipping that can be
due to:
• Machine setup
• Insufficient dwell time
• Compression force too low
• Tooling wear
• worn punches
• Poor granule
• too much fines
• Granule too dry
• Insufficient binder
• Excessive lubricant
• Not homogenous mix
• Possible remedial actions
• If clawed tooling, remove claws
• Increase pressure
• Slow down press

40. CRACKING
Cracking is where small, fine cracks observed on the upper and
lower central surface of tablets, or very rarely on the sidewall
Reason: It is observed as a result of rapid expansion of tablets,
especially when deep concave punches are used
Causes related to the granule:
• Large size of granules.
• Too dry granules
Causes related to the tablet press:
• Tablet expands on ejection due to air entrapment
• Deep concavities cause cracking while removing tablets
• Too much pressure
Possible remedial action:
• Use tapered die
• Use special take-off plate
• Reduce compression force

41. STICKING/FILMING
• Sticking refers to the tablet material adhering to the die wall.
• Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
• Reason: Improperly dried or improperly lubricated granules.
• Possible remedial action:
• Increase pressure.
• Reduce speed.

42. PICKING
 Picking is the term used when a small amount of material from a tablet is sticking to
and being removed off from the tablet-surface by a punch face.
 The problem is more prevalent on the upper punch faces. The problem worsens with time into
the run because more and more material is added to the already stuck material on the punch
face.
 Common causes related to the granule:
› Excessive moisture in granules
› Too little or improper lubrication
› Too warm granules when compressing.
› Too much binder.
 Common causes related to the tablet press:
› Rough or scratched punch faces
› Unpolished tooling
› Insufficient pressure
 Possible remedial actions:
› Increase compression pressure
› Polish tooling by hand
› Reduce press speed

43. BINDING
• Binding in the die, is the term used when the tablets adhere or tear in the die. A film is
formed in the die and ejection of tablet is hindered. With excessive binding, the tablet sides
are cracked and they may crumble apart
• Reason: Binding is usually due to excessive amount of moisture in granules, lack of
lubrication and/or use of worn dies.
• Causes due to worn dies:
• Poorly finished dies
• Rough dies due to abrasion
• Possible remedial action:
• Clean the dies properly
• If worn die is due to abrasion investigate use of other steels
• Reducing pressure in the tablet press may decrease binding.

44. Formula of
Paracetamol
Tablet

45. Procedure of Paracetamol
1. Add 2.1 grams of 4-aminophenol into the round-bottomed flask.
2. Using your 25 mL measuring cylinder, measure 18 mL of water and add this to
the flask.
3. Add a magnetic follower to the round-bottomed flask.
4. Carefully clamp the flask at the neck and position it in the metal Dry Syn block
which should be placed on the stirrer hotplate. Stir the reaction mixture using a
magnetic follower. Do not apply heat at this stage
5. Assemble the apparatus for reflux as shown in the diagram below. Tip: Do not
clamp the condenser

46. Procedure of
Paracetamol
6. Using a Pasteur pipette, measure 3 mL of ethanoic anhydride (also
known as acetic anhydride) into a 10 mL measuring cylinder. Add this to
your mixture by lifting the condenser and adding directly to the round-
bottomed flask.
7. Replace the condenser and switch on the heat to your hotplate (set
the dial to about 120°C). Make sure there is water going through your
condenser.
8. The reaction is heated at reflux for 15 minutes,stirring continuously.
The reaction mixture should become colorless.
9. After refluxing for 15 minutes, switch off the heat and carefully raise
the round-bottomed flask away from the Dry Syn block using the boss
and clamp.
10. Allow the flask to cool to room temperature.
11. On cooling, crude paracetamol should form in the round-bottomed
flask.

47. 12. filter the precipitate (using a Buchner funnel),
washing with small amounts of cold, distilled
water.
13. After drying, the crude product should be placed
in a clean 100cm3 conical flask and recrystallized
by heating until it just dissolves in approximately
20ml of water.
 Cool the flask in ice until crystals of the purified
paracetamol appear.
 Filter the crystals under vacuum, dry in a warm
oven and then record the melting point and
compare with standard paracetamol tablets
(~170oC). Repeat recrystalisation process to
achieve a purer product
Procedure of
Paracetamol

48. •Formulation
•Power Feeding
•Power Blending
•Granulation
•Hot Melt Extrusion
General Unit
Operations

49. Pharmaceutical water includes different types of water used in the
manufacture of drug products
THE 8 TYPES OF WATER ARE:
1. Non-potable
2. Potable (drinkable) water
3. USP purified water
4. USP water for injection (WFI)
5. USP sterile water for injection
6. LUSP sterile water for inhalation
7. USP bacteriostatic water for injection
8. USP sterile water for irrigation
Water for Pharmaceutical Use

50. Water Requirements
• Water is very much a necessity in pharmaceutical processes.
• Of course, various types of water are important for various processes.
• Also, the quality of water has to be certified in many cases.
• Generally, most water that is used in the pharmaceutical industry is for cleaning.
• Still, cleaning water needs to be potable, as non-potable water can disrupt the
manufacturing process.
• The other main uses of water are as an ingredient and as a carrier.
• Water can be an ingredient in the pharmaceutical process for various chemical
reactions.
• Water is often used for hydrolysis to break down organic compounds.
• In addition, water can be the medium or solvent for a particular drug, whether
administered orally, as a syrup, or as an injection, where the water is a medium.

51. Water Quality
The USP designation means that the water is subject to an official monograph by the US Pharmacopeia.
There are four different kinds of specifications for water, and these four have different functions.
Serial Parameter Potable Water Purified Water Water for Injection
Sterile Water for
Injection
1 Appearance
Clear, colorless, and no visible
particles
Clear, colorless, and no visible
particles
Clear and colorless Clear and colorless
2 Odor Odorless Odorless Odorless Odorless
3 pH 6.5-8.5 5.0-7.0 5.0-7.0 5.0-7.0
4 Chloride NMT 250 ppm 0 ppm 0 ppm 0 ppm
5 Aluminum 0.2 mg/L 0 mg/L 0 mg/L 0 mg/L
6 Arsenic 0.01 mg/L 0 mg/L 0 mg/L 0 mg/L
7 Fluoride 1.5 mg/L 0 mg/L 0 mg/L 0 mg/L
8 Boron 0.3 mg/L 0.3 mg/L 0 mg/L 0 mg/L
9 Sulfate NMT 300 ppm 0 ppm 0 ppm 0 ppm
10 Total hardness NMT 500 ppm 0 ppm 0 ppm 0 ppm
11 Microbial count 500 cfu/ml 100 cfu/ml 10 cfu/ml 10 cfu/ml
12
Acidity or
Alkalinity
- NMT 0.1 ml of 0.01M NaOH
NMT 0.1 ml of 0.01M
NaOH
NMT 0.1 ml of 0.01M
NaOH
13 Ammonia 0.5 ppm 0.2 ppm 0 ppm 0 ppm
14 Heavy Metals 0.5 ppm 0.1 ppm 0 ppm 0.1 ppm

52. Maximum
Allowable
Concentration
of Toxic
Substances
Toxic Substances Maximum Allowable
Concentration (mg/L)
Lead (Pb) 0.05
Selenium (Se) 0.01
Arsenic (As) 0.05
Chromium (Cr) 0.05
Cyanide (CN) 0.2

53. Sources of Water
• Potable Water is generally gathered from municipal
water systems or from a natural water source.
• However, for other kinds of water, other processing
must be done.
• These can be done on site, or if the plant is a small one,
higher grades of water have to be purchased.
• On site, sand filters are often used for purifying and
obtaining potable water.
• For high grades of water, specific equipment needs to
be present such as boilers, ionizers, etc.
• Certain high grades of water are still purchased as it is
not viable to manufacture them at a large scale as the
demand may not be there.

55. Characteristics
of wastewater
generated from
pharmaceutical
process
Parameter Concentration (mg/L)
pH 6.65-7.40
Total Alkalinity 1800-2100
TDS 15500-16700
VS 6400-6600
SS 9150-9240
COD 23700-24500
BOD5 11500-12100
Chlorides 3900-4100
Sulphates 400-650
Phosphates <98

56. Analysis
Most pharmaceutical
companies outside of
Bangladesh manufacture
medicine, but in Bangladesh,
the ingredients and
formulation is imported.
In factories in Bangladesh,
only the packaging and other
final procedures are done.
Standards in Bangladesh are
not specified, and different
pharmaceutical companies
do different procedures.
However, the standards of
the ingredients and raw
materials are generally met
according to foreign
standards.

57. The water used to supply the pharmaceutical industry usually comes from
• Underground-water
• Water from clean water supply plants in the area
• Underground-water sources are often characterized by high amounts of dissolved
substances, mainly manganese, calcium, and magnesium, while clean water from water
supply plants is not up to the production quality assurance.
• Therefore, pharmaceutical enterprises are required to treat input water sources to
remove impurities or microorganisms that affect the quality of pharmaceuticals.
WHY DO WE HAVE TO TREAT WATER BEFORE USING IT TO
MANUFACTURE PHARMACEUTICALS?

58. References
• Medical Waste Rules, 2008
• FDA Current Good Manufacturing Practice regulations, Federal Register, Vol. 43, No. 190,
Sept. 29, 1978
• Water Programs, Environmental Protection Agency, National Interim Primary Drinking
Water Regulations, Dec. 16, 1985
• United States Pharmacopeia, Water for Pharmaceutical Purposes, 1985

59. THANK YOU