Report on Water quality of Pharmaceutical Industry

 

Water is the one of the major commodities used by the pharmaceutical industry. It is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, compendial articles, and analytical reagents.[1]

Pharmaceutical water

The water that is used directly for the drug manufacturing process and indirectly for the system and equipments cleaning is known as pharmaceutical water.

Classification of Pharmaceuticals Water

Name

Definition

Purified Water

A clear, colorless, order less and tasteless liquid that complies all relevant regulations.

Sterile Purified Water

Purified water that is sterilized and suitably packed.

Water for Injection

A clear, colorless, order less, tasteless and pyrogenic liquid that complies all relevant regulations.

Sterile Water for Injection

Water for injection that is sterilized and suitably packed.

Bacteriostatic Water for Injection

Bacteriostatic water for injection is steriled water for injection that contains one or more anti-microbial agents.  It is intended to use to use as a diluent in the preparation of parenteral products.

Sterile Water for Irrigation

Water for injection that is suitably packed in a single dose container and rendered sterile and is intended to be delivered rapidly.

Sterile Water for Inhalation

Water for injection that is packed and rendered sterile and is intended for use in inhalators and in the preparation of inhalation solution.

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Use of Pharmaceutical Water

Name

Uses

Purified Water

1. Liquid preparation

2. Equipment cleaning

3. Bulk chemical manufacturing

Sterile Purified Water

Ophthalmic Preparation

Water for Injection

1. Parenteral preparation

2. Equipment cleaning

3. Bulk chemical manufacturing

Sterile Water for Injection

1. Parenteral preparation

2. Equipment cleaning

3. Bulk chemical manufacturing

Bacteriostatic Water for Injection

Some parenteral products preparation or dilution.

Sterile Water for Irrigation

To wash after operation.

Sterile Water for Inhalation

Inhalation preparation.

 

Pharmaceutical water quality standards

PHYSICAL STANDARD [2]

Sr No.

Characteristics 

Acceptable*

Cause for Rejection*

1

Turbidity (units on J.T.U. scale)

2.5

10

2

Colour (units on platinum-cobalt scale)

5.0

25

3

Taste and odour

Unobjectionable

Unobjectionable

 

CHEMICAL STANDARD [2]

Sr No.

Characteristics

Acceptable*

Cause for Rejection*

1

pH

7.0-8.5

6.5-9.2

2

Total dissolved solids (mg/l)

500

1500

3

Total hardness (as CaCo3) (mg/l)

200

600

 

 

4

Chlorides (as Cl) (mg/l)

200

1000

5

Sulphates (as So4) (mg/l)

200

400

6

Fluorides (as F) (mg/l)

1.0

1.5

7

Nitrates (as No3) (mg/l)

45

45

8

Calcium (as Ca) (mg/l)

75

200

9

Magnesium (as Mg) (mg/l)

>30

(If there are 250 mg/l of sulphates, Mg content can be increased to a maximum of 125 mg/l with the reduction of sulphates at the rate of 1 unit per every 2.5 units of sulphates)

150

10

Iron (as Fe) (mg/l)

0.1

1.0

11

Manganese (as Mn) (mg/l)

0.05

0.5

12

Copper (as Cu) (mg/l)

0.05

1.5

13

Zinc (as Zn) (mg/l)

5.0

15.0

14

Phenolic compounds (as phenol) (m

0.001

0.002

15

Anionic detergents (as MBAS) (mg/

0.2

1.0

16

Mineral oil (mg/l)

0.01

0.3

17

Arsenic (as As) (mg/l)

0.05

0.05

 

18

Cadmium (as Cd) (mg/l)

0.01

0.01

19

Chromium (as hexavalent Cr) (mg/l)

0.05

0.05

20

Cynides (as CN) (mg/l)

0.05

0.05

21

Lead (as Pb) (mg/l)

0.1

0.1

22

Selenium (as Se) (mg/l)

0.01

0.01

23

Mercury (total as Hg) (mg/l)

0.001

0.001

24

Polynuclear aromatic hydrocarbons (PAH) (µg/l)

0.2

0.2

25

Gross alpha activity (pCi/l)

3

3

26

Gross beta activity (pCi/l)

30

30

 BIOLOGICAL STANDARD [2]

BACTERIOLOGICAL STANDARDS

1) Water entering the distribution system in piped supply chlorinated or otherwise disinfected shall satisfy the following criteria : Coliform count in any sample of 100 ml should be zero. A sample of the water entering the distribution system that does not conform to this standard calls for an immediate investigation into both the efficacy of the purification process and the method of sampling

2)   Water in the distribution system shall satisfy these three criteria 1.  E.Coli count in 100 ml of any sample should be zero. 2.  Coliform organisms not more than 10 per 100 ml shall be present in any sample. 3.  Coliform organisms should not be detectable in 100 ml of any two consecutive samples or more than 50 percent of the samples collected for the year

3)  In individual or small community supplies E.Coli count should be zero in any sample of 100 ml and coliform organisms should not be more than 3 per 100 ml. If coliforms exceed 3 per 100  ml, the supply should be disinfected.

VIROLOGICAL STANDARDS

0.5 mg/l of free residual chlorine for one hour is sufficient to inactivate virus, even in water that was originally polluted. This free chlorine residual is to be insisted in all disinfected supplies in areas suspected of endemicity of infectious hepatities to inactivate virus and also bacteria. 0.2 mg/l of free residual chlorine for half an hour should be insisted for other areas.

Water purification techniques [2]

Techniques

Benefits

Limitations

Distillation

1. Removes a broad range of contaminants and therefore useful as a first purification step.

 2. Reusable.

1. Contaminants are carried to some extent into the condensate.

2.Requires careful maintenance to ensure purity.

3.Consumes large amounts of tap water (for cooling) and electrical energy (for heating).  4. Not environment-friendly.

Ion exchange

1. Removes dissolved inorganic (ions) effectively, allowing resistivity levels above 18.0 MΩ•cm at 25 °C to be reached (corresponding roughly to less than 1ppb total ionic contamination in water).

2. Regenerable (by acid and bases in “service deionization” or by electrode ionization).

3. Relatively inexpensive initial capital investment.

1. Limited capacity: once all ion binding sites are occupied, ions are no longer retained (except when operating in an electode ionization process). 2. Does not effectively remove organics, particles, pyrogens or bacteria.  3. Chemically regenerated DI beds can generate organics and particles.  4. Single use, “virgin” resins require good pretreated water quality to be economically efficient.

Activated carbon

1. Removes dissolved organics and chlorine effectively. 

2. Long life due to high binding capacity.

1. Does not efficiently remove ions and particulates. 

2. Limited capacity due to a high, but limited, number of binding sites. 

3. Can generate carbon fines.

Ultrafiltration

1.Effectively removes most particles, pyrogens, enzymes, microorganisms and colloids above their rated size, retaining them above the ultrafilter surface.

2.Efficient operation throughout their lifetime, unless they are damaged.

3. Their lifetime can be extended by a regular water flush at high speed.

1. Will not remove dissolved inorganics or organic substances. 

2.  May clog when challenged by an excessive level of high-molecular-weight contaminants.

Reverse osmosis

1. Effectively removes all types of contaminants to some extent (particles, pyrogens, microorganisms, colloids and dissolved inorganics), and is therefore useful as a first purification step.

2. Requires minimal maintenance.

3.Operation parameters (pressure, temperature, flow rate, ionic rejection) are easy to monitor.

1.LImited flow rates per surface unit require either large membrane surfaces or an intermediate storage device to satisfy user demand.

2. Requires good pretreatment to avoid rapid membrane damage by water contaminants

Elix Ion Exchange

1.Removes dissolved inorganics effectively, allowing resisti it above 5 Ω•cm at 25° to be reached

2. Environment-friendly No chemical regeneration No chemical disposal No resin disposal

3. Inexpensive to operate.

4. Safe: No heating element.

1. Removes only a limited number of charged organics.

2. Requires feed by good quality water (for instance, reverse osmosis-treated water) for economically efficient operation.

Ultraviolet (Uv) Radiation

1. Effective sanitizing treatment. 

2. Oxidation of organic compounds (185 nm and 254 nm) to reach water TOC levels below 5 ppb.

1. Photooxidation of organics is a polishing step, able to decrease the TOC level only by a limited value.

2.The CO2 produced during photooxidation decreases the water’s resistivity.

3. UV light will not affect ions, particles or colloids. 

 References

  1. QUALITY OF WATER FOR PHARMACEUTICAL USE: AN OVERVIEW by Yaswanth Allamneni, Navya Allamneni, P Dayananda Chary, G Vijay Kumar, Arun Kumar Kalekar, Pavan Kumar Potturi.
  2. WATER QUALITY FOR PHARMACEUTICAL USE: A REVIEW, Amit V. Patel, Dipen A. Trambadiya, Lalji Baldania Vol - 4, Issue - 3, Apr-Jul 2013

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