key points of Steril Aea(continued)

WATER
Dl water

Years ago, high purity water was used only in limited applications. Today, deionized (Dl) water has become an essential ingredient in hundreds of applications including: medical, laboratory, pharmaceutical, cosmetics, electronics manufacturing, food processing, plating, countless industrial processes, and even the final rinse at the local car wash.

THE DEIONIZATION PROCESS
The vast majority of dissolved impurities in modern water supplies are ions such as calcium, sodium, chlorides, etc. The deionization process removes ions from water via ion exchange. Positively charged ions (cations) and negatively charged ions (anions) are exchanged for hydrogen (H+) and hydroxyl (OH-) ions, respectively, due to the resin's greater affinity for other ions. The ion exchange process occurs on the binding sites of the resin beads. Once depleted of exchange capacity, the resin bed is regenerated with concentrated acid and caustic which strips away accumulated ions through physical displacement, leaving hydrogen or hydroxyl ions in their place.

DEIONIZER TYPES
Deionizers exist in four basic forms: disposable cartridges, portable exchange tanks, automatic units, and continuous units. A two-bed system employs separate cation and anion resin beds. Mixed-bed deionizers utilize both resins in the same vessel. The highest quality water is produced by mixed-bed deionizers, while two-bed deionizers have a larger capacity. Continuous deionizers, mainly used in labs for polishing, do not require regeneration.

Water for injection:
Water for the preparation of medicines other than those that are required to be both sterile and a pyrogenic, unless otherwise justified and authorized.
Purified water in the bulk is prepared by distillation, ion-exchange, by reverse osmosis or by another sutible method from water that complies with regulations on water intended for human consumption laid down by the competent authority
Water for pharmaceutical use
Testing setting specification for purified water or WFI (1)

Ph.Eur. JP USP Int.Ph.
PH 5.0-7.0 5.0-7.0 5.0-7.0 Pass the test
Cl <0.5 Pass the test - Pass the test
SO4 Pass the test Pass the test - Pass the test
NH4 <0.2 <0.05 - Pass the test
Ca/Mg Pass the test - - Pass the test
Nitrates <0.2 Pass the test - Pass the test
Nitrites - Pass the test - Pass the test
Conductivity - - <1.3 -
Oxidizable subs. Pass the test Pass the test - Pass the test
Solids (ppm) <10 <10 - Nmt 10
Heavy metals - - - Pass the test
TOC (ppm) - <0.5 <0.5 -
CO2 - - - Pass the test



Suggested bacterial limits ( Cfu/ml)

Sampling location Target Alert Action
Raw water 200 300 500
Post multimedia filter 100 300 500
Post softener 100 300 500
Post activated carbon filter 50 300 500
Feed to RO 20 200 500
RO permeate 10 50 100
Points of use 1 10 100


Testing specification of RO1 (purified water)

Tests Eur.Ph. JP USP B.P
PH 5.0-7.0 5.0-7.0 5.0-7.0 Pass the test
Cl Pass the test Pass the test Pass the test Pass the test
SO4 Pass the test Pass the test Pass the test Pass the test
NH4 <0.2mg/ml <0.5 mg/ml <0.6 mg/ml <0.6 mg/ml
Ca/Mg Nil Nil Nil Nil
CO2 - - - Pass the test
Nitrates <0.2ppm - <0.2ppm <0.2ppm
TDS <10ppm <10ppm <10ppm <10ppm
Conductivity 5.1 @ 25oC - 5.1 @ 25oC 5.1 @ 25oC
Oxidizable subs. Pass the test Pass the test pass the test Pass the test
Heavy metals <0.1ppm <0.1ppm <0.1ppm <0.1ppm
B.E.T <0.25 EU/ml <0.25 EU/ml <0.25 EU/ml <0.25 EU/ml
Bacterial limit <100 CFU <100 CFU <100 CFU <100 CFU



Testing specification of RO2 (Highly Purified Water)

Tests Eur.Ph. JP USP B.P
PH 5.0-7.0 5.0-7.0 5.0-7.0 Pass the test
Cl 0.5mg/ml Pass the test 0.5mg/ml 0.5mg/ml
SO4 Pass the test Pass the test Pass the test Pass the test
NH4 <0.2mg/ml <0.05 mg/ml <0.6 mg/ml <0.6 mg/ml
Ca/Mg Nil Nil Nil Nil
TOC <0.5mg/ml <0.5mg/ml <0.5mg/ml <0.5mg/ml
CO2 - - - Pass the test
Nitrates <0.2ppm - <0.2ppm <0.2ppm
TDS <10ppm <10ppm <10ppm <10ppm
Conductivity <1.3 @ 25oC - <1.3 @ 25oC <1.3 @ 25oC
Oxidizable subs. Pass the test Pass the test pass the test Pass the test
Heavy metals <0.1ppm <0.1ppm <0.1ppm <0.1ppm
B.E.T <0.25 EU/ml <0.25 EU/ml <0.25 EU/ml <0.25 EU/ml
Bacterial limit <50 CFU <50 CFU <10 CFU <10 CFU



.

Testing specification of water for injection

Tests Eur.Ph. JP USP B.P
PH 5.0-7.0 5.0-7.0 5.0-7.0 Pass the test
Cl 0.5mg/ml Pass the test 0.5mg/ml 0.5mg/ml
SO4 Pass the test Pass the test Pass the test Pass the test
NH4 <0.2mg/ml <0.05 mg/ml <0.6 mg/ml <0.6 mg/ml
Ca/Mg Nil Nil Nil Nil
TOC <0.5mg/ml <0.5mg/ml <0.5mg/ml <0.5mg/ml
CO2 - - - Pass the test
Nitrates <0.2ppm - <0.2ppm <0.2ppm
TDS <10ppm <10ppm <10ppm <10ppm
Conductivity <1.3 @ 25oC - <1.3 @ 25oC <1.3 @ 25oC
Oxidizable subs. Pass the test Pass the test pass the test Pass the test
Heavy metals <0.1ppm <0.1ppm <0.1ppm <0.1ppm
B.E.T <0.25 EU/ml <0.25 EU/ml <0.25 EU/ml <0.25 EU/ml
Bacterial limit <10 CFU <10 CFU <10 CFU <10 CFU