The difference between

Purified Water, HPW & WFI

David Gabriel, PE 7
11804003
STANDARD OF PURIFIED WATER

Parameters Ph.Eur USP

pH 5-7

TOC (mg/Litre) ≤0,5

Conductivity (μS/cm at 20 ≤4,3 at 20°C ≤1,3 at 25°C

C)

Aerobic bacteria (CFU/ml) ≤100

Endotoxins (unit/ml) ≤0,25

Nitrates (mg/litre) ≤0,2

Heavy Metals (mg/litre) ≤0,1

STANDARD OF HPW & WFI
Parameters Ph.Eur USP

pH 5-7

TOC (mg/Litre) ≤0,5

Conductivity (μS/cm) ≤1,1 at 20°C ≤1,3 at 25°C

Aerobic bacteria (CFU/100 ≤10

ml)

Endotoxins (unit/ml) ≤0,25

Nitrates (mg/litre) ≤0,2

Heavy Metals (mg/litre) ≤0,1

METHODS
PURIFIED WATER:
Purified Water (PW) Normally the Pharmacopoeias like EP, USP, WHO permit
production by distillation, reverse osmosis, deionization, filtration, or equivalent
means.
HIGHLY PURIFIED WATER:
HPW added an additional final step to the PW generation, by putting the
Ultrafiltration with ( depend on the size & output of the system ) 1 or more
catridges
METHODS
WATER FOR INJECTION:
Water for Injection (WFI) USP/JP permits “distillation or a purification process that
is equivalent or superior to distillation in the removal of chemicals or
microorganisms”
EP and WHO permit distillation with droplet separation only, but EP permit since
from 2017 membrane based processes (RO + UF) (direct influence to PIC and
ICH)
WHY THEY SHOULD BE CATEGORIZED?
- PW, HPW, WFI, lack minerals that are beneficial for daily needs for health
- Different standards for each type of water
- Different methods for each type of water
- Different uses for each type of water ( e.g, while PW can be used for many
pharmaceuticals product, product that require sensitive handling for sensitive
human body parts like,eye droplet rather to use HPW)
PW is used widely for Pharmaceutical Industry process, water drinking, etc.
HPW is used for Pharmaceutical Industry process, but can’t be used for WFI
WFI is used solely for injection-type of Pharmaceutical products
CONCLUSION
PURIFIED WATER HAS MORE THAN 1 METHOD OF GENERATION IN ORDER TO
GET THE OUTPUT.
WHILE, HPW CAN USE THE SAME METHOD + UF IN ORDER TO GET THE
OUTPUT.
WFI CAN ONLY BE RETRIEVED BY USING THE DISTILLATION METHOD
( ACCORDING TO PHARMACOPOEIA EUROPE ). IN USA & JAPAN, IT’S POSSIBLE
TO USE MEMBRANE-BASED PROCESS ( RO+UF)
WITH DIFFERENT STANDARDS FOR EACH TYPE OF WATER AND
APPLICATIONS, IT’S OBVIOUS TO THINK THAT THESE TYPES OF WATER ARE
DIFFERENT
REFERENCES
- Bosch, R., 2018. PHARMACEUTICAL WATER (PW AND WFI) IN STABLE QUALITY A CRUCIAL MATERIAL FOR VACCINE PRODUCTION.
[ebook] Bosch, pp.1-16. Available at: <https://www.dcvmn.org/IMG/pdf/bosch_pharma_water_hyderabad_2018_rr.pdf> [Accessed 13 September
2021].

- Bosch Packaging Technology Blog. 2021. Highly Purified Water (HPW) for pharmaceutical use | Corporate Blog. [online] Available at:
<https://blog.syntegon.com/blog/2015/07/24/highly-purified-water-hpw-for-pharmaceutical-use/> [Accessed 13 September 2021].