Industries
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High-Purity Manufacturing
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Pharmaceutical — API, Formulations & Injectables
Industries We Serve
★ Flagship Industry
Pharmaceutical API
Formulations & Injectables
Parenterals · WFI · Sterile & Non-Sterile
Purified Water (PW)
Water for Injection (WFI)
Pure Steam
CIP / SIP
Water is the most-used raw material — and the most heavily regulated ingredient — in medicine manufacturing. Ahura Aqua brings 25+ years of expertise delivering High-Purity and Ultra-Pure water systems to Formulations, API, Parenteral and WFI manufacturing units, where the chemical and microbial composition of every litre is dictated by country-specific pharmacopoeia.
Our systems consistently meet the highest international standards — USP / EP / WHO-GMP / USFDA / UK-MHRA — across the full chain of Generation, Storage and Distribution, engineered with sanitary design, full IQ / OQ / PQ validation and 21 CFR Part 11 data integrity.
Project Delivery & Validation Lifecycle
Design → Microbial Testing
From Design Qualification through to final microbial and endotoxin testing, we deliver the system and provide engineering support and on-site supervision across every validation phase. Authoring of qualification protocols and final batch release remain owned by your QA — we ensure the system passes cleanly.
DQ
01
Design Qualification
FAB
02
Fabrication & In-House QC
FAT
03
Factory Acceptance Test
SAT
04
Installation & Site Acceptance
IQ/OQ
05
Installation & Operational Qual.
PQ
06
Phase-wise Validation (PQ 1–3)
MICRO
07
Microbial & Endotoxin Testing
Pharmacopoeia Water Grades
USP & EP compliant
Each dosage form draws a specific water grade. We engineer the generation and distribution train to the tightest grade your process demands — and validate continuously against compendial limits.
Parameter
Purified Water
PW
Highly Purified
HPW
Water for Injection
WFI
Pure Steam
PS
Conductivity (25 °C)
≤ 1.3 µS/cm
≤ 1.3 µS/cm
≤ 1.3 µS/cm
Condensate = WFI
Total Organic Carbon
≤ 500 ppb
≤ 500 ppb
≤ 500 ppb
≤ 500 ppb
Bacterial Endotoxin
—
< 0.25 EU/mL
< 0.25 EU/mL
< 0.25 EU/mL
Microbial Limit
≤ 100 CFU/mL
≤ 10 CFU/100mL
≤ 10 CFU/100mL
Sterile
Typical Use
Oral · topical · API
EP biologicals
Parenterals · final rinse
SIP · sterilisation
System Design Schematic
Generation → Storage → Distribution → Ancillary
01
Generation
PWG
›Multi-barrier pre-treatment
›Softening · RO · Double-pass RO
›EDI polishing to PW
›Multi-column / VC distillation for WFI
02
Storage
Storage
›Sanitary 316L tanks, electropolished
›N₂ blanketing + hydrophobic vent filter
›Spray-ball flooding
›Hot-hold ≥ 70 °C for WFI
03
Distribution
Distribution
›Continuous recirculating loop
›Turbulent flow ≥ 1 m/s, Re > 10,000
›Zero dead-leg (≤ 3D) point-of-use valves
›Hot / cold or ozonated loop
04
Ancillary Services
Ancillary
›Pure steam generation
›CIP / SIP skids
›Ozone & UV sanitisation
›Boiler · cooling-tower · ETP / STP treatment
Compliance & Standards
USP
EP (Ph. Eur.)
WHO-GMP
USFDA
UK-MHRA
ISPE Baseline
21 CFR Part 11
Our Solutions for this Industry
i
High-Purity Water Generation
PW & WFI trains — RO-EDI, multi-column & VC distillation
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ii
High-Purity Water Storage & Loop Distribution
Sanitary recirculating hot / cold loops
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iii
High-Purity Water for Laboratory Applications
Type I / II / III compendial lab water
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iv
EDI Water Systems
Chemical-free continuous electrodeionisation
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v
Disinfection Systems
Ozone · UV · hot-water sanitisation
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vi
Pure Steam Generation
Clean steam for SIP & terminal sterilisation
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vii
Utility Process Equipment Treatment
Boilers · cooling towers · ETP · STP · MEE
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