Pharmaceutical water purification system
Ensure compliance with stringent pharmaceutical standards by integrating a reliable water purification system, designed to deliver ultrapure water essential for precise drug formulation and quality control.
The PURELAB Pharma Compliance from ELGA LabWater is an ultrapure water purification system meticulously designed for pharmaceutical manufacturers and QC laboratories operating under GMP regulations. It stands out by offering a modular and stackable framework that complies with FDA (21 CFR Part 11) and EUDRALEX Annex 11 standards. This system purifies water to United States Pharmacopeia standards 643 and 645, ensuring the highest quality control for critical applications such as cell and tissue culture, immunochemistry, and microbiology. Its continuous operation and integration into laboratory environments facilitate seamless digital traceability and efficient use of space. With a dispense flow rate of up to 2 liters per minute and a maximum daily usage of 120 liters, it supports a wide range of QC tests essential for validating pharmaceutical purity. The system’s design optimizes consumable life and minimizes environmental waste, maintaining operational efficiency and reducing total cost of ownership.
Benefits
- Ensures regulatory compliance with GxP standards, safeguarding production integrity.
- Optimizes laboratory space with modular, stackable design.
- Minimizes operational costs with efficient consumable usage.
- Provides robust digital traceability for audit-ready documentation.
- Enhances product quality by delivering ultrapure water crucial for sensitive QC applications.
- Applications
- Microbiology,Pharmaceuticals,Mass spectrometry,Molecular biology,Drug production,Biopharmaceuticals,Quality control (qc) laboratories,Immunochemistry,High performance liquid chromatography (hplc),Clinical biochemistry,Cell and tissue culture
- End products
- Hormone therapies,Antiviral medications,Pcr kits,Antibiotics,Stem cell therapies,Probiotics,Protein cultures,Biologic drugs,Insulin,Immunoassays,Vaccines,Qc samples,Dna/rna samples,Analytical standards,Cancer drugs,Pharmaceuticals quality testing samples,Monoclonal antibodies,Pain relief medication,Diagnostic reagents
- Steps before
- Water Pre-treatment,Feed Water Analysis
- Steps after
- Laboratory Quality Control,Validation,Record Keeping,Data Export
- Input ingredients
- feed water,inorganic compounds,microorganisms,bacteria,particulates,organic compounds,dissolved gases
- Output ingredients
- ultrapure water,18.2 MΩ.cm resistivity water,low TOC water,endotoxin-free water,neutral pH water,particle-free water,DNase-free water,RNase-free water
- Dispense Flowrate
- up to 2 L/min
- Inorganics (resistivity at 25°C)
- 18.2 MΩ.cm
- Organics (TOC)
- 1–3 ppb
- Bacteria
- <0.001 CFU/ml
- Bacterial Endotoxin
- <0.001 EU/ml
- PH
- Effectively Neutral
- Particles
- <0.01 μm
- DNase
- <5 pg/ml
- RNase
- <1 pg/ml
- Daily Usage (max)
- 120 l/day
- Daily Usage (min)
- 1 l/day
- Dispense Flowrate
- up to 2 L/min
- Delivery Flow Rate
- Up to 2.0 l/min
- Space Saving Design
- Modular and stackable
- Automation Level
- Digital record keeping compliance
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Capacity
- 15,30,60,100 liters
- Dimensions
- 470-806 (h) x 376-532 (w) x 340-522 (d) mm
- Compact footprint
- Modular and stackable design
- Control panel type
- Secure software interface
- Modular Design
- Stackable units
- Integration with QC Labs
- GXP Quality Control Integration
- Secure Software Integration
- Meets FDA and EU standards
- Space Saving
- Compact and space efficient
- Market info