Suppliers and packagers for STERILE WATER

STERILE WATER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	STERILE WATER	sterile water for irrigation	LIQUID;IRRIGATION	017428	NDA	Baxter Healthcare Corporation	0338-0004-02	24 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTIC	1974-12-31
Baxter Hlthcare	STERILE WATER	sterile water for irrigation	LIQUID;IRRIGATION	017428	NDA	Baxter Healthcare Corporation	0338-0004-03	18 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTIC	1974-12-31
Baxter Hlthcare	STERILE WATER	sterile water for irrigation	LIQUID;IRRIGATION	017428	NDA	Baxter Healthcare Corporation	0338-0004-04	12 BOTTLE, PLASTIC in 1 CARTON (0338-0004-04) / 1000 mL in 1 BOTTLE, PLASTIC	1974-12-31

Suppliers for the Pharmaceutical Drug: Sterile Water

Last updated: August 6, 2025

Introduction

Sterile water, a fundamental excipient in pharmaceutical manufacturing, plays a pivotal role in ensuring the safety, stability, and efficacy of injectable, ophthalmic, and other sterile formulations. Its purity, free from microbial contamination and pyrogens, makes it indispensable across various pharmaceutical applications. The procurement of high-quality sterile water necessitates partnerships with reliable suppliers with strict adherence to regulatory standards, including USP, EP, and JP classifications. This analysis explores prominent suppliers globally, their capabilities, compliance standards, and strategic considerations for pharmaceutical companies seeking sterile water sourcing.

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Market Overview of Sterile Water Suppliers

The sterile water market is characterized by a select cluster of global manufacturers capable of meeting stringent pharmacopeial quality specifications. This niche market is dominated primarily by established pharmaceutical equipment and excipients suppliers, Contract Manufacturing Organizations (CMOs), and specialized water purification companies. Suppliers are often located in regions with advanced regulatory oversight, such as North America, Europe, and Asia-Pacific.

Key factors influencing supplier selection include:

• Regulatory compliance (FDA, EMA, etc.)
• Purity standards (sterility, endotoxin levels)
• Production capacity and scalability
• Validation and quality assurance processes
• Cost and supply chain robustness

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Leading Suppliers of Sterile Water

1. Spectrum Water Systems (Renoline Group)

Overview: Spectrum Water Systems is a prominent player specializing in pharmaceutical-grade water purification systems. Their portfolio includes sterilization systems capable of producing sterile water in bulk.

Capabilities:

• Modular water purification units tailored for pharmaceutical needs
• Validation support for sterilization processes
• Compliance with USP <1231>, EP, and JP standards

Strengths:

• Proven track record in pharmaceutical manufacturing environments
• Extensive engineering support and validation services
• Integration with existing production lines

2. Rommelag Manufacturing GmbH (Filling Systems and Water Generation)

Overview:
While primarily known for blow-fill-seal (BFS) technology, Rommelag also supplies sterile water systems designed for aseptic environments.

Capabilities:

• On-site sterile water generation units
• Customized solutions for small- and large-scale production

Strengths:

• Integration with aseptic filling lines
• Focused on reducing contamination risks

3. Sartorius AG

Overview:
A leading provider of bioprocessing and filtration technology, Sartorius offers comprehensive sterile water production systems.

Capabilities:

• Single-use and multi-use sterile water generation modules
• Water purification systems compliant with GMP standards

Strengths:

• Advanced automation and validation features
• Extensive service and support network

4. Pall Corporation (Danaher Corporation)

Overview:
Pall provides high-quality sterilizing-grade filters, water treatment systems, and purification units.

Capabilities:

• Sterile water systems designed for pharmaceutical and biotech applications
• Endotoxin and pyrogen testing capabilities

Strengths:

• High-performance filtration technology
• Customizable solutions

5. BioPure (By Sangamo Therapeutics)

Overview:
BioPure specializes in sterile water manufacturing through validated processes.

Capabilities:

• Production of clinical and commercial sterile water
• Regulatory adherence and validation support

Strengths:

• Proven compliance with cGMP standards
• Extensive regulatory documentation

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Regional Suppliers and Considerations

North America

• General Water Systems: Known for reliable sterilizer and water treatment solutions.
• MB-Class: Suppliers focusing on large-volume sterilized water with validated processes.

Europe

• Sartorius, Filtration Technologies: Known for cutting-edge sterilization and purification systems.
• Evoqua Water Technologies: Provides high-purity water systems compliant with global standards.

Asia-Pacific

• Shandong Zibo Fuhuang Water Treatment Plant: Emerging supplier with cost-effective solutions.
• AICA Kogyo Co., Ltd.: Provides water purification systems tailored for pharmaceuticals.

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Regulatory and Quality Assurance Considerations

Suppliers must meet or exceed the requirements set by pharmacopeial standards such as:

• United States Pharmacopeia (USP): Establishes specifications for sterile water, including microbial limits, endotoxin levels, and pyrogens.
• European Pharmacopoeia (EP): Defines water quality criteria for various pharmaceutical grades.
• Japanese Pharmacopoeia (JP): Also sets standards for sterile water used in Japan.

Certification and documentation (e.g., Master Validation Protocols, Certificates of Analysis) are critical for validation and regulatory approval processes. Suppliers routinely undergo audits from pharmaceutical companies and regulatory agencies.

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Strategic Procurement Considerations

• Supply Chain Security: Establish diversified supplier lists to mitigate disruption risks.
• Validation Support: Ensure suppliers provide comprehensive validation documentation.
• Quality Monitoring: Regular on-site audits and quality tracking of incoming sterile water batches.
• Cost Optimization: Balance quality requirements with procurement costs, considering long-term relationships.

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Emerging Trends and Innovations

• On-site sterile water generation: Increasingly preferred for reducing inventory and contamination risk.
• Advanced pretreatment technologies: Enabling higher purity standards, such as high-grade ultrapure water systems.
• Sustainable practices: Focus on reducing energy consumption and waste in sterilization processes.

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Conclusion

Choosing the right supplier for sterile water is a strategic decision that influences pharmaceutical manufacturing quality, compliance, and operational efficiency. Leading global providers like Sartorius, Pall, and BioPure offer validated, regulatory-compliant solutions suitable for various production scales. Regional manufacturers can complement these sources, especially in cost-sensitive markets. Building a diversified, well-documented supply network ensures supply continuity and compliance adherence, critical for sterile pharmaceutical applications.

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Key Takeaways

• Strict adherence to pharmacopeial standards (USP, EP, JP) is non-negotiable for sterile water suppliers.
• Leading suppliers such as Sartorius, Pall, and BioPure provide validated, high-quality sterile water systems aligned with regulatory requirements.
• Diversification of supplier base reduces supply chain risks, especially amidst global disruptions.
• On-site sterile water generation systems are gaining popularity for flexibility and contamination control.
• Regular audits and validation support are essential components of supplier management in sterile water procurement.

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FAQs

1. What are the primary quality standards for sterile water in pharmaceuticals?
The main standards are United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). These define microbial limits, endotoxin levels, and pyrogen content necessary for sterile water used in injectables and ophthalmic products.

2. How do suppliers ensure the sterility and purity of sterile water?
Suppliers implement multi-stage water purification processes, including reverse osmosis, ultrafiltration, and sterilization through validated autoclaving or validated filtration. Quality is verified via microbiological testing, endotoxin detection, and routine audits.

3. What are the advantages of on-site sterile water generation?
On-site generation reduces inventory costs, minimizes contamination risks, and ensures real-time quality control. It allows for scalability and quick response to production needs.

4. How do regional suppliers compare to global companies in terms of quality?
Global companies like Sartorius and Pall typically have extensive validation, certified manufacturing facilities, and comprehensive support systems. Regional suppliers may offer cost advantages but require thorough validation and qualification to ensure compliance.

5. What are emerging trends influencing sterile water sourcing?
The adoption of single-use sterile water systems, development of ultrapure water technologies, and focus on sustainability are shaping the future of sterile water procurement in pharmaceuticals.

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Sources:

1. United States Pharmacopeia (USP) General Chapter <1231> Water for Pharmaceutical Purposes.
2. European Pharmacopoeia (EP) Monograph on Water for Pharmaceutical Use.
3. International Pharmaceutical Excipients Committee (IPEC).
4. Company websites of Sartorius, Pall, BioPure, and Rommelag.
5. Industry reports on sterile water market dynamics (2022).