Bulk Pharmaceutical API Sources for STERILE WATER IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for STERILE WATER IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		195294_ALDRICH
Sigma-Aldrich		2107_SIGMA
Sigma-Aldrich		W1503_SIGMA
Sigma-Aldrich		W1754_SIGMA
Sigma-Aldrich		W3500_SIGMA
Sigma-Aldrich		W3513_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for Sterile Water in Plastic Containers

Last updated: August 3, 2025

Introduction

Sterile Water in Plastic Containers (SWPC) is a critical component used across pharmaceutical, medical, and laboratory settings. It serves as a solvent in drug formulation, cleaning, and biological preparation applications. Unlike bulk active pharmaceutical ingredients (APIs) designed as therapeutic drugs, sterile water aligns more closely with excipient standards. However, for formulations requiring sterile water, sourcing high-quality, sterile-grade water in bulk is paramount.

In the pharmaceutical industry, sterile water is classified primarily as Water for Injection (WFI), which is sterilized and rendered pyrogen-free. While not an API in the traditional sense, sterile water is often regulated with the same rigor as APIs due to its critical role in drug manufacturing and process safety. Consequently, suppliers of sterile water adhere to stringent standards, including U.S. Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP).

This article evaluates the leading sources, manufacturers, and suppliers of sterile water in plastic containers, emphasizing compliance, quality assurance, and supply stability.

Global Market Overview

The global supply of sterile water for injection (WFI) and sterile water in plastic containers is dominated by a handful of multinational pharmaceutical excipient suppliers, sterile manufacturing facilities, and regional specialized vendors. Market dynamics are driven by increasing regulations, rising pharmaceutical R&D, and growth in biotechnology sectors.

According to industry reports, the sterile water segment experiences steady growth, with Asia-Pacific emerging as a significant manufacturing hub owing to cost efficiencies and expanding regulation adherence. North American and European suppliers maintain high standards, emphasizing purity, sterility assurance, and validation processes.

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Major Suppliers and Sources of Sterile Water (SWPC)

1. Medicinal-Grade Water Suppliers with Established Manufacturing Capabilities

a. Fresenius Kabi

• Overview: A global leader in infusion therapy solutions, Fresenius Kabi offers sterile water for injections in various container formats, including plastic bottles.
• Quality & Compliance: Their sterile water conforms to USP, EP, and JP standards. They operate compliant facilities globally, with strict validation and sterilization processes.
• Supply capacity: Large-scale manufacturing of sterile water in pre-sterilized containers, with consistent quality control.

b. B. Braun Melsungen AG

• Overview: B. Braun supplies sterile water and other injectable excipients, emphasizing hospital and pharmaceutical sector needs.
• Standards: Their sterile water products meet GMP standards, with supply chains capable of bulk delivery.
• Container types: Multiple formats, including polyethylene and polypropylene bottles.

c. Baxter International

• Overview: A significant supplier of sterile injectable solutions, Baxter offers sterile water for injection (WFI) in plastic containers.
• Certifications: Compliant with USP <71> sterility testing, endotoxin limits, and pyrogen-free standards.
• Global reach: Facilities across North America, Europe, and Asia serving regional and international markets.

2. Specialized Water Production & Bottling Companies

a. S. R. Pharmaceutical Private Limited (India)

• Overview: An Indian manufacturer specializing in sterile water for injection, widely supplying Asia and the Middle East.
• Manufacturing: Uses sterile, validated processes including multi-effect distillation, and filtration.
• Containerization: Offers sterile water in 500 mL to 20 L plastic bottles, with batch validation.

b. T.P.P. Pharma Inc. (Mexico)

• Overview: Provides sterile water in plastic containers for regional pharmaceutical manufacturing.
• Regulatory compliance: Adheres to local and international standards, including USP and Mexican pharmacopeia.

c. Wockhardt Ltd. (India)

• Overview: Offers sterile water and related solutions, focusing on high-volume, sterile manufacturing.
• Quality assurance: Emphasizes validated sterilization and endotoxin testing, supporting export markets.

3. Regional and Contract Manufacturing Organizations (CMOs)

Multiple CMOs provide custom sterile water solutions for pharmaceutical companies seeking to outsource manufacturing. These organizations typically operate under strict cGMP standards, offering tailored container formats and batch validation.

• Examples: WuXi AppTec, Samsung Biologicals, and Recipharm offer sterile water production, often in partnership with pharmaceutical clients.

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Standards and Regulatory Considerations

Sterile water in plastic containers must meet specific pharmacopoeial standards:

• USP (United States Pharmacopeia): Water for Injection (USP <719>) specifies endotoxin limits, microbial contamination, and pyrogen content.
• European Pharmacopoeia: Produces standards for Water for Injections and Sterile Water for Injections.
• Japanese Pharmacopoeia: Similar standards focusing on endotoxin and microbial limits.

Manufacturers must validate sterilization processes, endotoxin removal, and storage conditions to prevent contamination and ensure product integrity. Traceability, manufacturing validation, and certification documentation are requisites for global supply.

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Supply Chain and Distribution Factors

• Contamination Control: Suppliers employ aseptic fill-finish, sterilizing filters, and rigorous microbiological testing.
• Packaging: Plastic containers are typically made of medical-grade HDPE or PP, designed to resist sterilization processes and prevent leaching.
• Transportation: Cold chain and validated sterile handling processes reduce contamination risks during transit.
• Regulatory Documentation: Certificates of Analysis (CoA), Certificates of Sterility (COS), and Good Manufacturing Practice (GMP) compliance are critical for procurement.

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Emerging Trends and Challenges

• Increased Regulatory Scrutiny: Stricter endotoxin limits and bacterial endotoxin testing elevate manufacturing costs but improve safety.
• Regional Manufacturing Expansions: Asia-Pacific nations are expanding capacity for sterile water production, reducing lead times and costs.
• Sustainability Initiatives: Focus on reducing plastic waste and employing environmentally friendly sterilization methods.
• Quality Assurance Technologies: Advanced sterilization techniques such as vapor-phase hydrogen peroxide and gamma irradiation enhance sterility assurance.

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Key Considerations for Procurement

• Ensure supplier compliance with relevant pharmacopeial standards.
• Verify sterilization validation reports and endotoxin testing results.
• Confirm container compatibility and stability.
• Evaluate supply chain robustness and contingency plans.
• Review certifications, audit histories, and quality control processes.

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Key Takeaways

• Leading pharmaceutical suppliers such as Fresenius Kabi, B. Braun, and Baxter dominate the sterile water in plastic containers market, exemplifying high-quality, GMP-compliant products.
• Regional manufacturers, notably in India and Latin America, provide cost-effective solutions without compromising standards, expanding global access.
• Regulatory compliance, product validation, and supply chain integrity remain critical for procurement decisions.
• Innovations in sterilization and packaging are improving product safety and sustainability.
• Demand for sterile water in bulk is expected to grow alongside expanding pharmaceutical and biotechnology industries, especially in emerging markets.

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FAQs

1. What distinguishes Water for Injection (WFI) from other sterile water types?
WFI is produced via rigorous distillation or reverse osmosis, and sterilized via filtration or terminal sterilization. It meets strict specifications ensuring low endotoxin levels and microbial contamination, making it suitable for injectable drugs.

2. Are all suppliers of sterile water GMP-certified?
No. While many leading multinational suppliers are GMP-certified, regional and smaller vendors may not have full GMP accreditation. Verification of certification and compliance documentation is essential.

3. How is sterile water typically shipped to maintain purity?
Shipped in sterile, sealed plastic containers, often filled in aseptic environments. Temperature control and validated sterilization methods are employed to prevent contamination during transit.

4. Can sterile water in plastic containers be stored for extended periods?
Yes, if stored under proper conditions in sterile, sealed containers, and within validated shelf-life parameters, sterile water maintains its quality. Regular inspection and microbial testing should be conducted.

5. What factors influence the pricing of bulk sterile water?
Production scale, quality standards, sterilization validation, container size, and regional manufacturing costs. Long-term supplier relationships and certifications also impact pricing stability.

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Sources

[1] United States Pharmacopeia (USP), Water for Injection Monograph.
[2] European Pharmacopoeia, Water for Injections Standards.
[3] "Global API & Excipients Market Report," PharmSource, 2022.
[4] Industry reports on pharmaceutical water suppliers, 2021-2023.
[5] Company websites and regulatory filings of Fresenius Kabi, B. Braun, Baxter.