Last updated: July 27, 2025
Introduction
Sterile Water for Injection (SWFI) is a vital excipient in pharmaceutical manufacturing, used predominantly as a solvent for drug compounds, reconstitution of vaccines, and dilution in injectable formulations. Its high purity standards, sterile environment, and container integrity are paramount to ensure patient safety and compliance with strict regulatory guidelines. The demand for SWFI in plastic containers is rising due to the convenience, reduced breakage risk, and compatibility with advanced dosing systems. This report provides a comprehensive overview of leading suppliers globally producing pharmaceutical-grade SWFI in plastic containers, analyzing their capabilities, certifications, and market positioning to assist industry stakeholders in vendor selection.
Overview of Regulatory and Quality Standards
Manufacturers of SWFI must adhere to stringent regulatory standards set by authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and pharmacopoeias like USP, Ph. Eur., and JP. These standards specify that SWFI must be:
- Sterile: Free from viable microorganisms.
- Pyrogen-free: Free from fever-inducing endotoxins.
- Particulate-free: Free from visible and sub-visible particulates.
- Pure: Free from chemical impurities.
- Container Compatibility: Safe for contact with plastics used in manufacturing and storage.
Suppliers must implement aseptic manufacturing practices under ISO 14644 cleanroom standards, coupled with validated sterilization processes, typically via terminal sterilization or aseptic filtration.
Major Suppliers of Sterile Water for Injection in Plastic Containers
1. Baxter International Inc.
Overview: Baxter is a global leader in sterile pharmaceutical solutions, offering SWFI in various container formats, including plastic bottles. They emphasize high-quality manufacturing standards aligned with cGMP (current Good Manufacturing Practices).
Product Details:
- Container Types: Polypropylene bottles, polyethylene bags.
- Volume Range: 50 mL to 5L.
- Certifications: FDA approved, ISO 9001, ISO 13485, cGMP compliance.
- Key Differentiator: Robust sterility assurance via terminal sterilization and validated aseptic processes.
Market Position: Baxter’s extensive distribution network and adherence to strict quality standards make them a preferred supplier, particularly for large-volume orders and hospital formulations.
2. Fresenius Kabi
Overview: Known for its comprehensive range of sterile infusion solutions, Fresenius Kabi supplies SWFI in plastic containers suited for both commercial and hospital-grade applications.
Product Details:
- Container Types: HDPE bottles, blow-fill-seal (BFS) containers.
- Volume Range: 100 mL to 3L.
- Certifications: GMP-certified facilities, FDA, EMA, ISO 13485.
- Innovations: Use of BFS technology to enhance safety and minimize contamination risks.
Market Position: Fresenius Kabi emphasizes innovation and quality control, positioning itself as a reliable supplier for sterile water requirements, especially in single-dose applications.
3. B. Braun Melsungen AG
Overview: A leading German healthcare company, B. Braun supplies SWFI with a focus on safety and compatibility with plastic containers.
Product Details:
- Container Types: Polypropylene, polyethylene bottles.
- Volume Range: 50 mL to 1L.
- Certifications: CE Mark, FDA registered, ISO 9001, ISO 13485.
- Special Feature: Compatibility with their infusion and drug delivery systems.
Market Position: B. Braun’s expertise in device manufacturing enhances their offerings, ensuring container-drug compatibility and stability.
4. Hospira (a Pfizer company)
Overview: Hospira is renowned for its sterile injectable solutions, including SWFI packaged in plastic containers suitable for various clinical settings.
Product Details:
- Container Types: PET bottles, blow-fill-seal containers.
- Volume Range: 50 mL to 3L.
- Certifications: FDA, ISO 13485, PIC/s compliance.
- Key Advantages: Consistent quality, global distribution, and integrated supply chain.
Market Position: Hospira’s focus on cost-effective, high-throughput supply chain solutions appeals to large hospital networks and pharmaceutical manufactures.
5. West Pharmaceutical Services
Overview: Specializing in containment and delivery systems, West offers sterilized containers and closures optimized for SWFI.
Product Details:
- Container Types: Pre-sterilized plastic bottles with integrated closures.
- Volume Range: 100 mL to 2L.
- Certifications: ISO 9001, ISO 13485, FDA-registration.
- Unique Capabilities: Advanced barrier technology for maintaining sterility over extended storage.
Market Position: Their integrated approach ensures end-to-end solutions for pharmaceutical developers requiring sterility assurance and container integrity.
6. local and regional manufacturers
Given the high standards required, numerous regional manufacturers supply SWFI in plastic containers, often tailored for local regulatory compliance and logistical considerations. Examples include:
- Yunnan Baiyao Pharmaceutical (China)
- Selva Pharma (India)
- Eurapharm (Eastern Europe)
These suppliers often compete on cost and regional distribution, although stringent quality validation is essential before engagement.
Emerging Trends and Market Dynamics
Technological Innovations
The adoption of blow-fill-seal (BFS) technology by manufacturers like Fresenius Kabi enhances sterility assurance and reduces contamination risks. BFS containers are gaining preference for their integrity and ease of sterilization.
Regulatory Impact
Stringent regulations continue to drive supplier quality standards. Suppliers investing in validated processes and comprehensive certifications gain a competitive edge.
Supply Chain Resilience
Global disruptions, such as those experienced during the COVID-19 pandemic, emphasize the importance of diversified supplier networks. Localized manufacturing capabilities are increasingly prioritized to ensure supply continuity.
Criteria for Selecting a Sterile Water Supplier
- Regulatory Certifications: Ensure compliance with regional standards (FDA, EMA, USP).
- Manufacturing Standards: ISO 13485, cGMP accredited facilities.
- Container Compatibility: Material safety, stability, and drug compatibility.
- Quality Control and Testing: Robust microbiological, endotoxin, and particulate monitoring.
- Supply Reliability: Proven track record and capacity to meet demands.
- Cost and Lead Times: Competitive pricing aligned with delivery schedules.
Key Takeaways
- Leading global suppliers include Baxter, Fresenius Kabi, B. Braun, Hospira, and West Pharmaceutical; all uphold strict quality standards.
- Technology advancements like BFS containers are shaping the market, offering enhanced sterility and safety.
- Regulatory compliance and certifications are non-negotiable selection criteria to mitigate risks.
- Regional manufacturers provide cost-effective solutions but require careful validation of quality standards.
- Supply chain resilience is critical; diversified sourcing strategies reduce dependency on single suppliers.
FAQs
1. What are the primary quality requirements for SWFI in plastic containers?
SWFI must be sterile, pyrogen-free, particulate-free, chemically pure, and compatible with plastic materials. These standards are mandated by USP, Ph. Eur., and regulatory agencies like FDA and EMA.
2. Which container materials are most commonly used for SWFI?
Polypropylene and high-density polyethylene (HDPE) are prevalent due to their inertness, chemical resistance, and compatibility with sterilization processes.
3. How do BFS containers improve the safety of SWFI?
Blow-fill-seal technology offers a sealed, single-use container process that minimizes contamination risk, enhances sterility, and simplifies logistics, making it suitable for sensitive injectable solutions.
4. Are regional suppliers reliable for sterile water production?
Regional suppliers can be reliable if they meet international quality standards, possess necessary certifications, and have validated manufacturing processes. Due diligence is essential.
5. What factors influence the choice of a supplier for SWFI?
Regulatory compliance, container compatibility, manufacturing standards, certification, supply reliability, price, and the supplier’s reputation are key decision factors.
Sources
[1] United States Pharmacopeia (USP). Water for Injections, USP, 23rd Edition.
[2] European Pharmacopoeia (Ph. Eur.). Water for Injections, Monograph 0169.
[3] ISO 14644-1:2015. Cleanrooms and Controlled Environments Standards.
[4] Baxter International. Product Portfolio and Quality Certifications.
[5] Fresenius Kabi Annual Report 2022.
[6] B. Braun Annual Review 2022.
[7] Hospira (Pfizer) Official Website.
[8] West Pharmaceutical Services. Container Technologies for Injectable Drugs.
