Last updated: August 1, 2025
Introduction
PRISMASOL B22GK 4/0 in a plastic container is a hypertonic solution used primarily in clinical settings for fluid resuscitation, electrolyte management, and as a plasma volume expander. Its specialized formulation requires adherence to strict quality, safety, and regulatory standards. Identifying reliable suppliers is essential for healthcare providers, pharmacies, and distributors to ensure consistent product availability, compliance, and patient safety.
This comprehensive overview examines the key manufacturers and suppliers of PRISMASOL B22GK 4/0 in plastic containers, emphasizing their global reach, regulatory compliance, and distribution channels.
Product Overview: PRISMASOL B22GK 4/0
PRISMASOL B22GK 4/0 is a sterile, isotonic, or hypertonic saline solution, often containing specific electrolytes tailored to clinical needs [1]. It is supplied in pre-filled plastic containers, typically designed to facilitate safe infusion and minimize contamination risks. Parameters such as osmolarity, electrolyte composition, and container material are optimized to suit critical care applications.
The designation "4/0" generally refers to the concentration or specific formulation variant, which should be verified per product datasheet and regulatory documentation.
Leading Suppliers and Manufacturers
1. Fresenius Kabi
Fresenius Kabi ranks among the global leaders in infusion and hospital products, offering an extensive portfolio of intravenous solutions, including PRISMASOL formulations. Their manufacturing facilities adhere to ISO standards, and their products comply with stringent regulatory requirements from agencies such as the FDA, EMA, and WHO.
- Product line: PRISMASOL B22GK 4/0 in plastic containers
- Global reach: Europe, North America, Asia-Pacific
- Distribution channels: Hospitals, clinics, authorized distributors
- Certifications: ISO 13485, GMP compliance
Notes: Fresenius Kabi's reputation for high-quality sterile infusion solutions makes them a primary candidate for supplying PRISMASOL B22GK 4/0 bottles.
2. B. Braun Melsungen AG
B. Braun is a prominent German-based pharmaceutical and medical device manufacturer specializing in infusion solutions, including a variety of plasma expanders and electrolyte solutions.
- Product line: B. Braun's saline and electrolyte solutions in plastic containers
- Regulatory status: Compliant with global standards, including US FDA and EU directives
- Supply networks: Extensive, with authorized distributors across North America, Europe, and Asia
Notes: B. Braun's robust manufacturing and distribution infrastructure support widespread availability of similar solutions, making them a key supplier source.
3. Baxter International
Baxter specializes in infusion therapy and renal products, providing a range of sterile solutions suitable for critical care settings.
- Relevant products: Intravenous saline and electrolyte solutions in plastic containers
- Regulatory adherence: FDA approved, CE marked, and compliant with WHO guidelines
- Distribution scope: Americas, Europe, Asia, Africa
Notes: Baxter's global presence and commitment to supply chain resilience make them a reliable source for PRISMASOL B22GK 4/0 supplies.
4. Braun Melsungen AG (Other formulations)
Other formulations and variants of PRISMASOL are available through Braun's extensive portfolio, often tailored for specific clinical needs, including electrolyte balances.
5. Local and Regional Suppliers
Depending on the geographic region, several local manufacturers and authorized distributors offer PRISMASOL B22GK 4/0. These suppliers often hold regional approvals and certifications, facilitating faster procurement.
- Examples: In India, companies like Indovax or Livemax may facilitate access to imported or locally produced solutions meeting international standards.
- Regulatory considerations: Ensure local suppliers conform to national drug regulatory authorities' directives, such as the Drug Controller General of India (DCGI).
Considerations When Selecting Suppliers
Regulatory Compliance
Ensure that suppliers comply with the respective national and international regulatory standards, including ISO certifications, US FDA approval, European CE marking, and WHO Good Manufacturing Practices (GMP).
Supply Chain Reliability
Assess suppliers' manufacturing capacity, inventory management, and logistical capabilities to ensure consistent product supply, especially during global disruptions such as pandemics.
Product Authenticity and Traceability
Verify product authenticity through batch numbers, certificates of analysis, and serial codes to prevent counterfeit or substandard products.
Pricing and Contract Terms
Negotiate competitive pricing, volume discounts, and flexible contractual arrangements to optimize procurement costs without compromising standards.
Regulatory and Quality Assurance in Supplier Selection
Adherence to strict regulatory standards is critical. Suppliers should provide comprehensive documentation, including:
- Certificates of Analysis (CoA)
- Good Manufacturing Practice (GMP) compliance
- Batch-specific stability data
- Shelf-life and storage conditions
Healthcare providers must verify product registration status within their respective jurisdictions and ensure import licenses are obtained for international procurement.
Emerging Sources and Trends
Biotech and Innovative Manufacturers
Emerging biotech firms are developing advanced infusion solutions, potentially offering variations of PRISMASOL B22GK 4/0 with improved stability or enhanced safety profiles. However, their products must undergo rigorous regulatory review before widespread adoption.
Supply Chain Digitization
Automation and digital tracking systems enhance transparency, traceability, and real-time inventory management, reducing risks associated with supply shortages and counterfeit products.
Conclusion
Securing a reliable supplier for PRISMASOL B22GK 4/0 in plastic containers involves diligent evaluation of global manufacturers and regional distributors. Leading companies such as Fresenius Kabi, B. Braun, and Baxter demonstrate strong compliance with international standards and maintain extensive distribution networks. Regional suppliers may cater to local needs but require thorough validation of compliance and authenticity.
For healthcare providers, establishing relationships with certified suppliers offering transparent documentation and consistent supply ensures patient safety and operational efficiency.
Key Takeaways
- Prioritize regulatory compliance: Ensure suppliers meet international standards (FDA, EMA, ISO, GMP) to guarantee product safety and efficacy.
- Assess supply chain robustness: Reliable manufacturers with extensive logistics capabilities mitigate risks of shortages.
- Verify authenticity: Confirm product documentation, batch traceability, and licensing to prevent counterfeit risks.
- Leverage global and regional sources: Balance between major international suppliers and regional distributors based on urgency, cost, and regulatory approval.
- Stay informed on regulatory changes and emerging suppliers: Continuous monitoring optimizes procurement strategies and product availability.
FAQs
Q1: What are the primary regulatory requirements for suppliers of PRISMASOL B22GK 4/0 in plastic containers?
A1: Suppliers should comply with GMP (Good Manufacturing Practice), possess necessary certifications like ISO 13485, FDA approval (if applicable), CE marking (for Europe), and demonstrate adherence to regional regulatory standards.
Q2: Can I procure PRISMASOL B22GK 4/0 directly from manufacturers like Fresenius Kabi or Baxter?
A2: Direct procurement is generally limited to authorized distributors or regional subsidiaries due to regulatory restrictions. It's recommended to purchase through certified supply channels or authorized distributors.
Q3: How can healthcare providers verify the authenticity of PRISMASOL B22GK 4/0 in plastic containers?
A3: Verify batch numbers, certificates of analysis, serialization, and manufacturer documentation. Confirm that the supply chain documentation aligns with regional regulatory standards.
Q4: Are regional manufacturers a viable alternative to global suppliers for PRISMASOL B22GK 4/0?
A4: Yes, provided they meet international quality standards and possess appropriate certifications. Regional suppliers can offer faster delivery and lower logistic costs, but due diligence on compliance is essential.
Q5: What trends are influencing the supply chain for infusion solutions like PRISMASOL B22GK?
A5: Trends include increased digitization for traceability, enhancements in manufacturing processes, emergence of biotech solutions, and efforts to improve supply chain resilience amid global disruptions.
References
[1] Medical Device and Pharmaceutical datasheet on PRISMASOL solutions, Fresenius Kabi Documentation.
