ISOLYTE S IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	ISOLYTE S IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	019711	NDA	B. Braun Medical Inc.	0264-7703-00	12 CONTAINER in 1 CASE (0264-7703-00) / 1000 mL in 1 CONTAINER	1989-09-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The demand for injectable solutions like ISOLYTE S in plastic containers has surged within the global pharmaceutical landscape. This sterile, isotonic, electrolyte-balanced solution is primarily used for fluid replenishment and electrolyte management in clinical settings. Ensuring reliable sources of ISOLYTE S in suitable packaging is vital for healthcare providers, pharmaceutical manufacturers, and distributors aiming to maintain quality standards and supply chain efficiency.

Understanding ISOLYTE S and Its Packaging Requirements

ISOLYTE S, developed by Baxter International Inc., is an isotonic solution containing sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium acetate, sodium gluconate, and sodium lactate in water for injection, used for hydration and electrolyte correction. Its packaging in plastic containers, specifically polyethylene or polypropylene, offers advantages such as reduced weight, increased durability, and ease of handling over traditional glass containers.

The choice of plastic containers aligns with industry trends favoring flexible, sturdy, and patient-safe packaging. Regulatory agencies, including the U.S. Food and Drug Administration (FDA), emphasize the importance of quality control and material compatibility with pharmaceutical formulations, making reputable plastic container suppliers critical.

Key Attributes Sought in Suppliers

Regulatory Compliance: Suppliers must adhere strictly to pharmaceutical cGMP (current Good Manufacturing Practices) and possess necessary certifications (e.g., FDA, EMA, ISO 9001).
Material Quality: High-quality, medical-grade plastics such as polyethylene (PE) or polypropylene (PP) that ensure chemical inertness, barrier properties, and physical stability.
Manufacturing Capacity: Ability to supply large quantities consistently, with scalability for increased demand.
Compatibility and Seal Integrity: Containers that prevent leaching, contamination, and preserve sterility.
Supply Chain Reliability: Proven track record of timely deliveries, logistical support, and risk mitigation.

Major Suppliers of Plastic Containers for Pharmaceutical Use

1. Terumo Corporation

Overview: A global leader in medical devices and containers, Terumo supplies a broad range of pharmaceutical-grade plastic containers designed for injectable drugs, including ISOLYTE S. Their products include infusions bags, pre-filled syringes, and specialty containers made from high-grade plastics.

Capabilities:

Large-scale manufacturing compliant with international standards.
Customization options for size and closure types.
Extensive distribution network across North America, Europe, and Asia.

2. Baxter International Inc.

Overview: As the manufacturer of ISOLYTE S, Baxter supplies its own pre-filled plastic containers, including intravenous (IV) bags and bottles produced in compliance with stringent pharmaceutical standards.

Capabilities:

Vertically integrated manufacturing.
Use of medical-grade plastics with proven compatibility.
Facilities certified under ISO 13485.

3. Gerresheimer AG

Overview: A leading global supplier specializing in pharmaceutical and healthcare packaging solutions, Gerresheimer offers a variety of plastic containers, including bottles and cartridges suited for injectable solutions.

Capabilities:

Focus on innovation, with solutions such as blow-molded and injection-molded containers.
Quality management systems adhering to pharmaceutical standards.
Customer-specific customization and development.

4. West Pharmaceutical Services

Overview: A pioneer in drug containment systems, West provides complex plastic container systems including vials, bottles, and prefilled syringes that meet pharmaceutical safety requirements.

Capabilities:

Focused on sustainability and material safety.
Supply chain resilience with global manufacturing sites.
Emphasis on innovation to improve drug delivery efficacy.

5. Ndustrial Food Packages and Plastic Container Suppliers

While primarily catering to food industries, certain suppliers in this domain transition into pharmaceutical-grade manufacturing, notably offering high-density polyethylene (HDPE) bottles suitable for sterile solutions. Companies like Amcor and Berry Global also provide specialized containers for healthcare applications.

Emerging and Niche Suppliers

Growing regulatory scrutiny and technological advancements open opportunities for smaller or regional suppliers specializing in bespoke solutions:

Kuraray Co., Ltd. offers advanced polymers that can be molded into sterile, inert containers.
Sri Trang Gloves (regional supplier in Southeast Asia) expanding into prefilled plastic container offerings.
Local Chinese manufacturers with GMP certification are increasingly providing competitively priced containers with compliant specifications, though due diligence on quality is essential.

Regulatory Considerations and Qualification

Suppliers must meet the rigorous standards mandated by authorities like the FDA or EMA, including:

Certificate of Analysis (CoA): Detailing material purity and safety.
Sterility Assurance Level (SAL): Confirming container integrity and maintenance of sterility.
Extractables and Leachables Testing: Ensuring container materials do not compromise drug stability or safety.
Validation Documentation: For compatibility, durability, and container closure integrity.

Due diligence in supplier qualification is critical. Companies often conduct onsite audits or rely on third-party assessments to verify compliance.

Market Trends and Future Outlook

The pharmaceutical industry is increasingly adopting single-use, pre-sterilized plastic containers to streamline sterile processing, reduce contamination risk, and enhance supply chain agility. Innovations such as tamper-evident seals, lightweight designs, and materials with enhanced barrier properties are influencing supplier offerings.

Furthermore, biosimilar and monoclonal antibody therapies demand containers with superior chemical inertness, pushing suppliers to innovate materials and manufacturing processes. The trend toward regionalization to reduce supply chain vulnerabilities also encourages healthcare organizations to source containers locally but from brands compliant with international standards.

Conclusion

Securing reliable suppliers for ISOLYTE S in plastic containers demands a thorough understanding of product specifications, regulatory quality standards, and supply chain dynamics. Leading industry players like Terumo, Baxter, Gerresheimer, and West Pharma provide tested, compliant solutions that meet rigorous pharmaceutical needs. Emerging regional manufacturers may offer cost advantages, but thorough qualification is necessary.

As the market evolves, pharma companies should prioritize suppliers with proven quality assurance, flexibility for customization, and strong logistical support to ensure uninterrupted supply chains.

Key Takeaways

Prioritize compliance: Select suppliers with ISO 13485, cGMP certifications, and proven regulatory track records.
Verify material compatibility: Opt for containers made from high-quality, inert plastics such as medical-grade PE or PP.
Assess supply chain strength: Ensure suppliers have robust logistics, contingency plans, and capacity to meet increasing demand.
Consider innovation: Look for containers with advanced features like tamper-evidence, better barrier properties, and enhanced seal integrity.
Conduct thorough qualification: Perform audits, review certifications, and validate supplier quality before establishing long-term relationships.

Frequently Asked Questions

1. Are there regional suppliers for ISOLYTE S plastic containers?
Yes. Several regional suppliers, particularly in Asia and Europe, provide pharmaceutical-grade plastic containers compatible with ISOLYTE S, often at competitive prices. However, thorough qualification and certification reviews are essential.

2. What qualities should I look for in a supplier of plastic containers for injectable solutions?
Look for certifications such as ISO 13485, FDA or EMA approval, compliance with cGMP, proven material inertness, seal integrity, and reliable logistics.

3. Can plastic containers impact the stability of ISOLYTE S?
Properly manufactured, medical-grade plastic containers do not adversely affect ISOLYTE S. Material selection and testing for extractables and leachables are critical to ensure drug stability and safety.

4. How does the choice of plastic container influence supply chain efficiency?
Plastic containers are lightweight, durable, and less fragile than glass, increasing ease of transportation and reducing breakage during handling, which enhances supply chain resilience.

5. What innovations are shaping the future of plastic containers for sterile solutions?
Advances include barrier-enhanced plastics, tamper-evident closures, pre-sterilized ready-to-use formats, and environmentally sustainable materials, catering to improving safety and efficiency.

References

Baxter International Inc. — ISOLYTE S Product Information.
Gerresheimer AG — Pharmaceutical Packaging Solutions.
West Pharmaceutical Services — Container Closure Systems for Parenteral Drugs.
U.S. FDA — Regulatory Guidelines for Container Materials.
Market Reports — Pharmaceutical Plastic Container Market Trends and Forecasts.

Suppliers and packagers for ISOLYTE S IN PLASTIC CONTAINER