When it comes to sterile liquid manufacturing, choosing the right Contract Development and Manufacturing Organization (CDMO) is critical to ensuring product safety, regulatory compliance, and efficient market delivery. Halden Pharma stands as a leading partner for the manufacturing of IV Bags, offering unmatched capacity, regulatory strength, and technical excellence.
Specializing in IV Bags Manufacturing
Halden Pharma is one of Northern Europe’s most advanced sterile liquid manufacturing facilities, with a strong focus on IV bag production. Our facility is purpose-built to handle complex sterile liquid projects, supported by one fully automated IV bag production line.
With capabilities to manage batch sizes up to 15,000 liters and volumes ranging from 50 mL to 1,000 mL, Halden is equipped to meet both high-volume demands and diverse product specifications. Whether you’re launching a new parenteral therapy or scaling up production for established treatments, Halden offers the flexibility and efficiency your project needs.
A Full-Service CDMO for Sterile Liquid Manufacturing
At Halden Pharma, we deliver end-to-end sterile liquid solutions, from formulation development to final packaging and global distribution. Our integrated approach eliminates handoffs and accelerates timelines, keeping your product moving through the development and supply chain without unnecessary delays.
Our services include:
- Terminal sterilization for IV bag products
- Fill and finish for large- and small-volume parenterals
- Labeling, packaging, and regulatory support
- Comprehensive project management from concept to market
Our team of experts ensures that every batch meets stringent sterility, safety, and consistency standards, so your sterile liquid product is always ready for global markets.
Unmatched Regulatory Compliance in Sterile Liquid Manufacturing
Halden Pharma’s sterile liquid facility holds a comprehensive range of international regulatory certifications, demonstrating our dedication to global compliance and quality assurance. Our certifications include:
- EU – GMP
- US – FDA
- Brazil – ANVISA
- Japan – PMDA
- China – NMPA
- Turkey – MOH
- Australia – ARGPM
- Taiwan – TFDA
- UAE
These approvals allow us to manufacture and distribute sterile liquids to all major pharmaceutical markets worldwide. Our ongoing compliance with these agencies ensures that your products meet the most rigorous international safety and quality requirements.
Why Halden Pharma Is the CDMO of Choice for Sterile Liquid Production
Choosing Halden Pharma means choosing a CDMO that understands the critical importance of sterility, speed, and scalability. Our specialized infrastructure, automated systems, and global certifications make us a trusted partner for pharmaceutical companies seeking reliable, high-quality production of sterile liquid.
Frequently Asked Questions about Aseptic Filling (FAQs)
What is sterile liquid manufacturing in the pharmaceutical industry?
Sterile liquid manufacturing involves producing liquid pharmaceutical products in a contamination-free environment to ensure they are free from viable microorganisms. This process is essential for injectable products such as IV solutions, where sterility is critical for patient safety.
Why is sterility important in liquid pharmaceutical products?
Sterility ensures that the product does not introduce harmful bacteria, viruses, or other pathogens into the patient’s body. For injectable treatments, even minimal contamination can lead to serious infections or health complications, which is why sterile liquid manufacturing follows strict quality and regulatory protocols.
How does Halden Pharma maintain compliance with global regulatory standards?
Halden Pharma’s facility is certified by a wide range of health authorities, including the EU-GMP, US-FDA, Brazil-ANVISA, Japan-PMDA, China-NMPA, Turkey-MOH, Australia-ARGPM, Taiwan-TFDA, and the UAE. Ongoing audits, quality system updates, and strict process validation ensure full compliance.
