Choosing the right Contract Development and Manufacturing Organization (CDMO) for sterile liquid production is a crucial decision. You need speed, scalability, and unwavering compliance to bring your products to market efficiently and safely. That’s exactly what Halden Pharma, operating as a partnership with the Prange Group, the owner and a significant shareholder in the Adragos group delivers.
When you need sterile liquid products, time is everything. Delays in processes can mean lost revenue and missed opportunities. That’s why Halden Pharma is built for speed, using cutting-edge Blow-Fill-Seal (BFS) technology to streamline aseptic filling, reducing contamination risks and increasing efficiency.
Halden Pharma Advantages in Sterile Liquid
Blow Fill Seal Technology (BFS): Ensures seamless, high-speed fill and packaging, cutting production times significantly. Maintaining a clean production environment is crucial to ensure high-speed and contamination-free production.
Full-Service CDMO: From formulation to order fulfillment, our services eliminate bottlenecks and keep projects on track. Optimized Manufacturing Lines: Designed to deliver high volumes with precision, giving you faster access to market.
Whether you require small test batches or high-volume commercial production, Halden Pharma provides the flexibility to scale as your business grows. We accommodate a range of batch sizes and products, giving you the control you need over your production pipeline.
Our Production Capabilities and Processes for Sterile Liquid
Whether you require small test batches or high-volume commercial production, Halden Pharma provides the flexibility to scale as your business grows. We accommodate a range of batch sizes and products, giving you the control you need over your production pipeline.
- IV Bags: Up to 15,000 liters per batch, with volumes from 50 ml to 1,000 ml.
- Small Volume Parenterals (SVP): Batch sizes up to 5,000 liters.
- Blow Fill Seal Ampoules: From 5 ml to 30 ml, ensuring a wide range of applications.
With this kind of capacity, you’re never restricted by limitations, you scale production as needed without compromising quality.
Advanced Technologies and Capacities at Halden Pharma
At Halden Pharma, our state-of-the-art facility is equipped with cutting-edge technologies designed to support the production of high-quality sterile liquids. We understand that each customer has unique needs, which is why we offer a range of capacities to accommodate both small-scale and large-scale production requirements.
Our aseptic filling lines are meticulously designed to ensure the highest level of safety and quality, with a strong focus on minimizing contamination risks. Whether you need sterile liquids in vials, ampoules, or IV bags, our expertise ensures that we can meet your specific needs with precision and reliability.
Cleaning and cleaning validation processes are critical to maintaining the quality of our products. We have a dedicated team that oversees these processes, ensuring that every batch meets stringent quality standards. Our comprehensive range of services includes fill and finish, labeling, and packaging, providing a one-stop solution for all your sterile liquid manufacturing needs.
The Halden Pharma facility is versatile, capable of handling a wide range of products from small molecules to complex biologics. This flexibility allows us to manage even the most challenging formulations with ease. We prioritize customer safety and have implemented robust quality control measures to ensure the highest level of quality in our products.
Efficient stock management is another key aspect of our operations. Our system ensures that we can meet the needs of our customers quickly and efficiently, minimizing lead times and ensuring timely delivery. From development to commercialization, we offer a range of solutions to support your needs, backed by our extensive expertise in handling complex projects.
By choosing Halden Pharma, you gain access to a partner committed to delivering high-quality sterile liquids with unmatched reliability and efficiency.
The Multiple Regulatory Certifications at Halden Pharma
The Halden facility is trusted by clients globally and holds multiple regulatory certifications, including EU-GMP, US-FDA, Brazil-ANVISA, Japan-PMDA, China-NMPA, and Turkey-MOH, further emphasizing its commitment to excellence. Halden Pharma meets the highest international standards, ensuring your sterile liquid products are consistently manufactured to the most stringent quality and safety requirements.
Download our brochure to explore how we can support your needs with cutting-edge BFS technology and world-class IV bag manufacturing.
Why Choose Halden for Aseptic Filling and Sterile Liquid Manufacturing?
At Halden Pharma, we don’t just manufacture Sterile Liquid products we help you win in the market. Our commitment to delivering exceptional value ensures that you receive high-quality sterile solutions at competitive prices. Our commitment to speed, scale, and compliance makes us the CDMO of choice for pharmaceutical companies looking to deliver high-quality sterile solutions efficiently.
Frequently Asked Questions about Aseptic Filling (FAQs)
What is a sterile liquid?
A sterile liquid is a fluid that has undergone rigorous cleaning and sterilization to eliminate bacteria, viruses, and other contaminants, ensuring safety for medical use.
What liquids are sterile?
Sterile liquids include IV solutions, ophthalmic medications, and injectable drugs, all of which require strict sterile manufacturing to maintain purity.
How is a liquid made sterile?
Sterilization is achieved through aseptic filling techniques like BlowFillSeal (BFS), filtration, or high-temperature autoclaving, ensuring complete microbial elimination.
What is a sterile solution used for? Sterile solutions are used in critical medical applications, including intravenous therapy, wound care, and ophthalmology, where contamination could lead to severe complications..
