As the biopharmaceutical industry grows, single-use technology is becoming increasingly important. From smaller batch sizes used in preclinical and clinical testing to facilities producing multiple products, the need for flexible and adaptable manufacturing solutions has never been greater. Single-use components are crucial, offering increased efficiency, reduced risk of contamination, and lower capital costs.
To ensure a high level of quality control, manufacturers must closely monitor processes. However, this can be resource-intensive and time-consuming. Single-use technology helps manufacturers overcome this challenge by significantly reducing or eliminating the need for sterilization between batches, allowing quicker turnaround times and increasing overall efficiency and productivity.
Single-use technologies require less capital investment compared to traditional stainless-steel systems. The latter involves significant infrastructure and equipment expenses to set up, operate, and maintain. In contrast, single-use systems offer a more flexible, modular, and scalable approach that can be customized according to specific needs. This reduces the overall cost of setting up and running the manufacturing process.
Disposable Processing Systems for Biopharma
Disposable or single-use solutions have become indispensable to bioprocessing, revolutionizing how sterile liquids flow.
- Single-Use Liquid Bags
Fluid storage and transfer bags handle sterile liquids in the biotherapeutics and cell and gene therapy markets. They’re highly configurable with various sizes, ports, and components to safely store and transfer buffers, media, and bulk cGMP products.
- Single-Use Fluid Transfer Assemblies
Fluid transfer assemblies (FTAs) typically consist of pre-sterilized tubing, connectors, filters, and other components. They’re easy to use and integrate into manufacturing processes.
- Single-Use Bioreactors
Disposable bioreactors are designed with throwaway bags instead of culture vessels. They can be used immediately in cell separation processes without extensive cleaning.
Connecting the Dots with Silicone Tubing
Tubing is an essential component of single-use liquid bags and fluid transfer assemblies as it facilitates the transfer of sterile fluids between different processing steps. The tubing is connected to various ports using sterile connectors, which help maintain system integrity and seamless transfers.
Due to its inert nature, hydrophobicity, and biocompatibility, silicone is leveraged in aseptic applications. Silicone tubing can be manufactured through peroxide or platinum curing, with platinum-cured silicone tubing being the top choice in biopharmaceutical, pharmaceutical, and food and beverage industries for its high purity and superior physical properties.
Platinum-cured silicone tubing offers exceptional purity, clarity, and minimal leaching of byproducts. Platinum catalysts modify the crosslink density of the silicone polymer, resulting in improved physical properties, including ultra-smooth surfaces that minimize the growth and presence of bacteria.
Completing Your Single-Use GMP Solution
Without the ingredients, components, and elements supporting product development, single-use technologies would be useless. cGMP raw materials are manufactured, processed, packed, or held per the current Good Manufacturing Practices (cGMP) regulations, which ensure that raw materials are of consistent quality and purity. cGMP raw materials are also subject to regular testing and inspection to ensure they meet specifications and are free from contaminants. Raw materials might include:
- Buffer and cell culture media
- Pharmaceutical excipients
- Custom solution preparations
- Other salts, bases, carbohydrates, etc.
Dry repacking transfers dry or granular raw materials from original packaging to a new, airtight container to protect them from moisture, light, and other factors compromising quality. This method is often conducted under strict cGMP guidelines designed to reduce the risk of cross-contamination, poor facility maintenance, and human operator error—overall improving material handling, inventory control, and accuracy in measuring materials. Packaging might include:
- Glass bottles
- Plastic drums HDPE
- Stainless steel drums
- Single-use bioprocess bags
Water for Injection (WFI) Quality Water is used to prepare cell culture and buffers, reconstitute dry reagents, manufacture high-purity aqueous reagents, and rinse critical equipment. WFI is purified using various methods such as distillation, reverse osmosis, and ultrafiltration to remove contaminants, impurities, or microorganisms. It’s also tested to meet the USP, EP, and JP standards.
Total Repack Solution
ILC Dover specializes in crafting robust biopharmaceutical manufacturing solutions for equally robust applications in which product integrity is paramount. We’re a trusted market leader and full-service provider of single-use technologies and platinum-cured silicon tubing, driving new efficiencies in material delivery and handling.
ILC Dover delivers more than just disposable processing systems for biopharma. We source materials, consolidate supplier and order management, maintain a stocked inventory, and customize stocking agreements for specific requirements. We streamline quality assurance via cGMP compliance, quality control inspections, and comprehensive documentation. Lastly, we securely and efficiently integrate materials into packaging solutions tailored to batch-specific container sizes and unique application requirements.
Ultimately, ILC Dover provides everything biomanufacturers need to excel, from downstream and upstream processing to fill/finish activities—decreasing total costs and increasing product integrity.
Contact ILC Dover to learn more about our integrated suite of single-use technologies, packaging solutions, and component materials.