Disposable systems represent the future of biopharmaceutical therapeutic drug processing, offering significant advantages over traditional reusable stainless steel and partially disposable systems.

Although disposable systems might appear contrary to the global trend of reducing waste, they enhance sustainability by eliminating the need for chemicals and resources required to sterilize reusable systems.

Moreover, disposable systems are cost-effective, have shorter processing times, and virtually eliminate the risk of cross-contamination by discarding and replacing product runners after each batch.

By 2024, the global market for disposable technology is projected to exceed $10 billion. Among the most significant growth areas are highly adaptable disposable mixing systems, which are extensively used in various stages of biopharmaceutical production and testing.

What Are Single-Use Systems?

Disposable systems involve various polymer components such as membrane filters, bags, connectors, and tubing. The complexity of these systems ranges from simple transfer systems to intricate single-use filling lines.

Users face challenges including regulatory issues like microbial retention, sterility, endotoxins, and biosafety. Additionally, there are functional concerns such as flow rates, burst strength, temperature, and pressure resistance.

A critical issue is the presence of “extractables and leachables,” as they can affect product purity. Since single-use systems contain a variety of materials and components, the percentage of substances released into the product is crucial.

Users should specify acceptable levels to maintain product purity. Therefore, detailed data on extractables and leachables is essential for ensuring the integrity of single-use systems.

Manufacturing process systems

In the biopharmaceutical industry, three types of processing systems are used to produce therapeutic drugs. The first type involves stainless steel systems.

These systems are reusable, durable, and able to withstand exposure to the chemicals (usually at extreme temperatures) used to sterilize pharmaceutical processing systems.

This requires rigorous sterilization regimes, which may involve harsh chemicals and steam, resulting in considerable energy consumption to bring the system to the extreme temperatures required for effective sterilization.

Biopharmaceutical companies utilize disposable systems and large bioreactor bags to produce vaccines

The second type of system is the partially disposable system. Depending on the therapeutic drug being produced, these systems use certain components of the processing system multiple times.

Reused components are subjected to similar cleaning and sterilization processes as stainless steel systems and require maintenance because reusable components deteriorate over time.

Even with proven cleaning and sterilization procedures, there is an inherent risk of contamination of reusable components in both stainless steel and disposable systems.

Disposable systems are the third type of biopharmaceutical handling system designed to be used in the production process of a single batch of a therapeutic drug that is then discarded.

The growing use of disposable technology has proven to reduce the risk of product cross-contamination by eliminating the need for batch-to-batch cleaning.

Manufactured in cleanrooms, double-packed, and then sterilized by gamma, ethylene oxide, or X-ray sterilization methods, these systems ensure that each batch has a sterile system that is efficient and cost-effective.

In the biopharmaceutical industry, disposable technology refers to single-use products typically made from various types of plastics, including:

• Polyamide: a synthetic material similar to nylon
• Polycarbonate: a thermoplastic polymer formed from carbonate groups
• Polyethylene: commonly used for transparent films and bags
• Polyethersulfone: a heat-resistant plastic
• Polypropylene: a versatile thermoplastic used for both disposable and reusable applications
• Polytetrafluoroethylene (PTFE): a synthetic compound of fluorinated polymers with multiple uses
• Polyvinyl chloride (PVC): known for its heat and moisture resistance, often used in white color
• Cellulose acetate: a rigid plastic derived from cellulose acetate esters
• Ethylene-vinyl acetate (EVA): a copolymer of vinyl acetate and ethylene

Disposable filtration systems, including bags and filters, are now integral to the pharmaceutical industry beyond laboratory settings.

They are expanding into previously untapped areas like virus capture for gene therapy and vaccines, responding to the increasing diversity and demand for versatile and flexible solutions in therapy, treatment, and drug combinations.

A decade ago, bulk production of compounds was standard, whereas personalized therapies are now becoming increasingly viable.

Compared to traditional therapies, personalized treatments often involve smaller production volumes, necessitating flexible systems capable of handling both large and small drug quantities.

Successfully implementing single-use systems involves several key steps to ensure seamless integration and maximize the benefits. These steps encompass careful planning, selection of appropriate components, and thorough validation processes.

• Needs Assessment: Evaluate production requirements to determine the suitability of single-use systems.
• Supplier Selection: Choose reliable suppliers of single-use systems to ensure product quality and technical support.
• System Design: Design the single-use system according to specific production needs, including component selection and process layout.
• Installation and Validation: Install the system and conduct validation to ensure stable operation.
• Training and Operation: Train operators to ensure proper use of single-use systems.
• Monitoring and Maintenance: Continuously monitor and maintain the system to ensure long-term stability and efficiency.

Conclusion

Sanitek Filter offers a range of MDI-designed and manufactured gamma-irradiated single-use systems (SUS) tailored for critical applications across the biopharmaceutical and pharmaceutical sectors.

These products span from simple storage and transfer systems for media, buffers, and drug substances, to sampling manifolds for bioreactors and process intermediate vessels, and complex single-use filling lines with dedicated tubing connections for integrity testing and collection of humidification fluids.

Our disposable systems are custom-designed in close collaboration with users to enhance regulatory compliance and process efficiency to the fullest extent.

All major components used in these SUS are internally manufactured, thoroughly characterized, and validated for integrity, microbial retention/intrusion, sterility, endotoxin levels, biocompatibility, and extractability. The adoption of single-use systems in biopharmaceutical manufacturing represents a significant evolution in production methodologies.

Our capsule filters, as a critical component of single-use systems, provide exceptional performance and environmental benefits, making them indispensable in modern biopharmaceutical production.

Whether you require detailed information about our filtration products, need technical support for implementation, or wish to explore customized filtration solutions, our expert team is here to assist you.