Jeff Craig, Global Director of Business Development & Marketing, ATMI LifeSciences talks about the importance of continuous improvement and innovation for single-use storage systems and bioprocess vessels which are the building block of all other SUTs. ATMI is one of the leading SUT companies, innovators of single-use mixing and bioreactor technologies and an exhibitor at INTERPHEX.
The evolution of single-use technologies (SUT) has been highly visible in the biopharmaceutical industry in the last 10 years. The drivers of the fast evolving SUT industry include the operational, technical and economic advantages they provide, and a tremendous innovation has occurred in recent years. Across the industry, specific attention must be paid to manufacturing efficiency and quality, standardization and continuous improvement of these products. These needs are especially critical as the market further embraces the concept of sustainable technologies.
From a historical perspective, single-use storage bags began quietly making inroads to an entrenched stainless steel landscape more than 15 years ago. Beginning in about 2003, these inroads were aggressively followed by more sophisticated single-use technologies including mixers, bioreactors, connecting technologies and sensors. These enhanced technologies provide flexibility, speed, simplified validation processes, cost and time savings, and eliminate the need for cleaning systems. In fact, these SUTs have impacted the essence of bioprocessing in general and the industry is aggressively adopting these technologies as they become more commercially available.
Single-use storage technologies (Bioprocess vessels)
Applications for single-use storage and shipping bags vary based on the needs of end-users but, more often than not, they are used for collecting, feeding, storing or shipping the liquids and powders used in the production of biopharmaceuticals and vaccines. Based on the fact that these “bags” will either be used for transportation to an end user or used on-site for storage or processing of materials and intermediates, a major consideration for single-use bioprocess vessels is degree and consistency of quality. It is key for SUT manufacturers to take a comprehensive look at how to avoid contamination before, during and after use. At ATMI these factors are managed through upgraded and optimized manufacturing processes and a stringent focus on quality, integrity and supply chain security.
Quality has taken center stage in the industry, as concerns over contamination have been highlighted in the news lately. Consumers are becoming aware of these issues and the wave of news has resulted in an overwhelming trend in the industry towards re-evaluating how pharmaceutical ingredients are handled and the standards bioprocessing manufacturers employ. The most notable parameters impacting SUTs for fluids include film composition, bag integrity, particle control and sterility. For powder transfer vessels overall vessel soundness, materials composition, antistatic properties and shelf life are of equal importance. It is critical in all liquid and powders processed or stored in SUTs maintain their potency and purity.
ATMI: Industry innovator Single-use storage bags were already making their inroads when ATMI entered the SUT industry. As a company, ATMI became fully entrenched in the market through the invention, development and industrialization of single-use mixers, bioreactors and packaging technologies. ATMI’s strategy was to add value to single-use vessels by evolving them into processing technologies, such as mixers and bioreactors. ATMI also wanted to evolve films, vessels and manufacturing processes in order to offer higher levels of cleanliness, particle control, and uniformity, as well as exceptional integrity. These objectives were met by developing the industry’s most widely used single-use mixing technologies, multiple innovative bioreactor platforms and ultra-clean packaging solutions. The logical next step for ATMI became integrating its proprietary “One Film” film (TK8) and integrity testing technologies to develop and launch a “best of breed” line if IntegrtityTM Bioprocess Vessels (BPV). These storage bags round out ATMI’s Integrity platform of single-use technologies and represent the evolution of storage bags.
This proprietary TK8 film is produced in-house from resin to film. The layers of the TK8 film are made from medical grade materials in ATMI’s ISO Class 5. The film is constructed from laminated layers of PA (polyamide), EVOH (ethylene vinyl alcohol polymer) and ULDPE (ultralow density polyethylene). The outer PA layer provides puncture resistance, strength and thermal stability. The EVOH layer minimizes gas diffusion and maintains very good flex crack resistance. The ULDPE layer, which is blow-extruded in-house under cleanroom conditions (0.2µm filtered air), provides flexibility and an ultra-clean, ultra-pure, low-extractables product contacting layer. Lamination is also performed under ultra-clean conditions. The layers work together to provide a film that has excellent optical clarity, is easy to handle and has multiple applications.
ATMI has focused on process efficiency and quality in the manufacturing of their Integrity BPVs. These products are made in Class V laminar flow rooms to control particles and subjected to 100% integrity testing before the products go to market. ATMI also incorporates optimally engineered fittings employs manufacturing processes that offer the fastest delivery of standard and made-to-order (MTO) BPVs. Supply chain security is assured by manufacturing sites in both the United States and Belgium.
A peek into the future
ATMI expects the biopharmaceutical industry to evolve to the global industrial status of other high-tech industries like microelectronics. As SUTs are becoming more prevalent, the SUT providers as well as the biopharmaceutical and vaccine industries must remain targeted on advances that provide quality assurance, supply chain security and process efficiency. The evolution of the SUT market will require continued improvement and a like mindedness where innovators, suppliers and manufacturers work together to create solutions that enhance efficiency and performance. ATMI’s position of open architecture of integratable SUTs and licensing to enable the industry responds to end-users needs for access to best solutions. ATMI has decided to embrace these demands and approach the future with continuous improvement processes and a focus on innovation, quality and integrity of products throughout all levels of the SUT supply chain.