BioPharm June eBook: Single-Use Systems

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Page 7 of 46 June 2018 BioPharm International eBook 7 Single-Use Systems Materials used are exposures to very high or low pH conditions for a longer period of time. These conditions can slowly break down the silox- ane backbone of the silicone mate- rials and cause the degradation of the tubing. It is also well known in the industry that silicones swell in non-polar solvents and absorb non-polar preservatives into the tubing wall. Process parameters, such as shorter contact time, need to be adapted to overcome these potential challenges. Extractables testing information is important for the implementation of the single-use components and systems and for risk assessment of the potential impact on drug substances and drug products. The extractables testing packages between suppliers are not consistent or complete. For this reason, the BPOG developed a standardized protocol for generating extractables data that would meet the end-users requirements and simplify/ reduce the implementation time. To meet the end users' requirements in accessing reliable and consistent data for faster implementation of the tubing component, Dow Silicones Corporation has conducted a com- prehensive BPOG study. BioPharm: What are the concerns for single-use tubing/assemblies in continuous/long-term operations? K o l l a r a n d M a t h i s ( D o w ) : Continuous manufacturing is a focus area in the biopharma indus- try and is expected to prevail in the next 10 years. It will have an impact on the design and performance requirements of SUS and their com- ponents like tubing, in terms of: • Chemical compatibility of mate- r ia l w it h d r ug: silicones a re resistant to many commonly u se d c he m ic a l s i n t he bio - pharma processing industry. • P ressu re resista nce: pressu re resistance can be adjusted by the formulation of the silicone tubing, or the tubing wall can be reinforced by fibers. • Longer durability (an entire pro- cess, such as continuous per- fusion, may take two to seven days): silicones keep their physi- cal, performance, and resilience proper ties longer than most thermoplastic tubing. Silicones a re resilient a nd most com- monly used in peristaltic pumps, but over a longer per iod of pumping applications, depend- ing on the pumping conditions, they start to spall (i.e., flake). • Biofilm build-up: silicones have hydrophobic surfaces that limit biofilm formations. SUPPLY CHAIN BioPharm: What concerns does the bio/pharma industr y have with supply, consistency, specifications, and quality testing of single-use components? Kollar and Mathis (Dow): With the rising adoption of single-use com- ponents and systems, end-users increasingly rely on their suppliers to generate data on their supplied components. We are committed to help our customers mitigate risk and accelerate the implementation dur- ing the validation of single-use com- ponents by generating more data to demonstrate the performance, quality, and purity of our product solutions. With this, we have devel- oped our own set of comprehensive testing protocols that are aligned to industry standards to ensure our solutions meet the highest reliability. Tr ace abi l it y i s v it a l i n bio - ph a r m a pr o c e s si n g to e n s u r e proper equipment usage and elim- inate the possibility of errors in the production stage. By marking tubing to indicate its characteris- tics, production sites are more eas- ily able to track tubing to ensure the correct tubing is used when building assemblies in-house and to lower the probability of mix-up. We continuously explore new technologies to ensure securit y of supply and consistency in tub- ing through enhanced traceabil- ity. Currently, we offer ink-marked tubing, and we are evaluating laser marking technology. An integrated supply chain is an important element of traceabil- ity because it allows control over each process, from the synthesis of the starting monomers and the basic silicone polymers down to the extrusion into the tubing and the manufacture of over-molded assemblies. This control helps cre- ate high- qua lit y produc ts t hat ensure cleanliness, reliability of supply, and consistency. We offer the most complete vertical inte- gration for tubing with privileged access and control to the entire supply chain, from chemical build- ing blocks to finished tubing. This ensures traceability at every step of the manufacturing process and in the change-control process. To ensure our tubing upholds to the consistenc y and qualit y standards we have set, we perform purity testing on a yearly basis and allow our customers to access these data. The purity testing relates to the endotoxins, particulates, and bioburden characteristics of tubing and provides proof of cleanliness and ensure protection against con- tamination of the drug products.BP "Tubing represents one of the largest surface areas in direct contact with drug substances …" —Kollar and Mathis, Dow

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