BioPharm June eBook: Single-Use Systems

Issue link:

Contents of this Issue


Page 32 of 46

Single-Use Systems Supply Chain 32 BioPharm International eBook June 2018 disaster recovery planning, sup- ply chain mapping, and continu- ous improvement. As part of the BCP process at MilliporeSigma, a cross-functional team of subject matter experts assess risks related to demand volatility/forecast accu- rac y, ma nu fac t u r i ng c apac it y, process and equipment, sole/single- sourced raw materials, facilities, such as water, utilities, and power, IT/systems, and more. Risks above a certain risk priority number are mitigated and monitored. BCPs are revisited on a regular basis, and risk mitigation activities are updated continually. T he B ioPho r u m O p e r at io n s Group (BPOG) and the BioProcess Systems Alliance (BPSA) have gen- erated best practices for change notification of single-use biomanu- facturing systems (1). To assess the impact of a change, risk assessment should be based on qualit y by desig n and take into consideration the intended use of the product. The idea is to establish the foundation for the comparabilit y protocol and the qualification requirements. It is important that changes are com- mu n icated based on a cha nge notification commitment and that high quality data packages are pro- vided to reduce the level of effort required by biopha r maceut ica l manufacturers to assess and accept changes from their suppliers. In addition to BCP and change control, suppliers should ensure the continuity and reliability of single-use bags. At MilliporeSigma, we do so by maintaining design ownership of our film formulation, robust supplier agreements, and considerable safety stock. RESINS AND FILMS BioPharm: How do you vet and qualify resin and film suppliers? What are the criteria to look for in resin and film suppliers? Bell: Resin and film suppliers are critical to the single-use supply chain, as a large majority of sin- gle-use components are comprised of polymeric materials. Resin and film suppliers must have a good understanding of the requirements needed for the biopharmaceutical industry—things such as gamma stability, low extractables, clean processing, high purity, food and medical grade, and animal free. Additionally, they need to have a strong quality management system and change control procedures. For resins, the best place to start is with commodity resin types. These are resins that have multiple con- sumers, and are the least likely to be modified in the future, therefore, minimizing the risk of raw mate- rial changes and supply disruption. When selecting a film supplier, partnership is paramount. You need a supplier that will grow with you, evolve, and continuously improve their process to meet the changing requirements of the industry. BioPharm: How do you establish resin and film specifications? Bell: Resin and film specifica- tions are established by defining the critical quality attributes of the end-product, such as a single- use bag chamber. The attributes are then used to define the speci- fications of the raw materials that make up that bag chamber (e.g., film). CRITICAL QUALITY ATTRIBUTES BioPharm: W hat are the critical qualit y attr ibutes of single-use bags? Bell: The critical quality attri- butes of single-use bags are robust- ness, inertness, and cleanliness. Severa l d if ferent tests a re per- formed to ensure the film used to manufacture single-use bags does not pose any adverse impact to the product or solution in the bag, and that it maintains product and process sterility and stability over time. BioPharm: Can you tell us more about the importance of material science (especially in the case of the resin and film used to make single-use bags) and how it is used to develop the manufacturing pro- cess as well as achieve good control of the process? Bell: Films are made from mul- tiple layers, each with a unique p r o p e r t y a nd p u r p o s e i n t he overall makeup of the film. The product contact and gas barrier layers are the most critical lay- ers, because they affect perfor- mance most significantly. Polymer "The key is to adopt a comprehensive, 'risk-smart' approach to supply continuity and control." —Sara Bell "Resin and film suppliers are critical to the single-use supply chain, as a large majority of single-use components are comprised of polymeric materials." —Sara Bell

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm - BioPharm June eBook: Single-Use Systems