Pharmaceutical Technology - May 2021

Pharmaceutical Technology - Biologics and Sterile Drug Manufacturing - May 2021

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56 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Operations Technical pros and cons The technical and manufacturing strengths and benefits of BFS (1,6) include the following: • advanced aseptic processing • continuous, integrated operations to form, fill, and seal containers • ISO 5 enclosed space for fill/finish in rotary BFS machine model • economies and rapidity in container closure processing • a small footprint (no need for washing, depy- rogenation, cooling, accumulation, filling, stoppering, or capping stations) • relative lack of human intervention • reduced material supply chain • reduced risk of breakage • minimal risk of leaching • a compact supply chain. Specific considerations for determining the suit- able use of BFS prefilled syringes include questions about material compatibility, extractables and leachables, regulatory approval, drug formulation requirements, sterilization, supply chain issues, and environmental impact. Materials compatibility. Pharmaceutical-grade resin is used to deliver billions of doses of injection, ophthalmic, inhalation, and oral dosage forms an- nually. BFS can use several different polymers; the most common are low and high-density polyeth- ylene and polypropylene. Custom design of con- tainer shapes, thickness, weight, color, and other factors is enabled by the ability to create new molds to meet specific needs if required (7). Extractables and leachables. With funding from the Bill and Melinda Gates Foundation, BFS technol- ogy inventor Rommelag and its Maropack com- pany (now called Rommelag CMO) conducted a feasibility assessment of aluminum phosphate adjuvanted RSV F vaccine in BFS packaging. The vaccine stability profile in BFS was found to be similar to profiles in glass vials and syringe. No se- rious issues were found regarding potential leach- ables in a simulated leachables study (8). A report on adjuvanted recombinant RSV F vac- cine in BFS indicated "minimal leachable concern in initial extractable/leachable assessment," for BFS containers filled with aluminum phosphate diluted in RSV F vaccine formulation buffer, stored for one month at 2–8 ºC, 25 ºC and 40 ºC, using a control of aluminum phosphate diluted in RSV F vaccine formulation buffers in Tef lon bottles at the same conditions (9). Because the primary BFS container is semi-per- meable, there are potential risks of compounds leaching into the drug product, including from gas ingress from the immediate environment, as well as secondary packaging components (6). BFS filling occurs within an ISO-5 environment that is protected from any external environmental inf lu- ences by an envelope of molten resin. BFS contain- ers are sealed within the same controlled, aseptic area; upon leaving, they move to inspection for container-closure integrity testing (CCIT). In the case of ApiJect, all CCIT testing is per- formed via an in-line machine using the vacuum decay method. Vials that fail are detected and re- jected by the machine. For considerations of light sensitivity, specialized bulbs can be installed in the filling and adjacent suites; work-in-progress mate- rials can be stored in covered containers or bins. Secondary packaging of single-dose units or cards of five vials can be used to protect the pri- mary container product integrity; this packaging typically consists of a multi-layer aluminum foil

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