Issue link: https://www.e-digitaleditions.com/i/1373953
48 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Operations be printed with serialization, then individual la- bels would be randomly assigned from that lot to 'reference (R)' or 'test (T)' [material]. Only the labeler would hold the unblinding key between a serialized label and R/T treatment." LGM Pharma uses an automated vision system to ensure confor- mance of the label to specification. Thassu notes that automated inspection has been valuable for labeling and for other parts of packaging. "Technical advances in camera vision and verification systems over the past decade have allowed companies to replace manual inspection with an automated equivalent to ensure the uni- form presentation of packaging and labeling, at a faster pace," says Thassu. He says automation can create efficiencies in clinical trial management that can reduce the overall length of clinical trials. In addition to automating inspection, there are some opportunities for automation in the packaging process. Clinical kitting remains a generally man- ual process, although automation is used where its benefits can be justified, says Berrón. Automation requires some level of standardization, but clini- cal kitting has a wide variety of kits and requires f lexibility in volumes, which can vary widely at different clinical trial phases, she explains. Benefits of automation include increased productivity and consistency and eliminating ergonomic concerns for workers performing highly repetitive kitting activi- ties. "In 2020, the use of automation certainly picked up another driver when high assembly absenteeism impacted productivity," notes Berrón. "Efficiency driven by automation provides many benefits, but ultimately it is dependent on the size of the study and standardization of clinical trial kits across mul- tiple studies, [which] limits feeder reconfiguration and retooling [on automated lines]." Sourcing Another key consideration for packaging of clini- cal trial materials is the availability of packaging supplies. Due to the pandemic, the supply chain has been tight across most materials needed for clinical trials, particularly for ancillary items such as swabs, needles, and even gloves, notes Geiger. Existing relationships with suppliers are crucial to being able to source materials when allocations are limited, she points out. Vercruysse notes that biopharmaceutical manu- facturers can consider alternative materials to the traditional glass vials and syringes. Polymers such as polypropylene and cyclic olefin polymer are op- tions. "Careful consideration should be given to the selection of these materials, but also the sourcing to ensure high quality," he notes. "Speed and agility became even more evident dur- ing the pandemic as we needed to package treatments and vaccines quickly and get them out the door. This meant being creative when sourcing materials as sup- ply route and general availability of supplies was chal- lenged with global shut-downs and reduced travel and logistics routes," says Keesee. Material supply partners should have the flexibility to quickly meet changing demand, says Keesee. He also sees a trend toward global, integrated logistics and materials suppliers "Partners that can manage logistics, storage, materials, temperature monitors, and integrated proactive communication globally provide tremendous value to the supply chain eco- system," concludes Keesee. References 1. J. Markarian, "Tracking Technologies Safeguard Vaccine Cold Chain," PharmTech.com, April 2, 2021. 2. N. Balanvosky and B. Thompson, Pharm. Tech., Partnering for Bio/Pharma Success Supplement (February 2021) s26-s28. 3. A. Shanley, Pharm.Tech. 45 (3) 58-62 (2021). PT