Pharma cleanroom
The increasing complexity of drugs — including vaccines, biologics, sterile injectables and cell therapies — brings pharmaceutical companies significant manufacturing challenges during the pandemic. In turn, this complexity drives supply chain disruptions and changes to business and operational processes to accommodate social distancing, remote working and quarantining.
Some pharmaceutical manufacturers have prioritized the manufacture of products to battle the pandemic. That shift marks an additional transition for an industry, which has shifted its focus in recent years from producing blockbuster medicines toward personalized medicine to, more recently, COVID-19 vaccines.
The production teams involved in such transitions must manage increasing variations in production processes. To address the disruptions inherent in such processes underscores the need for clear communication between manufacturing team members. This requires agility, flexibility and the right tools and systems to automatically capture critical communications and critical information during shift handovers.
Shift communications in biopharma
One biopharma company initially focused on automating microbial quality control quickly expanded after the emergence of COVID-19 to deliver contaminant testing for pharmaceutical and vaccine manufacturing. As with many pharmaceutical companies, the pandemic helped drive the push to digitize shift management. The company sought to shorten the supply chain for critical drugs and vaccines while enabling biopharmaceutical partners to operate their manufacturing facilities with reduced staff.
In this example, the second shift of cleanroom automation operators required better communications with its third shift to ensure safe operations of its automation lines to optimize equipment effectiveness and product quality. Any communication gap between shifts could decrease quality in the production of cell culture cassettes and the potential loss of customers.
Cleanroom operators conduct manufacturing in a cleanroom environment (ISO 8) and carry out line cleaning, machine/process set up, web line set up and basic maintenance tasks related to the automation line. All manufacturing shifts must communicate clearly and work safely according to company and OSHA guidelines.
These operators need a smooth transition from the second to third shift. The digital shift management system enabled operators to identify past operating patterns and background details to make proper machine adjustments to optimize quality and performance.
Shifts must also communicate aseptic techniques they have performed and enforced while following the standard operating procedures for their operations. In conjunction with cross-functional teams, all cleanroom automation operators must work collaboratively to reinvestigate failures and perform corrective action preventive action (CAPA) investigations.
Automated shift handovers can be critical to complete timely validations and ensure paperwork completion. Continuous improvement efforts are vital. Also crucial is the need to accommodate a shifting work schedule as needed. Employees may need to work a four-day, 10-hour schedule or a five-day 8-hour schedule, for example.
A break in the clouds: Communication and collaboration
The pandemic has emphasized how we can strengthen our communications by, for instance, capturing, collecting and storing shift notes, tasks and directives.
Pharmaceutical manufacturing teams usually require considerable face-to-face communications and are used to working together. This tradition is why it’s crucial to develop an upfront approach to sharing information within the team and establishing guidelines to optimize team-to-team communications.
Automating at a pandemic speed
Through automation, shifts can access an intuitive handover system that ensures compliance with legal and other standards. For instance, audit trails have accessible, auditable data storage with chronological change history. Shift team members find that it’s helpful to have all events visible simultaneously. The management review process is also simplified because it supports acknowledgments through counter signatories.
Deploying a shift handover management system allows operators to conform to Current Good Manufacturing Practice (CGMP), which FDA enforces. Observance of CGMP regulations ensures the identity, strength, quality and purity of drug products by requiring that manufacturers provide adequate control of manufacturing operations. This goal is achieved by using quality management systems, procuring quality raw materials, establishing robust operating procedures, investigating product quality deviations and maintaining dependable testing laboratories.
The result of digitized communications
Digitizing and automating shift handovers has become more critical than ever because it can improve pharmaceutical production, increased performance, reduced risks and saved time. Additionally, it helps avoid potential communication disconnects among teams.
Andreas Eschbach is the founder and CEO of Shiftconnector.
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