By Jerry Martin, pharmaceutical and life sciences consultant to PMMI
The drive to reduce costs, increase speed to market, and meet regulatory requirements has led many pharmaceutical companies to consider single-use, pre-sterilized, plastic equipment systems as an alternative to stainless steel lines. Simultaneously companies are also looking to implement disposable delivery systems for filling of injectables, inhalers and other liquid dose forms, giving way to the spread of single-use technologies across the supply chain.
In drug production, single-use equipment allows pharmaceutical companies to build manufacturing capacity in less time and at lower cost than with traditional stainless-steel equipment and infrastructure. In addition to reducing these capital expenditure costs, single-use systems conserve water and energy, increasing facilities’ sustainability scores. Savings in both time and money grants the opportunity for manufacturers to build capacity at a later stage in the clinical cycle. In turn this results in increased facility utilization, translating into producing more product in the same facility.
Single-use systems also offer greater flexibility. During process design, single-use machinery makes it easier, faster and cheaper to change system configurations for subsequent trials. Manufacturers can adjust the size, length, number of tubes when ordering the next batch of single use equipment. In contrast, with stainless steel systems the lead-time for adjustments is much longer and costs much higher. Pre-assembled/pre-sterilized single-use systems, along with sterile connectors for combining sterile flow paths, mean downtime for cleaning and re-sterilization can be eliminated, along with the equipment required for them and the time and cost to validate those processes.
Of course, single-use systems still pose some challenges—primarily in qualifying the safety of extractables and process-derived leachables from fluid-contact plastics. The FDA does not proscribe the extent of studies required or allowable limits for extractable or leachable compounds, challenging suppliers and users to make educated guesses on how much data regulatory authorities will demand. There will always be some judgement required from both users and regulators, as extractables and leachables testing requirements and limits will are not yet standardized.
When considering for single-use solutions, pharmaceutical manufacturers should prioritize security, continuity and adequacy of supply, and should audit suppliers regularly. Suppliers’ manufacturing processes must be validated to ensure there is sufficient data to demonstrate the reliability and safety of their products, and that they have adequate quality systems in place as well as good data on the consistent supply of raw materials. Qualifying suppliers for single-use systems goes further than just documentation.
Pharmaceutical professionals can learn more about single-use solutions at Healthcare Packaging EXPO in 2019. Learn more at www.hcpelasvegas.com.
About Jerry Martin
Jerry Martin is an independent consultant to pharmaceutical manufacturers and equipment suppliers for filtration, single use manufacturing, marketing, business development and regulatory compliance. He was previously Sr. Vice President, Marketing and Global Scientific Affairs for Pall Life Sciences where he served the pharmaceutical, biotech, medical device and vaccine industries for over 37 years. He is currently chairman emeritus of the Bio-Process Systems Alliance, the single-use manufacturing trade association and a member of the USP Expert Panel on Plastic Systems Used for Manufacturing Pharmaceutical Products. He holds a M.Sc. in Microbiology from the University of Toronto.