Italy: Case Study Converting a Powder Aseptic Processing Line in Just 8 Months
Amidst the global pandemic, there was an urgent need to manufacture Covid vaccines across the globe. In this scenario, the pharma company Catalent converted one of its aseptic processing lines, which specialized in powder processing, to liquid processing. The move helped the firm to produce its first commercial batch of Covid vaccines in April 2021.
Catalent is a global pharmaceutical company headquartered in Somerset, New Jersey, USA with operations around the world. Located in Anagni, south east of Rome, the company’s Italian facility produces and packages cardiovascular, anticancer, metabolic and anti-inflammatory medicines, as well as non-penicillin-based antibiotics, antivirals, injectable and biological analgesics.
In the background of the Covid-19 pandemic, there was an urgent global need to manufacture vaccines and hence, when Catalent was taking over Bristol-Meyers Squibb’s facility at the beginning of 2020, the USA-based firm thought of converting the plant’s isolated aseptic processing line from powder processing to liquid processing. In April 2021, the company produced the first commercial batch of Covid vaccines.
Barbara Sambuco, General Manager of Catalent’s site in Anagni, Italy shares her insights on the process.
Converting from powder to liquid
Originally supplied by Ima Life in 2017, the line was designed to process powders in an aseptic environment. Now, it had to process liquids. The move was also undertaken due to the fact that it was in a separate building, making it an ideal choice for the production of biologics. As soon as the pandemic became a major international issue, the conversion project became a vital factor to enable production continuity of the vaccines.
As soon as the pandemic became a major international issue, the conversion project became a vital factor to enable production continuity of the vaccines. .
Aspects of the conversion
Before conversion, the line was made up of numerous elements such as the Vega 4 rotary vial washer, a Blue Galaxy Dry Heat 870 depyrogenating tunnel, a smart PWD aseptic powder filling and stoppering machine with integrated alu-capping and dedicated Cleaning In Place – Sterilization In Place skid (CIP/SIP), a hydra 100 external vial washer and a VL200 vial tray loader.
To adapt the line to aseptic liquids, the powder dosing system, featuring the Auger Technology, was replaced by 2 peristaltic pumps. This made it unnecessary to maintain the CIP/SIP skid which had been installed for powder, so this too was removed. Moreover, as Catalent had opted to implement Single Use Systems (SUS), there was no need for a CIP/SIP solution as any element that came in contact with the product would be fully disposable. Clearly, if Catalent had chosen to use a volumetric dosing system, the CIP/SIP solution would have been maintained.
Further to the straightforward substitution of sections of the processing line, the company ran tests on the pressure cascade of the isolated area and monitored temperature and humidity levels for production.
A challenging timeline
One aspect that was taken seriously by the entire team working towards the company’s objectives was the tight schedule. The quicker the plant become fully operational, the sooner the vaccines could be delivered to a global community in need. The conversion process began in September 2020 and was completed in February 2021. This included mechanical changes that were necessary to balance production, IOQ (Installation and Operational Qualification) activities and validation of the VHP cycle relating to the new sampling points.
At the beginning of February 2021, the activities related to Process Performance Qualification were completed in one and a half months, including Engineering Batch and APS (Aseptic Process Simulation) tests, also known as Media Fill, which simulate production using a sterile nutrient media. This establishes the effectiveness of the controls in place for aseptic processing, and is required by GMP guidelines, specifically for the Manufacture of Sterile Medicinal Products – Annex 1.
Approvals and authorizations
Since July 2020, Catalent has been working with AIFA (Italy’s Medicines Agency) to enable a rolling review of documents regarding new production lines or technology transfers associated with vaccine production. This facilitates the Pre-Approval Inspection (PAI) procedures. Revamping of the existing line is part of this activity, so AIFA regularly receives updates. All these efforts led to record-breaking schedules in which reports filed after inspection took less than two weeks to complete. Similarly, the European Medicines Agency (EMA) implemented the rolling review procedures and the approval arrived in less than two weeks after closing the qualification batches.
The conversion of the smart line enabled the pharma company to ensure continuity in vaccine production and gave rise to a record-breaking feat.