Design, Construct, Validate and Maintain

Automating the production of life-saving drugs

Porton Biopharma Limited (PBL) is a relatively new player in the pharmaceutical market. One of its main products, however, has been saving the lives of children for more than 30 years.

PBL is investing in new facilities that will enable the company to meet the growing demand for the product. An integrated filling line designed and supplied by Bosch Packaging Technology — in accordance with very challenging requirements for automation, safety and efficiency — is one of those investments.

Erwinase is used to treat acute lymphoblastic leukaemia (ALL), a type of cancer that particularly affects children. The enzyme asparaginase is used as part of the treatment protocols in conjunction with radiotherapy or chemotherapy.

Background to the project

To date, PBL has used a highly labour-intensive process. The vials are washed in an existing Bosch machine. However, loading and unloading, as well as transfer and inspection, are all done manually. The purpose of the PBL upgrade was to automate processes — to make them faster, easier, more reproducible and, most importantly, to remove the risk of operator contact with the product.

With a filling accuracy of more than 99.9%, the new line covers the entire process, from washing, depyrogenation and filling to stoppering, freeze drying and capping. 

The MLF 5044 vial filling and closing machine operates with a peristaltic pump and 100% in-process control. With such an expensive product as Erwinase, it is crucial to not waste a drop. Every vial only contains one millilitre of product, which means it must be filled with the greatest accuracy.

Scope of the project

T-SQUARED was responsible for the reconfiguration of the biopharmaceutical filling suite, consisting of cleanroom design, construction and validation of the suite incorporating the following:

  • environmental control
  • pressure regimes, electrical services, fire and smoke control
  • walk-on ceiling
  • extension of process utilities (WFI and CA)
  • equipment integration
  • building management system
  • environmental monitoring system

Despite the many challenging requirements of this ambitious project, the very first test run surpassed expectations, and all areas of Laminar flow achieved perfect target values. 

The new facility will make the workflow a lot easier and enable Porton Biopharma to scale-up the manufacture of this life-saving product.