Leak detection and packaging integrity checks on pharmaceutical products, at the end of the production cycle, are mandatory as per current international regulations. At the same time, they provide an opportunity to improve company performance. Davide Formenti, Bonfiglioli Engineering's R&D Manager, shares five reasons why leak detection technologies can improve operations at pharmaceutical companies, helping them to optimize the production process, reduce costs and improve quality.
International standards, such as the United States Pharmacopoeia (USP) 1207, the Good Manufacturing Practices (GMPs) of various countries and EU regulations, guarantee pharmaceutical product quality. These standards specify packaging integrity test types and methods to be conducted on products. They also define which products must undergo 100% testing and which can be subject to statistical controls.
Within this regulatory framework, each manufacturer can choose independently which machines to use to obtain the required results but implementing leak tests is mandatory. Bonfiglioli Engineering offer consultancy so that, not only will customers be able to comply with the regulations, but they will also benefit from the expertise of a partner with over twenty years of experience in the field, to optimally identify solutions for any production process.
Customized next-gen leak test machines, such as those developed by Bonfiglioli Engineering, help improve plant performance in many ways:
Leak test machine data permit regular plant monitoring to provide information on its overall state of health. By analyzing the types of defects that the machine identifies, companies can determine whether certain damage is created at a particular point of the process and intervene accordingly. Similarly, data provided by leak test machines can be used to schedule maintenance ahead of time, limiting system downtimes and acting before problems arise. Bonfiglioli Engineering machines store this type of data so the company can analyze them and decide how to intervene.
Even when there are no real malfunctions, leak testing provides information that can be used to improve process efficiency and cost-effectiveness. For example, leak test data helps to detect the presence of product components that are especially subject to breakage; collecting production waste of non-compliant containers can help understand whether some of the materials used are especially prone to damage so appropriate corrective action can be taken.
Leak test machines can be customized both from a technological and handling point of view to ensure maximum efficiency through costs, space, and throughput improvements.
Bonfiglioli Engineering draws on its 20-year experience in this area to design and develop machines guaranteeing excellent performance even for non-standard products with unusually shaped packaging or made with atypical materials.
An example is the design of a testing machine for small Pre-Filled Syringes (PFS), a container that had unusual characteristics making standard handling solutions unsuitable. A customized handling system was devised using two anthropomorphic robots, and a method that combined Vacuum Decay Testing and lid deflection technologies, based on measurements taken by linear lasers, was developed.
We offer customized solutions with combined testing technologies that satisfy specific needs and guarantee maximum efficiency.