While, quite rightly, plaudits have been heaped upon the teams of scientists around the world who have developed Coronavirus vaccines in such a short period, coupled with the expeditious mass vaccination programmes, there is one area of vaccine deployment that seems to be taken for granted, as Neil Sandhu, UKIVA Chairman, explains.
It is assumed that there will be sufficient syringes, needles and glass vials available, yet with a world population of almost 7.9 billion people to be protected, ultimately, this remains a significant manufacturing challenge. Machine vision can play an important role in the manufacture of these items at scale and at speed, from defect inspection through to packaging and aggregation, while meeting demanding industry regulatory requirements.
Syringe and vial inspection
Syringes and vials should be free of defects and contamination in any stage of production and in the case of vials in the fill or finish lines as well. Machine vision can be used to detect defects such as cracks, chips, scratches, dirt and inclusions.
Dimensional checks of the overall diameter and height can be made as well as individual areas such as a vial neck or lip. Vial integrity, fill level and vial counting are also tasks that can be performed by machine vision. Components such as the elastomer plungers used in syringes and stoppers used in vials can also be inspected during their manufacture. Since these both come into contact with the vaccine during use, it is essential that they are checked as being free from any particulate contamination that may result from the moulding and trimming processes.
OCR and Code reading
Print and text inspection and verification on products and packaging are essential in pharmaceutical manufacturing. Industry regulations, such as the EU Falsified Medicines Directive, require healthcare products to be traceable from manufacture to the point of use by printing serialised 2D codes on each pack. However, in September 2020, given the vaccine volume that would be required, the European Commission Directorate-General for Health and Food Safety announced some labelling and packaging flexibilities for Covid-19 vaccines to facilitate their rapid deployment.
High-speed OCR and code reading capabilities provided by machine vision enable the inspection and verification of both human and machine-readable information, such as lot & date codes; batch codes; OCV/OCR technology, as well as 1D & 2D barcodes. All data can be passed upstream to the appropriate place, meaning that capabilities can be extended if required to manual packaging and aggregation from the folding box to the pallet.
Machine vision solutions
Systems integrators and machine builders have developed numerous automated machine vision solutions to address vial and syringe inspection’s varied challenges using the diverse range of vision technologies available. Many applications involve carrying out multiple inspections and/or code reading. They can utilise multiple area scan or line scan cameras and strobed lighting as well as dedicated code-readers to allow the capture of the appropriate sequences of images at high speed for processing and measurement.
A variety of sophisticated image processing software environments provide versatile platforms for application software development, while high-performance processors enable the handling of high volumes of data at the required speeds. In addition to the practical considerations related to camera, lens and illumination positioning and the mechanical handling required to allow inspection of all the required surfaces, systems will also feature appropriate reject mechanisms to separate products that do not pass the inspection.
Machine vision solutions are generally integrated into existing manufacturing lines where appropriate or designed, installed as automated end of line inspection systems, but need to meet the regulatory demands of the pharmaceutical industry, such as CFR21 (Code of Federal Regulations) Pt 11 and GAMP5 (Good Automated Manufacturing Practice) requirements. They must be designed to be validation-ready and supported throughout their lifetime.
Offering 100% inspection at speed is clearly a critical requirement for syringe and vial inspection, but vision systems frequently provide the scalability needed to enable increased production speeds and volumes to be accommodated.