The team will trace the source of contamination on the factory floor using hand-held scanners which use the excitation of electrons and emission of X-rays to track different metal-types and alloys along with other inorganic materials, such as different fillers used in plastics or paint.
“When foreign body incidents occur, it’s quite likely they came from the factory, and if it’s a big scale production it’s very difficult to trace,” Tom Ray, microscopy laboratory manager at RSSL, told Outsourcing-Pharma.com. “This is a big benefit.”
The new service can also be employed as a precautionary method to catalogue all elements within the environment.
“If you have an assessment of everything in the factory – and I mean everything – then you’re in a better position to get production going again if you have to stop it,” Ray told us.
He added that using the method beforehand could provide a legal safeguard for drugsmakers when the factory is not the source of the foreign body.
“It’s one thing to specify in the documentation whether you have that material in your factory or not – but do you actually know for sure? When you already have this information there you can identify whether or not you use the material that caused the contamination,” he said.
Ray said that often when a product gets as far as OTC (over the counter) contamination could even be a result of the consumer, the supplier or even employees. “It could be a QC (quality control) or cGMP (current good manufacturing) issue within your staff members,” he added.
Regulatory brownie points
Though the firm admits there is no obligation for a manufacturer to adopt a service such as their own, doing so shows a commitment to preventing contamination issues.
Ray told us that, as far as the regulators are concerned, this can only be a plus.
“Having a library of materials used in the plant before an incident would help to demonstrate due diligence,” he said. “A manufacturer that does is showing that it takes the issue of potential contamination very seriously.”