Routine/Release Testing

Once a material or component specification has been accepted or authorised as part of a drug delivery device or product, routine analysis maybe required to confirm that production batches of the various device components meet the required specification. Examples of such release testing are:

• Analysis of a component to determine the amount of residual monomer (e.g. styrene, 1,4‑butadiene, vinyl chloride) which may present a toxicological risk
• Determination of molecular weight distribution by gel permeation chromatography to confirm polymer has not been degraded during processing
• Pharmacopeia testing

Smithers Rapra can delivery routine testing either to international standards or bespoke analytical methods developed and validated in our laboratories.