|Method Development/Validation||Quality Control||Chemical Characterization|
||Deformulation|| Stability/Release Testing
Extractable and leachable testing studies the organic and inorganic compounds that may be released from packaging materials. This release can be caused from additives within a plastic or from low molecular weight components present in some polymers that become absorbed by the product that they contain.
Avomeen’s chemists are trained to identify and quantify both extractables and leachables, validate the analytical methods utilized, and then work with your team to determine the safety implications present and suggest alternative packaging if necessary.
This type of testing is critical for the pharmaceutical and medical device industries, where packaging safety and toxicology studies are required for product registration.
Avomeen will work with clients to develop a customized testing protocol to meet your regulatory requirements, whether your need is for a package or medical device registration, a label migration study, packaging analysis for food contact materials, or simply consumer product testing to determine the presence of unknown contaminants such as Bisphenol A (BPA) or Phthalates such as DEPH.
Industry: Packaging Manufacturer
Problem: Choosing the right vendor to source plastic bottles
Solution: A baby food manufacturer wanted to switch from glass jars to plastic bottles to market its baby food product. The client was concerned that this would create safety issues though as plastics are known to leach chemicals such as plasticizers and other additives. The manufacturer had identified three vendors that supplied appropriate plastic bottles. The challenge was to identify the plastic bottle that would release the least amount of chemicals between the three supplier’s products. Our scientists performed a leachable and extractable testing study by exposing the plastic bottles to temperatures and foods similar to real life conditions.
The leached chemicals were then identified and quantified at parts per million level using techniques such as LC/MS and GC/MS. The study identified the supplier with the safest plastics packaging which allowed the baby food manufacturer to confidently make the switch from glass to plastic containers for their product line.