|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 material, or absorbed into a product from plastic additives, or low molecular weight components in the plastic. Avomeen’s chemists are trained to identify and quantitate the extractables and leachables, validate the analytical methods, and then work with your team to determine the safety implications and suggest alternative packaging if necessary.
This type of testing is critical for the pharmaceutical and medical devices 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 for food contact, or simply consumer product testing for unknown contaminates, Bisphenol A (BPA), and Phthalates (Such as DEPH).
Industry: Packaging Manufacturer
Problem: Choosing right vendor for 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 most concerned about safety concerns, as plastics are known to leach chemicals such as plasticizers and other additives. The manufacturer had identified three vendors that supplied plastic bottles. The challenge was to identify the plastic bottles that would release the least amount of chemicals. Our scientists performed a leachable and extractable testing study by exposing the plastic bottle 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.