Pine Lake Laboratories is the scientific leader in extractables and leachables (E&L) studies. We have extensive experience with a wide variety of pharmaceutical container closures systems, single use system components, and combination devices.
Our extraction studies are designed following the original PQRI guidance's and have evolved to include USP <1663> and <1664>. We can perform a material risk assessment at the beginning of the study to assure proper extraction study design and full compliance with the latest regulations.
