Pine Lake Laboratories is the scientific leader in extractables and leachables (E&L) studies. We have extensive experience performing extractables studies on a wide variety of Single-Use System components and manufacturing equipment used in biopharmaceutical manufacturing.
Our extraction studies were originally designed following the BPOG extraction protocol and have evolved to include USP<665>. 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.
