Pine Lake Laboratories is the scientificleader in extractables and leachables (E&L) studies. We have extensive experience performing extractablesstudies on a wide variety of Single-Use System components and manufacturingequipment 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.
Our experienced scientific staff utilizes the following analytical methods for expert identification of extractables observed in a forced extraction study:
- Headspace GC-MS for identification of volatile organic extractables
- GC-MS for identification of semi-volatile organic extractables
- LC-QToF for identification of non-volatile organic extractables
- ICP-MS for identification of inorganic extractables
Our team has experience performing extraction studies on a variety of biopharmaceutical manufacturing single use components:
- Filters
- Bioreactor bags
- Flow cells
- Filling assemblies
- Tubing
- Tangential Flow Systems
- Storage vessels
Studies are designed to follow the BPOG protocol and USP <665> but can be adapted to meet specific client needs.
A toxicological risk evaluation of the extractable results can be performed by our staff toxicologists.
