Common use of BIOLOGICAL TESTING Clause in Contracts

BIOLOGICAL TESTING. 5.1 Sterility Testing Sterile products are dosimetrically released in accordance with SOP M-016, prior to final packaging. No routine sterility testing is performed on a lot-to-lot basis. 5.2 Endotoxin Testing (LAL) One (1) sample ≥ 0.5cc, representative of final product, shall be removed from each lot after sterilization and submitted to a qualified test laboratory for bacterial endotoxin testing via Limulus Amebocyte Lysate (LAL), gel clot or kinetic turbidimetric according to test method. Document sample removal on Form-118. Note: If more than one size, remove sample from smallest size. Specification: < 0.5 EU/mL In the event of failure, additional testing shall be performed. Test shall be performed on one sample in quadruplicate test tubes for LAL gel clot only.

BIOLOGICAL TESTING. 5.1 Sterility Testing Sterile products are dosimetrically released in accordance with SOP M-016, prior to final packaging. No routine sterility testing is performed on a lot-to-lot basis. 5.2 Endotoxin Testing (LAL) One (1) sample ≥ 0.5cc, representative of final product, shall be removed from each lot after sterilization and submitted to a qualified test laboratory for bacterial endotoxin testing via Limulus Amebocyte Lysate (LAL)Lysate, gel clot or kinetic turbidimetric according to test method. Document sample removal on Form-118. Note: If more than one size, remove sample from smallest size. Specification: < 0.5 EU/mL ML In the event of failure, additional testing shall be performed. Test shall be performed on one sample in quadruplicate test tubes for LAL gel clot only.