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.

Appears in 1 contract

Sources: Processing and Supply Agreement (Capstone Dental Pubco, Inc.)

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.

Appears in 1 contract

Sources: Processing and Supply Agreement (Capstone Dental Pubco, Inc.)